rituximab

Generic Name: rituximab (ri TUX i mab)
Brand Names: 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 in combination with other cancer medicines 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?

You should not receive this medication if you have ever had a severe allergic reaction to rituximab. 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, or if you have a fever, cough, sore throat, skin rash, fast or uneven heart rate, weak or shallow breathing, or pain in your chest or shoulders.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your heart, liver, and kidney function may also need to be tested. Visit your doctor regularly.

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 for several months after you stop using rituximab. Visit your doctor regularly.

Rituximab may cause 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 any 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?

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 you can safely use rituximab, tell your doctor if you have any of these other conditions:

• 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;

• 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 that were not effective, 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. Rituximab can remain in the body for up to 6 months after you stop receiving it. It is not known whether rituximab passes into breast milk or if it could harm a nursing baby. Do not receive rituximab without telling your doctor if you are breast feeding a baby.

How is rituximab given?

Rituximab is injected into a vein through an IV. 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.

Rituximab 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. Follow-up injections are sometimes given every 16 to 24 weeks after your first two doses. Follow your doctor's dosing instructions very carefully.

To be sure this medication is not causing harmful effects, your blood cells, heart function, kidney function, and liver function may need to be tested often. Rituximab can have long lasting effects on your body. Do not miss any follow up visits to your doctor for blood or urine tests.

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 for several months after you stop using rituximab. Visit your doctor regularly.

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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

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, or if you have a fever, cough, sore throat, skin rash, fast or uneven heart rate, weak or shallow breathing, or pain in your chest or shoulders.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, chest tightness, trouble 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 other serious side effects, even if they occur several months after you receive rituximab, or after your treatment ends.

• lower back pain, blood in your urine, numbness or tingly feeling around your mouth;

• muscle weakness, tightness, or contraction, overactive reflexes;

• fast or slow heart rate, weak pulse, feeling short of breath, fainting;

• uneven heartbeats, wheezing or trouble breathing;

• confusion, dizziness, loss of balance, sudden numbness or weakness, especially on one side of the body;

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

• fever, chills, cough, body aches, flu symptoms, ongoing cold symptoms such as stuffy nose, sneezing, sore throat;

• easy bruising or bleeding, pale skin, trouble concentrating;

• pain or burning when you urinate, urinating less than usual;

• earache, painful mouth ulcers, skin sores, warmth or swelling with skin redness;

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

• severe constipation or stomach pain;

• black, bloody, or tarry stools; or

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

Less serious side effects may include:

• mild stomach pain, nausea, or diarrhea;

• swelling in your hands or feet;

• headache;

• muscle spasm, muscle or joint pain; 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.

See also: rituximab 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.

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.

Diffuse large B-cell NHL: 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?

Tell your doctor about all other medicines you use, especially cisplatin (Platinol).

There may be other drugs that can interact with rituximab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about rituximab.