Vyvanse

Lub npe dav: lisdexamfetamine dimesylate
Dosage form: tshuaj ntsiav; ntsiav tshuaj, chewable
Chav kawm tshuaj: CNS stimulants

Ntawm nplooj ntawv no

• Boxed Warning
• Indications thiab siv
• Dosage thiab Administration
• Daim ntawv siv tshuaj thiab muaj zog
• Contraindications
• Ceeb toom thiab ceev faj
• Cov Kev Phem Tsis Zoo/Sib Phem
• Cov tshuaj sib cuam tshuam
• Siv nyob rau hauv cov neeg tshwj xeeb
• Drug Abuse thiab Dependence
• Kev noj ntau dhau
• Kev piav qhia
• Clinical Pharmacology
• Nonclinical Toxicology
• Kev tshawb fawb soj ntsuam
• Yuav Ua Li Cas Muab / Cia thiab tuav
• Cov Ntaub Ntawv Qhia Txog Tus Neeg Mob
• Phau Ntawv Qhia Tshuaj

CNS stimulants, suav nrog Vyvanse, lwm yam khoom muaj amphetamine, thiab methylphenidate, muaj peev xwm ua rau muaj kev tsim txom thiab kev vam khom. Txheeb xyuas qhov pheej hmoo ntawm kev tsim txom ua ntej yuav tshuaj thiab saib xyuas cov cim ntawm kev tsim txom thiab kev vam khom thaum kho [saib Ceeb toom thiab ceev faj (5.1 ), thiab Kev siv tshuaj yeeb thiab kev cia siab (9.2 , 9.3) ].

Indications thiab siv rau Vyvanse

Vyvanse®yog qhia rau kev kho mob ntawm:

• Attention Deficit Hyperactivity Disorder (ADHD) nyob rau hauv cov neeg laus thiab cov menyuam yaus 6 xyoo thiab laus dua[saib Clinical Studies (14.1) ]
• Nruab nrab mus rau hnyav binge noj tsis meej (BED) rau cov neeg laus[saib Kev Kawm Kho Mob (14.2) ].

Kev txwv kev siv:

• Cov neeg mob menyuam yaus nrog ADHD hnub nyoog qis dua 6 xyoo tau ntsib kev poob phaus ntev dua li cov neeg mob 6 xyoo thiab laus dua[saib Siv hauv Cov Pej Xeem Tshwj Xeeb (8.4) ].
• Vyvanse tsis qhia lossis pom zoo rau kev poob phaus. Kev siv lwm cov tshuaj sympathomimetic rau kev poob phaus tau cuam tshuam nrog cov xwm txheej mob plawv loj. Kev nyab xeeb thiab kev ua tau zoo ntawm Vyvanse rau kev kho mob rog tsis tau tsim[saib Ceeb toom thiab ceev faj (5.2) ].

Vyvanse Dosage and Administration

Kev kuaj mob ua ntej

Ua ntej kho cov neeg mob nrog CNS stimulants, suav nrog Vyvanse, ntsuas seb puas muaj kab mob plawv (piv txwv li, keeb kwm ceev faj, tsev neeg keeb kwm ntawm kev tuag tam sim lossis ventricular arrhythmia, thiab kuaj lub cev)[saib Ceeb toom thiab ceev faj (5.2) ].

Txhawm rau txo qis kev tsim txom ntawm CNS stimulants suav nrog Vyvanse, ntsuas qhov kev pheej hmoo ntawm kev tsim txom, ua ntej yuav tshuaj. Tom qab muab tshuaj, khaws cov ntaub ntawv ceev faj, qhia cov neeg mob txog kev tsim txom, saib xyuas cov cim ntawm kev tsim txom thiab kev siv tshuaj ntau dhau, thiab rov ntsuas qhov xav tau ntawm kev siv Vyvanse[saib Ceeb toom thiab ceev faj (5.1) , Kev siv tshuaj yeeb thiab kev cia siab (9) ].

Cov lus qhia dav dav rau kev siv

Noj Vyvanse los ntawm qhov ncauj thaum sawv ntxov nrog lossis tsis muaj zaub mov; tsis txhob noj tav su vim muaj peev xwm ua rau insomnia. Vyvanse tuaj yeem raug tswj hwm hauv ib txoj hauv qab no:

Cov ntaub ntawv rau Vyvanse capsules:

• Ncua Vyvanse capsules tag nrho, los yog
• Qhib cov tshuaj ntsiav, khoob thiab sib tov tag nrho cov ntsiab lus nrog yogurt, dej, los yog kua txiv kab ntxwv. Yog tias cov ntsiab lus ntawm cov tshuaj ntsiav muaj xws li cov hmoov sib tov, ib rab diav yuav raug siv los ua kom cov hmoov sib cais. Cov ntsiab lus yuav tsum tau tov kom txog thaum tag nrho dispersed. Siv tag nrho cov sib tov tam sim ntawd. Nws yuav tsum tsis txhob muab khaws cia. Cov khoom xyaw nquag dissolves tag nrho ib zaug dispersed; Txawm li cas los xij, ib zaj duab xis uas muaj cov khoom xyaw uas tsis muaj zog tuaj yeem nyob hauv lub khob lossis lub thawv thaum cov khoom sib tov tau noj.

Cov ntaub ntawv rau Vyvanse chewable ntsiav tshuaj:

• Vyvanse chewable ntsiav tshuaj yuav tsum tau zom kom huv si ua ntej nqos.

Vyvanse capsules tuaj yeem hloov nrog Vyvanse chewable ntsiav tshuaj ntawm ib chav tsev / mg rau mg hauv qab (piv txwv li, 30 mg capsules rau 30 mg chewable ntsiav tshuaj)[saib Tshuaj Kho Mob (12.3) ].

Tsis txhob noj ib yam dab tsi tsawg tshaj li ib ntsiav tshuaj los yog chewable ntsiav tshuaj ib hnub twg. Ib koob tshuaj yuav tsum tsis txhob muab faib.

Dosage rau Kev Kho Mob ADHD

Qhov pom zoo pib noj tshuaj rau cov neeg laus thiab cov menyuam yaus hnub nyoog 6 xyoo thiab laus dua yog 30 mg ib hnub ib zaug thaum sawv ntxov. Kev noj tshuaj tuaj yeem hloov pauv hauv qhov nce ntxiv ntawm 10 mg lossis 20 mg ntawm kwv yees li ib lub lim tiam mus txog qhov siab tshaj plaws tau pom zoo noj ntawm 70 mg ib hnub ib zaug.[saib Clinical Studies (14.1) ].

Dosage for Treatment of Moderate to Severe BED in Adults

Qhov pom zoo pib noj tshuaj rau cov neeg laus yog 30 mg ib hnub ib zaug kom titrated hauv qhov nce ntawm 20 mg ntawm kwv yees li ib lub lim tiam kom ua tiav qhov pom zoo koob tshuaj ntawm 50 mg rau 70 mg ib hnub ib zaug. Qhov siab tshaj plaws kev noj tshuaj yog 70 mg ib hnub ib zaug[saib Kev Kawm Kho Mob (14.2) ]. Txiav Vyvanse yog tias noj binge tsis txhim kho.

Dosage nyob rau hauv cov neeg mob uas muaj lub raum tsis ua hauj lwm

Hauv cov neeg mob uas muaj lub raum tsis zoo (GFR 15 rau<30 mL/min/1.73 mob), qhov ntau npaum li cas yuav tsum tsis pub tshaj 50 mg ib hnub ib zaug. Hauv cov neeg mob uas muaj kab mob raum kawg (ESRD, GFR<15 mL/min/1.73 mob), qhov siab tshaj plaws kev noj tshuaj yog 30 mg ib hnub ib zaug[saib Siv hauv Cov Pej Xeem Tshwj Xeeb (8.6) ].

Dosage Modifications vim yog Kev Sib Tham Tshuaj

Cov tshuaj uas hloov cov zis pH tuaj yeem cuam tshuam cov zis tso zis thiab hloov cov ntshav ntawm amphetamine. Acidifying agents (piv txwv li, ascorbic acid) txo cov ntshav, thaum cov tshuaj alkalinizing (piv txwv li, sodium bicarbonate) nce ntshav. Kho Vyvanse ntau npaum li cas[saib Kev Sib Tham Txog Tshuaj (7.1) ].

Daim ntawv siv tshuaj thiab muaj zog

Vyvanse (lisdexamfetamine dimesylate) capsules:

• Capsules 10 mg: liab lub cev / lub kaus mom liab (imprinted nrog S489 thiab 10 mg)
• Capsules 20 mg: Ivory body/ivory cap (imprinted with S489 and 20 mg)
• Capsules 30 mg: dawb lub cev / txiv kab ntxwv cap (imprinted nrog S489 thiab 30 mg)
• Capsules 40 mg: lub cev dawb / xiav ntsuab cap (imprinted nrog S489 thiab 40 mg)
• Capsules 50 mg: lub cev dawb / lub kaus mom xiav (imprinted nrog S489 thiab 50 mg)
• Capsules 60 mg: aqua blue body/aqua blue cap (imprinted with S489 and 60 mg)
• Capsules 70 mg: xiav lub cev / txiv kab ntxwv cap (imprinted nrog S489 thiab 70 mg)

Vyvanse (lisdexamfetamine dimesylate) chewable ntsiav tshuaj:

• Chewable ntsiav tshuaj 10 mg: Dawb rau dawb-dawb puag ncig zoo li cov ntsiav tshuaj debossed nrog '10' ntawm ib sab thiab 'S489' ntawm lwm qhov
• Chewable ntsiav tshuaj 20 mg: Dawb rau dawb-dawb hexagonal zoo li cov ntsiav tshuaj debossed nrog '20' ntawm ib sab thiab 'S489' ntawm lwm qhov
• Chewable ntsiav tshuaj 30 mg: Dawb rau dawb arc daim duab peb sab zoo li ntsiav tshuaj debossed nrog '30' ntawm ib sab thiab 'S489' ntawm lwm qhov
• Chewable ntsiav tshuaj 40 mg: Dawb mus rau dawb-dawb capsule zoo li cov ntsiav tshuaj debossed nrog '40' ntawm ib sab thiab 'S489' ntawm lwm qhov
• Chewable ntsiav tshuaj 50 mg: Dawb rau off-dawb arc square zoo li ntsiav tshuaj debossed nrog '50' ntawm ib sab thiab 'S489' ntawm lwm qhov
• Chewable ntsiav tshuaj 60 mg: Dawb rau dawb arc pob zeb diamond zoo li ntsiav tshuaj debossed nrog '60' ntawm ib sab thiab 'S489' ntawm lwm qhov

Contraindications

Vyvanse yog contraindicated nyob rau hauv cov neeg mob nrog:

• Paub txog qhov tsis txaus siab rau cov khoom lag luam amphetamine lossis lwm cov khoom xyaw ntawm Vyvanse. Cov tshuaj tiv thaiv anaphylactic, Stevens-Johnson Syndrome, angioedema, thiab urticaria tau pom nyob rau hauv cov ntawv tshaj tawm tom khw[saib Kev Ua Phem Tsis Zoo (6.2) ].
• Cov neeg mob noj cov tshuaj monoamine oxidase inhibitors (MAOIs), lossis hauv 14 hnub ntawm kev tso tseg MAOIs (xws li MAOIs xws li linezolid lossis intravenous methylene xiav), vim tias muaj kev pheej hmoo siab ntawm kev kub ntxhov.[saib Ceeb toom thiab ceev faj (5.7) thiab Kev Sib Tham Txog Tshuaj (7.1) ].

Ceeb toom thiab ceev faj

Muaj peev xwm ua rau raug tsim txom thiab kev vam khom

CNS stimulants, suav nrog Vyvanse, lwm yam khoom muaj amphetamine, thiab methylphenidate, muaj peev xwm ua rau muaj kev tsim txom thiab kev vam khom. Txheeb xyuas qhov kev pheej hmoo ntawm kev tsim txom ua ntej yuav tshuaj, thiab saib xyuas cov cim ntawm kev tsim txom thiab kev vam khom thaum kho[saib Kev siv tshuaj yeeb thiab kev cia siab (9.2 , 9.3) ].

Mob plawv mob hnyav

Kev tuag sai sai, mob stroke, thiab myocardial infarction tau tshaj tawm rau cov neeg laus uas muaj CNS stimulant kho ntawm cov koob tshuaj pom zoo. Kev tuag tam sim ntawd tau tshaj tawm hauv cov neeg mob menyuam yaus uas muaj kev cuam tshuam ntawm lub plawv thiab lwm yam teeb meem loj hauv plawv noj CNS stimulants ntawm kev pom zoo koob tshuaj rau ADHD. Tsis txhob siv rau cov neeg mob uas paub qhov txawv txav ntawm lub plawv, cardiomyopathy, mob plawv arrhythmia, kab mob plawv, thiab lwm yam teeb meem loj hauv plawv. Ntxiv rau kev soj ntsuam cov neeg mob uas tsim kev mob hauv siab, tsis tau piav qhia, lossis arrhythmias thaum kho Vyvanse.

Ntshav siab thiab lub plawv dhia nce

CNS stimulants ua rau muaj kev nce ntshav siab (txhais tau tias nce li 2 mus rau 4 mm Hg) thiab lub plawv dhia (txhais tau tias nce li 3 txog 6 bpm). Saib xyuas txhua tus neeg mob kom muaj peev xwm tachycardia thiab kub siab.

Psychiatric Adverse Reactions

Exacerbation ntawm Pre-existing Psychosis

CNS stimulants tuaj yeem ua rau cov tsos mob ntawm tus cwj pwm cuam tshuam thiab kev xav tsis zoo hauv cov neeg mob uas muaj kev puas siab puas ntsws ua ntej.

