[Posted 09/25/2013]ISSUE: 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.
See the FDA Drug Safety Communication for additional information, including a Data Summary.
BACKGROUND: 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.
RECOMMENDATION: To decrease the risk of HBV reactivation, FDA recommends that health care professionals:
- 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
- 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
For more information visit the FDA website at: Web Siteand Web Site.
Ofatumumab injection is used to treat chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells) in adults who have not gotten better after treatment with fludarabine (Fludara) and alemtuzumab (Campath). Ofatumumab injection is in a class of medications called monoclonal antibodies. It works by killing cancer cells.
Ofatumumab injection comes as a solution (liquid) to be added to fluid and injected intravenously (into a vein) by a doctor or nurse in a medical office or hospital. It is usually injected once a week for 8 weeks then once a month for 4 months.
Your doctor may need to interrupt your treatment if you experience certain side effects. Your doctor will give you other medications to prevent or treat certain side effects 30 minutes to 2 hours before you receive each dose of ofatumumab injection. Be sure to tell your doctor how you are feeling during your treatment with ofatumumab injection.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before receiving ofatumumab injection,
- tell your doctor and pharmacist if you are allergic to ofatumumab, any other medications, or any of the ingredients in ofatumumab injection. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways) or hepatitis B (a virus that infects the liver and may cause severe liver damage or liver cancer).
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving ofatumumab injection, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving ofatumumab injection.
- ask your doctor whether you should receive any vaccinations before you begin your treatment with ofatumumab. Do not have any vaccinations during your treatment without talking to your doctor.
- you should know that progressive multifocal leukoencephalopathy (PML; a rare infection of the brain that cannot be treated, prevented, or cured and that usually causes death or severe disability) has occurred in patients receiving ofatumumab injection. Call your doctor right away if you have any of the following symptoms: confusion, dizziness, loss of balance, difficulty talking or walking, or vision problems.
Unless your doctor tells you otherwise, continue your normal diet.
Ofatumumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- muscle spasms
- stuffy or runny nose
Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section , call your doctor immediately:
- difficulty breathing
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- sudden reddening of the face, neck, or upper chest
- extreme tiredness
- yellowing of the skin or eyes
- unusual bleeding or bruising
- pale skin
- pinpoint, flat, round, red spots under the skin
- fever, chills, cough, sore throat, or other signs of infection
- pain in chest, arms, back, neck, jaw, or stomach
Ofatumumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to ofatumumab injection.
Ask your pharmacist any questions you have about ofatumumab injection.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: October 15, 2013.