Rituximab Hit With FDA Warning on HBV Risk


A black box warning has been added to the label of the commonly used anti-inflammatory drug rituximab warning that it may reactivate hepatitis B virus.

The US Food and Drug Administration has added a black box warning that ofatumumab (Arzerra) and rituximab (Rituxan) may reactivate hepatitis B virus (HBV).

Rituximab is used to treat rheumatoid arthritis and granulomatosis with polyangiitis, and both drugs are used for leukemia and lymphoma.

Patients should be screened for HBV with hepatitis B surface antigen and hepatitis B core antibody, says the notice.

If the result is positive:

1. Consult a hepatitis expert.

2. Monitor patients using these drugs for HBV.

3. If reactivated, stop and treat for HBV

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