Induction ntawm Manic rov nyob rau hauv cov neeg mob uas muaj kev puas siab puas ntsws bipolar

CNS stimulants tuaj yeem ua rau muaj kev sib xyaw / manic rov hauv cov neeg mob uas muaj kev puas siab puas ntsws bipolar. Ua ntej pib kev kho mob, tshuaj xyuas cov neeg mob rau qhov muaj feem cuam tshuam rau kev txhim kho manic rov (piv txwv li, comorbid lossis keeb kwm ntawm kev nyuaj siab lossis tsev neeg keeb kwm ntawm kev tua tus kheej, kev puas siab puas ntsws bipolar, thiab kev nyuaj siab).

New Psychotic or Manic Symptoms

CNS stimulants, ntawm cov koob tshuaj pom zoo, tuaj yeem ua rau muaj kev puas siab puas ntsws lossis manic cov tsos mob (xws li, hnov ​​​​lus, kev xav tsis zoo, lossis mania) hauv cov neeg mob uas tsis muaj keeb kwm yav dhau los ntawm kev puas siab puas ntsws lossis mania. Yog tias cov tsos mob zoo li no tshwm sim, txiav txim siab txiav Vyvanse. Hauv kev txheeb xyuas ntawm ntau lub sij hawm luv luv, cov kev tshawb fawb tswj cov placebo ntawm CNS stimulants, psychotic los yog manic tsos mob tshwm sim nyob rau hauv 0.1% ntawm CNS stimulant-kho cov neeg mob piv rau 0% nyob rau hauv placebo-kho cov neeg mob.

Kev Tiv Thaiv Kev Loj Hlob

CNS stimulants tau cuam tshuam nrog kev poob phaus thiab qeeb ntawm kev loj hlob ntawm cov menyuam yaus. Ua tib zoo saib xyuas kev loj hlob (qhov hnyav thiab qhov siab) hauv cov neeg mob menyuam yaus kho nrog CNS stimulants, suav nrog Vyvanse. Hauv 4-lub lim tiam, kev sim tshuaj placebo-tswj ntawm Vyvanse hauv cov neeg mob menyuam yaus hnub nyoog 6 txog 12 xyoos nrog ADHD, muaj qhov txo qis ntawm qhov hnyav hauv pawg Vyvanse piv rau qhov hnyav nce hauv pawg placebo. Tsis tas li ntawd, nyob rau hauv kev tshawb fawb ntawm lwm yam stimulant, muaj qeeb ntawm qhov nce hauv qhov siab[saib Kev Tsis Pom Zoo (6.1) ].

Cov neeg mob uas tsis loj hlob lossis nce qhov siab lossis qhov hnyav raws li qhov xav tau yuav xav tau kev kho mob cuam tshuam. Vyvanse tsis raug pom zoo siv rau hauv cov neeg mob menyuam yaus hnub nyoog qis dua 6 xyoo[saib Siv hauv Cov Pej Xeem Tshwj Xeeb (8.4) ].

Peripheral Vasculopathy, suav nrog Raynaud's Phenomenon

Stimulants, suav nrog Vyvanse, yog txuam nrog peripheral vasculopathy, suav nrog Raynaud qhov tshwm sim. Cov tsos mob thiab cov tsos mob feem ntau tsis sib xws thiab mob me; Txawm li cas los xij, qhov tshwm sim tsis tshua muaj xws li cov kab mob digital thiab / lossis cov nqaij mos tawg. Cov teebmeem ntawm peripheral vasculopathy, suav nrog Raynaud qhov tshwm sim, tau pom nyob rau hauv cov ntaub ntawv tshaj tawm kev lag luam ntawm lub sijhawm sib txawv thiab ntawm cov tshuaj kho mob hauv txhua pab pawg hnub nyoog thoob plaws hauv chav kho mob. Cov tsos mob thiab cov tsos mob feem ntau zoo dua tom qab txo cov koob tshuaj lossis txiav cov tshuaj. Kev soj ntsuam kom zoo rau cov kev hloov pauv digital yog tsim nyog thaum kho nrog cov tshuaj stimulants. Kev tshuaj ntsuam xyuas ntxiv (piv txwv li, kev xa mus rau rheumatology) yuav tsim nyog rau qee tus neeg mob.

Serotonin Syndrome

Serotonin Syndrome, uas muaj peev xwm ua rau muaj kev phom sij rau lub neej, yuav tshwm sim thaum cov tshuaj amphetamines siv nrog rau lwm cov tshuaj uas cuam tshuam rau serotonergic neurotransmitter systems xws li monoamine oxidase inhibitors (MAOIs), xaiv serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs). ), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, thiab St. John's Wort[saib Kev Sib Tham Txog Tshuaj (7.1) ]. Kev sib koom ua ke nrog cytochrome P450 2D6 (CYP2D6) inhibitors kuj tseem tuaj yeem ua rau muaj kev pheej hmoo ntxiv nrog rau kev nthuav tawm cov metabolite ntawm Vyvanse (dextroamphetamine). Hauv cov xwm txheej no, xav txog lwm yam tshuaj uas tsis yog-serotonergic lossis lwm yam tshuaj uas tsis txwv CYP2D6.[saib Kev Sib Tham Txog Tshuaj (7.1) ].

Cov tsos mob ntawm Serotonin syndrome tuaj yeem suav nrog kev hloov pauv ntawm lub hlwb (xws li, ntxhov siab, hnov ​​​​lus, delirium, thiab coma), autonomic instability (xws li, tachycardia, labile ntshav siab, kiv taub hau, diaphoresis, flushing, hyperthermia), neuromuscular tsos mob (xws li, tshee, rigidity, myoclonus, hyperreflexia, incoordination), qaug dab peg, thiab/los yog gastrointestinal tsos mob (xws li, xeev siab, ntuav, raws plab).

Concomitant siv Vyvanse nrog MAOI tshuaj yog contraindicated[saib Contraindications (4) ].

Tso tseg kev kho mob nrog Vyvanse thiab ib qho tshuaj serotonergic ua ke tam sim yog tias cov tsos mob ntawm serotonin syndrome tshwm sim, thiab pib kho cov tsos mob. Yog tias kev siv Vyvanse sib xyaw nrog lwm cov tshuaj serotonergic lossis CYP2D6 inhibitors raug lees paub hauv tsev kho mob, pib Vyvanse nrog cov koob tshuaj qis dua, saib xyuas cov neeg mob rau qhov tshwm sim ntawm serotonin syndrome thaum pib siv tshuaj lossis titration, thiab qhia rau cov neeg mob txog kev pheej hmoo ntawm serotonin syndrome.

Kev Phem Tsis Zoo

Cov kev cuam tshuam tsis zoo hauv qab no tau tham ntau dua hauv lwm ntu ntawm kev sau npe:

• Paub txog qhov tsis txaus siab rau cov khoom lag luam amphetamine lossis lwm cov khoom xyaw ntawm Vyvanse[saib Contraindications (4) ]
• Hypertensive Crisis Thaum Siv Concomitantly nrog Monoamine Oxidase Inhibitors[saib Contraindications (4) thiab Kev Sib Tham Txog Tshuaj (7.1) ]
• Drug Dependence[saib Boxed Warning , Ceeb toom thiab ceev faj (5.1) , thiab Kev siv tshuaj yeeb thiab kev cia siab (9.2 , 9.3) ]
• Mob plawv mob hnyav[saib Ceeb toom thiab ceev faj (5.2) ]
• Ntshav siab thiab lub plawv dhia nce[saib Ceeb toom thiab ceev faj (5.3) ]
• Psychiatric Adverse Reactions[saib Ceeb toom thiab ceev faj (5.4) ]
• Kev Tiv Thaiv Kev Loj Hlob[saib Ceeb toom thiab ceev faj (5.5) ]
• Peripheral Vasculopathy, suav nrog Raynaud qhov tshwm sim[saib Ceeb toom thiab ceev faj (5.6) ]
• Serotonin Syndrome[saib Ceeb toom thiab ceev faj (5.7) ]

Kev sim tshuaj ntsuam xyuas

Vim tias kev sim tshuaj tau ua nyob rau hauv ntau yam sib txawv, cov tshuaj tiv thaiv tsis zoo uas tau pom nyob rau hauv kev sim tshuaj ntawm cov tshuaj tsis tuaj yeem ncaj qha piv rau cov nqi hauv kev sim tshuaj ntawm lwm cov tshuaj thiab tej zaum yuav tsis cuam tshuam txog cov nqi kev coj ua.

Attention Deficit Hyperactivity Disorder

Cov ntaub ntawv kev nyab xeeb hauv ntu no yog ua raws cov ntaub ntawv los ntawm 4-lub lim tiam tswj kev sib luag-pab pawg kev tshawb fawb ntawm Vyvanse hauv cov neeg mob menyuam yaus thiab cov neeg laus nrog ADHD[saib Clinical Studies (14.1) ].

Cov Kev Phem Tsis Zoo Koom Nrog Kev Txiav Txim Kev Kho Mob hauv ADHD Kev Kho Mob

Hauv kev tswj hwm kev sim hauv cov neeg mob menyuam yaus hnub nyoog 6 txog 12 xyoos (Kev Kawm 1), 8% (18/218) ntawm cov neeg mob uas tau kho Vyvanse tsis txuas ntxiv vim muaj kev cuam tshuam tsis zoo piv rau 0% (0/72) ntawm cov neeg mob uas siv cov placebo. Feem ntau tshaj tawm cov kev phiv tshwm sim (1% lossis ntau dua thiab ob zaug tus nqi ntawm cov placebo) yog ECG voltage cov qauv rau ventricular hypertrophy, tic, ntuav, psychomotor hyperactivity, insomnia, tsis qab los noj mov thiab ua pob liab vog [2 piv txwv rau txhua qhov tsis zoo tshwm sim, piv txwv li, 2/ 218 (1%). Tsawg zaus tshaj tawm cov tshuaj tiv thaiv tsis zoo (tsawg dua 1% lossis tsawg dua ob zaug ntawm cov placebo) suav nrog mob plab sab sauv, qhov ncauj qhuav, qhov hnyav poob, kiv taub hau, somnolence, logorrhea, mob hauv siab, npau taws thiab kub siab.

Hauv kev tswj hwm kev sim hauv cov neeg mob menyuam yaus hnub nyoog 13 txog 17 xyoo (Kev Kawm 4), 3% (7/233) ntawm cov neeg mob uas tau kho Vyvanse tsis txuas ntxiv vim muaj kev cuam tshuam tsis zoo piv rau 1% (1/77) ntawm cov neeg mob uas siv cov placebo. Feem ntau tshaj tawm cov kev phiv tshwm sim (1% lossis ntau dua thiab ob zaug ntawm cov placebo) tau txo qis qab los noj mov (2/233; 1%) thiab insomnia (2/233; 1%). Tsawg zaus tshaj tawm cov tshuaj tiv thaiv tsis zoo (tsawg dua 1% lossis tsawg dua ob zaug ntawm cov placebo) suav nrog kev chim siab, dermatillomania, lub siab hloov pauv, thiab ua tsis taus pa.

Hauv kev tswj xyuas cov neeg laus (Study 7), 6% (21/358) ntawm cov neeg mob uas tau kho Vyvanse tau txiav tawm vim qhov tsis zoo tshwm sim piv rau 2% (1/62) ntawm cov neeg mob placebo. Feem ntau tshaj tawm tsis zoo tshwm sim (1% lossis ntau dua thiab ob zaug ntawm cov placebo) yog insomnia (8/358; 2%), tachycardia (3/358; 1%), chim siab (2/358; 1%), kub siab ( 4/358; 1%), mob taub hau (2/358; 1%), ntxhov siab vim (2/358; 1%), thiab dyspnea (3/358; 1%). Tsawg zaus tshaj tawm cov tshuaj tiv thaiv tsis zoo (tsawg dua 1% lossis tsawg dua ob zaug ntawm cov placebo) suav nrog palpitations, raws plab, xeev siab, tsis qab los noj mov, kiv taub hau, ntxhov siab, kev nyuaj siab, paranoia thiab nyob tsis tswm.

Kev tshwm sim tsis zoo tshwm sim ntawm qhov tshwm sim ntawm ≧5% lossis Ntau Ntawm Vyvanse kho cov neeg mob nrog ADHD hauv kev sim tshuaj

Feem ntau cov kev phiv tshwm sim (qhov tshwm sim ≧5% thiab ntawm tus nqi tsawg kawg yog ob zaug placebo) qhia hauv cov neeg mob hnub nyoog 6 txog 17 xyoo, thiab/los yog cov neeg laus muaj anorexia, ntxhov siab, tsis qab los noj mov, poob phaus, raws plab, kiv taub hau, qhuav qhov ncauj. , irritability, insomnia, xeev siab, mob plab, thiab ntuav.

Kev tshwm sim tsis zoo tshwm sim ntawm qhov tshwm sim ntawm 2% lossis ntau dua ntawm Vyvanse kho cov neeg mob nrog ADHD hauv kev sim tshuaj

Cov tshuaj tiv thaiv tsis zoo tau tshaj tawm hauv cov kev sim tshuaj hauv cov neeg mob hnub nyoog, 6 txog 12 xyoos (Study 1), cov neeg mob me hnub nyoog 13 txog 17 xyoo (Study 4), thiab cov neeg laus (Study 7) kho nrog Vyvanse lossis placebo yog nthuav tawm hauv Cov Lus 1 , 2 thiab 3 hauv qab no.

Tsis tas li ntawd, nyob rau hauv cov neeg laus cov neeg laus erectile kawg tau pom nyob rau hauv 2.6% ntawm cov txiv neej ntawm Vyvanse thiab 0% ntawm cov placebo; Kev txo qis libido tau pom hauv 1.4% ntawm cov ntsiab lus ntawm Vyvanse thiab 0% ntawm cov placebo.

