IVEMEND® 150 mg powder for solution for infusion.
Each vial contains fosaprepitant dimeglumine equivalent to 150 mg fosaprepitant, which corresponds to 130.5 mg of aprepitant. After reconstitution and dilution 1 ml of solution contains 1 mg fosaprepitant (1 mg/ml) (see section 6.6).
For the full list of excipients, see section 6.1.
Powder for solution for infusion.
White to off-white amorphous powder.
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.
IVEMEND 150 mg is given as part of a combination therapy (see section 4.2).
Posology
The recommended dose is 150 mg administered as an infusion over 20-30 minutes on Day 1, initiated approximately 30 minutes prior to chemotherapy (see section 6.6). IVEMEND should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in the tables below.
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
|
|
IVEMEND
|
150 mg intravenously
|
none
|
none
|
none
|
|
Dexamethasone
|
12 mg orally
|
8 mg orally
|
8 mg orally twice daily
|
8 mg orally twice daily
|
|
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. Dexamethasone should also be administered in the evenings on Days 3 and 4. The dose of dexamethasone accounts for active substance interactions.
Moderately Emetogenic Chemotherapy Regimen
|
|
Day 1
|
|
IVEMEND
|
150 mg intravenously
|
|
Dexamethasone
|
12 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
|
Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone accounts for active substance interactions.
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.
Refer to the Summary of Product Characteristics of co-administered 5-HT3 antagonist medicinal products.
Special populations
Older people (≥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. IVEMEND should be used with caution in these patients (see sections 4.4 and 5.2).
Paediatric population
The safety and efficacy of IVEMEND in children and adolescents below 18 years of age has not yet been established. No data are available.
Method of administration
IVEMEND 150 mg should be administered intravenously and should not be given by the intramuscular or subcutaneous route. Intravenous administration occurs preferably through a running intravenous infusion over 20-30 minutes (see section 6.6). Do not administer IVEMEND as a bolus injection or undiluted solution.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Hypersensitivity to the active substance or to polysorbate 80 or any of the other
