Ofatumumab, Injection

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KEY POINTS

• This medicine is given by IV to treat chronic lymphocytic leukemia.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine increases your risk of brain infection and liver injury. It may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); monoclonal antibody

Generic and brand names: ofatumumab, injection; Arzerra

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat chronic lymphocytic leukemia when other anticancer medicines are not effective.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Hepatitis B or other liver problems or severe infections. If you have had hepatitis B or are a carrier of hepatitis B virus, receiving this medicine could cause the virus to become an active infection again. This may cause serious liver problems including liver failure, and death.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

These infusions are given by your healthcare provider in a clinic or hospital. Each infusion will be given over several hours. The infusions are usually given once a week for 8 doses, then once a month for 4 doses. You will be monitored while you receive the medicine. How long you will need this treatment will be determined by your healthcare provider. Keep all appointments for the infusions.

You will be given medicines before the infusion to help prevent side effects.

What should I watch out for?

This medicine increases the risk of progressive multifocal leukoencephalopathy (PML), a brain infection that can lead to death or severe disability. You need to have exams and blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you have had hepatitis B, your healthcare provider will check you regularly for hepatitis B during treatment and for several months after you stop treatment. Your healthcare provider will also check you regularly and do blood tests to see how this medicine affects you. Keep all appointments.

This medicine may cause an infusion-related reaction. This is more likely with the first 2 infusions, but may happen with any infusion. You will be monitored closely while receiving this medicine.

You may bleed or bruise more easily or get infections, including fungal infections, more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Contact your healthcare provider right away if you develop unusual bruising or bleeding or a fever or ANY other symptoms of infection. Also, do not have any vaccines without getting your healthcare provider's approval first.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness or pain in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Cough, fever, unexplained sore throat, shortness of breath, trouble swallowing, chest pain, severe dizziness or fainting, confusion, trouble talking or walking, vision problems, severe headache, stiff neck, unusual bruising or bleeding, pinpoint red spots on the skin, yellowing of your skin or eyes, dark urine, light colored bowel movements, unexplained tiredness or weakness, new or worsening stomach pain or nausea, fast heartbeat; unexplained swelling in hands or feet.

Other: Redness, swelling, or bruising around the injection site; headache; nausea; dizziness; runny nose; heartburn; back pain; diarrhea; trouble sleeping; sweating.

What products might interact with this medicine?

Some vaccinations should not be given while you are receiving this medicine, and some should not be given for several months after you stop receiving this medicine. Ask your healthcare provider about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.