Poob qhov hnyav thiab qeeb qeeb qeeb hauv cov neeg mob menyuam yaus nrog ADHD

Hauv kev tswj hwm kev sim ntawm Vyvanse hauv cov menyuam yaus hnub nyoog 6 txog 12 xyoos (Study 1), txhais tau tias qhov hnyav poob los ntawm qhov pib tom qab 4 lub lis piam ntawm kev kho yog -0.9, -1.9, thiab -2.5 phaus, raws li, rau cov neeg mob tau txais 30 mg, 50. mg, thiab 70 mg ntawm Vyvanse, piv rau 1 phaus hnyav nce rau cov neeg mob tau txais cov placebo. Cov koob tshuaj ntau dua tau cuam tshuam nrog kev poob phaus ntau dua nrog 4 lub lis piam ntawm kev kho mob. Ua tib zoo saib xyuas qhov hnyav hauv cov neeg mob menyuam yaus hnub nyoog 6 txog 12 xyoos uas tau txais Vyvanse tshaj 12 lub hlis qhia tias cov neeg mob tau noj tshuaj tsis tu ncua (piv txwv li, kev kho mob rau 7 hnub hauv ib lub lis piam thoob plaws lub xyoo) muaj kev loj hlob qeeb, ntsuas los ntawm lub cev hnyav. Raws li pom los ntawm lub hnub nyoog- thiab kev sib deev-normalized txhais tau tias hloov pauv los ntawm lub hauv paus hauv feem pua, ntawm -13.4 tshaj 1 xyoo (qhov nruab nrab feem pua ​​​​ntawm qhov pib thiab 12 lub hlis yog 60.9 thiab 47.2, raws li). Hauv 4-lub lim tiam tswj kev sim ntawm Vyvanse hauv cov neeg mob menyuam yaus hnub nyoog 13 txog 17 xyoo, txhais tau tias qhov hnyav poob los ntawm lub hauv paus mus rau qhov kawg yog -2.7, -4.3, thiab -4.8 lbs., raws li, rau cov neeg mob tau txais 30 mg, 50 mg, thiab 70 mg ntawm Vyvanse, piv rau 2.0 phaus hnyav nce rau cov neeg mob tau txais cov placebo.

Ua tib zoo saib xyuas qhov hnyav thiab qhov siab hauv cov neeg mob menyuam yaus hnub nyoog 7 txog 10 xyoo uas tau randomized rau methylphenidate lossis tsis yog tshuaj kho mob ntau dua 14 lub hlis, nrog rau cov pab pawg naturalistic ntawm cov tshuaj tshiab methylphenidate-kho thiab tsis siv tshuaj kho cov neeg mob. tshaj 36 lub hlis (rau hnub nyoog ntawm 10 mus rau 13 xyoo), qhia tias kev noj tshuaj tsis tu ncua ntawm cov neeg mob hnub nyoog 7 txog 13 xyoos (piv txwv li, kev kho mob rau 7 hnub hauv ib lub lis piam thoob plaws lub xyoo) muaj kev loj hlob qeeb ib ntus (qhov nruab nrab, a tag nrho li ntawm 2 cm tsawg loj hlob nyob rau hauv qhov siab thiab 2.7 kg tsawg loj hlob nyob rau hauv qhov hnyav tshaj 3 xyoo), tsis muaj pov thawj ntawm kev loj hlob rebound nyob rau hauv lub sij hawm ntawm txoj kev loj hlob. Hauv kev sim tshuaj amphetamine (d- rau l-enantiomer piv ntawm 3: 1) hauv cov neeg mob menyuam yaus hnub nyoog 13 txog 17 xyoo, txhais tau tias qhov hnyav hloov ntawm qhov pib hauv thawj 4 lub lis piam ntawm kev kho yog -1.1 phaus thiab -2.8 phaus, feem. , rau cov neeg mob tau txais 10 mg thiab 20 mg ntawm amphetamine. Cov koob tshuaj ntau dua tau cuam tshuam nrog kev poob phaus ntau dua hauv thawj 4 lub lis piam ntawm kev kho mob[saib Ceeb toom thiab ceev faj (5.5) ].

Kev poob phaus hauv cov neeg laus nrog ADHD

Hauv kev tswj xyuas cov neeg laus (Study 7), txhais tau tias qhov hnyav poob tom qab 4 lub lis piam ntawm kev kho mob yog 2.8 phaus, 3.1 phaus, thiab 4.3 phaus, rau cov neeg mob tau txais koob tshuaj zaum kawg ntawm 30 mg, 50 mg, thiab 70 mg ntawm Vyvanse, feem, piv txwv. rau qhov hnyav nce ntawm 0.5 phaus rau cov neeg mob tau txais cov placebo.

Binge Eating Disorder

Cov ntaub ntawv kev nyab xeeb hauv ntu no yog ua raws li cov ntaub ntawv los ntawm ob pawg 12-lub lim tiam ua ke, hloov tau yooj yim, cov tshuaj placebo-tswj cov kev tshawb fawb hauv cov neeg laus nrog BED[saib Kev Kawm Kho Mob 14.2 ]. Cov neeg mob uas muaj kab mob plawv uas tsis yog kev rog thiab haus luam yeeb tsis suav nrog.

Kev tsis pom zoo cuam tshuam nrog kev txiav tawm ntawm kev kho mob hauv BED Clinical Trials

Hauv kev tswj hwm kev sim ntawm cov neeg mob hnub nyoog 18 txog 55 xyoo, 5.1% (19/373) ntawm cov neeg mob kho Vyvanse tsis txuas ntxiv vim qhov tsis zoo tshwm sim piv rau 2.4% (9/372) ntawm cov neeg mob uas siv cov placebo. Tsis muaj ib qho kev phiv tshwm sim ua rau kev txiav tawm hauv 1% lossis ntau dua ntawm cov neeg mob kho Vyvanse. Tsawg tshaj li qhov tshwm sim tsis zoo (tsawg dua 1% lossis tsawg dua ob zaug ntawm cov placebo) suav nrog kev nce siab hauv lub plawv, mob taub hau, mob plab sab sauv, ua tsis taus pa, ua pob liab liab, insomnia, chim siab, jittery thiab kev ntxhov siab.

Kev tshwm sim tsis zoo tshwm sim ntawm qhov tshwm sim ntawm 5% lossis ntau dua thiab tsawg kawg ob zaug placebo ntawm Vyvanse kho cov neeg mob nrog BED hauv kev sim tshuaj

Feem ntau cov kev phiv tshwm sim (qhov tshwm sim ≧5% thiab ntawm tus nqi tsawg kawg ob zaug placebo) qhia rau cov neeg laus yog qhov ncauj qhuav, insomnia, tsis qab los noj mov, nce plawv dhia, cem quav, xav jittery, thiab ntxhov siab vim.

Kev tshwm sim tsis zoo tshwm sim ntawm qhov tshwm sim ntawm 2% lossis ntau dua thiab tsawg kawg ob zaug placebo ntawm Vyvanse kho cov neeg mob nrog BED hauv kev sim tshuaj

Cov tshuaj tiv thaiv tsis zoo uas tau tshaj tawm hauv cov kev sim tshuaj sib xyaw ua ke hauv cov neeg mob laus (Kev Kawm 11 thiab 12) kho nrog Vyvanse lossis placebo tau nthuav tawm hauv Table 4 hauv qab no.

Postmarketing Experience

Cov kev tsis zoo hauv qab no tau raug txheeb xyuas thaum siv Vyvanse tom qab kev pom zoo. Vim tias cov tshuaj tiv thaiv no tau lees paub los ntawm cov pej xeem tsis paub meej qhov loj, nws tsis yog ib txwm ua tau kom ntseeg tau tias lawv cov zaus los yog tsim kom muaj kev sib raug zoo rau kev siv tshuaj. Cov xwm txheej no muaj raws li hauv qab no: cardiomyopathy, mydriasis, diplopia, teeb meem nrog kev pom kev, pom qhov muag tsis pom kev, eosinophilic kab mob siab, anaphylactic cov tshuaj tiv thaiv, hypersensitivity, dyskinesia, dysgeusia, tics, bruxism, kev nyuaj siab, dermatillomania, alopecia, hauv siab, aggression, mob, angioedema, urticaria, qaug dab peg, libido hloov, nquag los yog ntev erections, cem quav, thiab rhabdomyolysis.

Cov tshuaj sib cuam tshuam

Cov tshuaj muaj kev cuam tshuam tseem ceeb hauv kev kho mob nrog Amphetamines

Cov tshuaj tsis muaj kev cuam tshuam tseem ceeb hauv kev kho mob nrog Vyvanse

Los ntawm kev xav tshuaj pharmacokinetic, tsis muaj kev hloov kho koob tshuaj ntawm Vyvanse yog qhov tsim nyog thaum Vyvanse koom nrog nrog guanfacine, venlafaxine, lossis omeprazole. Tsis tas li ntawd, tsis muaj kev hloov kho koob tshuaj ntawm guanfacine lossis venlafaxine yog xav tau thaum Vyvanse koom nrog.[saib Tshuaj Kho Mob (12.3) ].

Los ntawm txoj kev xav pharmacokinetic, tsis muaj kev hloov kho koob tshuaj rau cov tshuaj uas yog substrates ntawm CYP1A2 (piv txwv li, theophylline, duloxetine, melatonin), CYP2D6 (xws li, atomoxetine, desipramine, venlafaxine), CYP2C19 (piv txwv li, CYP2C19), CYP2C19 (piv txwv li, Clopezol, CYP2C19), Piv txwv li, midazolam, pimozide, simvastatin) yog qhov tsim nyog thaum Vyvanse koom ua ke[saib Tshuaj Kho Mob (12.3) ].

Siv rau hauv cov neeg tshwj xeeb

Kev xeeb tub

Pregnancy Exposure Registry

Muaj ib daim ntawv teev npe cev xeeb tub uas saib xyuas qhov tshwm sim ntawm cev xeeb tub hauv cov poj niam raug ADHD cov tshuaj thaum cev xeeb tub. Cov kws kho mob raug txhawb kom sau npe cov neeg mob los ntawm kev hu rau National Pregnancy Registry for Psychostimulants ntawm 1-866-961-2388 lossis mus saib hauv online ntawm https://womensmentalhealth.org/clinical-and researchprograms/pregnancyregistry/adhd-medications/.

Risk Summary

Cov ntaub ntawv txwv tsis pub dhau los ntawm cov ntaub ntawv luam tawm thiab cov ntawv tshaj tawm kev tshaj tawm txog kev siv Vyvanse hauv cov poj niam cev xeeb tub tsis txaus los qhia txog kev pheej hmoo ntawm cov tshuaj muaj feem cuam tshuam rau kev yug menyuam loj thiab nchuav menyuam. Cov txiaj ntsig tsis zoo ntawm cev xeeb tub, suav nrog kev yug ntxov ntxov thiab tsis muaj qhov hnyav, tau pom nyob rau hauv cov menyuam mos yug los rau leej niam nyob ntawm amphetamines.[saib Kev txiav txim siab kho mob ]. Hauv kev tshawb nrhiav tsiaj txhu, lisdexamfetamine dimesylate (ib qho tshuaj ntawm d-amphetamine) tsis muaj teebmeem rau embryo-fetal morphological txoj kev loj hlob lossis ciaj sia thaum muab tshuaj noj rau cov nas cev xeeb tub thiab luav thoob plaws lub sijhawm ntawm organogenesis. Kev tshawb fawb ua ntej thiab tom qab yug me nyuam tsis tau ua nrog lisdexamfetamine dimesylate. Txawm li cas los xij, amphetamine (d- rau l- ratio ntawm 3: 1) kev tswj hwm rau cov nas cev xeeb tub thaum cev xeeb tub thiab lactation ua rau txo qis hauv cov menyuam muaj sia nyob thiab txo tus menyuam lub cev hnyav uas cuam tshuam nrog kev ncua ntawm kev loj hlob thaj chaw ntawm kev kho mob cov tshuaj amphetamine. . Tsis tas li ntawd, kev tsis zoo ntawm kev ua me nyuam tau pom nyob rau hauv cov menyuam mos uas nws niam tau kho nrog amphetamine. Lub sij hawm ntev neurochemical thiab kev coj cwj pwm cuam tshuam kuj tau tshaj tawm nyob rau hauv cov tsiaj kev loj hlob kev tshawb fawb siv cov tshuaj muaj feem xyuam rau cov tshuaj amphetamine.[saib Cov ntaub ntawv ].

Kev kwv yees keeb kwm yav dhau los ntawm kev yug me nyuam loj thiab nchuav menyuam rau cov pej xeem tsis paub. Txhua lub cev xeeb tub muaj keeb kwm muaj feem cuam tshuam txog kev yug menyuam, poob lossis lwm yam tshwm sim tsis zoo. Hauv Teb Chaws Asmeskas cov pej xeem, kwv yees keeb kwm kev pheej hmoo ntawm kev yug me nyuam loj thiab nchuav menyuam hauv kev kuaj mob pom zoo yog 2-4% thiab 15-20%, feem.

Kev txiav txim siab kho mob

Fetal/Neonatal Adverse Reactions

Amphetamines, xws li Vyvanse, ua rau vasoconstriction thiab yog li yuav txo qis placental perfusion. Tsis tas li ntawd, cov tshuaj amphetamines tuaj yeem ua rau cov qog nqaij hlav hauv plab ua rau muaj kev pheej hmoo ntawm kev yug ntxov ntxov. Cov menyuam mos yug los rau cov niam uas nyob hauv amphetamine muaj qhov pheej hmoo ntawm kev yug ntxov ntxov thiab kev yug menyuam qis.

Saib xyuas cov menyuam mos yug los rau cov niam uas noj tshuaj amphetamines rau cov tsos mob ntawm kev tshem tawm xws li noj zaub mov nyuaj, chim siab, ntxhov siab, thiab tsaug zog ntau dhau.

Cov ntaub ntawv

Cov ntaub ntawv tsiaj

Lisdexamfetamine dimesylate tsis muaj kev cuam tshuam rau embryo-fetal morphological txoj kev loj hlob los yog ciaj sia thaum muab qhov ncauj rau cov nas cev xeeb tub thiab luav thoob plaws lub sijhawm ntawm organogenesis ntawm koob tshuaj txog li 40 thiab 120 mg / kg / hnub, feem. Cov koob tshuaj no yog kwv yees li 5.5 thiab 33 zaug, raws li, qhov siab tshaj plaws pom zoo tib neeg koob tshuaj (MRHD) ntawm 70 mg / hnub muab rau cov neeg laus, ntawm ib mg / m.oblub hauv paus ntawm lub cev nto.

