Generic Name: ofatumumab (OH fa TOO mue mab)Brand Names: Arzerra
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.
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.
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);
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.
Contact your doctor if you miss an appointment for your ofatumumab injection.
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.
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.
Usual Adult Dose for Chronic Lymphocytic Leukemia:
Patients should be premedicated before each infusion.Initial dose (Dose 1): 300 mgDoses 2 through 8: 1 week after initial dose, begin 2,000 mg weekly for 7 dosesDoses 9 through 12: 4 weeks after dose 8, begin 2,000 mg every 4 weeks for 4 doses
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.