This is a very important notice from the Food and Drug Administration about possible re-activation of hepatitis B when using immunosuppressive drugs (Arzerra (ofatumumab) and Rituxam (rituximab). Everyone should be screened for HBV before using these drugs due to reactivation and possible severe disease progression and death. Many patients and medical providers are confused about hepatitis B infection status—resolved and chronic. Be sure to tell your medical provider of a previous hepatitis B infection and also request a test to find out your current HBV status. As you can see by the information below, there is a real possibility of serious health consequences if a person’s status is not monitored. –Alan Franciscus
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).
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.
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.
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.
- Arzerra and Rituxan are in a class of drugs called anti-CD20-directed monoclonal antibodies.
- 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.
- If you have had hepatitis B or are a carrier of hepatitis B virus (HBV), receiving Arzerra (ofatumumab) or Rituxan (rituximab) could cause the virus to become an active infection again. HBV reactivation may cause serious liver problems, including liver failure and death.
- Before receiving Arzerra or Rituxan, tell your health care professional if you have or have had any severe infections, including HBV.
- If you have had HBV infection, your health care professional should monitor you for HBV infection during treatment and for several months after you stop treatment with Arzerra or Rituxan.
- Talk to your health care professional if you have any questions or concerns about Arzerra or Rituxan.
- Report side effects from Arzerra or Rituxan to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.
- Hepatitis B virus (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.
- HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis (i.e., increase in transaminase levels and, in severe cases, increase in bilirubin levels, liver failure, and death).
- Cases of HBV reactivation have been reported in patients who are hepatitis B surface antigen (HBsAg) positive.
- Cases have also been reported in patients who are HBsAg negative, but test positive for hepatitis B core antibody (anti-HBc). Reactivation also has occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive, and hepatitis B surface antibody [anti-HBs] positive).
- Screen all patients for HBV infection before initiating treatment with Arzerra or Rituxan by measuring HBsAg and anti-HBc.
- Note that patients who have protective antibodies due to immunization will test positive only for anti-HBs.
- For patients who show evidence of prior HBV exposure by testing positive for HBsAg or anti-HBc, consult with physicians with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy.
- Monitor patients with evidence of prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following Arzerra or Rituxan therapy. HBV reactivation has been reported up to 12 months following completion of therapy.
- In patients who develop reactivation of HBV while on Arzerra or Rituxan, immediately discontinue the drug and institute appropriate HBV treatment. Also discontinue any concomitant 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.
- Report adverse events involving Arzerra or Rituxan to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.