No black box warning on record for Hemgenix

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

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Infusion reactions: Monitor during administration and for at least 3 hours after end of infusion. If symptoms occur, slow or interrupt administration. Re-start administration at a slower infusion once resolved. ( 2.3 , 5.1 ) Hepatotoxicity: Monitor transaminase levels once per week for 3 months and thereafter monthly up to 1 year after HEMGENIX administration to mitigate

No black box warning on record for Hemgenix

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Infusion reactions: Monitor during administration and for at least 3 hours after end of infusion. If symptoms occur, slow or interrupt administration. Re-start administration at a slower infusion once resolved. ( 2.3 , 5.1 ) Hepatotoxicity: Monitor transaminase levels once per week for 3 months and thereafter monthly up to 1 year after HEMGENIX administration to mitigate

Hemgenix Black Box Warning

No black box warning on record for Hemgenix

Other warnings & precautions

Hemgenix Black Box Warning

No black box warning on record for Hemgenix

Other warnings & precautions