Aptant Capsule 80 mg (Aprepitant)

Adult dose

1. Prevention of chemotherapy-induced nausea and vomiting (CINV) This medication is administered for 3 days in combination with a corticosteroid and a 5-HT3 antagonist. Recommended dosage: On Day 1, administer this medication 125 mg orally 1 hour before chemotherapy; on Days 2 and 3, administer this medication 80 mg orally once daily in the morning. This medication may be administered with or without food. In clinical trials for the prevention of nausea and vomiting caused by highly emetogenic chemotherapy, this medication was administered as follows: Day 1: This medication* 125 mg orally; Dexamethasone** 12 mg orally; Ondansetron+ See below+ Day 2: This medication* 80 mg orally; Dexamethasone** 8 mg orally; Ondansetron+ Not applicable Day 3: This medication* 80 mg orally; Dexamethasone** 8 mg orally; Ondansetron+ Not applicable Day 4: This medication* 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 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 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 clinical trials for the prevention of nausea and vomiting caused by moderately emetogenic chemotherapy, this medication was administered as follows: Day 1: This medication* 125 mg orally; Dexamethasone** 12 mg orally; Ondansetron+ 2 x 8 mg orally Day 2: This medication* 80 mg orally; Dexamethasone** Not applicable; Ondansetron+ Not applicable Day 3: This medication* 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. + The first dose was administered 30 to 60 minutes before chemotherapy on Day 1, and the second dose was administered 8 hours later. When administered with this medication, the corticosteroid dose should be adjusted to account for drug interactions (see Precautions for Use, 4. Interactions). The prescribing information for the antiemetic administered with this medication should be consulted. 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 drug inhibits a specific enzyme, CYP3A4, and can increase the blood concentration of other drugs metabolized by this enzyme, leading to serious side effects. Therefore, it should not be taken with drugs such as Pimozide, terfenadine, astemizole, and cisapride. People allergic to any component of this drug should not take it. This drug is primarily used to prevent nausea and vomiting due to cancer treatment, and while most side effects reported in clinical trials were mild to moderate, severe side effects can occur in some patients. Gastrointestinal symptoms such as abdominal pain, fatigue, dehydration, dizziness, fever, mucosal abnormalities, constipation, diarrhea, gastritis, heartburn, nausea, and vomiting may occur frequently. Additionally, symptoms such as tinnitus, neutropenia, decreased appetite, headache, insomnia, and hiccups have also been reported. Rarely, serious side effects such as myocardial infarction, arrhythmia, thrombosis, pneumonia, skin rash, myalgia, and urinary difficulties can occur, thus caution is needed. As this drug inhibits CYP3A4, dose adjustment and monitoring are necessary when taken with other anticancer drugs or medications metabolized by this enzyme. In particular, when taken with warfarin, monitoring of blood coagulation tests is necessary due to possible changes in results. Also, during and for one month after taking this drug, the efficacy of hormonal contraceptives may be reduced, so an alternative contraceptive method should be used. The safety in pregnant or nursing women has not been established, so it is essential to consult a doctor; discontinuation of the drug is recommended during breastfeeding. Safety in pediatric patients has not been established, and while special dose adjustments are not required for elderly patients, caution is advised. In case of overdose, immediately stop taking the drug and seek appropriate treatment and monitoring at a hospital, as this drug is not removed by dialysis. While taking this drug, patients should always carefully observe for potential drug interactions and the occurrence of side effects.

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

This medicine should be stored in a tightly sealed container to prevent exposure to air and moisture. Additionally, it is best stored at room temperature between 1 degree and 30 degrees Celsius.

Appearance

A hard capsule with a white upper part and white lower part containing granules that are white to off-white.

Package unit

1 capsule/PTP - 1 capsule/PTP