Ofatumumab Solution for injection

What is this medicine?

OFATUMUMAB (O fa TOOM ue mab) is a monoclonal antibody. It is used to treat chronic lymphocytic leukemia (CLL).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• hepatitis

• low blood counts, like low white cell, platelet, or red cell counts

• lung or breathing disease

• stomach problems

• an unusual or allergic reaction to ofatumumab, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses as directed. It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• live virus vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Report any side effects that you notice during your treatment right away, such as changes in your breathing, fever, chills, dizziness or lightheadedness. These effects are more common with the first dose.

Visit your prescriber or health care professional for checks on your progress. You will need to have regular blood work. Report any other side effects. The side effects of this medicine can continue after you finish your treatment. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• confusion, trouble speaking or understanding

• cough

• fainting spells

• fever or chills

• general ill feeling or flu-like symptoms

• lightheadedness

• loss of appetite, nausea

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• right upper belly pain

• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine

• sore throat

• stomach pain

• trouble walking, dizziness, loss of balance or coordination

• unusual bleeding or bruising

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• difficulty sleeping

• headache

• swelling of the legs or ankles

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is only given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.