No black box warning on record for Orkambi

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

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Use in patients with advanced liver disease: ORKAMBI should be used with caution in these patients and only if the benefits are expected to outweigh the risks. If ORKAMBI is used in these patients, they should be closely monitored after the initiation of treatment and the dosage should be reduced. Liver function decompensation, including liver failure leading to death, h

No black box warning on record for Orkambi

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Use in patients with advanced liver disease: ORKAMBI should be used with caution in these patients and only if the benefits are expected to outweigh the risks. If ORKAMBI is used in these patients, they should be closely monitored after the initiation of treatment and the dosage should be reduced. Liver function decompensation, including liver failure leading to death, h

Orkambi Black Box Warning

No black box warning on record for Orkambi

Other warnings & precautions

Orkambi Black Box Warning

No black box warning on record for Orkambi

Other warnings & precautions