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Orkambi 100/125 TM

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.

Active ingredients: lumacaftor + ivacaftor, ivacaftor

Brand name

(ARTG)

: ORKAMBI 100/125 lumacaftor/ivacaftor 100 mg/125 mg film-coated tablet blister pack

Download the Consumer Medicine Information Leaflet

Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website

What this medicine is used for

(ARTG)

ORKAMBI is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene.

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Tablet, film coated
  • Oral
  • Pink, oval-shaped tablets printed with "1V125" in black ink on one side and plain on the other.

Storage conditions

(ARTG)

  • Store below 30 degrees Celsius
  • Store in Original Container
  • Shelf lifetime is 30 Months.

Do I need a prescription ?

(ARTG)

These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

  • 112 Tablets pack

Is this medicine subsidised ?

(PBS)

This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on September, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient lumacaftor + ivacaftor

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

For the active ingredient ivacaftor

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

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