Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Prevention 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).
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 ppropriate dosing nformation | 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.
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.
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.
No dose adjustment is necessary for the elderly (see section 5.2).
No dose adjustment is necessary based on gender (see section 5.2).
No dose adjustment is necessary for patients with renal impairment or for patients with end stage renal disease undergoing haemodialysis (see section 5.2).
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).
The hard capsule should be swallowed whole.
EMEND may be taken with or without food.
In the event of overdose, EMEND should be discontinued and general supportive treatment and monitoring should be provided. Because of the antiemetic activity of aprepitant, emesis induced by a medicinal product may not be effective.
Aprepitant cannot be removed by haemodialysis.
4 years.
Store in the original package in order to protect from moisture.
Different pack sizes including different strengths are available.
Aluminium blister containing one 80 mg capsule.
Aluminium blister containing two 80 mg capsules.
5 Aluminium blisters each containing one 80 mg capsule.
Aluminium blister containing one 125 mg capsule.
5 Aluminium blisters each containing one 125 mg capsule.
Aluminium blister containing one 125 mg capsule and two 80 mg capsules.
Not all pack sizes may be marketed.
No special requirements for disposal.
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