When This Medicine Should Not Be Used:
You should not receive this medicine if you have had an allergic reaction to rituximab or other murine (mice or rat) proteins.

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.
• 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.
• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• Rituximab must be given slowly, so the needle will remain in place for a few hours. You may also receive medicines (such as acetaminophen, antihistamines) to help prevent possible allergic reactions to the injection.
• You will be watched closely for unwanted side effects while you are receiving this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

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

• Make sure your doctor knows if you are also receiving cisplatin (Platinol®). Tell your doctor if you have taken other medicines to treat rheumatoid arthritis such as adalimumab (Humira®), etanercept (Enbrel®), or infliximab (Remicade®).
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. Some vaccines may be given 4 weeks before a rituximab injection.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or planning to become pregnant. You must use an effective form of birth control to prevent pregnancy. You should not become pregnant while you are receiving this medicine and for 12 months after stopping it.
• Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, liver disease (including hepatitis B), chest pain (angina), heart disease, heart rhythm problems, or lung problems. Also tell your doctor if you have a weak immune system or any type of infection.
• Tell your doctor if you have had a reaction to murine (mice or rat) proteins. Murine proteins are also used in other medicines.
• Rituximab may cause a serious side effect called an infusion reaction. This can be life-threatening and requires immediate medical attention. Check with your doctor or nurse right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain.
• This medicine may cause a serious reaction called tumor lysis syndrome. Call your doctor right away if you have changes in how often you urinate, rapid weight gain, swelling of the feet or lower legs, uneven heartbeat, or seizures.
• If you have a severe skin reaction, tell your doctor right away. Symptoms may include blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills.
• This medicine may increase your risk of infections during treatment and up to a year after treatment. These infections can be severe and lead to death. Avoid being near people who are sick. Wash your hands often. Tell your doctor if you have lupus or have ever had an infection that kept coming back.
• Call your doctor right away if you have a cough that won't go away, weight loss, night sweats, fever, chills, flu-like symptoms (such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill), painful or difficult urination, or sores, ulcers, or white spots in the mouth or on the lips. These may be signs of infection.
• This medicine may cause a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML). The risk for getting this infection is higher if you have rheumatoid arthritis. Check with your doctor right away if you have more than one of these symptoms: vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.
• Check with your doctor right away if you have any symptoms of liver problems, including yellow skin and eyes, dark urine or pale stools, nausea and vomiting, or upper stomach pain.
• Check with your doctor right away if you have abdominal pain. This medicine could cause serious stomach and bowel problems, such as a bowel obstruction or a hole in your bowel.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. 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
• Blistering, peeling, red skin rash
• Bloody vomit or vomit that looks like coffee grounds, severe stomach pain
• Changes in vision
• Chest pain, uneven heartbeat, sudden fainting
• Confusion, body weakness, shortness of breath, numbness or tingling in your hands, feet, or lips
• Dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow eyes or skin
• Decrease in how much or how often you urinate, pain while urinating
• Dizziness, lightheadedness, drowsiness
• Fever, chills, cough, sore throat, and body aches
• Joint pain, stiffness, or swelling
• Problems with coordination or speech
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sores, ulcers, or white spots in the mouth or on the lips
• Unusual bleeding or bruising
• Unusual tiredness or weakness

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

• Headache
• Mild skin rash or itching
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

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