EMEND® 125 mg hard capsules

EMEND® 80 mg hard capsules

Each 125 mg capsule contains 125 mg of aprepitant. Each 80 mg capsule contains 80 mg of aprepitant.

Excipient with known effect

Each capsule contains 125 mg of sucrose (in the 125 mg capsule).

Excipient with known effect

Each capsule contains 80 mg of sucrose (in the 80 mg capsule).

For the full list of excipients, see section 6.1.

Hard capsule.

The 125 mg capsule is opaque with a white body and pink cap with “462” and “125 mg” printed radially in black ink on the body. The 80 mg capsules are opaque with a white body and cap with “461” and “80 mg” printed radially in black ink on the body.

Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12.

EMEND 125 mg/80 mg is given as part of combination therapy (see section 4.2).

Posology

Adults

EMEND 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:

Highly Emetogenic Chemotherapy Regimen

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.

Moderately Emetogenic Chemotherapy Regimen

Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone accounts for active substance interactions.

Paediatric population

Adolescents (aged 12 through 17 years)

EMEND is given for 3 days as part of a regimen that includes a 5-HT₃ antagonist. The recommended dose of capsules of EMEND is 125 mg orally on Day 1 and 80 mg orally on Days 2 and 3. EMEND is administered orally 1 hour prior to chemotherapy on Days 1, 2 and 3. If no chemotherapy is given on Days 2 and 3, EMEND 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 EMEND, the dose of the corticosteroid should be administered at 50 % of the usual dose (see sections 4.5 and 5.1).

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. Refer to the powder for oral suspension SmPC for appropriate dosing in infants, toddlers and children aged 6 months to less than 12 years.

General

Efficacy data in combination with other corticosteroids and 5-HT₃ antagonists are limited. For additional information on the co-administration with corticosteroids, see section 4.5. Please 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 section 5.2).

Gender

No dose adjustment is necessary based on gender (see section 5.2).

Renal impairment

No dose adjustment is necessary for patients with renal impairment or for patients with end stage renal disease undergoing haemodialysis (see section 5.2).

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 sections 4.4 and 5.2).

Method of administration

The hard capsule should be swallowed whole.

EMEND may be taken with or without food.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Co-administration with pimozide, terfenadine, astemizole or cisapride (see section 4.5).