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: 125 mg sucrose (in the 125 mg capsule).

Excipient: 80 mg sucrose (in the 80 mg capsule).

For a 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 acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy in adults.

Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.

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

Posology

EMEND is given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT₃ antagonist. The recommended posology of EMEND 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. Fosaprepitant 115 mg, a lyophilized prodrug of aprepitant, may be substituted for oral EMEND (125 mg), 30 minutes prior to chemotherapy, on Day 1 only of the chemotherapy-induced nausea and vomiting (CINV) regimen as an intravenous infusion administered over 15 minutes. Please refer to the Summary of Product Characteristics for fosaprepitant 115 mg.

In clinical studies with EMEND, the following regimens were used for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy:

Highly Emetogenic Chemotherapy Regimen

EMEND was administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3.

Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 to 4. The dose of dexamethasone was chosen to account for active substance interactions.

Ondansetron was administered intravenously 30 minutes prior to chemotherapy treatment on Day 1.

Moderately Emetogenic Chemotherapy Regimen

EMEND was administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3.

Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone was chosen to account for active substance interactions.

One 8 mg capsule of ondansetron was administered 30 to 60 minutes prior to chemotherapy treatment and one 8 mg capsule was administered 8 hours after first dose on Day 1.

Efficacy data on 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 Summary of Product Characteristics of co-administered antiemetic medicinal products.

Special populations

Elderly ( 65 years)

No dose adjustment is necessary for the elderly (see section 5.2).

Gender

No dosage 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. EMEND should be used with caution in these patients (see sections 4.4 and 5.2).