There are no known interactions between Trikafta 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 or on offspring development with Trikafta’s active components, except decreased fetal body weights and early developmental delays with tezacaftor. However, clinical trial data on pregnant women are limited. It is not known whether this treatment passes to breast milk. 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 weight gain have been reported as a side effect of Trikafta. Patients who experience unanticipated effects after starting a new cystic fibrosis therapy are advised to talk to their healthcare provider.
One of the Phase 3 clinical trials that supported Trikafta’s approval showed that the therapy led to a statistically significant improvement in lung function as early as day 15 of treatment, compared with another approved CFTR modulator, Symdeko. However, each person may respond differently to treatment, thus patients are advised to discuss with their healthcare team how Trikafta can help in their particular case.
Trikafta was approved by the U.S. Food and Drug Administration in October 2019 for cystic fibrosis (CF) patients, ages 12 and older, with at least one F508del mutation. The number of eligible mutations was expanded in December 2020, followed by the FDA’s decision in 2021 to cover children as young as 6, and in 2023 to cover children 2 and older.