Emend Capsule 125 mg (Aprepitant)

Adult dose

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

This medicine is a strong inhibitor of a specific enzyme, CYP3A4. Therefore, when taken with other medications that are metabolized by this enzyme, blood levels of those drugs can rise to dangerous levels, so caution is required. Individuals with an allergy to the components of this drug should not take it. Side effects such as nausea, vomiting, headache, dizziness, constipation, diarrhea, and fatigue may occur when taking this medication. Serious skin reactions or allergic responses may occur, so if any unusual symptoms arise, medical consultation should be sought immediately. This medication has many drug interactions, and careful dosage adjustments and regular blood tests are necessary when used with anticoagulants like warfarin, hormonal contraceptives, and certain anticancer agents. Pregnant or breastfeeding women should consult a doctor before taking this medication, as it may affect the fetus or baby, and it is safer to discontinue breastfeeding. Safety has not been established in pediatric patients, and while special dosage adjustment is not required for older adults, they may be more sensitive to its effects. In cases of overdose, since no specific antidote exists, immediate discontinuation of use and appropriate treatment and monitoring at a hospital are necessary. Long-term use of this medication is not recommended, and it is safest to use it short-term solely for the prevention of nausea and vomiting.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it should be kept at room temperature, neither too hot nor too cold.

Appearance

An opaque hard gelatin capsule with a pink upper part and a white lower part, imprinted in black with "462" and "125 mg" on the lower half.

Package unit

1 capsule/PTP