Revised SPC: Imnovid (pomalidomide) 4mg

SPC has been updated to warn that hepatitis B virus (HBV) reactivation has been reported rarely in patients receiving pomalidomide in combination with dexamethasone who have previously been infected with HBV, and advise on monitoring. New text on haemorrhage has also been added.

As pomalidomide can cause hepatitis B reactivation, the MHRA recently issued the following advice for healthcare professionals:

 

• Hepatitis B virus status should be established before starting treatment with pomalidomide.

 

• For patients who test positive, consultation with a physician with expertise in the treatment of hepatitis B is recommended.

 

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