Rituximab

Rituximab is a prescription medication used to treat certain types of non-Hodgkin's lymphoma (a type of cancer that begins in a type of white blood cells that normally fights infection) and chronic lymphocytic leukemia (a type of cancer that begins in the white blood cells).

Rituximab is also used with another medication to treat the symptoms of rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function) in people who have already been treated with a certain type of medication called a tumor necrosis factor inhibitor.

Rituximab is also used with other medications to treat granulomatosis with polyangiitis (Wegener's Granulomatosis) and microscopic polyangiitis, which are conditions in which the body attacks its own veins and other blood vessels and causes damage to organs, such as the heart and lungs.

Rituximab belongs to a group of drugs called monoclonal antibodies. These work by killing cancer cells and blocking activation of the immune system.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of rituximab include infections, diarrhea, back or joint pain, and anxiety.

Rituximab can cause dizziness and blurred vision. Do not drive or operate heavy machinery until you know how rituximab affects you.

Rituximab is a prescription medication used to treat several types of cancer and autoimmune disorders including:

• non-Hodgkin's lymphoma
• chronic lymphocytic leukemia
• rheumatoid arthritis
• granulomatosis with polyangiitis (Wegener's Granulomatosis) and microscopic polyangiitis in adult patients in combination with glucocorticoids

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Rituximab may be found in some form under the following brand names:

• Rituxan

Serious side effects have been reported with rituximab. See the “Rituximab Precautions” section.

Common side effects of rituximab include the following:

• diarrhea
• back or joint pain
• flushing
• night sweats
• feeling unusually anxious or worried
• runny nose

This is not a complete list of rituximab side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• adalimumab (Humira)
• certolizumab (Cimzia)
• cisplatin (Platinol)
• etanercept (Enbrel)
• golimumab (Simponi)
• infliximab (Remicade)
• medications for high blood pressure
• other medications for rheumatoid arthritis
• medications that suppress the immune system such as azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Prograf)

This is not a complete list of rituximab drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with rituximab including the following:

• hypersensitivity. Serious infusion reactions including anaphylaxis or serum sickness-like reactions may occur. Tell your doctor or get medical help right away if you get any of these symptoms during or after an infusion this medication:
  • hives (red itchy welts) or rash
  • itching
  • swelling of your lips, tongue, throat or face
  • sudden cough
  • shortness of breath, difficulty breathing, or wheezing
  • weakness
  • dizziness or feel faint
  • palpitations (feel like your heart is racing or fluttering)
  • chest pain
• severe reactions of the skin or mucous membranes. Tell your doctor or get medical help right away if you get any of these symptoms at anytime during your treatment:
  • painful sores or ulcers on your skin, lips or in your mouth
  • blisters
  • peeling skin
  • rash
  • pustules
• hepatitis B virus (HBV) reactivation. Patients should be tested for HBV infection before starting rituximab. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop infliximab and begin anti-viral therapy.
• tumor lysis syndrome (TLS). TLS is a severe, sometimes life-threatening alteration in blood chemistry that occurs with the release of materials formerly contained within cancer cells into the bloodstream. It is important to stay hydrated and follow directions with any medications your doctor may prescribe in order to prevent TLS.
• serious infections, including fungal infections. Do not administer infliximab during an active infection. If an infection develops, monitor carefully and stop infliximab if infection becomes serious.
• progressive multifocal leukoencephalopathy (PML). PML is a rare, serious brain infection caused by a virus. People with weakened immune systems can get PML. Your chance of getting PML may be higher if you are treated with rituximab alone or with other medicines that weaken your immune system. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your doctor right away if you have any of the following symptoms of PML:
  • confusion or problems thinking
  • loss of balance
  • change in the way you walk or talk
  • decreased strength or weakness on one side of your body
  • blurred vision or loss of vision

Do not take rituximab if you are allergic to rituximab or to any of its ingredients.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of rituximab there are no specific foods that you must exclude from your diet when receiving rituximab.

Before taking rituximab, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to rituximab or to any of its ingredients
• have had a severe infusion reaction to rituximab in the past
• have a history of heart problems, irregular heart beat or chest pain
• have lung or kidney problems
• have an infection or weakened immune system.
• have or have had any severe infections including, hepatitis B virus (HBV), hepatitis C virus (HCV), cytomegalovirus (CMV), herpes simplex virus (HSV), parvovirus B19, varicella zoster virus (chickenpox or shingles), West Nile virus
• have had a recent vaccination or are scheduled to receive vaccinations
• have taken rituximab in the past
• are pregnant or planning to become pregnant
• are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Rituximab falls into category C. There are no adequate and well-controlled studies of rituximab in pregnant women. Women of childbearing potential should use effective contraception while receiving rituximab and for 12 months following treatment. Rituximab should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if rituximab crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using rituximab.

Take rituximab exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you miss a dose, call your healthcare provider right away to reschedule your appointment.

Take this medication exactly as prescribed by your doctor.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication
• your body surface area, which is determined by your height and weight

Rituximab should be administered by infusion directly into a vein by a healthcare professional with medical support to manage severe reactions should they occur during the infusion.

The recommended dose of rituximab for the treatment of non-Hodgkin’s lymphoma is 375 mg/m2.

The recommended dose of rituximab for the treatment of CLL is 375 mg/m2 in the first cycle and 500 mg/m2 in cycles 2–6, administered every 28 days in combination with fludarabine and cyclophosphamide.

The recommended dose of rituximab for the treatment of rheumatoid arthritis in combination with methotrexate is two-1000 mg infusions separated by 2 weeks (one course) every 24 weeks. Methylprednisolone 100 mg intravenous or equivalent glucocorticoid is recommended 30 minutes prior to each infusion.

The recommended dose of rituximab for the treatment of granulomatosis with polyangiitis (Wegener's Granulomatosis) and microscopic polyangiitis in combination with glucocorticoids is 375 mg/m2 once weekly for 4 weeks.

If you take too much rituximab, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If rituximab is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep this and all medicines out of the reach of children.
• Keep all appointments with your doctor and the laboratory.

WARNING: FATAL INFUSION REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

Infusion Reactions

Rituxan administration can result in serious, including fatal infusion reactions. Deaths within 24 hours of Rituxan infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue Rituxan infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion reactions.

Severe Mucocutaneous Reactions

Severe, including fatal, mucocutaneous reactions can occur in patients receiving Rituxan.

Hepatitis B Virus (HBV) Reactivation

HBV reactivation can occur in patients treated with Rituxan, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with Rituxan. Discontinue Rituxan and concomitant medications in the event of HBV reactivation.

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving Rituxan.