MTX Hep B reactivation risk added to PI

Product Information for methotrexate has been updated to include a precaution regarding reactivation of hepatitis B virus.

In its latest Medicines Safety Update the TGA said it had received two reports of possible hepatitis B reactivation associated with methotrexate treatment.

Analysis of these two cases found that they were confounded by other drug therapy however a causal role for methotrexate could not be excluded.

The updated PI advises health professionals to perform clinical and laboratory evaluation of pre-existing liver disease in patients with prior hepatitis B or hepatitis C infections before commencing treatment with methotrexate.

It also recommends close monitoring of these patients who are already taking methotrexate.

“Based on these evaluations, treatment or continuation of treatment with methotrexate may not be appropriate for some patients,” the advisory says.

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