Ofatumumab 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 is also used to treat multiple sclerosis.

How should I use this medicine?

This medicine is for infusion into a vein or for injection under the skin. Infusions are given by a health care professional in a hospital or clinic setting. If you are to give your own medicine at home, you will be taught how to prepare and give this medicine under the skin. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or health care provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

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

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

• chest pain

• changes in vision

• confusion

• diarrhea

• fast, irregular heartbeat

• 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.

• problems with balance, talking, or walking

• mouth sores

• redness, blistering, peeling, or loosening of the skin, including inside the mouth

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• stomach pain

• unusual bleeding or bruising

• vomiting

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

• headache

• joint pain

• muscle pain

• swelling of the ankles, feet, hands

What may interact with this medicine?

• live virus vaccines

• steroid medicines like prednisone or cortisone

What if I miss a dose?

If you are to be given an infusion of this medicine, it is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

If you are given this medicine by injection under the skin, it is important not to miss any doses. Talk to your health care professional about what to do if you miss a dose.

Where should I keep my medicine?

Infusions will be given in a hospital or clinic and will not be stored at home.

Storage for syringes and autoinjector pens stored at home:

Keep out of the reach of children. You will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.

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

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

• heart disease

• infection (especially a virus infection such as hepatitis B, chickenpox, cold sores, or herpes)

• immune system problems

• irregular heartbeat

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

• lung or breathing disease, like asthma

• recently received or scheduled to receive a vaccine

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

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. You may need blood work done while you are taking this medicine.

This medicine can cause serious allergic reactions. To reduce your risk you may need to take medicine before treatment with this medicine. Take your medicine as directed.

In some patients, this medicine may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your healthcare professional right away. If you cannot reach your healthcare professional, urgently seek other source of medical care.

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.

Do not become pregnant while taking this medicine or for 6 after stopping it. Women should inform their health care professional if they wish to become pregnant or think they might be pregnant. There is potential for serious side effects to an unborn child. Talk to your health care professional for more information.