There are no known interactions between Symdeko and alcohol. Patients are advised to speak with their healthcare team about whether it is safe to drink alcohol while on this medication.
Animal studies generally indicated no treatment-related adverse effects on the fetus when using either of Symdeko’s active components, except decreased fetal body weight and early developmental delays with tezacaftor. However, data on pregnant women are limited. It is not known whether this treatment passes to human breast milk. Before taking Symdeko, patients should inform their healthcare team if they are pregnant or plan to become pregnant, are breastfeeding, or plan to do so.
Neither hair loss nor abnormal weight gain have been reported as a side effect of Symdeko. Patients who experience unanticipated effects after starting a new cystic fibrosis therapy are advised to talk to their healthcare provider.
In a Phase 3 trial that supported Symdeko’s initial approval, lung function improvements were seen within 15 days after treatment start. These gains were sustained through treatment conclusion at 24 weeks or about six months. However, each person may respond differently to treatment, so patients are advised to discuss with their healthcare team how Symdeko may help in their particular case.
Symdeko was approved by the U.S. Food and Drug Administration in February 2018 for cystic fibrosis (CF) patients, ages 12 and older, carrying two copies of the F508del mutation in the CFTR gene or with one mutation that responds to Symdeko. This approval was later expanded, now covering individuals 6 years and older with CF caused by one of 154 genetic mutations.