No black box warning on record for Symdeko

As of the latest FDA labeling reviewed, Symdeko (TEZACAFTOR AND IVACAFTOR) does not carry a black box warning. Standard warnings and precautions still apply — see the full Symdeko medicine page for the complete safety profile.

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Elevated transaminases (ALT or AST): Transaminases (ALT and AST) should be assessed prior to initiating SYMDEKO, every 3 months during the first year of treatment, and annually thereafter. In patients with a history of transaminase elevations, more frequent monitoring should be considered. Dosing should be interrupted in patients with significant elevations of transamina

No black box warning on record for Symdeko

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Elevated transaminases (ALT or AST): Transaminases (ALT and AST) should be assessed prior to initiating SYMDEKO, every 3 months during the first year of treatment, and annually thereafter. In patients with a history of transaminase elevations, more frequent monitoring should be considered. Dosing should be interrupted in patients with significant elevations of transamina

Symdeko Black Box Warning

No black box warning on record for Symdeko

Other warnings & precautions

Symdeko Black Box Warning

No black box warning on record for Symdeko

Other warnings & precautions