Rituxan

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.

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 injection into a vein as directed by your doctor. It should be injected slowly over several hours. 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. If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. 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.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: 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.

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).

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.

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.

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. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. 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.

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets. 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.

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 right away if you have any serious side effects, including: 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. Get medical help right away 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 get medical help right away 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.

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.