EMEND- aprepitant capsule EMEND- aprepitant kit EMEND- aprepitant powder, for suspension

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

aprepitant (UNII: 1NF15YR6UY) (aprepitant - UNII:1NF15YR6UY)

Tersedia dari:

Merck Sharp & Dohme LLC

INN (Nama Internasional):

aprepitant

Komposisi:

aprepitant 80 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

EMEND® for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. - nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). EMEND® capsules, in combination with other antiemetic agents, is indicated in patients 12 years of age and older for the prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. - nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use - EMEND has not been studied for the treatment of established nausea and vomiting. - Chronic continuous administration of EMEND is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use. EMEND is contraindicated in patients: - who are hypersensitive to any component of the product. Hypersensitivity reactions including anaphylactic reactions have been reported [see Adverse Reactions (6.2)] . - taking pimozide. Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of this drug which is a CYP3A4 substrate, potentially causing serious or life-threatening reactions, such as QT prolongation, a known adverse reaction of pimozide [see Warnings and Precautions (5.1)] . Risk Summary There are insufficient data on use of EMEND 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 EMEND 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 EMEND 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 EMEND and any potential adverse effects on the breastfed infant from EMEND or from the underlying maternal condition. Contraception Upon administration of EMEND, 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 EMEND and for 1 month following the last dose [see Drug Interactions (7.1), Clinical Pharmacology (12.3)] . The safety and effectiveness of EMEND for oral suspension have been established in pediatric patients 6 months of age and older and EMEND 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 EMEND in these age groups is supported by evidence from 302 pediatric patients in a randomized, double-blind, active comparator controlled clinical study (n = 207 patients aged 6 months to less than 12 years, n = 95 patients aged 12 through 17 years). EMEND 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 EMEND for the prevention of nausea and vomiting associated with HEC or MEC have not been established in patients less than 6 months. 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 EMEND in CINV clinical studies, 31% were aged 65 and over, while 5% were aged 75 and over. Other reported clinical experience with EMEND 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 EMEND is administered [see Clinical Pharmacology (12.3)] . EMEND® (EE- mend) (aprepitant) for oral suspension Read the Patient Information and Instructions for Use for EMEND for oral suspension before you take or before you give a dose to your child Take by mouth only - Store EMEND in the refrigerator between 36°F to 46°F (2°C to 8°C). - Use EMEND within 2 days of getting the medicine from the healthcare provider. - When ready to use, EMEND can be kept at room temperature, between 68°F to 77°F (20°C to 25°C) for up to 3 hours. - Keep EMEND and all medicines out of the reach of children. - Take the cap off the oral dosing dispenser. - Place the tip of the oral dosing dispenser in your mouth or in your child's mouth along the inner cheek on either the right or left side. - Slowly push the plunger all the way down to give all of the medicine in the oral dosing dispenser. Call the healthcare provider if you or your child is not able to take the prescribed dose.

Ringkasan produk:

80-mg capsules: White, opaque, hard gelatin capsule with "461" and "80 mg" printed radially in black ink on the body. They are supplied as follows: NDC 0006-0461-02 unit-of-use BiPack of 2 Unit-of-use TriPack containing one 125-mg capsule and two 80-mg capsules. 125 mg-capsules: Opaque, hard gelatin capsule with white body and pink cap with “462” and “125 mg” printed radially in black ink on the body. 80-mg capsules: White, opaque, hard gelatin capsule with “461” and “80 mg” printed radially in black ink on the body. NDC 0006-3862-03. 125 mg for oral suspension: Pink to light pink powder, in a single-use pouch, packaged as a kit with one 1 mL oral dosing dispenser, one 5 mL oral dosing dispenser, one cap and one mixing cup. It is supplied as follows: NDC 0006-3066-03 – unit of use carton. Storage and Handling Capsules Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. For Oral Suspension Store unopened pouch at 20-25°C (68-77°F); excursions permitted between 15-30°C (between 59-86°F). Store in the original container. Do not open pouch until ready for use. Once prepared, if suspension is not used immediately, store refrigerated [between 36°F-46°F (2°C-8°C)] for up to 72 hours prior to use. When ready to use, the mixture can be kept at room temperature [between 68°F-77°F (20°C-25°C)] for up to 3 hours.

Status otorisasi:

New Drug Application

Karakteristik produk

EMEND- APREPITANT CAPSULE
EMEND- APREPITANT
EMEND- APREPITANT POWDER, FOR SUSPENSION
MERCK SHARP & DOHME LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EMEND CAPSULES AND
EMEND FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
EMEND CAPSULES AND EMEND FOR ORAL SUSPENSION.
EMEND (APREPITANT) CAPSULES, FOR ORAL USE
EMEND (APREPITANT) FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
EMEND is a substance P/neurokinin 1 (NK ) receptor antagonist.
EMEND for oral suspension is indicated
in combination with other antiemetic agents, in patients 6 months 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)
nausea and vomiting associated with initial and repeat courses of
moderately emetogenic cancer
chemotherapy (MEC) (1)
EMEND capsules is indicated
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)
nausea and vomiting associated with initial and repeat courses of
moderately emetogenic cancer
chemotherapy (MEC) (1)
Limitations of Use (1)
EMEND has not been studied for treatment of established nausea and
vomiting.
Chronic continuous administration of EMEND is not recommended.
DOSAGE AND ADMINISTRATION
Recommended Dosage (2.1)
EMEND 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.
EMEND for oral suspension in pediatric patients 6 months to less than
12 years of age or pediatric and
adult patients unable to swallow capsules: see dosing recommendations
in Table 3 in the Full
Prescribing Information.
Administer EMEND 1 hour prior to chemotherapy on Days 1, 2, and 3. If
no chemotherapy is gi