ORKAMBI Granules Ref.[51441] Active ingredients: Ivacaftor Ivacaftor and Lumacaftor Lumacaftor

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Vertex Pharmaceuticals (Ireland) Limited, Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland

Product name and form

Orkambi 75 mg/94 mg granules in sachet.

Orkambi 100 mg/125 mg granules in sachet.

Orkambi 150 mg/188 mg granules in sachet.

Pharmaceutical Form

Granules.

White to off-white granules.

Qualitative and quantitative composition

Orkambi 75 mg/94 mg granules in sachet: Each sachet contains 75 mg of lumacaftor and 94 mg of ivacaftor.

Orkambi 100 mg/125 mg granules in sachet: Each sachet contains 100 mg of lumacaftor and 125 mg of ivacaftor.

Orkambi 150 mg/188 mg granules in sachet: Each sachet contains 150 mg of lumacaftor and 188 mg of ivacaftor.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ivacaftor

Ivacaftor is a potentiator of the CFTR protein, i.e., in vitro ivacaftor increases CFTR channel gating to enhance chloride transport in specified gating mutations with reduced channel-open probability compared to normal CFTR. Ivacaftor also potentiated the channel-open probability of R117H-CFTR, which has both low channel-open probability (gating) and reduced channel current amplitude (conductance).
Ivacaftor and Lumacaftor

The combined effect of lumacaftor and ivacaftor is increased quantity and function of F508delCFTR at the cell surface, resulting in increased chloride ion transport. The exact mechanisms by which lumacaftor improves cellular processing and trafficking of F508delCFTR and ivacaftor potentiates F508del-CFTR are not known.
Lumacaftor
List of Excipients

Cellulose, microcrystalline
Croscarmellose sodium
Hypromellose acetate succinate
Povidone (K30)
Sodium laurilsulfate

Pack sizes and marketing

Orkambi granules are packaged in a foil laminate [biaxially-oriented polyethylene terephthalate/polyethylene/foil/polyethylene (BOPET/PE/Foil/PE)] sachet.

Pack size of 56 (4 wallets with 14 sachets per wallet) sachets.

Marketing authorization holder

Vertex Pharmaceuticals (Ireland) Limited, Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland

Marketing authorization dates and numbers

EU/1/15/1059/006
EU/1/15/1059/007
EU/1/15/1059/008

Date of first authorisation: 19 November 2015
Date of latest renewal: 18 November 2020

Drugs

Drug Countries
ORKAMBI Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States
 
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