Arzerra

Generic Name: ofatumumab (OH-fa-TOOM-ue-mab)
Brand Name: Arzerra

If you have had hepatitis B before or carry the virus, Arzerra can cause the virus to become active again. This can lead to severe and sometimes deadly liver problems. Your doctor will watch you for hepatitis B infection before treatment, while you take Arzerra, and for several months after you stop Arzerra. Do not take Arzerra if you have active hepatitis liver disease.

Arzerra increases the risk of a certain type of viral brain infection (progressive multifocal leukoencephalopathy) (PML). PML may cause severe disability or death. Tell your doctor at once if you notice any new or worsening symptoms. These may include confusion; dizziness; difficulty talking or walking; or changes in thinking, eyesight, balance, or strength.


Arzerra is used for:

Treating chronic lymphocytic leukemia (CLL) in certain patients. It may also be used for other conditions as determined by your doctor.

Arzerra is a monoclonal antibody. It works by killing cancer cells.

Do NOT use Arzerra if:

  • you are allergic to any ingredient in Arzerra

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Arzerra:

Some medical conditions may interact with Arzerra. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of hepatitis B infection or you are at risk for hepatitis B infection
  • if you have chronic obstructive pulmonary disease (COPD), blockage of the stomach or bowel, nervous system problems, or white blood cell problems
  • if you have flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin), have recently received a vaccine, or are scheduled to receive a vaccine

Some MEDICINES MAY INTERACT with Arzerra. However, no specific interactions with Arzerra are known at this time.

Ask your health care provider if Arzerra may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Arzerra:

Use Arzerra as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Arzerra is usually given as an injection at your doctor's office, hospital, or clinic.
  • You will receive certain other medicines (acetaminophen, antihistamines, corticosteroids) before you receive your dose of Arzerra.
  • Do not shake Arzerra.
  • Do not use Arzerra if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • If you miss a dose of Arzerra, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Arzerra.

Important safety information:

  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Arzerra. Talk with your doctor before you receive any vaccine.
  • Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Arzerra may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Arzerra may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Some people have had side effects while getting this drug or within 24 hours after. Sometimes, these reactions have been deadly. Call your doctor right away if you have back pain; chest pain or pressure; fainting; fast, slow, or irregular heartbeat; fever or chills; flushing; rash; severe dizziness or headache; shortness of breath or other breathing problems; stomach pain; or swelling of the mouth, face, lips, throat, or tongue.
  • Tell your doctor or dentist that you take Arzerra before you receive any medical or dental care, emergency care, or surgery.
  • Patients who take Arzerra may have an increased risk of getting a serious and sometimes fatal health problem called tumor lysis syndrome (TLS). Call your doctor right away if you have a fast or irregular heartbeat; fainting; trouble passing urine; muscle weakness or cramps; severe nausea, vomiting, diarrhea, or loss of appetite; or sluggishness.
  • Lab tests, including complete blood cell counts, may be performed while you use Arzerra. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Arzerra with caution in the ELDERLY; they may be more sensitive to its effects.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Arzerra while you are pregnant. It is not known if Arzerra is found in breast milk. If you are or will be breast-feeding while you use Arzerra, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Arzerra:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; muscle spasms; nausea; tiredness or weakness; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); dark urine; pain, swelling, or redness at the injection site; pale stools; severe or persistent stomach pain, nausea, or vomiting; severe or persistent tiredness or weakness; swelling of the hands, ankles, or feet; symptoms of infection (eg, fever, chills, cough, or sore throat; warm, red, or painful skin; increased or painful urination); symptoms of PML (eg, confusion; dizziness; difficulty talking or walking; changes in thinking, eyesight, balance, or strength); unusual bruising or bleeding; unusually pale skin; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Arzerra:

Arzerra is handled and stored by a health care provider. You will not store it at home. Keep all medicines out of the reach of children and away from pets.

General information:

  • If you have any questions about Arzerra, please talk with your doctor, pharmacist, or other health care provider.
  • Arzerra is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Arzerra or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Arzerra. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Arzerra. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Arzerra.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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