APREPITANT capsule APREPITANT kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

APREPITANT (UNII: 1NF15YR6UY) (APREPITANT - UNII:1NF15YR6UY)

Disponível em:

Glenmark Pharmaceuticals Inc., USA

DCI (Denominação Comum Internacional):

APREPITANT

Composição:

APREPITANT 40 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Aprepitant capsules, in combination with other antiemetic agents, are indicated in patients 12 years of age and older for the prevention of: Aprepitant capsules are indicated in adults for the prevention of postoperative nausea and vomiting. Aprepitant is contraindicated in patients: Risk Summary There are insufficient data on use of aprepitant in pregnant women to inform a drug associated risk. In animal reproduction studies, no adverse developmental effects were observed in rats or rabbits exposed during the period of organogenesis to systemic drug levels (AUC) approximately 1.5 times the adult human exposure at the 125 mg/80 mg/80 mg aprepitant regimen [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In embryofetal development studies in rats and rabbits, aprepitant was administered during the period of organogenesis at oral doses up to 1000 mg/kg twice daily in rats and up to the maximum tolerated dose of 25 mg/kg/day in rabbits. No embryofetal lethality or malformations were observed at any dose level in either species. The exposures (AUC) in pregnant rats at 1000 mg/kg twice daily and in pregnant rabbits at 125 mg/kg/day were approximately 1.5 times the adult exposure at the 125 mg/80 mg/80 mg aprepitant regimen. Aprepitant crosses the placenta in rats and rabbits. Risk Summary Lactation studies have not been conducted to assess the presence of aprepitant in human milk, the effects on the breastfed infant, or the effects on milk production. Aprepitant is present in rat milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for aprepitant and any potential adverse effects on the breastfed infant from aprepitant or from the underlying maternal condition. Contraception Upon administration of aprepitant, the efficacy of hormonal contraceptives may be reduced. Advise females of reproductive potential using hormonal contraceptives to use an effective alternative or back-up non-hormonal contraceptive (such as condoms and spermicides) during treatment with aprepitant and for 1 month following the last dose [see Drug Interactions (7.1), Clinical Pharmacology (12.3)] .  Prevention of Nausea and Vomiting Associated with HEC or MEC The safety and effectiveness of aprepitant capsules in pediatric patients 12 years of age and older for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC, including high-dose cisplatin, and MEC. Use of aprepitant in these age groups is supported by evidence from 95 pediatric patients in a randomized, double-blind, active comparator controlled clinical study (n = 95 patients aged 12 through 17 years). Aprepitant was studied in combination with ondansetron with or without dexamethasone (at the discretion of the physician) [see Clinical Studies (14.3)] . Adverse reactions were similar to those reported in adult patients [see Adverse Reactions (6.1)] . The safety and effectiveness of aprepitant for the prevention of nausea and vomiting associated with HEC or MEC have not been established in patients less than 6 months. Prevention of Postoperative Nausea and Vomiting (PONV) The safety and effectiveness of aprepitant have not been established for the prevention of postoperative nausea and vomiting in pediatric patients. Juvenile Animal Study A study was conducted in young rats to evaluate the effects of aprepitant on growth and on neurobehavioral and sexual development. Rats were treated at oral doses up to the maximum feasible dose of 1000 mg/kg twice daily (providing exposure in male rats lower than the exposure at the recommended pediatric human dose and exposure in female rats equivalent to the pediatric human exposure) from the early postnatal period (Postnatal Day 10) through Postnatal Day 58. Slight changes in the onset of sexual maturation were observed in female and male rats; however, there were no effects on mating, fertility, embryonic-fetal survival, or histomorphology of the reproductive organs. There were no effects in neurobehavioral tests of sensory function, motor function, and learning and memory. Of the 544 adult cancer patients treated with aprepitant in CINV clinical studies, 31% were aged 65 and over, while 5% were aged 75 and over. Of the 1120 adult cancer patients treated with aprepitant in PONV clinical studies, 7% were aged 65 and over, while 2% were aged 75 and over. Other reported clinical experience with aprepitant has not identified differences in responses between elderly and younger patients. In general, use caution when dosing elderly patients as they have a greater frequency of decreased hepatic, renal or cardiac function and concomitant disease or other drug therapy [see Clinical Pharmacology (12.3)] .  The pharmacokinetics of aprepitant in patients with severe renal impairment and those with end stage renal disease (ESRD) requiring hemodialysis were similar to those of healthy subjects with normal renal function. No dosage adjustment is necessary for patients with any degree of renal impairment or for patients with ESRD undergoing hemodialysis. The pharmacokinetics of aprepitant in patients with mild and moderate hepatic impairment were similar to those of healthy subjects with normal hepatic function. No dosage adjustment is necessary for patients with mild to moderate hepatic impairment (Child-Pugh score 5 to 9). There are no clinical or pharmacokinetic data in patients with severe hepatic impairment (Child-Pugh score greater than 9). Therefore, additional monitoring for adverse reactions in these patients may be warranted when aprepitant is administered [see Clinical Pharmacology (12.3)] .

