Imnovid: new safety warnings

27 May 2015

Healthcare professionals should be vigilant for signs or symptoms of cardiac failure, interstitial lung disease (ILD) and hepatotoxicity in patients taking the myeloma treatment pomalidomide (Imnovid), the MHRA has advised.

The safety review of Imnovid (pomalidomide) was based on data from clinical trials, reports from clinical practice and published case reports.

Imnovid is indicated in combination with dexamethasone for relapsed and refractory multiple myeloma that has progressed in patients who have received at least two prior therapies, including lenalidomide and bortezomib.

Monitoring requirements for pomalidomide have been revised following a review conducted by the MHRA and other EU regulators.

Cardiac failure

Further information
MHRA Drug Safety Update

Cardiac failure was reported to be a common side-effect of pomalidomide. Prescribers should use Imnovid with caution in patients with risk factors for or active cardiac disease. Healthcare professionals are advised to monitor for signs or symptoms of cardiac failure. The review also concluded that pomalidomide can cause atrial fibrillation, which may precipitate cardiac failure.

Interstitial lung disease

ILD and related events such as pneumonitis were also commonly reported as an adverse effect of pomalidomide treatment. Patients with acute onset or unexplained worsening of respiratory symptoms should be assessed to confirm or exclude ILD. During this time, pomalidomide should be stopped and only resumed after thorough evaluation of the benefits and risks of continued treatment.

Hepatotoxicity

In light of limited data, specific guidance on the frequency of liver function monitoring could not be provided. The review found the risk of serious hepatic events to be higher in the first 6 months of treatment; therefore, regular LFTs are recommended during this period.