Ib txoj kev tshawb fawb tau ua nrog amphetamine (d- rau l- enantiomer piv ntawm 3: 1) uas cov nas cev xeeb tub tau txais txhua hnub koob tshuaj ntawm qhov ncauj ntawm 2, 6, thiab 10 mg / kg txij hnub gestation day 6 mus rau hnub lactation 20. Tag nrho cov koob tshuaj ua rau muaj kev ntxhov siab. thiab txo qhov hnyav nce hauv dams. Qhov txo qis hauv cov menyuam muaj sia nyob tau pom ntawm txhua qhov koob tshuaj. Qhov txo qis hauv tus menyuam lub cev qhov hnyav tau pom ntawm 6 thiab 10 mg / kg uas cuam tshuam nrog kev qeeb hauv kev loj hlob, xws li kev sib cais ua ntej thiab qhov chaw mos. Kev ua haujlwm ntawm cov menyuam yaus nce ntxiv tau pom ntawm 10 mg / kg rau hnub 22 tom qab yug menyuam tab sis tsis nyob ntawm 5 lub lis piam tom qab yug menyuam. Thaum cov menyuam yaus raug kuaj rau kev ua menyuam yaus ntawm kev loj hlob, qhov hnyav ntawm gestational nce, tus naj npawb ntawm cov implantation, thiab tus naj npawb ntawm cov menyuam yug los tau txo qis hauv pab pawg uas leej niam tau muab 10 mg / kg.

Ib tug xov tooj ntawm cov kev tshawb fawb los ntawm cov ntaub ntawv nyob rau hauv nas qhia hais tias prenatal los yog thaum ntxov postnatal raug rau amphetamine (d- los yog d, l-) ntawm koob tshuaj zoo ib yam li cov siv kho mob yuav ua rau lub sij hawm ntev neurochemical thiab kev coj cwj pwm hloov. Kev tshaj tawm txog kev coj tus cwj pwm muaj xws li kev kawm thiab kev nco tsis txaus, hloov pauv kev ua haujlwm hauv locomotor, thiab kev hloov pauv hauv kev ua haujlwm ntawm kev sib deev.

lactation

Risk Summary

Lisdexamfetamine yog ib qho tshuaj tiv thaiv ntawm dextroamphetamine. Raws li cov ntaub ntawv tsawg tsawg hauv cov ntaub ntawv luam tawm, amphetamine (d-lossis d, l-) muaj nyob rau hauv tib neeg cov mis nyuj, ntawm cov menyuam mos noj cov tshuaj ntawm 2% mus rau 13.8% ntawm cov niam txiv qhov hnyav-hloov ntau npaum li cas thiab mis nyuj / ntshav sib piv ntawm 1.9 thiab 7.5. Tsis muaj ntawv ceeb toom txog qhov tsis zoo rau tus menyuam mos uas pub niam mis. Lub sij hawm ntev neurodevelopmental cuam tshuam rau cov me nyuam mos los ntawm amphetamine raug tsis paub. Nws muaj peev xwm hais tias ntau npaum li cas ntawm dextroamphetamine yuav cuam tshuam rau cov kua mis, tshwj xeeb tshaj yog cov poj niam uas lactation tsis zoo. Vim tias muaj peev xwm ua rau muaj kev cuam tshuam loj heev hauv cov menyuam mos, nrog rau cov kev mob plawv loj, cov ntshav siab thiab lub plawv dhia nce, txo qis kev loj hlob, thiab peripheral vasculopathy, qhia cov neeg mob tias kev pub niam mis tsis pom zoo thaum kho nrog Vyvanse.

Kev siv menyuam yaus

ADHD

Kev nyab xeeb thiab kev ua tau zoo ntawm Vyvanse tau tsim nyob rau hauv cov neeg mob menyuam yaus nrog ADHD hnub nyoog 6 txog 17 xyoo[saib Dosage thiab Administration (2.3) , Kev Tsis Pom Zoo (6.1) , Tshuaj Kho Mob (12.3) , thiab Clinical Studies (14.1) ].

Kev nyab xeeb thiab kev ua tau zoo ntawm Vyvanse tsis tau tsim nyob rau hauv cov neeg mob menyuam yaus hnub nyoog qis dua 6 xyoo.

Kev nyab xeeb thiab kev ua tau zoo ntawm Vyvanse tau raug soj ntsuam hauv ob qhov muag tsis pom kev, randomized, sib npaug-pab pawg, cov tshuaj placebo-tswj, kev tshawb fawb tas li hauv cov neeg mob menyuam yaus hnub nyoog 4 txog 5 xyoos nrog ADHD, ua raws li kev tshawb fawb 1-xyoo qhib-daim ntawv txuas ntxiv. Hauv cov kev tshawb fawb no, cov neeg mob tau ntsib kev nce siab ntawm qhov tsis zoo, suav nrog kev poob phaus, txo BMI, txo qis qab los noj mov, insomnia, kab mob (ua pa sab sauv thiab nasopharyngitis), chim siab, thiab cuam tshuam rau lability.

Nrog rau tib koob tshuaj Vyvanse, txhais tau tias lub xeev tsis tu ncua ntawm dextroamphetamine yog kwv yees li 44% siab dua hauv cov neeg mob menyuam yaus hnub nyoog 4 txog 5 xyoos piv rau cov neeg mob menyuam yaus hnub nyoog 6 txog 11 xyoos.

BED

Kev nyab xeeb thiab kev ua tau zoo ntawm Vyvanse tsis tau tsim nyob rau hauv cov neeg mob qis dua 18 xyoo.

Txoj Kev Loj Hlob

Kev loj hlob yuav tsum tau saib xyuas thaum kho nrog cov tshuaj txhawb nqa, suav nrog Vyvanse, thiab cov neeg mob menyuam yaus uas tsis loj hlob lossis nce qhov hnyav raws li qhov xav tau yuav tsum muaj kev kho mob cuam tshuam.[saib Ceeb toom thiab ceev faj (5.5) thiab Kev Tsis Pom Zoo (6.1) ].

Juvenile Animal Data

Cov kev tshawb fawb tau ua nyob rau hauv cov menyuam yaus nas thiab dev ntawm cov tshuaj muaj feem cuam tshuam tau pom tias muaj kev loj hlob ntawm kev txwv tsis pub ib nrab lossis tag nrho rov qab rau cov dev thiab poj niam nas tab sis tsis nyob hauv txiv neej nas tom qab plaub lub lis piam rov qab tsis muaj tshuaj.

Kev tshawb fawb tau ua nyob rau hauv uas cov menyuam yaus nas tau txais koob tshuaj ntawm qhov ncauj ntawm 4, 10, lossis 40 mg / kg / hnub ntawm lisdexamfetamine dimesylate txij hnub 7 txog hnub nyoog 63 xyoos. Cov koob tshuaj no yog kwv yees li 0.3, 0.7, thiab 3 npaug ntawm qhov siab tshaj plaws pom zoo tib neeg noj txhua hnub ntawm 70 mg ntawm ib mg / m.obhauv paus rau me nyuam. Cov koob tshuaj txo qis hauv kev noj zaub mov, qhov hnyav nce, thiab qhov ntev ntawm lub hauv siab tau pom; Tom qab plaub lub lis piam rov qab siv tshuaj tsis muaj tshuaj, lub cev hnyav thiab lub hauv caug-rump ntev tau rov zoo dua hauv cov poj niam tab sis tseem txo qis hauv cov txiv neej. Lub sij hawm qhib qhov chaw mos tau ncua rau cov poj niam ntawm qhov koob tshuaj ntau tshaj, tab sis tsis muaj tshuaj cuam tshuam rau kev xeeb tub thaum cov tsiaj txhu tau sib yuav pib hnub 85 ntawm hnub nyoog.

Hauv ib txoj kev tshawb fawb uas cov menyuam yaus tau txais lisdexamfetamine dimesylate rau 6 lub hlis pib thaum muaj hnub nyoog 10 lub lis piam, qhov kev poob qis hauv lub cev tau pom ntawm txhua qhov kev sim tshuaj (2, 5, thiab 12 mg / kg / hnub, uas yog kwv yees li 0.5, 1, thiab 3 npaug ntawm qhov siab tshaj plaws uas tib neeg tau pom zoo txhua hnub ntawm ib mg / mobhauv paus rau me nyuam). Qhov no cuam tshuam ib nrab lossis tag nrho thim rov qab thaum lub sijhawm plaub lub lis piam rov qab tsis muaj tshuaj.

Kev siv Geriatric

Cov kev tshawb fawb soj ntsuam ntawm Vyvanse tsis suav nrog cov naj npawb txaus ntawm cov neeg muaj hnub nyoog 65 thiab tshaj los txiav txim seb lawv teb txawv li cas ntawm cov menyuam yaus. Lwm cov ntaub ntawv qhia txog kev kho mob thiab cov ntaub ntawv pharmacokinetic[saib Tshuaj Kho Mob (12.3) ]tsis tau txheeb xyuas qhov sib txawv ntawm cov lus teb ntawm cov neeg laus thiab cov neeg hluas. Feem ntau, kev xaiv koob tshuaj rau tus neeg mob laus yuav tsum pib ntawm qhov qis kawg ntawm qhov koob tshuaj, qhia txog qhov ntau dua ntawm kev txo qis hauv siab, lub raum, lossis lub plawv ua haujlwm, thiab ntawm cov kab mob sib kis lossis lwm yam tshuaj kho.

Lub raum tsis zoo

Vim qhov txo qis hauv cov neeg mob lub raum tsis zoo (GFR 15 rau<30 mL/min/1.73 mob), qhov siab tshaj plaws koob tshuaj yuav tsum tsis pub tshaj 50 mg / hnub. Qhov siab tshaj plaws pom zoo koob tshuaj hauv ESRD (GFR<15 mL/min/1.73 mob) cov neeg mob yog 30 mg / hnub[saib Tshuaj Kho Mob (12.3) ].

Lisdexamfetamine thiab d-amphetamine tsis yog dialyzable.

Drug Abuse thiab Dependence

Tshuaj tswj

Vyvanse muaj lisdexamfetamine, ib tug prodrug ntawm amphetamine, ib tug Schedule II tswj tshuaj.

Kev tsim txom

CNS stimulants, suav nrog Vyvanse, lwm yam khoom muaj amphetamine, thiab methylphenidate muaj peev xwm ua rau muaj kev tsim txom. Kev tsim txom yog kev txhob txwm tsis siv tshuaj kho mob, txawm tias ib zaug, kom ua tiav qhov kev xav tau ntawm lub hlwb lossis lub cev muaj zog. Kev tsim txom yog tshwm sim los ntawm kev tswj tsis tau ntawm kev siv yeeb tshuaj, kev siv dag zog, kev siv txuas ntxiv txawm tias muaj kev puas tsuaj, thiab kev ntshaw. Kev quav yeeb tshuaj yog ib pawg ntawm kev coj cwj pwm, kev txawj ntse, thiab lub cev muaj zog uas tuaj yeem muaj lub siab xav noj tshuaj, muaj teeb meem hauv kev tswj hwm kev siv yeeb tshuaj (xws li kev siv tshuaj txuas ntxiv txawm tias muaj teeb meem tshwm sim, muab qhov tseem ceeb rau kev siv tshuaj ntau dua li lwm yam dej num thiab lub luag haujlwm. ), thiab ua tau siab ntev los yog lub cev dependence. Kev tsim txom thiab kev siv tsis raug yuav ua rau muaj kev quav yeeb quav tshuaj, thiab qee tus neeg tuaj yeem tsim kev quav yeeb quav tshuaj txawm tias thaum noj Vyvanse raws li tau sau tseg.

Cov tsos mob thiab cov tsos mob ntawm kev tsim txom amphetamine tej zaum yuav muaj xws li lub plawv dhia, ua pa, ntshav siab, thiab/los yog tawm hws, dilated cov menyuam kawm ntawv, hyperactivity, nyob tsis tswm, insomnia, tsis qab los noj mov, poob ntawm kev sib koom tes, tremors, flushed daim tawv nqaij, ntuav, thiab / los yog mob plab. mob. Kev ntxhov siab, kev puas siab puas ntsws, kev ua siab phem, kev ua phem, kev tua tus kheej lossis homicidal ideation kuj tau pom. Kev tsim txom ntawm CNS stimulants tuaj yeem zom, snort, txhaj, lossis siv lwm txoj hauv kev tsis pom zoo ntawm kev tswj hwm uas tuaj yeem ua rau ntau dhau thiab tuag.[saib Kev noj ntau dhau (10) ].

Txhawm rau txo qis kev tsim txom ntawm CNS stimulants, suav nrog Vyvanse, ntsuas qhov kev pheej hmoo ntawm kev tsim txom ua ntej yuav tshuaj. Tom qab muab tshuaj, khaws cov ntaub ntawv ceev faj, qhia cov neeg mob thiab lawv tsev neeg txog kev tsim txom thiab khaws cia thiab pov tseg ntawm CNS stimulants. Saib xyuas cov cim qhia ntawm kev tsim txom thaum kho, thiab rov ntsuas qhov xav tau ntawm kev siv Vyvanse.

