No black box warning on record for Kalydeco

As of the latest FDA labeling reviewed, Kalydeco (IVACAFTOR) does not carry a black box warning. Standard warnings and precautions still apply — see the full Kalydeco 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 KALYDECO, every 3 months during the first year of treatment, and annually thereafter. In patients with a history of transaminase elevations, more frequent monitoring of liver function tests should be considered. Patients who develop increased transaminase levels should

No black box warning on record for Kalydeco

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Elevated transaminases (ALT or AST): Transaminases (ALT and AST) should be assessed prior to initiating KALYDECO, every 3 months during the first year of treatment, and annually thereafter. In patients with a history of transaminase elevations, more frequent monitoring of liver function tests should be considered. Patients who develop increased transaminase levels should

Kalydeco Black Box Warning

No black box warning on record for Kalydeco

Other warnings & precautions

Kalydeco Black Box Warning

No black box warning on record for Kalydeco

Other warnings & precautions