Skip to Content

rituximab

Pronunciation

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

What is rituximab?

Rituximab is a cancer medicine 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 brain infection that can lead to disability or death. Call your doctor right away if you have changes in your mental state, decreased vision, weakness, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Tell your doctor if you have ever had hepatitis B. Rituximab can cause this condition to come back or get worse.

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 afterward. 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?

Rituximab may cause a serious brain infection called progressive multifocal leukoencephalopathy (PML). This infection may be more likely if have used an immunosuppressant drug in the past, or if you have received rituximab with a stem cell transplant.

You should not be treated with rituximab if you are allergic to it.

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

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

  • kidney disease;

  • 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, or hepatitis B or C;

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

  • a history of using rituximab in the past.

Using rituximab during pregnancy could harm the unborn baby. Tell your doctor if you are pregnant or if you become pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 12 months after your last dose.

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. Rituximab is not given daily. Your schedule will depend on the condition being treated. Follow your doctor's dosing instructions very carefully.

Before each injection, you may be given other medications to prevent certain side effects of rituximab.

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 liver function tests 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 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 afterward). Tell your caregiver right away if you feel itchy, 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 or spinal cord that can lead to disability or death. Call your doctor right away if you have any of the following symptoms (which may start gradually and get worse quickly):

  • confusion, memory problems, or other changes in your mental state;

  • weakness on one side of your body;

  • vision changes; or

  • problems with speech or walking.

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, cold or flu symptoms, cough, sore throat, headache, earache;

  • pain or burning when you urinate;

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

  • redness, warmth, or swelling of the skin;

  • severe stomach pain, vomiting, constipation, bloody or tarry stools;

  • chest pain, irregular heartbeats;

  • 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:

  • fever, chills, body aches;

  • feeling tired;

  • joint pain; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

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 this drug: Administer this drug only as an IV infusion. Do not administer as an IV push or bolus. Premedicate before each infusion with acetaminophen and an antihistamine.

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:
STANDARD INFUSION: 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-HODGKIN'S 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:
-Initiate 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.

RECOMMENDED DOSE FOR NON-HODGKIN'S LYMPHOMA (NHL):
Recommended dose: 375 mg/m2 IV according to the following schedules:
-Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell 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
-Diffuse Large B-Cell NHL: 375 mg/m2 on Day 1 of each cycle of chemotherapy for up to 8 infusions

RECOMMENDED DOSE AS A COMPONENT OF IBRITUMOMAB TIUXETAN THERAPY FOR TREATMENT OF NHL:
-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.
-Refer to the ibritumomab tiuxetan package insert for full prescribing information regarding the ibritumomab tiuxetan therapeutic regimen.

Use: Non-Hodgkin's Lymphoma (NHL):
-Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
-Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to this drug in combination with chemotherapy, as single-agent maintenance therapy
-Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line CVP chemotherapy
-Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens

Usual Adult Dose for Rheumatoid Arthritis:

Information for all healthcare professionals administering this drug: Administer this drug only as an IV infusion. Do not administer as an IV push or bolus. 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.

-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.

RECOMMENDED DOSE FOR RHEUMATOID ARTHRITIS (RA):
-This drug is given in combination with methotrexate
-Administer rituximab 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

Use: Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies

Usual Adult Dose for Chronic Lymphocytic Leukemia:

Information for all healthcare professionals administering this drug: Administer this drug only as an IV infusion. Do not administer as an IV push or bolus. Premedicate before each infusion with acetaminophen and an antihistamine. 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.

RECOMMENDED DOSE FOR CHRONIC LYMPHOCYTIC LEUKEMIA (CLL): 375 mg/m2 IV the day prior to the initiation of FC chemotherapy, then 500 mg/m2 on Day 1 of cycles 2 through 6 (every 28 days)

Use: This drug is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated CD20-positive CLL

Usual Adult Dose for Wegener's Granulomatosus:

Information for all healthcare professionals administering this drug: Administer this drug only as an IV infusion. Do not administer as an IV push or bolus. Premedicate before each infusion with acetaminophen and an antihistamine. Pneumocystis jiroveci pneumonia (PCP) is recommended for patients with GPA and MPA during treatment and for at least 6 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.

RECOMMENDED DOSE FOR GRANULOMATOSIS WITH POLYANGIITIS (GPA) (WEGENER'S GRANULOMATOSIS) AND MICROSCOPIC POLYANGIITIS (MPA):
-Administer rituximab as a 375 mg/m2 intravenous infusion once weekly for 4 weeks
-Glucocorticoids administered as methylprednisolone 1000 mg IV per day 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 this drug have not been established

Use: This drug, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)

Usual Adult Dose for Microscopic Polyangiitis:

Information for all healthcare professionals administering this drug: Administer this drug only as an IV infusion. Do not administer as an IV push or bolus. Premedicate before each infusion with acetaminophen and an antihistamine. Pneumocystis jiroveci pneumonia (PCP) is recommended for patients with GPA and MPA during treatment and for at least 6 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.

RECOMMENDED DOSE FOR GRANULOMATOSIS WITH POLYANGIITIS (GPA) (WEGENER'S GRANULOMATOSIS) AND MICROSCOPIC POLYANGIITIS (MPA):
-Administer rituximab as a 375 mg/m2 intravenous infusion once weekly for 4 weeks
-Glucocorticoids administered as methylprednisolone 1000 mg IV per day 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 this drug have not been established

Use: This drug, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)

What other drugs will affect rituximab?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • medicines to treat rheumatoid arthritis--adalimumab, certolizumab, etanercept, golimumab.

This list is not complete. Other drugs may interact with rituximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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: 11.01. Revision Date: 2016-07-29, 1:10:28 PM.

Hide