Kev tshawb fawb ntawm Vyvanse nyob rau hauv Drug Abusers

Ib qho randomized, ob-dig muag, placebo-tswj, hla dhau, kev tsim txom kev lav phib xaub hauv 38 cov neeg mob uas muaj keeb kwm ntawm kev siv yeeb tshuaj tau ua nrog ib koob tshuaj ntawm 50, 100, lossis 150 mg ntawm Vyvanse, 40 mg ntawm kev tso tawm tam sim. d-amphetamine sulphate (ib yam tshuaj tiv thaiv II), thiab 200 mg ntawm diethylpropion hydrochloride (ib yam tshuaj IV tswj). Vyvanse 100 mg ua tau tsawg dua 'Drug Liking Effects' raws li ntsuas los ntawm Kev Ntsuas Tshuaj Ntsuam Xyuas Cov Lus Nug-Subject qhab nia, piv rau d-amphetamine 40 mg; thiab 150 mg ntawm Vyvanse tau pom zoo sib xws 'Drug-Liking Effects' piv rau 40 mg ntawm d-amphetamine thiab 200 mg ntawm diethylpropion.

Intravenous tswj ntawm 50 mg lisdexamfetamine dimesylate rau cov tib neeg uas muaj keeb kwm ntawm kev siv yeeb tshuaj ua rau cov lus teb zoo ntawm cov ntsuas ntsuas 'Drug Liking', 'Euphoria', 'Amphetamine Effects', thiab 'Benzedrine Effects' uas muaj ntau dua li cov placebo tab sis tsawg dua cov. tsim los ntawm qhov sib npaug koob tshuaj (20 mg) ntawm cov tshuaj d-amphetamine intravenous.

Kev vam meej

Lub cev nyob ruaj khov

Vyvanse tuaj yeem tsim lub cev dependence los ntawm kev kho txuas ntxiv. Lub cev dependence yog ib lub xeev ntawm adaptation tshwm sim los ntawm ib tug tshem tawm syndrome uas ua los ntawm sai sai cessation, txo koob tshuaj sai, los yog kev tswj ntawm ib tug antagonist. Kev tshem tawm cov tsos mob tom qab tshem tawm sai sai tom qab lub sijhawm ntev ntawm kev noj tshuaj ntau ntawm CNS stimulants suav nrog kev qaug zog thiab kev nyuaj siab.

Ua siab ntev

Vyvanse tuaj yeem tsim kev ua siab ntev los ntawm kev kho txuas ntxiv. Kev kam rau siab yog lub xeev ntawm kev hloov pauv uas raug rau ib koob tshuaj tshwj xeeb ntawm cov tshuaj ua rau txo qis ntawm cov tshuaj uas xav tau thiab / lossis tsis xav tau los ntawm lub sijhawm.

Kev noj ntau dhau

Tham nrog Lub Chaw Tswj Tshuaj Pov Hwm Pov Hwm (1-800-222-1222) kom paub cov lus qhia tshiab thiab cov lus qhia txog kev kho mob ntau dhau. Tus neeg mob cov lus teb rau amphetamines sib txawv. Cov tsos mob lom yuav tshwm sim idiosyncratically ntawm koob tshuaj tsawg.

Kev tshwm sim ntawm amphetamine overdose muaj xws li tsis xis nyob, tshee, hyperreflexia, ua pa nrawm, tsis meej pem, kev ua phem, hnov ​​​​qab, ceeb ntshai, hyperpyrexia thiab rhabdomyolysis. Kev qaug zog thiab kev nyuaj siab feem ntau ua raws li lub hauv paus paj hlwb stimulation. Serotonin syndrome tau tshaj tawm nrog kev siv tshuaj amphetamine, suav nrog Vyvanse. Cov teebmeem ntawm cov hlab plawv muaj xws li arrhythmias, kub siab lossis hypotension thiab circulatory collapse. Cov tsos mob ntawm plab hnyuv muaj xws li xeev siab, ntuav, raws plab thiab mob plab. Kev lom neeg tuag feem ntau yog ua ntej ntawm convulsions thiab coma.

Lisdexamfetamine thiab d-amphetamine tsis yog dialyzable.

Vyvanse Description

Vyvanse (lisdexamfetamine dimesylate), CNS stimulant, yog rau kev tswj hwm qhov ncauj ib hnub. Lub npe tshuaj rau lisdexamfetamine dimesylate yog (2S)-2,6-diamino-N-[(ibS)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. Cov mis mos molecular yog Ckaum tsibH25N3O∙(CH4LUB3S)ob, uas sib haum mus rau qhov hnyav molecular ntawm 455.60. Cov qauv tshuaj lom neeg yog:

Lisdexamfetamine dimesylate yog cov hmoov dawb rau dawb uas yog soluble hauv dej (792 mg / mL).

Cov ntaub ntawv rau Vyvanse capsules:

Vyvanse capsules muaj 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, thiab 70 mg ntawm lisdexamfetamine dimesylate (sib npaug rau 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.97 mg, thiab 34. mg ntawm lisdexamfetamine).

Cov khoom xyaw uas tsis muaj zog: microcrystalline cellulose, croscarmellose sodium, thiab magnesium stearate. Lub plhaub plhaub muaj cov gelatin, titanium dioxide, thiab ib lossis ntau dua ntawm cov hauv qab no: FD&C Liab #3, FD&C daj #6, FD&C Xiav #1, Dub Iron Oxide, thiab Yellow Iron Oxide.

Cov ntaub ntawv rau Vyvanse chewable ntsiav tshuaj:

Vyvanse chewable ntsiav tshuaj muaj 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, thiab 60 mg ntawm lisdexamfetamine dimesylate (sib npaug rau 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, thiab lisdexam 34.

Cov khoom xyaw uas tsis muaj zog: colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, sucralose, dag strawberry tsw.

Vyvanse - Clinical Pharmacology

Mechanism ntawm Action

Lisdexamfetamine yog ib tug prodrug ntawm dextroamphetamine. Amphetamines yog non-catecholamine sympathomimetic amines nrog CNS stimulant kev ua. Lub hom phiaj ntawm kev kho mob hauv ADHD thiab BED tsis paub.

Pharmacodynamics

Amphetamines thaiv kev rov ua dua ntawm norepinephrine thiab dopamine rau hauv presynaptic neuron thiab nce tso tawm ntawm cov monoamines rau hauv qhov chaw extraneuronal. Cov tshuaj niam txiv, lisdexamfetamine, tsis khi rau cov chaw ua haujlwm rau kev rov ua dua ntawm norepinephrine thiab dopamine.hauv vitro.

Pharmacokinetics

Kev tshawb fawb Pharmacokinetic tom qab kev tswj hwm qhov ncauj ntawm lisdexamfetamine dimesylate tau ua rau cov neeg laus noj qab haus huv (cov tshuaj ntsiav thiab cov ntsiav tshuaj chewable) thiab cov menyuam yaus (6 txog 12 xyoos) cov neeg mob ADHD (capsule formulation). Tom qab ib koob tshuaj ntawm lisdexamfetamine dimesylate, pharmacokinetics ntawm dextroamphetamine tau pom tias yog linear ntawm 30 mg thiab 70 mg hauv kev tshawb fawb menyuam yaus (6 txog 12 xyoos), thiab nruab nrab ntawm 50 mg thiab 250 mg hauv kev tshawb fawb neeg laus. Dextroamphetamine pharmacokinetic tsis ua raws li kev tswj hwm ntawm lisdexamfetamine dimesylate hauv cov neeg laus pom qhov tsis sib xws (<25%) and intra-subject (<8%) variability. There is no accumulation of lisdexamfetamine and dextroamphetamine at steady state in healthy adults.

Kev nqus

Capsule formulation

Tom qab noj ib koob tshuaj ntawm qhov ncauj ntawm Vyvanse capsule (30 mg, 50 mg, lossis 70 mg) hauv cov neeg mob hnub nyoog 6 txog 12 xyoos nrog ADHD nyob rau hauv kev yoo mov, Tmaxntawm lisdexamfetamine thiab dextroamphetamine tau mus txog ntawm kwv yees li 1 teev thiab 3.5 teev tom qab noj tshuaj, feem. Qhov hnyav / Dose normalized AUC thiab CmaxCov txiaj ntsig tau zoo ib yam hauv cov neeg mob menyuam yaus hnub nyoog 6 txog 12 xyoos raws li cov neeg laus tom qab ib koob tshuaj ntawm 30 mg rau 70 mg Vyvanse capsule.

Cov nyhuv ntawm cov zaub mov ntawm cov tshuaj capsule formulation

Tsis muaj zaub mov (cov zaub mov muaj roj ntau lossis yogurt) lossis kua txiv kab ntxwv cuam tshuam rau AUC thiab Cmaxntawm dextroamphetamine rau cov neeg laus noj qab haus huv tom qab ib koob tshuaj ntawm qhov ncauj ntawm 70 mg ntawm Vyvanse capsules. Zaub mov prolongs Tmaxlos ntawm kwv yees li 1 teev (los ntawm 3.8 teev ntawm lub xeev yoo mov mus rau 4.7 teev tom qab noj zaub mov muaj roj ntau lossis mus txog 4.2 teev nrog yogurt). Tom qab 8-teev nrawm, AUC rau dextroamphetamine tom qab kev tswj hwm qhov ncauj ntawm lisdexamfetamine dimesylate hauv cov tshuaj thiab cov tshuaj ntsiav tsis zoo sib npaug.

Chewable Tablet formulation

Tom qab kev tswj hwm ib koob ntawm 60 mg Vyvanse chewable ntsiav tshuaj hauv cov neeg noj qab haus huv hauv cov xwm txheej ceev, Tmaxntawm lisdexamfetamine thiab dextroamphetamine tau mus txog ntawm kwv yees li 1 teev thiab 4.4 teev tom qab noj tshuaj, feem. Piv rau 60 mg Vyvanse capsule, raug (Cmaxthiab AUC) rau lisdexamfetamine yog kwv yees li 15% qis dua. Kev nthuav qhia (Cmaxthiab AUCua inf) ntawm dextroamphetamine zoo ib yam ntawm Vyvanse chewable ntsiav tshuaj thiab Vyvanse capsule.

Cov nyhuv ntawm cov zaub mov ntawm cov ntsiav tshuaj formulation

Kev tswj hwm ntawm 60 mg Vyvanse chewable ntsiav tshuaj nrog zaub mov (mob rog rog) txo qis qhov kis (Cmaxthiab AUCua inf) ntawm dextroamphetamine li ntawm 5% mus rau 7%, thiab ntev txhais tau tias Tmaxlos ntawm kwv yees li 1 teev (los ntawm 3.9 teev ntawm lub xeev yoo mov mus rau 4.9 teev).

Kev tshem tawm

Plasma concentrations ntawm cov tsis hloov pauv lisdexamfetamine yog qhov tsawg thiab ntuav, feem ntau dhau los ua tsis muaj nuj nqis los ntawm 8 teev tom qab tswj hwm. Kev tshem tawm ntshav plasma ib nrab-lub neej ntawm lisdexamfetamine feem ntau nruab nrab tsawg dua ib teev hauv cov neeg tuaj yeem pab dawb hnub nyoog 6 xyoo thiab laus dua..Kev tshem tawm plasma ib nrab ntawm lub neej ntawm dextroamphetamine yog kwv yees li 8.6 txog 9.5 teev hauv cov neeg mob menyuam yaus hnub nyoog 6 txog 12 xyoos thiab 10 mus rau 11.3 teev hauv cov neeg laus noj qab haus huv.

Metabolism

Lisdexamfetamine hloov mus rau dextroamphetamine thiab l-lysine feem ntau hauv cov ntshav vim yog kev ua haujlwm hydrolytic ntawm cov qe ntshav liab tom qab noj qhov ncauj ntawm lisdexamfetamine dimesylate.Hauv vitrocov ntaub ntawv qhia tias cov qe ntshav liab muaj peev xwm ua kom cov metabolism ntawm lisdexamfetamine; Cov hydrolysis loj heev tshwm sim txawm tias qis hematocrit (33% ntawm qhov qub). Lisdexamfetamine tsis metabolized los ntawm cytochrome P450 enzymes.

Kev tso tawm

Tom qab kev tswj hwm qhov ncauj ntawm koob tshuaj 70 mg ntawm radiolabeled lisdexamfetamine dimesylate rau 6 tus neeg noj qab haus huv, kwv yees li 96% ntawm qhov ncauj tshuaj radioactivity tau rov qab los hauv cov zis thiab tsuas yog 0.3% zoo hauv cov quav hauv lub sijhawm 120 teev. Ntawm cov xov tooj cua rov qab los hauv cov zis, 42% ntawm cov koob tshuaj muaj feem xyuam rau amphetamine, 25% rau hippuric acid, thiab 2% rau lisdexamfetamine tsis zoo.

Cov pejxeem tshwj xeeb

Kev nthuav tawm ntawm dextroamphetamine hauv cov neeg tshwj xeeb tau sau tseg hauv daim duab 1.

Kev Tshawb Fawb Kev Sib Tham Txog Tshuaj

Kev cuam tshuam ntawm lwm yam tshuaj ntawm kev nthuav tawm ntawm dextroamphetamine tau sau tseg hauv daim duab 2.

Cov teebmeem ntawm Vyvanse ntawm qhov raug ntawm lwm cov tshuaj tau sau tseg hauv daim duab 3.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, thiab Impairment of Fertility

Carcinogenesis

Kev tshawb fawb carcinogenicity ntawm lisdexamfetamine dimesylate tsis tau ua. Tsis muaj pov thawj ntawm carcinogenicity tau pom nyob rau hauv cov kev tshawb fawb uas d-, l-amphetamine (enantiomer ratio ntawm 1: 1) tau muab rau cov nas thiab nas nyob rau hauv kev noj haus rau 2 xyoos ntawm koob tshuaj txog li 30 mg / kg / hnub hauv txiv neej nas. , 19 mg / kg / hnub hauv poj niam nas, thiab 5 mg / kg / hnub hauv txiv neej thiab poj niam nas.

Mutagenesis

Lisdexamfetamine dimesylate tsis yog clastogenic hauv nas pob txha pob txha micronucleus kuajnyobthiab tsis zoo thaum kuaj hauv lubE. colithiabS. typhimuriumCheebtsam ntawm Ames xeem thiab hauv L5178Y/TK+/-nas lymphoma assayhauv vitro.

