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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 (CLL). In some patients, ofatumumab is given with another medicine called chlorambucil.

Ofatumumab is sometimes 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.

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:

  • an active infection;

  • hepatitis; or

  • a history of liver disease or hepatitis B.

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.

Using ofatumumab during pregnancy could affect the immune system of the unborn baby. Tell your doctor if you are pregnant or if you become pregnant while using this medicine.

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 treatment cycle over several weeks, beginning with one infusion per week. Then you will receive your infusions less often, depending on the type of CLL for which you are being treated.

Your dosing schedule may change with further doses. Your doctor will determine how long to treat you with ofatumumab.

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.

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. Ofatumumab can cause hepatitis B to come back or get worse. You will need frequent blood tests to check your liver function.

Ofatumumab can have long lasting effects on your body. You may also need medical tests 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), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Ofatumumab side effects

Get emergency medical help if you have 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 right away if you have signs of a serious brain infection: change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Call your doctor at once if you have:

  • fever, chills, cough with yellow or green mucus;

  • stabbing chest pain, wheezing, feeling short of breath;

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

  • low blood cell counts--fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed; or

  • signs of tumor cell breakdown--lower back pain, blood in your urine, little or no urination; 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:

  • fever, cough, flu symptoms;

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

  • trouble breathing;

  • 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:

RECOMMENDED DOSAGE REGIMEN:
-PREVIOUSLY UNTREATED CLL: This drug, in combination with chlorambucil, is indicated for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate:
300 mg IV on Day 1, followed by:
1000 mg IV one week later on Day 8 (Cycle 1) followed by:
1000 mg IV on Day 1 of subsequent 28-day cycles for a minimum of 3 cycles until best response or a maximum of 12 cycles
-EXTENDED TREATMENT IN CLL: As a single agent, this drug is indicated for extended treatment of patients who are in complete or partial response after at least 2 lines of therapy for recurrent or progressive CLL:
300 mg on Day 1, followed by:
1000 mg 1 week later on Day 8, followed by:
1000 mg 7 weeks later and every 8 weeks thereafter for up to a maximum of 2 years
-REFRACTORY CLL: For the treatment of patients with CLL refractory to fludarabine and alemtuzumab. The recommended dosage and schedule is 12 doses administered as follows:
300 mg initial dose on Day 1, followed 1 week later by:
2000 mg weekly for 7 doses (Infusions 2 through 8), followed 4 weeks later by:
2000 mg every 4 weeks for 4 doses (Infusions 9 through 12)

PRIOR TO ADMINISTRATION FOR ALL PATIENTS:
-This drug should be administered under the supervision of a physician experienced in cancer therapy and in an environment where full resuscitation facilities are immediately available.
-Patients should be premedicated before each infusion.
-Patients should be closely monitored during administration for the onset of infusion reactions, including cytokine release syndrome, particularly during the first infusion.
-This drug should not be administered as an IV push or bolus or as a subcutaneous injection.

PREMEDICATION:
PATIENTS SHOULD RECEIVE ALL OF THE FOLLOWING PREMEDICATION AGENTS 30 MINUTES TO 2 HOURS PRIOR TO EACH INFUSION:
PREVIOUSLY UNTREATED CLL OR EXTENDED TREATMENT IN CLL:
-Infusions 1 and 2: IV corticosteroid (prednisolone or equivalent) 50 mg AND oral acetaminophen 1000 mg AND oral or IV antihistamine (diphenhydramine 50 mg or cetirizine 10 mg (or equivalent)
Infusions 3 and beyond (up to 13 infusions in previously untreated CLL; up to 14 infusions in extended treatment in CLL): IV corticosteroid (prednisolone or equivalent) 0 to 50 mg (the corticosteroid may be reduced or omitted for subsequent infusions if a Grade 3 or greater infusion related adverse event did not occur with the preceding infusion) AND oral acetaminophen 1000 mg AND oral or IV antihistamine (diphenhydramine 50 mg or cetirizine 10 mg (or equivalent)
REFRACTORY CLL:
-Infusions 1, 2, and 9: IV corticosteroid (prednisolone or equivalent) 100 mg AND oral acetaminophen 1000 mg AND oral or IV antihistamine (diphenhydramine 50 mg or cetirizine 10 mg (or equivalent)
-Infusions 3 to 8: IV corticosteroid (prednisolone or equivalent) 0 to 100 mg (the corticosteroid may be reduced or omitted for subsequent infusions if a Grade 3 or greater infusion related adverse event did not occur with the preceding infusion) AND oral acetaminophen 1000 mg AND oral or IV antihistamine (diphenhydramine 50 mg or cetirizine 10 mg (or equivalent)
-Infusions 10 to 12: IV corticosteroid (prednisolone or equivalent) 50 to 100 mg (the corticosteroid may be given at a reduced dose of 50 mg to 100 mg if a Grade 3 or greater infusion related adverse event did not occur with Infusion 9) AND oral acetaminophen 1000 mg AND oral or IV antihistamine (diphenhydramine 50 mg or cetirizine 10 mg (or equivalent)

ADMINISTRATION:
PREVIOUSLY UNTREATED CLL AND EXTENDED TREATMENT IN CLL:
-Cycle 1, Day 1: Initiate the first dose (300 mg) at 12 mL/hr for 30 minutes; if tolerated, increase to 25 mL/hr for 30 minutes; if tolerated increase to 50 mL/hr for 30 minutes; if tolerated increase to 100 mL/hr for 30 minutes; if tolerated increase to 200 mL/hr for 30 minutes; if tolerated increase to 300 mL/hr for 30 minutes; if tolerated increase to 400 mL/hr for remainder of the infusion. The median duration of infusion is 4.8 to 5.2 hours.
-Cycle 1, day 8 and cycles 2 to 12 (if no reaction to previous infusion): Initiate infusion at 25 mL/hr for 30 minutes, if tolerated increase to 50 mL/hr for 30 minutes, if tolerated increase to 100 mL/hr for 30 minutes, if tolerated increase to 200 mL/hr for 30 minutes, if tolerated increase to 400 mL/hr for remainder of infusion. The median duration of infusion is 4.2 to 4.4 hours.
REFRACTORY CLL: The recommended dosage and schedule is 12 doses administered as follows:
-Doses 1 and 2: Initiate infusion at 12 mL/hr for 30 minutes, if tolerated, increase to 25 mL/hr for 30 minutes, if tolerated increase to 50 mL/hr for 30 minutes, if tolerated increase to 100 mL/hr for 30 minutes, if tolerated increase to 200 mL/hr for remainder of infusion. The median duration of infusion is 6.8 hours.
-Doses 3 to 12: Initiate infusion at 25 mL/hr for 30 minutes, if tolerated, increase to 50 mL/hr for 30 minutes, if tolerated, increase to 100 mL/hr for 30 minutes, if tolerated, increase to 200 mL/hr for 30 minutes, if tolerated, increase to 400 mL/hr for remainder of infusion. The median duration of infusion is 4.2 to 4.4 hours.

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: 2.03. Revision Date: 2016-02-08, 5:29:05 PM.

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