1. Name of the medicinal product
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
|
|
Day 1
|
Day 2
|
Day 3
|
Day 4
|
|
EMEND
|
125 mg orally
|
80 mg orally
|
80 mg orally
|
none
|
|
Dexamethasone
|
12 mg orally
|
8 mg orally
|
8 mg orally
|
8 mg orally
|
|
5-HT3 antagonists
|
Standard dose of 5-HT3 antagonists. See the product information for the selected 5-HT3 antagonist for appropriate dosing information
|
none
|
none
|
none
|
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
|
|
Day 1
|
Day 2
|
Day 3
|
|
EMEND
|
125 mg orally
|
80 mg orally
|
80 mg orally
|
|
Dexamethasone
|
12 mg orally
|
none
|
none
|
|
5-HT3 antagonists
|
Standard dose of 5-HT3 antagonists. See the product information for the selected 5-HT3 antagonist for appropriate dosing information
|
none
|
none
|
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