Kev puas tsuaj ntawm Fertility

Amphetamine (d- rau l-enantiomer piv ntawm 3: 1) tsis cuam tshuam rau fertility lossis ntxov embryonic txoj kev loj hlob ntawm tus nas ntawm koob txog li 20 mg / kg / hnub.

Tsiaj Toxicology thiab/los yog Pharmacology

Kev tswj hwm nruj ntawm cov tshuaj amphetamine siab (d- lossis d, l-) tau pom tias tsim cov teebmeem neurotoxic ntev ntev, suav nrog kev puas tsuaj rau cov hlab ntsha tsis tuaj yeem, hauv cov nas. Qhov tseem ceeb ntawm cov kev tshawb pom no rau tib neeg tsis paub.

Kev tshawb fawb soj ntsuam

Attention Deficit Hyperactivity Disorder (ADHD)

Cov neeg mob menyuam yaus hnub nyoog 6 txog 12 xyoos nrog ADHD

Ob qhov muag tsis pom kev, randomized, placebo-tshwj xeeb, kev tshawb fawb ua ke ntawm pawg (Study 1) tau ua nyob rau hauv cov neeg mob uas muaj hnub nyoog 6 txog 12 xyoo (N = 290) uas tau ntsib DSM-IV cov qauv rau ADHD (xws li hom kev sib koom ua ke lossis kev ua siab ntev. - hom impulsive). Cov neeg mob tau randomized kom tau txais koob tshuaj zaum kawg ntawm 30 mg, 50 mg, lossis 70 mg ntawm Vyvanse lossis cov placebo ib hnub ib zaug thaum sawv ntxov rau tag nrho plaub lub lis piam ntawm kev kho mob. Txhua tus neeg mob tau txais Vyvanse tau pib ntawm 30 mg rau thawj lub lim tiam ntawm kev kho mob. Cov neeg mob tau muab rau pawg koob tshuaj 50 mg thiab 70 mg tau titrated los ntawm 20 mg ib lub lis piam mus txog thaum lawv ua tiav lawv cov koob tshuaj. Thawj qhov kev ua tau zoo tau hloov pauv hauv Tag Nrho Cov qhab nia los ntawm qhov pib mus rau qhov kawg hauv cov neeg tshawb xyuas cov qhab nia ntawm ADHD Rating Scale (ADHD-RS), 18-cov lus nug nrog cov qhab nia ntawm 0-54 cov ntsiab lus uas ntsuas cov tsos mob tseem ceeb ntawm ADHD uas suav nrog ob qho tib si hyperactive / impulsive thiab inattentive subscales. Endpoint tau txhais tias yog lub lim tiam dhau los tom qab kev kho mob randomization (piv txwv li, Lub lis piam 1 txog 4) uas tau txais cov qhab nia siv tau. Txhua pawg koob tshuaj Vyvanse tau zoo dua rau cov placebo hauv thawj qhov txiaj ntsig tau zoo. Qhov txiaj ntsig ntawm txhua qhov koob tshuaj zoo sib xws; Txawm li cas los xij, qhov koob tshuaj ntau tshaj (70 mg / hnub) yog tus lej zoo dua rau ob koob tshuaj qis dua (Study 1 hauv Table 6). Cov kev cuam tshuam tau tswj hwm txhua hnub raws li niam txiv kev ntsuas (Conners 'Parent Rating Scale) thaum sawv ntxov (kwv yees li 10 teev sawv ntxov), tav su (kwv yees li 2 teev tsaus ntuj), thiab yav tsaus ntuj (kwv yees li 6 teev tsaus ntuj).

Ob qhov muag tsis pom kev, tshuaj placebo-tswj, randomized, crossover tsim, kev tshawb fawb hauv chav kawm analog (Study 2) tau ua rau cov neeg mob menyuam yaus hnub nyoog 6 txog 12 xyoos (N = 52) uas tau ntsib DSM-IV cov qauv rau ADHD (xws li hom sib xyaw lossis hom hyperactive-impulsive). Ua raws li 3 lub lis piam qhib-daim ntawv sau tshuaj kom zoo nrog Adderall XR®, cov neeg mob tau raug muab tso tseg kom txuas ntxiv lawv cov koob tshuaj zoo tshaj plaws ntawm Adderall XR (10 mg, 20 mg, lossis 30 mg), Vyvanse (30 mg, 50 mg, lossis 70 mg), lossis placebo ib hnub ib hnub thaum sawv ntxov rau 1 lub lis piam txhua qhov kev kho mob. . Kev ntsuas kev ua tau zoo tau ua tiav ntawm 1, 2, 3, 4.5, 6, 8, 10, thiab 12 teev tom qab noj tshuaj siv Swanson, Kotkin, Agler, M.Flynn, thiab Pelham Cov qhab nia Deportment (SKAMP-DS), 4- cov khoom subscale ntawm SKAMP nrog cov qhab nia ntawm 0 txog 24 cov ntsiab lus uas ntsuas cov teeb meem kev xa tawm mus rau kev cuam tshuam hauv chav kawm. Qhov sib txawv tseem ceeb ntawm tus neeg mob tus cwj pwm, raws li qhov nruab nrab ntawm cov neeg soj ntsuam ntsuam xyuas ntawm SKAMP-DS thoob plaws 8 qhov kev ntsuam xyuas tau pom ntawm cov neeg mob thaum lawv tau txais Vyvanse piv rau cov neeg mob thaum lawv tau txais cov placebo (Study 2 hauv Table 6). Cov nyhuv ntawm cov tshuaj tau nce mus txog qhov tseem ceeb ntawm cov sij hawm 2 txog 12 teev tom qab noj, tab sis tsis tseem ceeb ntawm 1 teev.

Qhov thib ob ob qhov muag tsis pom kev, tshuaj placebo-tswj, randomized, crossover tsim, kev tshawb fawb hauv chav kawm analog (Study 3) tau ua rau cov neeg mob menyuam yaus hnub nyoog 6 txog 12 xyoo (N = 129) uas tau ntsib DSM-IV cov qauv rau ADHD (xws li hom kev sib xyaw ua ke. los yog hom hyperactive-impulsive). Tom qab 4 lub lis piam qhib-daim ntawv lo optimization nrog Vyvanse (30 mg, 50 mg, 70 mg), cov neeg mob tau random xa mus txuas ntxiv lawv cov tshuaj kho kom zoo ntawm Vyvanse lossis placebo ib hnub ib hnub thaum sawv ntxov rau 1 lub lis piam txhua qhov kev kho mob. Qhov sib txawv tseem ceeb ntawm tus neeg mob tus cwj pwm, raws li qhov nruab nrab ntawm cov neeg soj ntsuam ntsuam xyuas ntawm SKAMP-Deportment cov qhab nia hla txhua 7 qhov kev ntsuam xyuas ua ntawm 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, thiab 13.0 teev tom qab noj tshuaj, tau pom ntawm cov neeg mob thaum lawv tau txais Vyvanse piv rau cov neeg mob thaum lawv tau txais cov placebo (Study 3 hauv Table 6, Daim duab 4).

Cov neeg mob menyuam yaus hnub nyoog 13 txog 17 xyoo nrog ADHD

Ob qhov muag tsis pom kev, randomized, placebo-tswj, kev tshawb fawb ntawm pawg sib npaug (Study 4) tau ua rau cov neeg mob menyuam yaus hnub nyoog 13 txog 17 xyoo (N = 314) uas tau ntsib DSM-IV cov qauv rau ADHD. Nyob rau hauv txoj kev tshawb no, cov neeg mob tau randomized nyob rau hauv ib tug 1: 1: 1: 1 piv rau ib hnub sawv ntxov koob ntawm Vyvanse (30 mg / hnub, 50 mg / hnub los yog 70 mg / hnub) los yog placebo rau tag nrho plaub lub lis piam ntawm kev kho mob. . Txhua tus neeg mob tau txais Vyvanse tau pib ntawm 30 mg rau thawj lub lim tiam ntawm kev kho mob. Cov neeg mob tau muab rau pawg koob tshuaj 50 mg thiab 70 mg tau titrated los ntawm 20 mg ib lub lis piam mus txog thaum lawv ua tiav lawv cov koob tshuaj. Thawj qhov txiaj ntsig tau zoo yog hloov pauv hauv Tag Nrho Cov qhab nia los ntawm qhov pib mus rau qhov kawg hauv cov neeg soj ntsuam ntsuam xyuas ntawm ADHD Rating Scale (ADHD-RS). Endpoint tau txhais tias yog lub lim tiam dhau los tom qab kev kho mob randomization (piv txwv li, Lub lis piam 1 txog 4) uas tau txais cov qhab nia siv tau. Txhua pawg koob tshuaj Vyvanse tau zoo dua rau cov placebo hauv thawj qhov txiaj ntsig tau zoo (Study 4 hauv Table 6).

Cov neeg mob menyuam yaus hnub nyoog 6 txog 17 xyoo: Kev kho mob luv luv hauv ADHD

Ob qhov muag tsis pom kev, randomized, placebo- thiab active-controlled parallel-group, dose-optimization study (Study 5) tau ua nyob rau hauv cov menyuam yaus hnub nyoog 6 txog 17 xyoo (n = 336) uas tau ntsib DSM-IV cov qauv rau ADHD. Hauv kev tshawb fawb yim lub lis piam no, cov neeg mob tau randomized rau ib hnub sawv ntxov koob ntawm Vyvanse (30, 50 lossis 70 mg / hnub), kev tswj hwm, lossis placebo (1: 1: 1). Txoj kev tshawb no suav nrog Lub Sijhawm Kev Tshuaj Xyuas thiab Kev Ncua Sijhawm (txog 42 hnub), 7-lub limtiam Ob-qhov muag tsis pom kev soj ntsuam Lub Sijhawm (suav nrog 4-lub limtiam Dose-Optimization Lub Sijhawm ua raws li 3-lub limtiam Dose-Maintenance Period), thiab 1-lub lis piam ntxuav thiab ua raws sijhawm. Thaum Lub Sijhawm Kev Siv Tshuaj Zoo Tshaj Plaws, cov ntsiab lus tau titrated kom txog rau thaum qhov kev pom zoo, raws li kev zam thiab tus neeg soj ntsuam qhov kev txiav txim, tau mus txog. Vyvanse tau pom tias muaj txiaj ntsig zoo dua li cov placebo. Cov placebo-hloov txhais tau tias txo los ntawm lub hauv paus hauv ADHD-RS-IV tag nrho cov qhab nia yog 18.6. Cov ncauj lus ntawm Vyvanse kuj tau pom tias muaj kev txhim kho ntau dua ntawm Kev Kho Mob Ntiaj Teb Kev Txaus Siab-Kev Txhim Kho (CGI-I) qhov ntsuas ntsuas piv rau cov ntsiab lus ntawm cov placebo (Study 5 hauv Table 6).

Cov neeg mob menyuam yaus hnub nyoog 6 txog 17 xyoo: Kev Kho Mob hauv ADHD

Kev Saib Xyuas Kev Ua Haujlwm Zoo (Study 6) - Ob qhov muag tsis pom kev, tswj cov placebo, randomized tshem tawm kev tshawb fawb tau ua rau cov neeg mob menyuam yaus hnub nyoog 6 txog 17 xyoo (N = 276) uas tau ntsib qhov kev kuaj mob ntawm ADHD (DSM-IV cov qauv). Tag nrho ntawm 276 tus neeg mob tau cuv npe rau hauv txoj kev tshawb no, 236 tus neeg mob tau koom nrog hauv Kev Kawm 5 thiab 40 yam kev kawm ncaj qha. Cov ncauj lus raug kho nrog qhib-daim ntawv Vyvanse tsawg kawg 26 lub lis piam ua ntej raug soj ntsuam rau kev nkag mus rau lub sijhawm rho tawm randomized. Cov neeg mob tsim nyog yuav tsum ua kom pom kev kho mob raws li tau hais los ntawm CGI-S<3 and Total Score on the ADHD-RS ≦22. Patients that maintained treatment response for 2 weeks at the end of the open label treatment period were eligible to be randomized to ongoing treatment with the same dose of Vyvanse (N=78) or switched to placebo (N=79) during the double-blind phase. Patients were observed for relapse (treatment failure) during the 6 week double blind phase. A significantly lower proportion of treatment failures occurred among Vyvanse subjects (15.8%) compared to placebo (67.5%) at endpoint of the randomized withdrawal period. The endpoint measurement was defined as the last post-randomization treatment week at which a valid ADHD-RS Total Score and CGI-S were observed. Treatment failure was defined as a ≧50% increase (worsening) in the ADHD-RS Total Score and a ≧2-point increase in the CGI-S score compared to scores at entry into the double-blind randomized withdrawal phase. Subjects who withdrew from the randomized withdrawal period and who did not provide efficacy data at their last on-treatment visit were classified as treatment failures (Study 6, Figure 5).

Cov neeg laus: Kev kho mob luv luv hauv ADHD

Ob qhov muag tsis pom kev, randomized, tshuaj placebo-tswj, kev tshawb fawb ua ke ntawm pawg (Study 7) tau ua rau cov neeg laus hnub nyoog 18 txog 55 (N = 420) uas tau ntsib DSM-IV cov qauv rau ADHD. Nyob rau hauv txoj kev tshawb no, cov neeg mob tau randomized kom tau txais koob tshuaj zaum kawg ntawm 30 mg, 50 mg, los yog 70 mg ntawm Vyvanse los yog placebo rau tag nrho plaub lub lis piam ntawm kev kho mob. Txhua tus neeg mob tau txais Vyvanse tau pib ntawm 30 mg rau thawj lub lim tiam ntawm kev kho mob. Cov neeg mob tau muab rau pawg koob tshuaj 50 mg thiab 70 mg tau titrated los ntawm 20 mg ib lub lis piam mus txog thaum lawv ua tiav lawv cov koob tshuaj. Thawj qhov txiaj ntsig tau zoo yog hloov pauv hauv Tag Nrho Cov qhab nia los ntawm qhov pib mus rau qhov kawg hauv cov neeg soj ntsuam ntsuam xyuas ntawm ADHD Rating Scale (ADHD-RS). Endpoint tau txhais tias yog lub lim tiam dhau los tom qab kev kho mob randomization (piv txwv li, Lub lis piam 1 txog 4) uas tau txais cov qhab nia siv tau. Txhua pawg koob tshuaj Vyvanse tau zoo dua rau cov placebo hauv thawj qhov kev ua tau zoo (Study 7 hauv Table 6).

