ABILIFY MAINTENA- aripiprazole kit

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)

Mevcut itibaren:

Otsuka America Pharmaceutical, Inc.

INN (International Adı):

aripiprazole

Kompozisyon:

aripiprazole 300 mg in 1.5 mL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

ABILIFY MAINTENA (aripiprazole) is indicated for: - Treatment of schizophrenia in adults [see Clinical Studies (14.1)] - Maintenance monotherapy treatment of bipolar I disorder in adults [see Clinical Studies (14.2)] ABILIFY MAINTENA is contraindicated in patients with a known hypersensitivity to aripiprazole. Hypersensitivity reactions ranging from pruritus/urticaria to anaphylaxis have been reported in patients receiving aripiprazole [see Adverse Reactions (6.1 and 6.2)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ABILIFY during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs, including ABILIFY MAINTENA, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. There are insufficient data with ABILIFY MAINTENA use in pregnant women to inform a drug-associated risk. In animal reproduction studies, oral and intravenous aripiprazole administration during organogenesis in rats and/or rabbits at doses 10 and 11 times, respectively, the maximum recommended human dose (MRHD) produced fetal death, decreased fetal weight, undescended testicles, delayed skeletal ossification, skeletal abnormalities, and diaphragmatic hernia. Oral and intravenous aripiprazole administration during the pre- and post-natal period in rats at doses 10 times the MRHD produced prolonged gestation, stillbirths, decreased pup weight, and decreased pup survival. Consider the benefits and risks of ABILIFY MAINTENA and possible risks to the fetus when prescribing ABILIFY MAINTENA to a pregnant woman. Advise pregnant women of potential fetal risk. The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs (including oral aripiprazole) during the third trimester of pregnancy. These symptoms have varied in severity. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Monitor neonates exhibiting extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Animal Data In animal studies, aripiprazole demonstrated developmental toxicity, including possible teratogenic effects in rats and rabbits. Pregnant rats were treated with oral doses of 3, 10, and 30 mg/kg/day which are approximately 1 to 10 times the MRHD of 30 mg/day on mg/m2 basis of aripiprazole during the period of organogenesis. Treatment at the highest dose caused a slight prolongation of gestation and delay in fetal development, as evidenced by decreased fetal weight and undescended testes. Delayed skeletal ossification was observed at 3 and 10 times the oral MRHD on mg/m2 basis. At 3 and 10 times the oral MRHD on mg/m2 basis, delivered offspring had decreased body weights. Increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia were observed in offspring from the highest dose group (the other dose groups were not examined for these findings). Postnatally, delayed vaginal opening was seen at 3 and 10 times the oral MRHD on mg/m2 basis and impaired reproductive performance (decreased fertility rate, corpora lutea, implants, live fetuses, and increased post-implantation loss, likely mediated through effects on female offspring) along with some maternal toxicity were seen at the highest dose; however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity. In pregnant rats treated with aripiprazole intravenously at doses of 3, 9, and 27 mg/kg/day, which are 1 to 9 times the oral MRHD on mg/m2 basis, during the period of organogenesis, decreased fetal weight and delayed skeletal ossification were seen at the highest dose which also caused maternal toxicity. In pregnant rabbits treated with oral doses of 10, 30, and 100 mg/kg/day which are 2 to 11 times human exposure at the oral MRHD based on AUC and 6 to 65 times the oral MRHD of aripiprazole on mg/m2 basis during the period of organogenesis, decreased maternal food consumption and increased abortions were seen at the highest dose as well as increased fetal mortality. Decreased fetal weight and increased incidence of fused sternebrae were observed at 3 and 11 times the MRHD based on AUC. In pregnant rabbits receiving aripiprazole injection intravenously at doses of 3, 10, and 30 mg/kg/day, which are 2 to 19 times the oral MRHD on mg/m2 basis during the period of organogenesis, the highest dose caused pronounced maternal toxicity that resulted in decreased fetal weight, increased fetal abnormalities (primarily skeletal), and decreased fetal skeletal ossification. The fetal no-effect dose was 5 times the human exposure at the oral MRHD based on AUC and is 6 times the oral MRHD on mg/m2 basis. In rats treated with oral doses of 3, 10, and 30 mg/kg/day, which are 1 to 10 times the oral MRHD of