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Precautions and Warnings With Ofatumumab

To help minimize risks while using ofatumumab, tell your healthcare provider if you have a history of hepatitis B, a bowel obstruction, or lung disease. It is also important for your healthcare provider to know about any other medications, vitamins, or supplements you are taking to avoid potentially serious drug interactions with ofatumumab. Other warnings and safety precautions apply to women who are pregnant or breastfeeding.

What Should I Tell My Healthcare Provider Before Using Ofatumumab?

You should talk with your healthcare provider prior to receiving ofatumumab (Arzerra®) if you have:
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Ofatumumab Precautions and Warnings

Some warnings and precautions to be aware of prior to receiving this medication include the following:
  • Ofatumumab can cause serious, life-threatening reactions, known as infusion reactions, which may occur during or shortly after receiving your dose. Infusion reactions are more likely to occur with the first two ofatumumab injections, but can happen anytime. Your healthcare provider will give you other medicines before giving you ofatumumab, to help reduce the likelihood that you will experience an infusion reaction.

You will also be closely monitored while receiving ofatumumab. Your dose will need to be interrupted if you experience an infusion reaction during treatment. Tell your healthcare provider if you have any of the following symptoms during or any time after your infusion:

    • Fever
    • Chills
    • Dizziness, lightheadedness, or fainting
    • Skin rash or hives
    • Swelling of the mouth, tongue, face, lips, or throat
    • Back pain
    • Abdominal (stomach) pain
    • Redness of the skin and warmth in the face, neck, and chest area
    • Difficulty breathing or shortness of breath
    • Wheezing
    • Tightness in the chest or throat
    • Chest pain.
  • Ofatumumab may cause abnormally low white blood cell and platelet counts, which could increase your risk for infections and bleeding. Your healthcare provider will monitor your blood cell counts regularly during treatment with a simple blood test. Contact your healthcare provided right away if you experience any symptoms of infection, such as:
    • High fever
    • Body aches
    • Chills
    • Coughing
    • A sore throat
    • Abnormal bleeding or bruising.
  • You could develop a serious brain infection known as progressive multifocal leukoencephalopathy (PML) during ofatumumab treatment. PML can cause severe disability and death. Contact your healthcare provider right away if experience any symptoms of PML, including:
    • Vision problems
    • Confusion
    • Dizziness
    • Loss of balance or difficulty walking
    • Difficulty talking or thinking.
  • Hepatitis B infections (an infection of the liver caused by the hepatitis B virus) have occurred in people using ofatumumab. If you have been infected with the hepatitis B virus in the past, ofatumumab could cause the infection to come back. Liver failure and death may result. Your healthcare provider will monitor you for active hepatitis B virus infection during treatment and for 6 to 12 months after your last dose.
Because of the risks of hepatitis B reactivation, all people should be tested using a blood test to check for a current or past hepatitis B infection before starting this medication.
  • You may be at risk for intestinal obstruction during ofatumumab treatment. Intestinal obstruction is a potentially serious blockage of the small intestine and bowel. Contact your healthcare provider right away if you experience any signs of an intestinal blockage, such as:
    • Abdominal (stomach) pain or cramping
    • Stomach distention (swelling)
    • Nausea and vomiting
    • An inability to have a bowel movement.
  • Talk to your healthcare provider before getting any type of vaccination or immunization during ofatumumab treatment. Vaccines may be less effective in people receiving ofatumumab. You could also become infected with the bacteria or viruses used to make "live" vaccines (see Drug Interactions With Ofatumumab).
  • Ofatumumab is a pregnancy Category C medication, which means it may not be safe for use during pregnancy. Talk to your healthcare provider about the risks and benefits of using this medication during pregnancy (see Arzerra and Pregnancy).
  • It is unknown whether ofatumumab passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to receiving the drug (see Arzerra and Breastfeeding).
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