Qhov thib ob txoj kev tshawb no yog ib tug ntau-center, randomized, ob-dig muag, placebo-tswj, cross-over, hloov analog classroom study (Study 8) ntawm Vyvanse los simulate ib qho chaw ua hauj lwm nyob rau hauv 142 cov neeg laus hnub nyoog 18 mus rau 55 xyoo uas tau ntsib DSM-IV. -TR cov qauv rau ADHD. Muaj 4 lub lis piam qhib-daim ntawv lo, theem kev ua kom zoo dua nrog Vyvanse (30 mg / hnub, 50 mg / hnub, lossis 70 mg / hnub thaum sawv ntxov). Tom qab ntawd cov neeg mob tau randomized rau ib qho ntawm ob txoj kev kho mob: 1) Vyvanse (cov tshuaj kho kom zoo) ua raws li cov placebo, txhua lub lim tiam, lossis 2) cov placebo ua raws li Vyvanse, txhua lub lis piam. Kev ntsuas kev ua tau zoo tau tshwm sim thaum kawg ntawm txhua lub lim tiam, siv Cov Khoom Siv Ua Haujlwm Mus Ib Txhis Ntsuas Kev Ua Haujlwm (PERMP), kev ntsuas txuj ci kho lej uas ntsuas kev saib xyuas hauv ADHD. PERMP tag nrho cov qhab nia tau los ntawm cov lej ntawm tus lej ntawm cov teeb meem lej sim ntxiv rau cov lej ntawm cov teeb meem lej teb kom raug. Kev kho Vyvanse, piv rau cov placebo, ua rau muaj kev txhim kho tseem ceeb hauv kev saib xyuas thoob plaws txhua lub sijhawm tom qab koob tshuaj, raws li ntsuas los ntawm qhov nruab nrab PERMP tag nrho cov qhab nia nyob rau hauv ib hnub kev ntsuam xyuas, nrog rau txhua lub sijhawm ntsuas. Cov kev ntsuam xyuas PERMP tau raug tswj hwm ntawm koob tshuaj ua ntej (-0.5 teev) thiab tom qab 2, 4, 8, 10, 12, thiab 14 teev tom qab koob tshuaj (Kev Kawm 8 hauv Table 6, Daim duab 6).

Cov Neeg Laus: Kev Kho Mob hauv ADHD

Ob qhov muag tsis pom kev, tshuaj placebo-tswj, randomized tshem tawm tsim kev tshawb fawb (Study 9) tau ua rau cov neeg laus hnub nyoog 18 txog 55 (N = 123) uas muaj ntaub ntawv kuaj mob ADHD lossis ua tau raws li DSM-IV cov qauv rau ADHD. Ntawm kev kawm nkag, cov neeg mob yuav tsum muaj ntaub ntawv kho mob nrog Vyvanse tsawg kawg yog 6 lub hlis thiab yuav tsum tau ua kom pom kev kho mob raws li tau hais tseg los ntawm Clinical Global Impression Severity (CGI-S) ≦3 thiab Tag Nrho Cov qhab nia ntawm ADHD-RS<22. ADHD-RS Total Score is a measure of core symptoms of ADHD. The CGI-S score assesses the clinician's impression of the patient's current illness state and ranges from 1 (not at all ill) to 7 (extremely ill). Patients that maintained treatment response at Week 3 of the open label treatment phase (N=116) were eligible to be randomized to ongoing treatment with the same dose of Vyvanse (N=56) or switched to placebo (N=60) during the double-blind phase. Patients were observed for relapse (treatment failure) during the 6-week double-blind phase. The efficacy endpoint was the proportion of patients with treatment failure during the double-blind phase. Treatment failure was defined as a ≧50% increase (worsening) in the ADHD-RS Total Score and ≧2-point increase in the CGI-S score compared to scores at entry into the double-blind phase. Maintenance of efficacy for patients treated with Vyvanse was demonstrated by the significantly lower proportion of patients with treatment failure (9%) compared to patients receiving placebo (75%) at endpoint during the double-blind phase (Study 9, Figure 7).

Daim duab 4 LS txhais tau tias SKAMP Kev Ncua Sijhawm Cov Qhab Nia los ntawm Kev Kho Mob thiab Lub Sijhawm-point rau Cov Neeg Mob Me Me Hnub nyoog 6 txog 12 nrog ADHD tom qab 1 Lub Limtiam Kev Kho Mob Ob Qhov Muag (Study 3)

Cov qhab nias siab dua ntawm SKAMP-Deportment scale qhia tias muaj cov tsos mob hnyav dua

Daim duab 5 Kaplan-Meier kwv yees qhov feem ntawm cov neeg mob nrog kev kho mob tsis ua hauj lwm rau cov neeg mob uas muaj hnub nyoog 6 txog 17 xyoo (Study 6)

Daim duab 6 LS Mean (SE) PERMP Tag Nrho Cov qhab nia los ntawm Kev Kho Mob thiab Lub Sijhawm-point rau Cov Neeg Laus Hnub nyoog 18 txog 55 nrog ADHD tom qab 1 Lub Limtiam Kev Kho Mob Ob Qhov Muag (Study 8)

Cov qhab-nees siab dua ntawm PERMP qhia tau tias muaj cov tsos mob hnyav dua.

Daim duab 7 Kaplan-Meier kwv yees qhov feem ntawm cov kev kawm nrog rov qab los rau cov neeg laus nrog ADHD (Study 9)

Binge Eating Disorder (BED)

Ib txoj kev tshawb fawb theem 2 tau soj ntsuam qhov ua tau zoo ntawm Vyvanse 30, 50 thiab 70 mg / hnub piv rau cov placebo hauv kev txo cov naj npawb ntawm binge hnub / lub lis piam hauv cov neeg laus uas muaj tsawg kawg yog nruab nrab mus rau BED hnyav. Qhov no randomized, ob-dig muag, sib npaug-pab pawg, placebo-tswj, yuam-dose titration txoj kev kawm (Study 10) muaj 11-lub lim tiam ob-dig muag kev kho mob lub sij hawm (3 lub lis piam ntawm yuam-dose titration tom qab 8 lub lis piam ntawm kev kho tshuaj. ). Vyvanse 30 mg / hnub tsis sib txawv ntawm cov placebo ntawm thawj qhov kawg. Qhov koob tshuaj 50 thiab 70 mg / hnub tau suav hais tias zoo dua rau cov placebo ntawm thawj qhov kawg.

Kev ua tau zoo ntawm Vyvanse hauv kev kho mob ntawm BED tau pom nyob rau hauv ob lub lis piam 12-lub lim tiam randomized, ob-dig muag, ntau-center, parallel-pab pawg, tshuaj placebo-tswj, kev tshawb fawb koob tshuaj (Study 11 thiab Study 12) hauv cov neeg laus hnub nyoog 18- 55 xyoo (Study 11: N = 374, Kawm 12: N = 350) nrog rau nruab nrab mus rau hnyav BED. Kev kuaj mob ntawm BED tau lees paub siv DSM-IV cov qauv rau BED. Qhov hnyav ntawm BED tau txiav txim siab raws li muaj tsawg kawg 3 hnub nyob rau ib lub lis piam rau 2 lub lis piam ua ntej mus ntsib lub hauv paus thiab muaj qhov Clinical Global Impression Severity (CGI-S) qhab nia ntawm ≧4 ntawm qhov kev mus ntsib hauv paus. Rau ob txoj kev tshawb fawb, ib hnub binge tau txhais tias yog ib hnub nrog tsawg kawg yog 1 binge rov, raws li tau txiav txim los ntawm qhov kev kawm txhua hnub binge diary.

Ob qho kev tshawb fawb 12-lub lim tiam muaj 4-lub lim tiam-kev siv tshuaj-qhov zoo tshaj plaws thiab lub sijhawm 8-lub lim tiam-tswj tshuaj. Thaum noj tshuaj kom zoo, cov neeg mob tau muab rau Vyvanse pib kho ntawm qhov koob tshuaj titration ntawm 30 mg / hnub thiab, tom qab 1 lub lis piam ntawm kev kho mob, tom qab ntawd titrated rau 50 mg / hnub. Kev nce ntxiv mus rau 70 mg / hnub tau ua raws li kev zam thiab kev kho mob qhia. Tom qab lub sijhawm tshuaj xyuas kom zoo, cov neeg kawm txuas ntxiv ntawm lawv cov koob tshuaj kom zoo rau lub sijhawm ntawm lub sijhawm kho tshuaj.

Thawj qhov txiaj ntsig tau zoo rau ob txoj kev tshawb fawb tau txhais tias yog qhov hloov pauv ntawm qhov pib ntawm Lub Limtiam 12 hauv cov naj npawb ntawm binge hnub hauv ib lub lis piam. Lub hauv paus yog txhais raws li qhov nruab nrab txhua lub lim tiam ntawm cov naj npawb ntawm binge hnub hauv ib lub lis piam rau 14 hnub ua ntej mus ntsib hauv paus. Cov ncauj lus los ntawm ob qho kev tshawb fawb ntawm Vyvanse tau txo qis ntau dua los ntawm cov hauv paus hauv cov ntsiab lus ntawm cov hnub binge hauv ib lub lis piam ntawm Lub Limtiam 12. Tsis tas li ntawd, cov ntsiab lus ntawm Vyvanse tau pom tias muaj kev txhim kho ntau dua li piv rau cov placebo hla cov txiaj ntsig thib ob uas muaj feem ntau ntawm cov kev kawm tau zoo dua. ntawm CGI-I rating scale, ntau dua ntawm cov kev kawm nrog 4-lub lim tiam binge cessation, thiab ntau dua txo nyob rau hauv lub Yale-Brown Obsessive Compulsive Scale Hloov kho rau Binge noj (Y-BOCS-BE) tag nrho cov qhab nia.

Ob qhov muag tsis pom kev, cov placebo tswj, randomized tshem tawm txoj kev tshawb fawb (Study 13) tau ua los ntsuas kev saib xyuas kev ua tau zoo raws li lub sijhawm rov qab los ntawm Vyvanse thiab placebo hauv cov neeg laus hnub nyoog 18 txog 55 (N = 267) nrog rau nruab nrab mus rau BED hnyav. Hauv qhov kev tshawb fawb ntev ntev no cov neeg mob uas tau teb rau Vyvanse hauv 12 lub lis piam ua ntej qhib-label kho theem tau randomized mus txuas ntxiv ntawm Vyvanse lossis placebo txog li 26 lub lis piam ntawm kev soj ntsuam rau kev rov qab los. Teb nyob rau theem qhib-daim ntawv lo tau txhais tias yog 1 lossis tsawg dua binge hnub txhua lub lis piam rau plaub lub lis piam sib law liag ua ntej mus ntsib zaum kawg thaum kawg ntawm 12-lub lim tiam qhib-label theem thiab CGI-S qhab nia ntawm 2 lossis tsawg dua ntawm tib mus saib. Kev rov ua dua thaum lub sijhawm ob qhov muag tsis pom kev tau txhais tias muaj 2 lossis ntau dua binge hnub txhua lub lis piam rau ob lub lis piam sib law liag (14 hnub) ua ntej kev mus ntsib thiab muaj qhov nce hauv CGI-S qhab nia ntawm 2 lossis ntau dua cov ntsiab lus piv rau randomized-tho rho tawm. hauv paus. Kev saib xyuas kev ua tau zoo rau cov neeg mob uas tau teb thawj zaug thaum lub sij hawm qhib-daim ntawv lo thiab tom qab ntawd txuas ntxiv rau Vyvanse thaum lub sij hawm 26-lub lim tiam ob-dig muag randomized-tshem tawm theem tau pom tias Vyvanse ua tau zoo tshaj cov placebo raws li ntsuas los ntawm lub sij hawm rov qab los.

Daim duab 8 Kaplan-Meier kwv yees qhov feem ntawm cov kev kawm nrog rov qab nyob rau hauv cov neeg laus nrog BED (Kev Kawm 13)

Kev tshuaj xyuas cov pab pawg neeg raws li hnub nyoog (tsis muaj cov neeg mob tshaj 65 xyoos), poj niam txiv neej, thiab haiv neeg tsis tau qhia meej cov pov thawj ntawm kev sib txawv ntawm kev kho BED.

