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rituximab

Pronunciation

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

What is rituximab?

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

Rituximab is used to treat non-Hodgkin's lymphoma or chronic lymphocytic leukemia. Rituximab is also used in combination with another drug called methotrexate to treat symptoms of adult rheumatoid arthritis.

Rituximab is also used in combination with steroid medicines to treat certain rare disorders that cause inflammation of blood vessels and other tissues in the body.

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

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

Rituximab may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

If you have ever had hepatitis B, rituximab can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine. Call your doctor at once if you have upper stomach pain, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

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Severe skin problems can also occur during treatment with rituximab. Call your doctor if you have painful skin or mouth sores, or a severe skin rash with blistering, peeling, or pus.

Some side effects may occur during the injection (or within 24 hours after the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, weak, light-headed, short of breath, or if you have chest pain, wheezing, sudden cough, or pounding heartbeats or fluttering in your chest.

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

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

To make sure rituximab is safe for you, tell your doctor if you have:

  • 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 weak immune system (caused by disease or by using certain medicines);

  • a recent or active infection, including herpes, shingles, cytomegalovirus, chickenpox, parvovirus, West Nile virus, hepatitis C, or any infection that keeps coming back or does not clear up;

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

  • if you have used certain arthritis medicines in the past, including adalimumab (Humira), certolizumab (Cimzia), golimumab (Simponi), etanercept (Enbrel), or infliximab (Remicade).

FDA pregnancy category C. It is not known whether rituximab will harm an unborn baby. Rituximab can affect the immune system of a newborn if the mother receives the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control while you are using this medication and for at least 12 months after your treatment ends.

It is not known whether rituximab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is rituximab given?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using rituximab.

Rituximab is injected into a vein through an IV. A healthcare provider will give you this injection. Follow your doctor's dosing instructions very carefully.

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

While using rituximab, you may need frequent blood tests.

If you have ever had hepatitis B, rituximab can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

If you need surgery, tell the surgeon ahead of time that you are using 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?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving rituximab?

Do not receive a "live" vaccine while using rituximab, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Rituximab side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection (or within 24 hours after the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, weak, light-headed, short of breath, or if you have chest pain, wheezing, sudden cough, or pounding heartbeats or fluttering in your chest.

Rituximab may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, thinking problems or confusion, decreased vision, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Call your doctor at once if you have any of these other side effects, even if they occur several months after you receive rituximab, or after your treatment ends.

  • fever, chills, flu symptoms, pale skin, easy bruising or bleeding, feeling weak or tired;

  • ongoing cough, sinus pain, wheezing, or breathing problems;

  • ongoing diarrhea and weight loss;

  • headache, earache, warmth or swelling with skin redness;

  • pain or burning when you urinate;

  • severe skin reaction--painful skin or mouth sores, or a severe skin rash with blistering, peeling, or pus;

  • liver problems--upper stomach pain, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes); or

  • signs of tumor cell breakdown--lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, trouble breathing; fainting.

Common side effects may include:

  • runny or stuffy nose, sneezing;

  • nausea, diarrhea;

  • muscle pain; or

  • swelling in your hands or feet.

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.

See also: Side effects (in more detail)

Rituximab dosing information

Usual Adult Dose for non-Hodgkin's Lymphoma:

Information for all healthcare professionals administering rituximab: Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Premedicate before each infusion with acetaminophen and an antihistamine. For RA patients, methylprednisolone 100 mg IV or its equivalent is recommended 30 minutes prior to each infusion. Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

First Infusion: Initiate infusion at a rate of 50 mg/hr. In the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.

Subsequent Infusions: Initiate infusion at a rate of 100 mg/hr. In the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr.

For previously untreated follicular Non-Hodgkins Lymphoma (NHL) and Diffuse Large B-cell NHL (DLBCL) patients: If patients did not experience a Grade 3 or 4 infusion related adverse event during Cycle 1, a 90-minute infusion can be administered in Cycle 2 with a glucocorticoid-containing chemotherapy regimen. Begin the infusion at a rate of 20% of the total dose given in the first 30 minutes and administer the remaining 80% of the total dose over the next 60 minutes. If the 90-minute infusion is tolerated in Cycle 2, the same rate can be used for subsequent cycles. Patients who have clinically significant cardiovascular disease or who have a circulating lymphocyte count greater than or equal to 5000/mm3 before Cycle 2 should not be given the 90-minute infusion.

Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

Relapsed or Refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's Lymphoma (NHL): 375 mg/m2 IV once weekly for 4 or 8 doses.

Retreatment for Relapsed or Refractory, low-grade or follicular, CD20-positive, B-cell NHL: 375 mg/m2 IV once weekly for 4 doses.

