Posology : מינונים

4.2    Posology and method of administration

Posology
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 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        none                none                none 5-HT3 antagonists. See the product information for the selected
5-HT3 antagonist for appropriate dosing information
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              none              none antagonists. See the product information for the selected 5-HT3 antagonist for appropriate dosing information
Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone accounts for active substance interactions.

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 Summary of Product Characteristics 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).

Paediatric population
EMEND is not approved for use in paediatric patients.

Method of administration
The capsule should be swallowed whole.
EMEND may be taken with or without food.