Aprepitant Capsule 125mg (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 has an inhibitory effect on a specific enzyme, CYP3A4, which can lead to increased blood levels of other medications broken down by this enzyme when taken together. Therefore, caution is necessary when combining this drug with specific medications as it may be risky. It should not be used in case of hypersensitivity to its components. Various side effects such as vomiting, headache, dizziness, constipation, diarrhea may occur during the use of this drug, and if any abnormal symptoms appear, please inform your healthcare provider. Especially in patients with impaired liver or kidney function, or elderly patients, it should be used with extra caution. If you are pregnant or breastfeeding, you must consult a doctor before taking this medicine, and it is recommended to discontinue breastfeeding while taking this drug. Long-term use of this drug is not recommended, and due to potential interactions with other medications, you should inform your healthcare provider about all medications you are taking. Additionally, during the use of this drug, the effectiveness of hormonal contraceptives may decrease, so it is safe to use additional contraception methods. In case of overdose, stop taking the drug immediately and follow the instructions of your healthcare provider, as this drug is not removed by dialysis and requires special monitoring. Finally, this drug may rarely cause serious allergic reactions or skin reactions, so if symptoms such as rash, itching, or difficulty breathing occur, visit a hospital immediately.

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

This drug may be sensitive to air or moisture, so it must be stored in a tightly sealed container. The recommended storage temperature is at room temperature between 1 to 30 degrees Celsius.

Appearance

A pink hard capsule with white to off-white granules inside.

Package unit

1 capsule/PTP - 1 capsule/PTP