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    Rituximab Concentrate

    COMMON BRAND NAME(S): Rituxan

    GENERIC NAME(S): Rituximab

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    WARNINGS:

    Rituximab may rarely cause serious (sometimes fatal) side effects including severe breathing problems or heart problems (such as heart attack, irregular heartbeat). If these serious side effects occur, they usually happen during the first treatment with 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. Get medical help right away if you have trouble breathing, itching, swelling (especially of the throat/lips), dizziness, fast/slow/irregular heartbeat, or chest pain.

    Rarely, people using 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.

    This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, vision changes.

    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 this medication, tell your doctor if you have ever had hepatitis B. Your doctor should order a test to see if you have the hepatitis B infection before starting treatment. Tell your doctor right away if you have symptoms of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, or dark urine.

    Who should not take Rituximab Concentrate?
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    Uses

    Rituximab is used to treat certain types of cancer (such as non-Hodgkin's lymphoma, chronic lymphocytic leukemia). It works by slowing or stopping the growth of cancer cells.

    Rituximab is used to treat rheumatoid arthritis and 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) and can decrease the swelling of the blood vessels.

    How to use Rituximab Concentrate

    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, ask your doctor or pharmacist.

    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, body size, and response to treatment.

    Side Effects

    See also Warning section.

    Nausea, vomiting, headache, dizziness, joint/muscle pain, weakness, or flushing may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

    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.

    Tell your doctor right away if you have any serious side effects, including: swelling hands/ankles/feet, increased thirst/urination, numbness/tingling of arms/legs.

    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 decrease blood cells, which can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: easy bleeding/bruising, black/tarry stools, vomit that looks like coffee grounds, signs of an infection (such as sore throat that doesn't go away, fever, chills), unusual tiredness, pale skin.

    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.

    Precautions

    Before using rituximab, tell your doctor or pharmacist if you are allergic to it; or to mouse protein; 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: lung disease, heart problems (such as irregular heartbeat, previous heart attack), bleeding/blood disorders, current/recent infections.

    This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

    Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

    Rituximab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

    Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

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

    Older adults may be at greater risk for heart problems (such as irregular heartbeat) or lung problems while using this drug.

    During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 1 year after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

    It is unknown if 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 breast-feed until treatment is finished and a blood test shows that there is no more rituximab in your body. Ask your doctor when it is safe to breast-feed.

    Interactions

    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 are: other drugs that weaken the immune system/increase the risk of infection (such as tofacitinib, natalizumab, fingolimod).

    Overdose

    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.

    Notes

    Lab and/or medical tests (such as complete blood count, hepatitis B virus, kidney/liver function) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments.

    Missed Dose

    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 or pharmacist right away to establish a new dosing schedule.

    Storage

    Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

    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 June 2017. Copyright(c) 2017 First Databank, Inc.

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    Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

    CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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