Symdeko
What it is used for
Symdeko is indicated for the treatment of patients with cystic fibrosis (CF) aged 12 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 take it
This medicine is a pack that contains more than one part.
Part 1: Tablet, film coated
Yellow, capsule-shaped tablet debossed with V100 on one side and plain on the other (15.9 mm x 8.5 mm)
The way to take this medicine is: Oral. This medicine is taken by mouth.
Part 2: Tablet, film coated
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).
The way to take this medicine is: Oral. This medicine is taken by mouth.
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.
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
How to take it
This medicine is a pack that contains more than one part.
Part 1: Tablet, film coated
Yellow, capsule-shaped tablet debossed with V100 on one side and plain on the other (15.9 mm x 8.5 mm)
The way to take this medicine is: Oral. This medicine is taken by mouth.
Part 2: Tablet, film coated
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).
The way to take this medicine is: Oral. This medicine is taken by mouth.
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.
Pregnant or planning a 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.
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.
Do I need a prescription?
This medicine is available from a pharmacist and requires a prescription. It is
Is this medicine subsidised?
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on March 1, 2020. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.