aripiprazole on a mg/m2 basis, peri- and post-natally (from Day 17 of gestation through Day 21 postpartum), slight maternal toxicity and slightly prolonged gestation were seen at the highest dose. An increase in stillbirths and decreases in pup weight (persisting into adulthood) and survival were also seen at this dose. In rats treated with aripiprazole intravenously at doses of 3, 8, and 20 mg/kg/day which are 1 to 6 times the oral MRHD on mg/m2 basis from Day 6 of gestation through Day 20 postpartum, increased stillbirths were seen at 3 and 6 times the MRHD on mg/m2 basis, and decreases in early postnatal pup weight and survival were seen at the highest dose; these doses produced some maternal toxicity. There were no effects on postnatal behavioral and reproductive development. Risk Summary Aripiprazole is present in human breast milk; however, there are insufficient data to assess the amount in human milk, the effects on the breastfed infant, or the effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for ABILIFY MAINTENA and any potential adverse effects on the breastfed infant from ABILIFY MAINTENA or from the underlying maternal condition. ABILIFY MAINTENA has not been studied in children 18 years of age or younger. However, juvenile animal studies have been conducted in rats and dogs. Juvenile Animal Studies Aripiprazole in juvenile rats caused mortality, CNS clinical signs, impaired memory and learning, and delayed sexual maturation when administered at oral doses of 10, 20, 40 mg/kg/day from weaning (21 days old) through maturity (80 days old). At 40 mg/kg/day, mortality, decreased activity, splayed hind limbs, hunched posture, ataxia, tremors and other CNS signs were observed in both genders. In addition, delayed sexual maturation was observed in males. At all doses and in a dose-dependent manner, impaired memory and learning, increased motor activity, and histopathology changes in the pituitary (atrophy), adrenals (adrenocortical hypertrophy), mammary glands (hyperplasia and increased secretion), and female reproductive organs (vaginal mucification, endometrial atrophy, decrease in ovarian corpora lutea) were observed. The changes in female reproductive organs were considered secondary to the increase in prolactin serum levels. A No Observed Adverse Effect Level (NOAEL) could not be determined and, at the lowest tested dose of 10 mg/kg/day, there is no safety margin relative to the systemic exposures (AUC0-24 ) for aripiprazole or its major active metabolite in adolescents at the maximum recommended pediatric dose of 15 mg/day. All drug-related effects were reversible after a 2-month recovery period, and most of the drug effects in juvenile rats were also observed in adult rats from previously conducted studies. Aripiprazole in juvenile dogs (2 months old) caused CNS clinical signs of tremors, hypoactivity, ataxia, recumbency and limited use of hind limbs when administered orally for 6 months at 3, 10, 30 mg/kg/day. Mean body weight and weight gain were decreased up to 18% in females in all drug groups relative to control values. A NOAEL could not be determined and, at the lowest tested dose of 3 mg/kg/day, there is no safety margin relative to the systemic exposures (AUC0-24 ) for aripiprazole or its major active metabolite in adolescents at the maximum recommended pediatric dose of 15 mg/day. All drug-related effects were reversible after a 2-month recovery period. Clinical studies of oral aripiprazole did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience and pharmacokinetic data [see Clinical Pharmacology (12.3)] have not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In single-dose and multiple-dose pharmacokinetic studies, there was no detectable age effect in the population pharmacokinetic analysis of oral aripiprazole in schizophrenia patients [see Clinical Pharmacology (12.3)] . No dosage adjustments are recommended based on age alone. ABILIFY MAINTENA is not approved for the treatment of patients with dementia-related psychosis [see also Boxed Warning and Warnings and Precautions (5.1)]. Dosage adjustment is recommended in known CYP2D6 poor metabolizers due to high aripiprazole concentrations. Approximately 8% of Caucasians and 3% to 8% of Black/African Americans cannot metabolize CYP2D6 substrates and are classified as poor metabolizers (PM) [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)] . No dosage adjustment for ABILIFY MAINTENA is required on the basis of a patient's hepatic function (mild to severe hepatic impairment, Child-Pugh score between 5 and 15), or renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 mL/minute) [see Clinical Pharmacology (12.3)] . No dosage adjustment for ABILIFY MAINTENA is required on the basis of a patient's sex, race, or smoking status [see Clinical Pharmacology (12.3)] .

