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Kalydeco TM

Listen to the Pronunciation:

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: ivacaftor

Brand name

(ARTG)

: KALYDECO ivacaftor 50 mg granules sachet

Consumer Medicine Information (CMI)

Read the CMI leaflet for facts you need to know before, during and after taking your medicine.

Listen to the audio transcription of the CMI leaflet.

For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).


What this medicine is used for

(ARTG)

KALYDECO is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 month and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, and Section 5.1 PHARMACODYNAMIC PROPERTIES).

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Granules
  • Oral
  • white to off white granules

Storage conditions

(ARTG)

  • Store below 30 degrees Celsius
  • Shelf lifetime is 4 Years.

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.

  • 56 sachets pack

Pregnant or planning a pregnancy ?

(AHT)

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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