Emend Capsule 80 mg (Aprepitant)

Adult dose

Administer this medicine for 3 days in combination with a corticosteroid and a 5-HT3 antagonist. Recommended dose: On day 1, administer 125 mg of this medicine orally 1 hour before chemotherapy; on days 2 and 3, administer 80 mg orally once daily in the morning. This medicine may be administered without regard to food. In clinical trials for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy, this medicine was administered as follows: Day 1 Day 2 Day 3 Day 4 This medicine* 125 mg orally 80 mg orally 80 mg orally Not applicable Dexamethasone** 12 mg orally 8 mg orally 8 mg orally 8 mg orally Ondansetron+ See below+ Not applicable Not applicable Not applicable * Administer orally 1 hour before chemotherapy on day 1 and in the morning on days 2 and 3. ** Administer 30 minutes before chemotherapy on day 1 and in the morning on days 2 through 4. The dose was adjusted to account for drug interactions. + Refer to the prescribing information for the 5-HT3 antagonist for appropriate dosage and administration. In the clinical trial, ondansetron was administered at 32 mg IV on day 1, 30 minutes before chemotherapy. However, this dose (32 mg) is no longer the recommended dose of ondansetron. In clinical trials for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy, this medicine was administered as follows: Day 1 Day 2 Day 3 This medicine* 125 mg orally 80 mg orally 80 mg orally Dexamethasone** 12 mg orally Not applicable Not applicable Ondansetron+ 2 x 8 mg orally Not applicable Not applicable * Administer orally 1 hour before chemotherapy on day 1 and in the morning on days 2 and 3. ** Administer 30 minutes before chemotherapy on day 1. The dose was adjusted to account for drug interactions. + Administer the first dose 30 to 60 minutes before chemotherapy on day 1 and the second dose 8 hours later. When this medicine is administered concomitantly, adjust the corticosteroid dose to account for drug interactions (see Precautions, 4. Interactions). No dose adjustment is necessary in older patients, patients with renal impairment, or patients with end-stage renal disease (ESRD) requiring hemodialysis. No dose adjustment is necessary in patients with mild to moderate hepatic impairment (Child-Pugh score 5~9). There are no clinical data in patients with severe hepatic impairment (Child-Pugh score >9).

This drug acts as an inhibitor of a specific enzyme, CYP3A4, which can cause the blood concentration of other drugs metabolized by this enzyme to rise to dangerous levels when taken concurrently. Therefore, it should not be taken with other interacting drugs, especially pimozide, terfenadine, astemizole, and cisapride. Individuals with hypersensitivity to this drug should not use it. This drug is used to prevent nausea and vomiting due to chemotherapy, and mild to moderate side effects have been reported primarily in clinical trials. Side effects may include abdominal pain, fatigue, dehydration, dizziness, fever, mucosal abnormalities, constipation, diarrhea, nausea, vomiting, headache, insomnia, and hiccups. Rarely, serious side effects such as heart problems, infections, neurological abnormalities, skin rashes, and liver function abnormalities have been reported. This drug moderately inhibits and induces the CYP3A4 enzyme, so caution is needed when used in conjunction with other drugs metabolized by this enzyme. In particular, when taken with chemotherapy drugs, steroids, anticoagulants, and oral contraceptives, changes in drug concentration can alter effectiveness or side effects, so consultation with a specialist is necessary. Pregnant or breastfeeding women should only use this drug when safety is not sufficiently established, and breastfeeding should be interrupted if used. Safety in pediatric patients has not been established, and no special dosage adjustments are necessary for the elderly, but caution is advised. In case of overdose, there is no specific antidote, so immediate cessation of use is required, along with appropriate treatment and monitoring as symptoms dictate. This drug is not removed by hemodialysis. Long-term use is not recommended, and during treatment, careful monitoring for potential drug interactions and side effects should always be maintained.

• abdominal pain
• lethargy
• fatigue
• dehydration
• dizziness
• fever
• mucosal abnormalities
• constipation
• diarrhea
• upper abdominal discomfort

This drug can be sensitive to air and moisture, so it must be stored in an airtight container. It should also be kept at normal room temperature, avoiding excessively hot or cold places.

Appearance

An opaque hard gelatin capsule in white with '461' and '80mg' printed in black on the bottom.

Package unit

1 capsule/PTP