Leading the way to safer medication
 Crosscheck  Recommender

KYPROLIS Powder for solution for infusion (2020)

Active ingredients: Carfilzomib

Product Name and Form

Kyprolis 10 mg powder for solution for infusion.

Kyprolis 30 mg powder for solution for infusion.

Kyprolis 60 mg powder for solution for infusion.

Pharmaceutical form

Powder for solution for infusion.

White to off-white lyophilised powder.

Qualitative and Quantitative Composition

Kyprolis 10 mg powder for solution for infusion: Each vial contains 10 mg of carfilzomib.

Kyprolis 30 mg powder for solution for infusion: Each vial contains 30 mg of carfilzomib.

Kyprolis 60 mg powder for solution for infusion: Each vial contains 60 mg of carfilzomib.

After reconstitution, 1 mL of solution contains 2 mg of carfilzomib.

Excipient with known effect: Each mL of reconstituted solution contains 7 mg of sodium.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Carfilzomib

Carfilzomib is a tetrapeptide epoxyketone proteasome inhibitor that selectively and irreversibly binds to the N-terminal threonine containing active sites of the 20S proteasome, the proteolytic core particle within the 26S proteasome, and displays little to no activity against other protease classes. Carfilzomib had antiproliferative and proapoptotic activities in preclinical models in haematologic tumours.

List of excipients

Betadex sulfobutyl ether sodium
Anhydrous citric acid (E330)
Sodium hydroxide (for pH adjustment)

Pack sizes and Marketing

Kyprolis 10 mg powder for solution for infusion: 10 mL type I clear glass vial, closed with fluoropolymer laminated elastomeric stopper and aluminium seal with a light blue plastic flip off cap.

Kyprolis 30 mg powder for solution for infusion: 30 mL type I clear glass vial, closed with fluoropolymer laminated elastomeric stopper and aluminium seal with an orange plastic flip off cap.

Kyprolis 60 mg powder for solution for infusion: 50 mL type I clear glass vial, closed with fluoropolymer laminated elastomeric stopper and aluminium seal with a purple plastic flip off cap.

Pack size of one vial.

Marketing authorization holder
Authorization dates

Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands

Date of first authorisation: 19 November 2015

Marketing authorization number:

EU/1/15/1060/002
EU/1/15/1060/003
EU/1/15/1060/001