No black box warning on record for Tecelra

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

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) : Monitor for ICANS events for at least 4 weeks after treatment with TECELRA ( 5.2 ). Prolonged Severe Cytopenia : Patients may exhibit severe cytopenia (hemoglobin < 8.0 g/dL, neutrophils < 1,000/mm 3 , platelets < 50,000/mm 3 ) for several weeks following lymphodepleting chemotherapy and TECELRA infusion. M

No black box warning on record for Tecelra

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) : Monitor for ICANS events for at least 4 weeks after treatment with TECELRA ( 5.2 ). Prolonged Severe Cytopenia : Patients may exhibit severe cytopenia (hemoglobin < 8.0 g/dL, neutrophils < 1,000/mm 3 , platelets < 50,000/mm 3 ) for several weeks following lymphodepleting chemotherapy and TECELRA infusion. M

Tecelra Black Box Warning

No black box warning on record for Tecelra

Other warnings & precautions

Tecelra Black Box Warning

No black box warning on record for Tecelra

Other warnings & precautions