Rituxan rituximab

Get an overview of RITUXAN (rituximab injection, solution), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Rituxan can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Rituxan.

Drug Basics

Brand Name: Rituxan

Generic Name: RITUXIMAB

Drug Type: HUMAN PRESCRIPTION DRUG

Route: INTRAVENOUS

Dosage Form: INJECTION, SOLUTION

Data Current As Of: 2019-10-21

Indications and Usage, GPA and MPA (1.4) 09/2019
Dosage and Administration, GPA and MPA (2.6) 09/2019
Warnings and Precautions, Immunization (5.10) 09/2019
Warnings and Precautions, Follow up Treatment in Patients with GPA and MPA (5.14) Removed 10/2018

indications & usage

RITUXAN (rituximab) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with:

  • Non-Hodgkin's Lymphoma (NHL) (1.1).
    • 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 a rituximab product 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 cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
    • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.
  • Chronic Lymphocytic Leukemia (CLL) (1.2).
    • Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC).
  • 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 (1.3).
  • Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult and pediatric patients 2 years of age and older in combination with glucocorticoids (1.4).
  • Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).

non–hodgkin's lymphoma (nhl)

RITUXAN (rituximab) is indicated for the treatment of adult patients with:

  • 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 a rituximab product 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 cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
  • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.

chronic lymphocytic leukemia (cll)

RITUXAN is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.

rheumatoid arthritis (ra)

RITUXAN in combination with methotrexate is indicated for the treatment of adult patients with moderately- to severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.

granulomatosis with polyangiitis (gpa) (wegener's granulomatosis) & microscopic polyangiitis (mpa)

RITUXAN, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).

pemphigus vulgaris (pv)

RITUXAN is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.

drug interactions

Formal drug interaction studies have not been performed with RITUXAN. In patients with CLL, RITUXAN did not alter systemic exposure to fludarabine or cyclophosphamide. In clinical trials of patients with RA, concomitant administration of methotrexate or cyclophosphamide did not alter the pharmacokinetics of rituximab.

Renal toxicity when used in combination with cisplatin (5.8).

patient counseling information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Infusion-Related Reactions

Inform patients about the signs and symptoms of infusion-related reactions. Advise patients to contact their healthcare provider immediately to report symptoms of infusion-related reactions including urticaria, hypotension, angioedema, sudden cough, breathing problems, weakness, dizziness, palpitations, or chest pain [see Warnings and Precautions (5.1)].

Severe Mucocutaneous Reactions

Advise patients to contact their healthcare provider immediately for symptoms of severe mucocutaneous reactions, including painful sores or ulcers on the mouth, blisters, peeling skin, rash, and pustules [see Warnings and Precautions (5.2)].

Hepatitis B Virus Reactivation

Advise patients to contact their healthcare provider immediately for symptoms of hepatitis including worsening fatigue or yellow discoloration of skin or eyes [see Warnings and Precautions (5.3)].

Progressive Multifocal Leukoencephalopathy (PML)

Advise patients to contact their healthcare provider immediately for signs and symptoms of PML, including new or changes in neurological symptoms such as confusion, dizziness or loss of balance, difficulty talking or walking, decreased strength or weakness on one side of the body, or vision problems [see Warnings and Precautions (5.4)].

Tumor Lysis Syndrome (TLS)

Advise patients to contact their healthcare provider immediately for signs and symptoms of tumor lysis syndrome such as nausea, vomiting, diarrhea, and lethargy [see Warnings and Precautions (5.5)].

Infections

Advise patients to contact their healthcare provider immediately for signs and symptoms of infections including fever, cold symptoms (e.g., rhinorrhea or laryngitis), flu symptoms (e.g., cough, fatigue, body aches), earache or headache, dysuria, oral herpes simplex infection, and painful wounds with erythema and advise patients of the increased risk of infections during and after treatment with RITUXAN [see Warnings and Precautions (5.6)].

Cardiovascular Adverse Reactions

Advise patients of the risk of cardiovascular adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock. Advise patients to contact their healthcare provider immediately to report chest pain and irregular heartbeats [see Warnings and Precautions (5.7)].

