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 in to treat chronic lymphocytic leukemia.
Ofatumumab is usually given after other medications have been tried without successful treatment of symptoms.
Ofatumumab may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about 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. Call your doctor right away if you have symptoms such as change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.
Before you receive ofatumumab, tell your doctor if you have hepatitis or severe COPD.
To be sure this medication is not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested for several months, even after you stop using ofatumumab. Do not miss any follow-up visits to your doctor.
Call your doctor at once if you develop any symptoms of liver damage, such as nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).
You should also call your doctor right away if you develop any signs of infection such as fever, chills, body aches, flu symptoms, mouth and throat ulcers, easy bruising or bleeding, or cough with mucus and stabbing chest pain.
Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection. Do not receive a "live" vaccine while you are being treated with ofatumumab.
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.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
severe COPD (chronic obstructive pulmonary disease);
FDA pregnancy category C. It is not known whether ofatumumab is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether ofatumumab passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How is ofatumumab given?
Ofatumumab is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. 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. Your dosing schedule may be different. Follow your doctor's instructions.
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.
To be sure this medication is not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested on a regular basis. Ofatumumab can have long-lasting effects on your body. Do not miss any follow-up visits to your doctor for blood or urine tests.
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 at regular visits for several months after you stop using ofatumumab. Do not miss any scheduled appointments.
What happens if I miss a dose?
Contact your doctor if you miss an appointment for your ofatumumab injection.
What happens if I overdose?
Seek emergency medical attention if you think you have received too much of this medicine. Symptoms of a ofatumumab overdose are unknown.
What should I avoid while receiving ofatumumab?
Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while you are being treated with ofatumumab. The live vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.
Ofatumumab side effects
Some people receiving a ofatumumab injection have had a reaction to the infusion (when the medicine is injected into the vein). 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..
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.
Call your doctor at once if you have any of these serious side effects:
change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);
nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
fever, chills, body aches, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
confusion, weakness on one side of the body, loss of balance or coordination; or
Less serious side effects may include:
mild nausea, diarrhea;
swelling in your hands or feet.
cold symptoms such as stuffy nose, sneezing, sore throat;
tired feeling; or
mild skin rash.
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: ofatumumab 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?
There may be other drugs that can interact with ofatumumab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
More ofatumumab resources
Compare ofatumumab with other medications
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.
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