ORKAMBI Film-coated tablet Ref.[51439] 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 100 mg/125 mg film-coated tablets.

Orkambi 200 mg/125 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Orkambi 100 mg/125 mg film-coated tablets: Pink, oval-shaped tablets (dimensions 14 × 7.6 × 4.9 mm) printed with “1V125” in black ink on one side.

Orkambi 200 mg/125 mg film-coated tablets: Pink, oval-shaped tablets (dimensions 14 × 8.4 × 6.8 mm) printed with “2V125” in black ink on one side.

Qualitative and quantitative composition

Orkambi 100 mg/125 mg film-coated tablets: Each film-coated tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor.

Orkambi 200 mg/125 mg film-coated tablets: Each film-coated tablet contains 200 mg of lumacaftor and 125 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

Tablet core:

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

Coating:

Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol (3350)
Talc
Carmine (E120)
Brilliant blue FCF aluminium lake (E133)
Indigo carmine aluminium lake (E132)

Printing ink:

Shellac
Iron oxide black (E172)
Propylene glycol
Ammonia solution, concentrated

Pack sizes and marketing

Blister consisting of PolyChloroTriFluoroEthylene (PCTFE)/PolyVinyl Chloride (PVC) with a paper-backed aluminium foil lidding.

Orkambi 100 mg/125 mg film-coated tablets: Pack containing 112 (4 packs of 28) film-coated tablets.

Orkambi 200 mg/125 mg film-coated tablets: Multipacks containing 112 (4 packs of 28) film-coated tablets.

Not all pack sizes may be marketed.

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/1/15/1059/001
EU/1/15/1059/005

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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