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Symdeko 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: ivacaftor, tezacaftor + ivacaftor
Brand name
(ARTG)
: SYMDEKO 100/150 tezacaftor 100 mg/ivacaftor 150 mg film-coated tablet and ivacaftor 150 mg film-coated tablet composite packDownload 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)
SYMDEKO is indicated for the treatment of patients with cystic fibrosis (CF) aged 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.,Refer to Table 1 for a list of responsive mutations.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Tablet, film coated
- Oral
- Yellow, capsule-shaped tablet debossed with V100 on one side and plain on the other (15.9 mm x 8.5 mm)
Component :
- Tablet, film coated
- Oral
- Light blue, capsule-shaped tablet, printed with v150 in black ink on one side and plain on the other (16.5 mm x 8.4 mm).
Storage conditions
(ARTG)
- Store below 30 degrees Celsius
- Shelf lifetime is 36 Months.
Do I need a prescription ?
(ARTG)
This medicine is available from a pharmacist and requires a prescription. It is
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.
For the active ingredient tezacaftor + 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
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
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