Rituximab may rarely 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 had a serious reaction to rituximab. 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, they will usually happen within two hours from the start of your first treatment (IV infusion) with rituximab. However, severe side effects might occur during any rituximab treatment, or several weeks to months after your last treatment, so 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. See also the How To Use section.
Rarely, people taking this medication have had serious (sometimes fatal) skin reactions (such as Stevens-Johnson syndrome). Get medical help right away if you develop any rash, blisters, peeling skin, or sores on your skin, lips, or in your mouth.
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.
Rituximab may cause serious (possibly fatal) liver disease in people who have a current or past infection with hepatitis B. This may occur during treatment or up to 2 years after treatment is finished. Before starting treatment with this medication, your doctor may order a test to see if you have the hepatitis B infection. Your doctor may also order blood tests and watch for symptoms of liver disease during treatment and for months after your last dose of this medication. Get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.Who should not take Rituximab Concentrate?
Rituximab is used alone or with other medications to treat certain types of cancer (e.g., non-Hodgkin's lymphoma, chronic lymphocytic leukemia). 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. It is also used to treat certain types of blood vessel disease (such as Wegener's granulomatosis, microscopic polyangiitis).
Your doctor should prescribe other medications (such as acetaminophen, an antihistamine, methylprednisolone) for you to take before each treatment to help reduce side effects, such as fever and chills. Carefully follow your doctor's instructions.
This medication is given by slow injection into a vein by a health care professional as directed by your doctor. The dosage and treatment schedule are based on your medical condition, other medications you may be taking, and response to treatment.
Ask your doctor if you should take your regular medications (e.g., drugs for high blood pressure) before your treatment.
See also Warning section.
People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.
Rituximab sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.
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 (such as fever, chills, persistent sore throat, painful urination).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.
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. 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, virus infection (e.g., chickenpox, hepatitis B or C, herpes, JC virus).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
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.
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.
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), other drugs that weaken the immune system/increase the risk of infection (e.g., azathioprine, tofacitinib, cyclosporine, natalizumab, fingolimod, corticosteroids such as prednisone), recent or planned immunizations (e.g., polio vaccine taken by mouth, measles vaccines).
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can 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 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.Information last revised December 2016. Copyright(c) 2016 First Databank, Inc.
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