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ofatumumab

Generic Name: ofatumumab (OH fa TOO mue mab)
Brand Name: Arzerra

What is ofatumumab?

Ofatumumab is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Ofatumumab is used to treat chronic lymphocytic leukemia.

Ofatumumab is usually given after other medications have been tried without success.

Ofatumumab may also be used for purposes not listed in this medication guide.

What is the most important information I should know about ofatumumab?

If you have certain risk factors for hepatitis B, ofatumumab can cause this condition to come back or get worse, which could lead to liver failure or death. You will need frequent blood tests to check your liver function.

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Ofatumumab may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking.

What should I discuss with my healthcare provider before receiving ofatumumab?

Ofatumumab increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines.

To make sure ofatumumab is safe for you, tell your doctor if you have:

  • hepatitis;

  • severe infections; or

  • severe COPD (chronic obstructive pulmonary disease).

If you have certain risk factors for hepatitis B, the virus could become active again while you are using ofatumumab and for up to several months after you stop using it. This has resulted in liver failure or death in some people using ofatumumab. Your doctor will perform blood tests to make sure you do not have conditions that may cause you to develop hepatitis B.

FDA pregnancy category C. It is not known whether ofatumumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether ofatumumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is ofatumumab given?

Ofatumumab is injected into a vein through an IV. A healthcare provider will give you this injection. The medicine must be given slowly through an IV infusion, and one dose can take up to several hours to complete.

Ofatumumab is usually given in a series of 12 doses. The first 8 doses are given 1 week apart. The last 4 doses are given 4 weeks apart. You may also need to take antiviral medications if you are found to have any risk factors for hepatitis B. Follow your doctor's dosing instructions very carefully.

You will be given other IV or oral (by mouth) medications to prevent certain side effects of ofatumumab. You may need to start using these medications up to 2 hours before the start of your ofatumumab infusion.

Ofatumumab can have long lasting effects on your body. You may also need frequent medical tests while you are using ofatumumab and for a short time after you stop using this medication.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using ofatumumab.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your ofatumumab injection.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving ofatumumab?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using ofatumumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Ofatumumab side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, confused, itchy, tingly, or have chest pain, jaw or arm pain, back pain, stomach pain, wheezing, chest tightness, or trouble breathing. These reactions can occur during the injection or within 24 hours afterward.

Call your doctor at once if you have:

  • change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);

  • fever, chills, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms;

  • stabbing chest pain, wheezing, feeling short of breath, cough with yellow or green mucus;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • signs of tumor cell breakdown--lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, feeling short of breath; confusion, fainting.

Common side effects may include:

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • diarrhea, nausea;

  • mild rash; or

  • tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Ofatumumab dosing information

Usual Adult Dose for Chronic Lymphocytic Leukemia:

Patients should be premedicated before each infusion.

Total of 12 doses:
Initial dose (Dose 1): 300 mg
Doses 2 through 8: 1 week after initial dose, begin 2,000 mg weekly for 7 doses
Doses 9 through 12: 4 weeks after dose 8, begin 2,000 mg every 4 weeks for 4 doses

Each dose diluted in 1000 mL of 0.9% sodium chloride and given by slow intravenous infusion

What other drugs will affect ofatumumab?

Other drugs may interact with ofatumumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about ofatumumab.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2014-01-13, 8:15:45 PM.

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