Aprepilor Trio Dosage/Direction for Use

Posology: Adults: APREPILOR TRIO is given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT₃ antagonist. The recommended dose is 125 mg orally once daily one hour before start of chemotherapy on Day 1 and 80 mg orally once daily on Days 2 and 3 in the morning.
The following regimens are recommended in adults for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy: See Table 5.

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Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 to 4. The dose of dexamethasone accounts for active substance interactions. (See Table 6.)

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Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone accounts for 2 active substance interactions.
Paediatric population: Adolescents (aged 12 through 17 years): APREPILOR TRIO is given for 3 days as part of a regimen that includes a 5-HT₃ antagonist. The recommended dose of capsules of APREPILOR TRIO is 125 mg orally on Day 1 and 80 mg orally on Days 2 and 3. APREPILOR TRIO is administered orally 1 hour prior to chemotherapy on Days 1, 2 and 3. If no chemotherapy is given on Days 2 and 3, APREPILOR TRIO should be administered in the morning. See the Summary of Product Characteristics (SmPC) for the selected 5-HT₃ antagonist for appropriate dosing information. If a corticosteroid, such as dexamethasone, is co-administered with APREPILOR TRIO, the dose of the corticosteroid should be administered at 50% of the usual dose (see Interactions and Pharmacology: Pharmacodynamics under Actions).
The safety and efficacy of the 80 mg and 125 mg capsules have not been demonstrated in children less than 12 years of age. No data are available.
General: Efficacy data in combination with other corticosteroids and 5-HT₃ antagonists are limited. For additional information on the co-administration with corticosteroids, see Interactions. Refer to the SmPC of co-administered 5-HT₃ antagonist medicinal products.
Special populations: Elderly (≥65 years): No dose adjustment is necessary for the elderly (see Pharmacology: Pharmacokinetics under Actions).
Gender: No dose adjustment is necessary based on gender (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is necessary for patients with renal impairment or for patients with end stage renal disease undergoing haemodialysis (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is necessary for patients with mild hepatic impairment. There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment. Aprepitant should be used with caution in these patients (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Method of administration: The hard capsule should be swallowed whole.
APREPILOR TRIO may be taken with or without food.