Rituximab

Generic Name: rituximab (ri TUX i mab)Brand Names: Rituxan

What is rituximab?

Rituximab is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Rituximab is used in combination with other cancer medicines to treat non-Hodgkin's lymphoma. Rituximab is also used in combination with another drug called methotrexate to treat symptoms of adult rheumatoid arthritis.

Rituximab may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about rituximab?

Do not receive this medication if you have ever had a severe allergic reaction to rituximab, or if you are allergic to mouse protein.

Some people receiving a rituximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, weak, nauseated, light-headed, itchy, or if you have a fever, chills, muscle pain, sneezing, sore throat, trouble breathing, or pain in your chest or shoulders. Infusion reactions often occur within the first 24 hours after the start of your rituximab infusion.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

If you have hepatitis B you may develop liver symptoms after you stop using this medication, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using rituximab. Do not miss any scheduled visits.

Rituximab increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you have symptoms such as change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

What should I discuss with my healthcare provider before receiving rituximab?

Do not receive this medication if you have ever had a severe allergic reaction to rituximab, or if you are allergic to mouse protein.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely receive rituximab:

  • liver disease or hepatitis B (or if you are a carrier of hepatitis B);

  • kidney disease;

  • systemic lupus erythematosus (SLE);

  • lung disease or a breathing disorder;

  • a history of heart disease, angina (chest pain), or heart rhythm disorder; or

  • a recent or active infection, including herpes, shingles, cytomegalovirus, or any infection that keeps coming back or does not clear up.

FDA pregnancy category C. It is not known whether rituximab is harmful to an unborn baby. Before you receive this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether rituximab passes into breast milk or if it could harm a nursing baby. Do not take rituximab without telling your doctor if you are breast feeding a baby.

Older adults may be more likely to have side effects from rituximab, causing breathing difficulty or heart rhythm problems.

How is rituximab given?

Rituximab is given as an injection through a needle placed into a vein. The medicine must be given slowly through an IV infusion. You will receive this injection in a clinic or hospital setting.

Before you receive rituximab, you may be given other medications to prevent certain side effects that rituximab can cause.

The medicine is usually given once per week for 4 to 8 weeks. In the treatment of rheumatoid arthritis, you may receive only two injections of rituximab, with 2 weeks in between treatments.

If you take any medications for high blood pressure, your doctor may ask you not to take them within 12 hours before you receive rituximab. This is to prevent your blood pressure from getting too low during your rituximab infusion. Follow your doctor's instructions.

To be sure rituximab is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

If you have hepatitis B you may develop liver symptoms after you stop using this medication, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using rituximab. Do not miss any scheduled visits.

If you need to have any type of surgery, tell the surgeon ahead of time that you are being treated with rituximab.

What happens if I miss a dose?

Call your doctor if you miss an appointment for your rituximab injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. Symptoms of a rituximab overdose are not known.

What should I avoid while receiving rituximab?

Do not receive a "live" vaccine while you are being treated with rituximab.

Rituximab side effects

Some people receiving a rituximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, weak, nauseated, light-headed, itchy, or if you have a fever, chills, muscle pain, sneezing, sore throat, trouble breathing, or pain in your chest or shoulders. Infusion reactions often occur within the first 24 hours after the start of your rituximab infusion.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Rituximab increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you have symptoms such as change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly. Call your doctor at once if you have any of these serious side effects, even if they occur several months after you receive rituximab, or after your treatment ends.
  • sudden numbness or weakness, especially on one side of the body;

  • confusion, dizziness, loss of balance, blurred vision, and problems with speech or walking; or

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  • uneven heartbeats, wheezing or trouble breathing;

  • urinating more or less than usual;

  • fever, chills, cough, body aches, flu symptoms;

  • easy bruising or bleeding;

  • a red, raised, blistering, scaly, itchy, or peeling skin rash;

  • severe constipation or stomach pain;

  • black, bloody, or tarry stools; or

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • pain where the IV needle is placed;

  • headache, back pain;

  • mild stomach pain, nausea, or diarrhea;

  • swelling in your hands or feet;

  • muscle or joint pain;

  • runny or stuffy nose; or

  • night sweats.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Rituximab Dosing Information

Usual Adult Dose for non-Hodgkin's Lymphoma:

Relapsed or Refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's Lymphoma:375 mg/m2 IV infusion once weekly for 4 or 8 doses. Patients who subsequently develop progressive disease may be safely retreated with rituximab 375 mg/m2 IV infusion once weekly for 4 doses. Currently there are limited data concerning more than 2 courses. Diffuse large B-cell non-Hodgkin's Lymphoma:375 mg/m2 IV per infusion given on day 1 of each cycle of chemotherapy for up to 8 infusionsAs a required component of ibritumomab tiuxetan therapeutic regimen:rituximab 250 mg/m2 should be infused within 4 hours prior to the administration of Indium-111- (In-111-) ibritumomab tiuxetan and within 4 hours prior to the administration of Yttrium90- (Y-90-) ibritumomab tiuxetan. Administration of rituximab and In-111-ibritumomab tiuxetan should precede rituximab and Y-90-ibritumomab tiuxetan by 7 to 9 days.(Note: The ibritumomab tiuxetan therapeutic regimen, is indicated for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with rituximab-refractory follicular non-Hodgkin's lymphoma.)

Usual Adult Dose for Rheumatoid Arthritis:

Rheumatoid Arthritis: Rituximab is given in combination with methotrexate. Rituximab is given as two-1000 mg IV infusions separated by 2 weeks. Glucocorticoids administered as methylprednisolone 100 mg IV or its equivalent 30 minutes prior to each infusion are recommended to reduce the incidence and severity of infusion reactions. Safety and efficacy of retreatment have not been established in controlled trials.

What other drugs will affect rituximab?

Before receiving rituximab, tell your doctor if you are also being treated with any of the following drugs:

  • cisplatin (Platinol);

  • adalimumab (Humira);

  • auranofin (Ridaura);

  • azathioprine (Imuran);

  • cyclosporine (Gengraf, Neoral, Sandimmune);

  • etanercept (Enbrel);

  • infliximab (Remicade);

  • leflunomide (Arava);

  • minocycline (Dynacin, Minocin, Vectrin);

  • sulfasalazine (Azulfidine);

  • blood pressure medications; or

  • medication to treat malaria, such as chloroquine (Aralen) or hydroxychloroquine (Plaquenil, Quineprox).

This is not a complete list and there may be other drugs that can affect rituximab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about rituximab.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 4.02. Revision Date: 08/20/2009 12:10:14 PM.
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