ADR that result in revision of patient information
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| The United States: Arzerra (ofatumumab) and Rituxan (rituximab): Drug Safety Communication - New Boxed Warning, Recommendations to Decrease Risk of Hepatitis B Reactivation |
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The Food and Drug Administration (FDA) approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection. The revised labels also will include additional recommendations for screening, monitoring, and managing patients on these drugs to decrease this risk.
In patients with prior HBV infection, HBV reactivation may occur when the body’s immune system is impaired. HBV reactivation has occurred in patients with prior HBV exposure who are later treated with drugs classified as CD20-directed cytolytic antibodies, including Arzerra (ofatumumab) and Rituxan (rituximab). Some cases have resulted in fulminant hepatitis, hepatic failure, and death.
Arzerra is used to treat chronic lymphocytic leukemia (CLL) in patients who have further disease after treatment with the anti-cancer drugs fludarabine and alemtuzumab. Rituxan is used to treat non-Hodgkin’s lymphoma and CLL. It is also used to treat other medical conditions, including rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.
To decrease the risk of HBV reactivation, FDA recommends that healthcare professionals:
1. Screen all patients for HBV infection before starting treatment with Arzerra or Rituxan by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).
2. Consult with hepatitis experts regarding monitoring and use of HBV antiviral therapy when screening identifies patients at risk of HBV reactivation due to evidence of prior HBV infection.
3. Monitor patients with evidence of prior HBV infection for clinical and laboratory signs of hepatitis B or HBV reactivation during Arzerra or Rituxan therapy and for several months thereafter, since reactivations have occurred several months following completion of therapy with these drugs.
4. In patients who develop reactivation of HBV while on Arzerra or Rituxan, immediately discontinue the drug and start appropriate treatment for HBV. Also discontinue any chemotherapy the patient is receiving until the HBV infection is controlled or resolved. Because of insufficient data, no recommendation can be made regarding the resumption of Arzerra or Rituxan in patients who develop HBV reactivation hepatitis.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm369846.htm
In Hong Kong, there is no registered pharmaceutical product containing ofatumumab; and there are four registered pharmaceutical products containing rituximab, namely MabThera Inj 100mg/10ml (HK-46232), 500mg/50ml (HK-46231), and MabThera Conc for Sol for Inf 100mg/10ml (HK-59248), 500mg/50ml (HK-59249). They are registered by Roche Hong Kong Limited (Roche) and are prescription-only medicines. Roche informed the Department of Health (DH) that they had issued their “Direct Healthcare Professional Communication” on 25 June 2013 and informed healthcare providers of the recommendations for screening and management of hepatitis B virus reactivation in patients treated with MabThera. Besides, Roche has submitted applications to DH to change the package inserts of their products to include the new safety information. DH is processing the applications and will remain vigilant on new safety updates of the drug. Related news has been released by Singapore HSA and Health Canada, and was posted on the Drug Office website on 25 and 30 July 2013 respectively.
Ends/ Thursday, September 26, 2013
Issued at HKT 12:30
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