Renal Toxicity

Advise patients of the risk of renal toxicity. Inform patients of the need for healthcare providers to monitor kidney function [see Warnings and Precautions (5.8)].

Bowel Obstruction and Perforation

Advise patients to contact their healthcare provider immediately for signs and symptoms of bowel obstruction and perforation, including severe abdominal pain or repeated vomiting [see Warnings and Precautions (5.9)].

Embryo-Fetal Toxicity

Advise a pregnant woman of the potential risk to a fetus. Advise female patients that rituximab can cause fetal harm if taken during pregnancy and to use effective contraception during treatment with RITUXAN and for at least 12 months after the last dose of RITUXAN. Advise patients to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.11) and Use in Specific Populations (8.1, 8.3)].

Lactation

Advise women not to breastfeed during treatment with RITUXAN and for 6 months after the last dose [see Use in Specific Populations (8.2)].

RITUXAN® [rituximab]
Manufactured by:
Genentech, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990
US License Number 1048

RITUXAN® is a registered trademark of Biogen.
Jointly marketed by Biogen and Genentech USA, Inc.
©2019 Biogen and Genentech, Inc.

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 09/2019           
MEDICATION GUIDE
RITUXAN® (ri tuk san)
(rituximab)
injection
What is the most important information I should know about RITUXAN?
RITUXAN can cause serious side effects that can lead to death, including:
  • Infusion-related reactions. Infusion-related reactions are very common side effects of RITUXAN treatment. Serious infusion-related reactions can happen during your infusion or within 24 hours after your infusion of RITUXAN. Your healthcare provider should give you medicines before your infusion of RITUXAN to decrease your chance of having a severe infusion-related reaction.
    Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of RITUXAN:
  • hives (red itchy welts) or rash
  • itching
  • swelling of your lips, tongue, throat or face
  • sudden cough
  • Severe skin and mouth reactions. Tell your healthcare provider or get medical help right away if you get any of these symptoms at any time during your treatment with RITUXAN:
    • painful sores or ulcers on your skin, lips or in your mouth
    • blisters
    • peeling skin
    • rash
    • pustules
  • Hepatitis B virus (HBV) reactivation. Before you receive your RITUXAN treatment, your healthcare provider will do blood tests to check for HBV infection. If you have had hepatitis B or are a carrier of hepatitis B virus, receiving RITUXAN could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems including liver failure, and death. You should not receive RITUXAN if you have active hepatitis B liver disease. Your healthcare provider will monitor you for hepatitis B infection during and for several months after you stop receiving RITUXAN.
    Tell your healthcare provider right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes, during treatment with RITUXAN.
  • Progressive Multifocal Leukoencephalopathy (PML). PML is a rare, serious brain infection caused by a virus that can happen in people who receive RITUXAN. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML.
    Tell your healthcare provider right away if you have any new or worsening symptoms or if anyone close to you notices these symptoms:
  • decreased strength or weakness on one side of your body
  • vision problems
See " What are the possible side effects of RITUXAN? " for more information about side effects.
What is RITUXAN?
RITUXAN is a prescription medicine used to treat:
  • Adults with Non-Hodgkin's Lymphoma (NHL): alone or with other chemotherapy medicines.
  • Adults with Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide.
  • Adults with Rheumatoid Arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a Tumor Necrosis Factor (TNF) antagonist has been used and did not work well enough.
  • People with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) ages 2 years and above: with glucocorticoids, to treat GPA and MPA.
  • Adults with Pemphigus Vulgaris (PV): to treat moderate to severe PV.

RITUXAN is not indicated in children less than 2 years of age with GPA or MPA or in children with conditions other than GPA or MPA.

