IVEMEND Powder for solution for infusion (2019)
Active ingredients: Fosaprepitant
Product Name and Form
IVEMEND 150 mg powder for solution for infusion.
Powder for solution for infusion.
White to off-white amorphous powder.
Qualitative and Quantitative Composition
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.
Fosaprepitant is the prodrug of aprepitant and when administered intravenously is converted rapidly to aprepitant. The contribution of fosaprepitant to the overall antiemetic effect has not fully been characterised, but a transient contribution during the initial phase cannot be ruled out.
Disodium edetate (E386)
Polysorbate 80 (E433)
Sodium hydroxide (E524) (for pH adjustment) and/or
Hydrochloric acid diluted (E507) (for pH adjustment)
Pack sizes and Marketing
10 ml Type I clear glass vial with a chlorobutyl or bromobutyl rubber stopper and an aluminum seal with a grey plastic flip off cap.
Pack sizes: 1 or 10 vials.
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Date of first authorisation: 11 January 2008
Date of latest renewal: 11 January 2013