Rituximab may infrequently cause serious (sometimes fatal) side effects including severe breathing problems (e.g., hypoxia, pulmonary infiltrates, acute respiratory distress syndrome) or heart problems (e.g., heart attack, irregular heartbeat, low blood pressure). These effects are more likely if you already have heart or lung problems. Your doctor will carefully watch you during treatment and may stop or slow down your treatment if you have any signs of a reaction. If these serious side effects occur, it will usually be within 30 minutes to 2 hours of receiving this drug. The risk is also higher during your first treatment. However, severe side effects may occur several weeks to months after your last treatment, so it is very important to keep all your follow-up appointments. Seek immediate medical attention if you have trouble breathing (e.g., cough, wheezing), itching, swelling (especially of the throat/lips), dizziness, fast/slow/irregular heartbeat, or chest pain.

Rarely, serious (sometimes fatal) skin reactions (e.g., Stevens-Johnson syndrome) have occurred in people taking this medication. Seek immediate medical attention if you develop any rash, blisters, peeling skin, or sores. These reactions can occur weeks to months after your treatment has ended.

Rarely, a serious (sometimes fatal) brain infection (Progressive Multifocal Leukoencephalopathy-PML) has occurred in people taking this medication. Seek immediate medical attention if you develop any signs of PML, including vision problems, loss of balance/coordination, or confusion.

When large numbers of cancer cells are killed quickly, kidney failure can occur because the kidneys can have trouble getting rid of the dead cells. Tell your doctor immediately if there is a large change in the amount of urine, which could be a sign of a kidney problem. The risk is greater within the first 1-2 days after your treatment is begun. Kidney failure is more likely if you have a large number of cancer cells in the blood, a large tumor, or are being treated with cis-platinum. Laboratory tests (e.g., electrolytes, kidney function) may be performed to monitor your progress and watch for side effects.

Rituximab is used alone or with other medications to treat certain types of cancer (e.g., non-Hodgkin's lymphoma). It is a type of medication called a monoclonal antibody. It works by attaching to certain blood cells from your immune system (B cells) and killing them. It is also used with other monoclonal antibodies and radioactive drugs to treat certain cancers.

Rituximab is also used with methotrexate to treat moderate-to-severe forms of rheumatoid arthritis. It is usually used for arthritis only after other medications have not worked. It can decrease joint pain and swelling.

Read the Medication Guide provided by your pharmacist before you start using rituximab and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This medication will be given by a health care professional. It is mixed in a solution and given slowly over several hours by vein (IV) as directed by your doctor. The dose and how often you receive the medication depends on your condition, other treatments, and response to therapy. If you are being treated for cancer, you will receive one or more doses, usually once a week. If you are being treated for arthritis, you will usually receive 2 doses, usually 2 weeks apart.

Your doctor may prescribe other medications (e.g., acetaminophen, diphenhydramine, methylprednisolone) for you to take 30 minutes before the start of your treatment to help prevent serious side effects. Your dose will be started slowly, and the rate will be increased if you are tolerating the medication well.

Ask your doctor if you should take your regular medications (e.g., drugs for high blood pressure) before your treatment.

Follow all instructions for proper mixing and dilution with correct IV fluids. Follow all safety precautions. Ask your pharmacist if you have questions about the use of this medication.

Do not shake the IV liquid. After adding the drug to the IV fluid, gently turn the bag upside down and over to mix the drug into the liquid. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

See also Warning section.

Headache, fever, chills, nausea, heartburn, flushing, weakness, or dizziness may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: back/joint/muscle pain, increased thirst/urination, swelling of the hands/feet, tingling of the hands/feet.

If you have a current or past infection with hepatitis B or other virus infections (e.g., herpes, JC virus), rituximab may infrequently cause the infection to return or worsen. This may happen during treatment or up to 1 year after treatment is finished. Very serious liver disease could occur. If you have hepatitis B, you may be given antiviral medications to control the disease. Seek immediate medical attention if you develop signs of a new or returning infection or liver disease such as: persistent stomach/abdominal pain, extreme tiredness, dark urine, yellowing eyes/skin.

This medication can cause a decrease in blood cells (cytopenia), which can cause bleeding problems and lower the body's ability to fight an infection. This serious side effect can happen days, weeks, or months after your treatment has finished. Notify your doctor promptly if you develop any of the following side effects: easy bleeding/bruising, black/tarry stools, vomit that looks like coffee grounds, signs of an infection (e.g., fever, chills, persistent sore throat, painful urination).

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using rituximab, tell your doctor or pharmacist if you are allergic to it; or to other mouse protein medications; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (e.g., thrombocytopenia), heart problems (e.g., irregular heartbeat, angina), current or returning infections, lung problems (e.g., pulmonary infiltrates), previous severe reaction to monoclonal antibody treatment, planned surgery/vaccinations, virus infection (e.g., chickenpox, hepatitis B or C, herpes).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Wash your hands well to prevent the spread of infections.

Caution should be used when using this in the elderly because they may be at greater risk for heart problems (e.g., irregular heartbeat) or lung problems (e.g., pneumonia).

During pregnancy, this medication must not be used unless clearly needed due to a risk of harm to the unborn baby. Discuss the risks and benefits with your doctor. Becoming pregnant is not recommended during treatment with this medication and for at least 12 months after treatment is finished. Consult your doctor or pharmacist about using a reliable form of birth control (e.g., condoms, birth control pills).

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. You should not begin breast-feeding until treatment is finished and blood test show that there is no more rituximab in your body. Consult your doctor to decide when it is safe to start breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other anti-cancer drugs (e.g., cis-platinum, fludarabine), drugs for high blood pressure (e.g., enalapril, metoprolol, verapamil), drugs that affect the immune system (e.g., azathioprine, cyclosporine, corticosteroids such as prednisone), recent or planned immunizations (e.g., polio vaccine taken by mouth, measles vaccines).

Do not start or stop any medicine without the approval of your doctor or pharmacist.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.

Laboratory and/or medical tests (e.g., complete blood count, platelet count, electrolytes, hepatitis B virus, kidney/liver function) may be performed to monitor for side effects and response to treatment.

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule. Do not double the dose to catch up.

Store unopened vials in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light and moisture. Discard any unused liquid left in the vial after mixing. Do not freeze or shake the vials.

Store the mixed solution in the refrigerator at 36-46 degrees F (2-8 degrees C ) for up to 24 hours. Protect from light. Do not freeze. The mixed solution is stable for an additional 24 hours at room temperature if protected from direct sunlight. Discard the mixed solution after 24 hours.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.