Ofatumumab (Injection)

Introduction

Ofatumumab (oh-FAT-oo-moo-mab)

Treats chronic lymphocytic leukemia (CLL). This medicine is given to patients who have already received other cancer medicines (such as alemtuzumab or fludarabine) that did not work.

Brand Name(s)

Arzerra

How to Use This Medicine

Injectable

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins. This medicine needs to be given slowly, so the needle will remain in place for at least an hour. You may also receive medicines to help prevent allergic reactions.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease, a history of hepatitis B, or bowel blockage.
• This medicine may cause chest pain; fever; chills; itching; hives; flushing of the face; rash; dizziness, fainting, or lightheadedness; troubled breathing; or swelling of the face, tongue, and throat within a few hours after you receive it. Check with your doctor or nurse right away if you have any of these symptoms.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you are having more than one of these symptoms: confusion, vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.
• Check with your doctor immediately if you have any symptoms of liver problems including skin and eyes turning yellow, dark brown-colored urine, right-sided abdominal or stomach pain, fever, or severe tiredness.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain.
• Confusion, dizziness, loss of balance, difficulty with speaking or understanding what others say, and vision problems.
• Dark-colored urine or pale stools.
• Fast, pounding, or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Lightheadedness or fainting.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Shortness of breath or troubled breathing.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding, bruising, or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Diarrhea.
• Headache or back pain.
• Pain, itching, burning, swelling, bleeding, or a lump under your skin where the needle is placed.
• Rash.
• Stuffy or runny nose.
• Trouble sleeping.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

When This Medicine Should Not Be Used