Domide® (thalidomide): New important advice regarding viral reactivation and pulmonary hypertension

User Rating: 3 / 5

Star ActiveStar ActiveStar ActiveStar InactiveStar Inactive

Date: 8 May 2017



Cases of viral reactivation, some serious, have been reported following treatment with thalidomide, particularly in patients previously infected with the varicella-zoster or hepatitis B viruses (HBV). Some of the cases of varicella-zoster reactivation resulted in disseminated herpes zoster, necessitating antiviral treatment and the temporary interruption of treatment with thalidomide. Some of the HBV reactivation cases progressed to acute hepatic failure and resulted in discontinuation of thalidomide. Thus, hepatitis B virus status should be established before initiating treatment with thalidomide. For patients who test positive for HBV infection, 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 viral reactivation, including active HBV infection, throughout therapy.

Cases of pulmonary hypertension, some fatal, have also been reported following treatment with thalidomide. As such, patients on thalidomide should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to initiating and during thalidomide therapy. 

A Direct Healthcare Professional Communication (DHPC) has been issued by Pharm-D Sdn. Bhd. in agreement with NPRA to highlight these two safety issues. Please refer to this DHPC for further information.

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400



Image   Image   Image   Image  


The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Mobile Web :

Site Last Modified

  • Last Modified: Thursday 20 June 2024, 10:17:13.
© Copyright 2023 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA


Main Menu English