Yuav Ua Li Cas Muab / Cia thiab tuav

Yuav Ua Li Cas

Vyvanse (lisdexamfetamine dimesylate) capsules:

• Vyvanse capsules 10 mg: liab lub cev / lub kaus mom liab (imprinted nrog S489 thiab 10 mg), fwj ntawm 100, NDC 59417-101-10
• Vyvanse capsules 20 mg: ivory body/ivory cap (imprinted with S489 and 20 mg), fwj 100, NDC 59417-102-10
• Vyvanse capsules 30 mg: dawb lub cev / txiv kab ntxwv cap (imprinted nrog S489 thiab 30 mg), fwj ntawm 100, NDC 59417-103-10
• Vyvanse capsules 40 mg: lub cev dawb / xiav ntsuab cap (imprinted nrog S489 thiab 40 mg), fwj ntawm 100, NDC 59417-104-10
• Vyvanse capsules 50 mg: white body/blue cap (imprinted with S489 and 50 mg), fwj 100, NDC 59417-105-10
• Vyvanse capsules 60 mg: aqua blue body/aqua blue cap (imprinted with S489 and 60 mg), fwj 100, NDC 59417-106-10
• Vyvanse capsules 70 mg: xiav lub cev / txiv kab ntxwv cap (imprinted nrog S489 thiab 70 mg), fwj ntawm 100, NDC 59417-107-10

Vyvanse (lisdexamfetamine dimesylate) chewable ntsiav tshuaj:

• Vyvanse chewable ntsiav tshuaj 10 mg: Dawb rau dawb-dawb puag ncig zoo li cov ntsiav tshuaj debossed nrog '10' ntawm ib sab thiab 'S489' ntawm lwm qhov, fwj ntawm 100, NDC 59417-115-01
• Vyvanse chewable tablets 20 mg: White to off-white hexagonal shaped tablet debossed with '20' on one side and 'S489' on the other, fwj ntawm 100, NDC 59417-116-01
• Vyvanse chewable ntsiav tshuaj 30 mg: Dawb mus rau dawb arc daim duab peb sab zoo li ntsiav tshuaj debossed nrog '30' ntawm ib sab thiab 'S489' ntawm lwm tus, fwj ntawm 100, NDC 59417-117-01
• Vyvanse chewable tablets 40 mg: White to off-white capsule shaped tablet debossed with '40' on one side and 'S489' on the other, fwj ntawm 100, NDC 59417-118-01
• Vyvanse chewable ntsiav tshuaj 50 mg: Dawb rau off-dawb arc square zoo li ntsiav tshuaj debossed nrog '50' ntawm ib sab thiab 'S489' ntawm lwm tus, fwj ntawm 100, NDC 59417-119-01
• Vyvanse chewable ntsiav tshuaj 60 mg: Dawb rau dawb arc pob zeb diamond zoo li ntsiav tshuaj debossed nrog '60' ntawm ib sab thiab 'S489' ntawm lwm tus, fwj ntawm 100, NDC 59417-120-01

Cia thiab tuav

Muab tso rau hauv lub thawv nruj, lub teeb-resistant raws li tau hais tseg hauv USP.

Khaws ntawm chav tsev kub, 20ºC txog 25ºC (68ºF txog 77ºF). Excursions tso cai ntawm 15ºC thiab 30ºC (59 txog 86ºF)[saib USP Controlled Room Temperature].

Kev pov tseg

Ua raws li cov cai hauv zos thiab cov kev cai ntawm kev pov tseg tshuaj ntawm CNS stimulants. Tshem tawm cov seem, tsis siv, lossis tas sij hawm Vyvanse los ntawm kev pab cuam kho mob rov qab.

Cov Ntaub Ntawv Qhia Txog Tus Neeg Mob

Qhia rau tus neeg mob kom nyeem daim ntawv teev cov neeg mob uas tau pom zoo los ntawm FDA (Kev Qhia Tshuaj).

Tswj Cov Khoom Siv Hluav Taws Xob / Muaj Peev Xwm Loj rau Kev Tsim Nyog thiab Kev Cia Siab

Qhia cov neeg mob tias Vyvanse yog cov tshuaj tswj tau thiab nws tuaj yeem raug tsim txom thiab ua rau muaj kev vam khom thiab tsis pub Vyvanse rau lwm tus.[saib Kev siv tshuaj yeeb thiab kev cia siab (9.1 , 9.2 ib , thiab 9.3) ]. Qhia cov neeg mob kom khaws Vyvanse rau hauv qhov chaw nyab xeeb, nyiam dua xauv, tiv thaiv kev tsim txom. Qhia cov neeg mob kom pov tseg cov khoom seem, tsis siv, lossis tas sij hawm Vyvanse los ntawm kev pab cuam kho mob rov qab.

Mob plawv txaus ntshai

Qhia rau cov neeg mob tias muaj peev xwm ua rau mob plawv mob hnyav nrog rau kev tuag sai, myocardial infarction, mob stroke, thiab kub siab nrog kev siv Vyvanse. Qhia cov neeg mob kom tiv tauj tus kws kho mob tam sim yog tias lawv muaj cov tsos mob xws li mob hauv siab, tsis tau piav qhia, lossis lwm yam tsos mob qhia txog kab mob plawv[saib Ceeb toom thiab ceev faj (5.2) ].

Ntshav siab thiab tachycardia

Qhia cov neeg mob tias Vyvanse tuaj yeem ua rau nce siab ntawm lawv cov ntshav siab thiab mem tes npaum li cas thiab lawv yuav tsum tau saib xyuas rau cov teebmeem no.

Psychiatric Risks

Qhia rau cov neeg mob tias Vyvanse ntawm koob tshuaj pom zoo yuav ua rau muaj kev puas siab puas ntsws lossis manic tsos mob txawm tias cov neeg mob tsis muaj keeb kwm yav dhau los ntawm cov tsos mob puas siab puas ntsws lossis mania[saib Ceeb toom thiab ceev faj (5.4) ].

Kev Tiv Thaiv Kev Loj Hlob

Qhia cov neeg mob tias Vyvanse tuaj yeem ua rau qeeb ntawm kev loj hlob nrog rau kev poob phaus[saib Ceeb toom thiab ceev faj (5.5) ].

Kev puas tsuaj rau lub peev xwm ua haujlwm tshuab lossis tsheb

Qhia rau cov neeg mob tias Vyvanse tuaj yeem ua rau lawv lub peev xwm ua rau muaj kev phom sij xws li kev siv tshuab lossis tsheb. Qhia cov neeg mob kom paub seb Vyvanse yuav cuam tshuam li cas rau lawv ua ntej koom nrog cov dej num uas txaus ntshai[saib Kev Tsis Pom Zoo (6.1 , 6.2) ].

Cov teeb meem hauv cov ntiv tes thiab ntiv taw [Peripheral vasculopathy, suav nrog Raynaud's phenomenon]

Qhia cov neeg mob pib kho nrog Vyvanse txog kev pheej hmoo ntawm peripheral vasculopathy, suav nrog Raynaud qhov tshwm sim, thiab cov cim qhia thiab cov tsos mob: ntiv tes lossis ntiv taw yuav hnov ​​​​tsw, txias, mob, thiab / lossis tuaj yeem hloov pauv ntawm daj ntseg, xiav, liab. Qhia cov neeg mob kom ceeb toom rau lawv tus kws kho mob txog qhov mob loog tshiab, mob, hloov xim ntawm daim tawv nqaij, lossis rhiab rau qhov kub ntawm cov ntiv tes lossis ntiv taw. Qhia cov neeg mob hu rau lawv tus kws kho mob tam sim ntawd nrog cov cim qhia ntawm qhov txhab uas tsis tau piav qhia tshwm sim ntawm cov ntiv tes lossis ntiv taw thaum noj Vyvanse. Kev soj ntsuam ntxiv (piv txwv li, rheumatology xa mus) yuav tsim nyog rau qee tus neeg mob[saib Ceeb toom thiab ceev faj (5.6) ].

Serotonin Syndrome

Ceev faj cov neeg mob txog kev pheej hmoo ntawm serotonin syndrome nrog kev siv Vyvanse thiab lwm yam tshuaj serotonergic suav nrog SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort, thiab nrog cov tshuaj uas cuam tshuam cov metabolism hauv cov metabolism (tshwj xeeb yog MAOIs, ob qho tib si cov uas npaj los kho cov kab mob puas hlwb thiab lwm yam xws li linezolid[saib Contraindications (4) , Ceeb toom thiab ceev faj (5.7) thiab Kev Sib Tham Txog Tshuaj (7.1) ]. Qhia rau cov neeg mob hu rau lawv tus kws kho mob lossis ceeb toom rau chav xwm txheej ceev yog tias lawv pom cov tsos mob lossis cov tsos mob ntawm serotonin syndrome.

Concomitant Tshuaj

Qhia rau cov neeg mob kom ceeb toom rau lawv cov kws kho mob yog tias lawv noj, lossis npaj yuav noj, cov tshuaj noj lossis tshuaj tom khw muag khoom vim tias muaj peev xwm sib cuam tshuam[saib Kev Sib Tham Txog Tshuaj (7.1) ].

Kev xeeb tub

Qhia rau cov neeg mob txog qhov muaj peev xwm fetus cuam tshuam los ntawm kev siv Vyvanse thaum cev xeeb tub. Qhia cov neeg mob kom ceeb toom rau lawv tus kws kho mob yog tias lawv xeeb tub lossis npaj siab yuav xeeb tub thaum kho nrog Vyvanse[saib Siv hauv Cov Pej Xeem Tshwj Xeeb (8.1) ].

lactation

Qhia cov poj niam tsis txhob pub niam mis yog tias lawv noj Vyvanse[saib Siv hauv Cov Pej Xeem Tshwj Xeeb (8.2) ].

Cov lus qhia kev tswj hwm

• Capsules: Qhia cov neeg mob kom noj cov tshuaj ntsiav tag nrho lossis khoob thiab sib tov tag nrho cov ntsiab lus nrog yogurt, dej, los yog kua txiv kab ntxwv. Qhia cov neeg mob kom haus cov tshuaj sib tov tam sim ntawd thiab tsis txhob khaws cia rau yav tom ntej[saib Dosage thiab Administration (2.2) ].
• Chewable tablets: Qhia rau cov neeg mob tias cov ntsiav tshuaj chewable yuav tsum tau chewable kom huv si ua ntej nqos[saib Dosage thiab Administration (2.2) ].

Muab faib los ntawm:
Takeda Pharmaceuticals America, Inc.
Lexington, MA 02421

Ua hauv teb chaws USA

Yog xav paub ntxiv hu rau 1-800-828-2088

Vyvanse®thiab Vyvanse Logo®yog cov npe lag luam ntawm Takeda Pharmaceuticals USA, Inc.

© 2021 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved.

US Pat No. 7,105,486, 7,223,735, 7,655,630, 7,659,253, 7,659,254, 7,662,787, 7,662,788, 7,671,030, 7,671,031, 7,674,774, 7,678,770, 7,678,771, 7,687,466, 7,687,467, 7,713,936, 7,718,936, 7,718,619

PRINCIPAL DISPLAY PANEL - 10 mg Capsule Bottle Label

NDC 59417-101-10

Vyvanse®
(lisdexamfetamine
dimesylate) capsules

10 mg

CII
Rx xwb

100 CAPSULES
Takeda

PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Label

NDC 59417-102-10

Vyvanse®
(lisdexamfetamine
dimesylate) capsules

20 mg ib

CII
Rx xwb

100 CAPSULES
Takeda

PRINCIPAL DISPLAY PANEL - 30 mg Capsule Bottle Label

NDC 59417-103-10

Vyvanse®
(lisdexamfetamine
dimesylate) capsules

30 mg

CII
Rx xwb

100 CAPSULES
Takeda

PRINCIPAL DISPLAY PANEL - 40 mg Capsule Bottle Label

NDC 59417-104-10

Vyvanse®
(lisdexamfetamine
dimesylate) capsules

40 mg ib

CII
Rx xwb

100 CAPSULES
Takeda

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label

NDC 59417-105-10

Vyvanse®
(lisdexamfetamine
dimesylate) capsules

50 mg ib

CII
Rx xwb

100 CAPSULES
Takeda

PRINCIPAL DISPLAY PANEL - 60 mg Capsule Bottle Label

NDC 59417-106-10

Vyvanse®
(lisdexamfetamine
dimesylate) capsules

60 mg ib

CII
Rx xwb

100 CAPSULES
Takeda

PRINCIPAL DISPLAY PANEL - 70 mg Capsule Bottle Label

NDC 59417-107-10

Vyvanse®
(lisdexamfetamine
dimesylate) capsules

70mg ib

CII
Rx xwb

cov txiaj ntsig ntawm metformin

100 CAPSULES
Takeda

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NWS 59417-115-01

Vyvanse®
(lisdexamfetamine
dimesylate) cov ntsiav tshuaj chewable

10 mg

100 CHEWABLE
NPAJ

Chew cov ntsiav tshuaj kom tiav
ua ntej nqos. Ua
tsis nqos ntsiav tshuaj tag nrho.

CII
Rx xwb
Takeda

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label

NWS 59417-116-01

Vyvanse®
(lisdexamfetamine
dimesylate) cov ntsiav tshuaj chewable

20 mg ib

100 CHEWABLE
NPAJ

Chew cov ntsiav tshuaj kom tiav
ua ntej nqos. Ua
tsis nqos ntsiav tshuaj tag nrho.

CII
Rx xwb
Takeda

PRINCIPAL DISPLAY PANEL - 30 mg Tablet Bottle Label

NWS 59417-117-01

Vyvanse®
(lisdexamfetamine
dimesylate) cov ntsiav tshuaj chewable

30 mg

100 CHEWABLE
NPAJ

Chew cov ntsiav tshuaj kom tiav
ua ntej nqos. Ua
tsis nqos ntsiav tshuaj tag nrho.

CII
Rx xwb
Takeda

PRINCIPAL DISPLAY PANEL - 40 mg Tablet Bottle Label

NWS 59417-118-01

Vyvanse®
(lisdexamfetamine
dimesylate) cov ntsiav tshuaj chewable

40 mg ib

100 CHEWABLE
NPAJ

Chew cov ntsiav tshuaj kom tiav
ua ntej nqos. Ua
tsis nqos ntsiav tshuaj tag nrho.

CII
Rx xwb
Takeda

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label

NWS 59417-119-01

Vyvanse®
(lisdexamfetamine
dimesylate) cov ntsiav tshuaj chewable

50 mg ib

100 CHEWABLE
NPAJ

Chew cov ntsiav tshuaj kom tiav
ua ntej nqos. Ua
tsis nqos ntsiav tshuaj tag nrho.

CII
Rx xwb
Takeda

PRINCIPAL DISPLAY PANEL - 60 mg Tablet Bottle Label

NWS 59417-120-01

Vyvanse®
(lisdexamfetamine
dimesylate) cov ntsiav tshuaj chewable

60 mg ib

100 CHEWABLE
NPAJ

Chew cov ntsiav tshuaj kom tiav
ua ntej nqos. Ua
tsis nqos ntsiav tshuaj tag nrho.

CII
Rx xwb
Takeda