Previously untreated, follicular, CD20-positive, B-cell NHL: 375 mg/m2 IV, administered on Day 1 of each cycle of chemotherapy, for up to 8 doses. In patients with complete or partial response, initiate rituximab maintenance 8 weeks following completion of rituximab in combination with chemotherapy. Administer rituximab as a single agent every 8 weeks for 12 doses.

Non-progressing, Low-grade, CD20-positive, B-cell NHL, after first-line CVP chemotherapy: Following completion of 6 to 8 cycles of CVP chemotherapy, administer 375 mg/m2 IV once weekly for 4 doses at 6 month intervals to a maximum of 16 doses.

DLBCL: 375 mg/m2 IV given on day 1 of each cycle of chemotherapy for up to 8 doses.

Chronic Lymphocytic Leukemia (CLL): 375 mg/m2 the day prior to initiation of FC chemotherapy, then 500 mg/m2 on Day 1 of cycles 2 through 6 (every 28 days).

As 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 Yttrium-90- (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 or follicular B-cell non-Hodgkin's lymphoma, including patients with rituximab refractory follicular non-Hodgkin's lymphoma.)

Usual Adult Dose for Rheumatoid Arthritis:

Information for all healthcare professionals administering rituximab: Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Premedicate before each infusion with acetaminophen and an antihistamine. For RA patients, methylprednisolone 100 mg IV or its equivalent is recommended 30 minutes prior to each infusion. Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

First Infusion: Initiate infusion at a rate of 50 mg/hr. In the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.

Subsequent Infusions: Initiate infusion at a rate of 100 mg/hr. In the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr.

Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

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. Subsequent courses should be administered every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks.

Usual Adult Dose for Chronic Lymphocytic Leukemia:

Information for all healthcare professionals administering rituximab: Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Premedicate before each infusion with acetaminophen and an antihistamine. For RA patients, methylprednisolone 100 mg IV or its equivalent is recommended 30 minutes prior to each infusion. Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

First Infusion: Initiate infusion at a rate of 50 mg/hr. In the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.

Subsequent Infusions: Initiate infusion at a rate of 100 mg/hr. In the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr.

Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

Chronic Lymphocytic Leukemia (CLL): 375 mg/m2 IV the day prior to the initiation of fludarabine and cyclophosphamide (FC) chemotherapy, then 500 mg/m2 on Day 1 of cycles 2 to 6 (every 28 days).

Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

Usual Adult Dose for Wegener's Granulomatosus:

Information for all healthcare professionals administering rituximab: Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Premedicate before each infusion with acetaminophen and an antihistamine. For RA patients, methylprednisolone 100 mg IV or its equivalent is recommended 30 minutes prior to each infusion. Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

First Infusion: Initiate infusion at a rate of 50 mg/hr. In the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.

Subsequent Infusions: Initiate infusion at a rate of 100 mg/hr. In the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr.

Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA): 375 mg/m2 IV administered once weekly for 4 weeks.

Glucocorticoids administered as methylprednisolone 1000 mg IV daily for 1 to 3 days followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day and tapered per clinical need) are recommended to treat severe vasculitis symptoms. This regimen should begin within 14 days prior to or with the initiation of rituximab and may continue during and after the 4 week course of rituximab treatment.

Safety and efficacy of treatment with subsequent courses of rituximab have not been established.

PCP prophylaxis is recommended for patients with WG and MPA during treatment and for at least 6 months following the last rituximab infusion.

Usual Adult Dose for Microscopic Polyangiitis:

Information for all healthcare professionals administering rituximab: Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Premedicate before each infusion with acetaminophen and an antihistamine. For RA patients, methylprednisolone 100 mg IV or its equivalent is recommended 30 minutes prior to each infusion. Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

First Infusion: Initiate infusion at a rate of 50 mg/hr. In the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.

Subsequent Infusions: Initiate infusion at a rate of 100 mg/hr. In the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr.

Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA): 375 mg/m2 IV administered once weekly for 4 weeks.

Glucocorticoids administered as methylprednisolone 1000 mg IV daily for 1 to 3 days followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day and tapered per clinical need) are recommended to treat severe vasculitis symptoms. This regimen should begin within 14 days prior to or with the initiation of rituximab and may continue during and after the 4 week course of rituximab treatment.

Safety and efficacy of treatment with subsequent courses of rituximab have not been established.

PCP prophylaxis is recommended for patients with WG and MPA during treatment and for at least 6 months following the last rituximab infusion.

What other drugs will affect rituximab?

Other drugs may interact with rituximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about rituximab.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: 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 1996-2012 Cerner Multum, Inc. Version: 10.01. Revision Date: 2013-11-14, 10:03:42 AM.

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