Before you receive RITUXAN, tell your healthcare provider about all of your medical conditions, including if you:
  • have had a severe reaction to RITUXAN or a rituximab product
  • 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:
  • have had a recent vaccination or are scheduled to receive vaccinations. You should not receive certain vaccines before or during treatment with RITUXAN.
  • are pregnant or plan to become pregnant. Talk to your healthcare provider about the risks to your unborn baby if you receive RITUXAN during pregnancy.
    Females who are able to become pregnant should use effective birth control (contraception) during treatment with RITUXAN and for 12 months after the last dose of RITUXAN. Talk to your healthcare provider about effective birth control.
    Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with RITUXAN.
  • are breastfeeding or plan to breastfeed. It is not known if RITUXAN passes into your breast milk. Do not breastfeed during treatment and for at least 6 months after your last dose of RITUXAN.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take or have taken:

  • a Tumor Necrosis Factor (TNF) inhibitor medicine
  • a Disease Modifying Anti-Rheumatic Drug (DMARD)

If you are not sure if your medicine is one listed above, ask your healthcare provider.

How will I receive RITUXAN?
  • RITUXAN is given by infusion through a needle placed in a vein (intravenous infusion), in your arm. Talk to your healthcare provider about how you will receive RITUXAN.
  • Your healthcare provider may prescribe medicines before each infusion of RITUXAN to reduce infusion side effects such as fever and chills.
  • Your healthcare provider should do blood tests regularly to check for side effects to RITUXAN.
  • Before each RITUXAN treatment, your healthcare provider or nurse will ask you questions about your general health. Tell your healthcare provider or nurse about any new symptoms.
What are the possible side effects of RITUXAN?
RITUXAN can cause serious side effects, including:
  • See " What is the most important information I should know about RITUXAN? "
  • Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have:

    TLS can happen within 12 to 24 hours after an infusion of RITUXAN. Your healthcare provider may do blood tests to check you for TLS. Your healthcare provider may give you medicine to help prevent TLS. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS:

  • Serious infections. Serious infections can happen during and after treatment with RITUXAN, and can lead to death. RITUXAN can increase your risk of getting infections and can lower the ability of your immune system to fight infections. Types of serious infections that can happen with RITUXAN include bacterial, fungal, and viral infections. After receiving RITUXAN, some people have developed low levels of certain antibodies in their blood for a long period of time (longer than 11 months). Some of these people with low antibody levels developed infections. People with serious infections should not receive RITUXAN. Tell your healthcare provider right away if you have any symptoms of infection:
    • fever
    • cold symptoms, such as runny nose or sore throat that do not go away
    • flu symptoms, such as cough, tiredness, and body aches
    • earache or headache
    • pain during urination
    • cold sores in the mouth or throat
    • cuts, scrapes or incisions that are red, warm, swollen or painful
  • Heart problems. RITUXAN may cause chest pain, irregular heartbeats, and heart attack. Your healthcare provider may monitor your heart during and after treatment with RITUXAN if you have symptoms of heart problems or have a history of heart problems. Tell your healthcare provider right away if you have chest pain or irregular heartbeats during treatment with RITUXAN.
  • Kidney problems, especially if you are receiving RITUXAN for NHL. RITUXAN can cause severe kidney problems that lead to death. Your healthcare provider should do blood tests to check how well your kidneys are working.
  • Stomach and Serious bowel problems that can sometimes lead to death. Bowel problems, including blockage or tears in the bowel can happen if you receive RITUXAN with chemotherapy medicines. Tell your healthcare provider right away if you have any severe stomach-area (abdomen) pain or repeated vomiting during treatment with RITUXAN.

Your healthcare provider will stop treatment with RITUXAN if you have severe, serious or life-threatening side effects. The most common side effects of RITUXAN include:

In adult patients with GPA or MPA the most common side effects of RITUXAN also include:

Other side effects with RITUXAN include:

These are not all of the possible side effects with RITUXAN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of RITUXAN.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about Rituxan that is written for healthcare professionals.
What are the ingredients in RITUXAN?
Active ingredient: rituximab
Inactive ingredients: polysorbate 80, sodium chloride, sodium citrate dihydrate, and Water for Injection, USP.
Manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990
Jointly Marketed by Biogen and Genentech USA, Inc.
US License Number 1048
RITUXAN® is a registered trademark of Biogen. ©2019 Biogen and Genentech, Inc.
For more information, go to www.RITUXAN.com or call 1-877-474-8892.

Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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