Resumo do produto:

Aprepitant Capsules USP, 125 mg: hard gelatin capsules with a pink opaque colored cap imprinted with a Glenmark logo 'G' in black ink and a white opaque colored body imprinted with '585' in black ink. They are supplied as follows: Aprepitant Capsules USP, 80 mg: hard gelatin capsules with a white opaque colored cap imprinted with a Glenmark logo 'G' in black ink and a white opaque colored body imprinted with '584' in black ink. They are supplied as follows: Aprepitant Capsules USP, 3-day pack (125 mg/80 mg/80 mg): Aprepitant Capsules USP, 40 mg: hard gelatin capsules with a mustard yellow colored cap imprinted with a Glenmark logo 'G' in black ink and a white opaque colored body imprinted with '583' in black ink. They are supplied as follows: Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

APREPITANT- APREPITANT CAPSULE
APREPITANT- APREPITANT
GLENMARK PHARMACEUTICALS INC., USA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
APREPITANT CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
APREPITANT CAPSULES.
APREPITANT CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Aprepitant is a substance P/neurokinin 1 (NK ) receptor antagonist.
Aprepitant capsules are indicated
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Limitations of Use: (1.3)
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DOSAGE AND ADMINISTRATION
Recommended Dosage for Prevention of Chemotherapy Induced Nausea and
Vomiting (CINV) (2.1)
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Recommended Dosage for PONV (2.2)
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Administration (2.4)
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DOSAGE FORMS AND STRENGTHS
Aprepitant Capsules, USP: 40 mg; 80 mg; 125 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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1
in combination with other antiemetic agents, in patients 12 years of
age and older for prevention of:
acute and delayed nausea and vomiting associated with initial and
repeat courses of highly
emetogenic cancer chemotherapy (HEC) including high-dose cisplatin
(1.1)
•
nausea and vomiting associated with initial and repeat courses of
moderately emetogenic cancer
chemotherapy (MEC) (1.1)
for prevention of postoperative nausea and vomiting (PONV) in adults
(1.2)
Aprepitant has not been studied for treatment of established nausea
and vomiting.
Chronic continuous administration of aprepitant is not recommended.
Aprepitant capsules in adults and pediatric patients 12 years of age
and older: is 125 mg on Day 1
and 80 mg on Days 2 and 3.
Administer aprepitant 1 hour prior to chemotherapy on Days 1, 2, and
3. If no chemotherapy is given
on Days 2 and 3, administer aprepitant in morning.
See Full Prescribing Information for recommended dosages of
concomitant dexamethasone and 5-
HT antagonist for HEC and MEC.
3
Adults: 40 mg aprepitant capsules within 3 hours prior to induction of
anesthesia.
Aprepitant capsules can be administered with or without food.
Swallow apre