Clarification of Hepatitis B Virus Status Needed Before Starting Treatment with Pomalidomide

Rare cases of HBV reactivation after treatment with pomalidomide plus dexamethasone reported in patients with preceding hepatitis B infection

On 1 March 2017, the authorization holder of pomalidomide (Imnovid®) Celgene GmbH in consultation with Swissmedic (Swiss Agency for Therapeutic Products) informed that rare cases of a hepatitis B virus reactivation have been reported after treatment with pomalidomide plus dexamethasone in patients with preceding hepatitis B infection. Some of these cases have evolved to acute liver failure and resulted in discontinuation of pomalidomide.

The Hepatitis B virus (HBV) status must be assessed before initiating treatment with pomalidomide.

If tested positive for HBV infection, it is recommended that patients consult a doctor with experience in the treatment of hepatitis B infection.

Particular caution is required when pomalidomide is used in combination with dexamethasone in patients previously infected with HBV.

Previously infected patients should be closely monitored throughout treatment for signs and symptoms of active HBV infection.