Ürün özeti:

Pre-filled Dual Chamber Syringe: ABILIFY MAINTENA (aripiprazole) pre-filled dual chamber syringe for extended-release injectable suspension in single-use syringes is available in 300-mg or 400-mg strength syringes. The pre-filled dual chamber syringe consists of a front chamber that contains the lyophilized powder of aripiprazole monohydrate and a rear chamber that contains sterile water for injection. The 300-mg kit includes (NDC 59148-045-80): The 400-mg kit includes (NDC 59148-072-80): Single-Use Vial: ABILIFY MAINTENA (aripiprazole) extended-release injectable suspension in single-use vials is available in 300-mg or 400-mg strength vials. The 300-mg kit includes (NDC 59148-018-71): The 400-mg kit includes (NDC 59148-019-71): Pre-filled dual chamber syringe: Store below 30°C [86°F]. Do not freeze. Protect the syringe from light by storing in the original package until time of use. Vial: Store at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Yetkilendirme durumu:

New Drug Application

Bilgilendirme broşürü

Otsuka America Pharmaceutical, Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 06/2020
MEDICATION GUIDE
ABILIFY MAINTENA® (a-BIL-i-fy main-TEN-a)
(aripiprazole) for extended-release injectable suspension, for
intramuscular use
What is the most important information I should know about ABILIFY
MAINTENA?
Each injection of ABILIFY MAINTENA must be administered by a
healthcare provider only.
ABILIFY MAINTENA may cause serious side effects, including:
•
Increased risk of death in elderly people with dementia-related
psychosis. ABILIFY MAINTENA
is not for the treatment of people who have lost touch with reality
(psychosis) due to confusion
and memory loss (dementia).
What is ABILIFY MAINTENA?
ABILIFY MAINTENA is a prescription medicine given by injection by a
healthcare provider for:
•
treatment of schizophrenia in adults
•
maintenance treatment of bipolar I disorder in adults
It is not known if ABILIFY MAINTENA is safe and effective in children
under 18 years of age.
Do not receive ABILIFY MAINTENA if you are allergic to aripiprazole or
any of the ingredients in
ABILIFY MAINTENA. See the end of this Medication Guide for a complete
list of ingredients in
ABILIFY MAINTENA.
Before receiving ABILIFY MAINTENA, tell your healthcare provider about
all your medical conditions,
including if you:
•
have never taken aripiprazole before
•
have diabetes or high blood sugar or a family history of diabetes or
high blood sugar. Your
healthcare provider should check your blood sugar before you start
receiving ABILIFY
MAINTENA and during your treatment.
•
have or had seizures (convulsions)
•
have or had low or high blood pressure
•
have or had heart problems or a stroke
•
have or had a low white blood cell count
•
have problems that may affect you receiving an injection in your arm
or buttocks
•
are pregnant or plan to become pregnant. It is not known if ABILIFY
MAINTENA will harm
your unborn baby.
•
If you become pregnant while receiving ABILIFY MAINTE

Ürün özellikleri

ABILIFY MAINTENA- ARIPIPRAZOLE
OTSUKA AMERICA PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABILIFY MAINTENA SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ABILIFY
MAINTENA.
ABILIFY MAINTENA (ARIPIPRAZOLE) FOR EXTENDED-RELEASE INJECTABLE
SUSPENSION, FOR
INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 2002
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS
ARE AT AN INCREASED RISK OF DEATH (5.1)
ABILIFY MAINTENA IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH
DEMENTIA-
RELATED PSYCHOSIS (5.1)
INDICATIONS AND USAGE
ABILIFY MAINTENA is an atypical antipsychotic indicated for:
Treatment of schizophrenia in adults (1)
Maintenance monotherapy treatment of bipolar I disorder in adults (1)
DOSAGE AND ADMINISTRATION
Only to be administered by intramuscular injection in the deltoid or
gluteal muscle by a healthcare
professional (2.1)
For patients naïve to aripiprazole, establish tolerability with oral
aripiprazole prior to initiating ABILIFY
MAINTENA (2.1)
Recommended starting and maintenance dose is 400 mg administered
monthly as a single injection.
Dose can be reduced to 300 mg in patients with adverse reactions (2.1)
In conjunction with first dose, take 14 consecutive days of concurrent
oral aripiprazole (10 mg to 20 mg)
or current oral antipsychotic (2.1)
Dosage adjustments are required for missed doses (2.2)
Known CYP2D6 poor metabolizers: Recommended starting and maintenance
dose is 300 mg
administered monthly as a single injection (2.3)
ABILIFY MAINTENA comes in two types of kits. See instructions for
reconstitution/injection/disposal
procedures for 1) Pre-filled Dual Chamber Syringe (2.5), and 2) Vials
(2.6).
DOSAGE FORMS AND STRENGTHS
_For extended-release injectable suspension:_ 300-mg and 400-mg
strength lyophilized powder for
reconstitution