(rituximab-pvvr)

Prescribing Information
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HIGHLIGHTS OF PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use RUXIENCE safely and effectively. See full prescribing information for RUXIENCE.

RUXIENCE® (rituximab-pvvr) injection, for intravenous use
Initial U.S. Approval: 2019

RUXIENCE (rituximab-pvvr) is biosimilar* to RITUXAN (rituximab)

WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

See full prescribing information for complete boxed warning.

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Fatal infusion-related reactions within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue RUXIENCE infusion for severe reactions (5.1, 6.1).
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Severe mucocutaneous reactions, some with fatal outcomes (5.2).
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Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death (5.3).
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Progressive multifocal leukoencephalopathy (PML) resulting in death (5.4, 6.3).

RECENT MAJOR CHANGES

Indications and Usage, Pemphigus Vulgaris (PV) (1.5)

6/2025

Dosage and Administration (2)

6/2025

Warnings and Precautions (5)

6/2025

INDICATIONS AND USAGE

RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of:

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Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).
o
Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.
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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.
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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.
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Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.
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Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).
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Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC).
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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).
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Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4).
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Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).

DOSAGE AND ADMINISTRATION

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Administer only as an intravenous infusion (2.1).
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Do not administer as an intravenous push or bolus (2.1).
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RUXIENCE should only be administered by a healthcare professional with appropriate medical support to manage severe infusion-related reactions that can be fatal if they occur (2.1).
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The dose for adult B-cell NHL is 375 mg/m2 (2.2).
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The dose for CLL is 375 mg/m2 in the first cycle and 500 mg/m2 in Cycles 2–6, in combination with FC, administered every 28 days (2.3).
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The dose as a component of Zevalin® (ibritumomab tiuxetan) Therapeutic Regimen is 250 mg/m2 (2.4).
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The dose for RA in combination with methotrexate is two-1,000 mg intravenous infusions separated by 2 weeks (one course) every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks. Methylprednisolone 100 mg intravenous or equivalent glucocorticoid is recommended 30 minutes prior to each infusion (2.5).
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The induction dose for adult patients with active GPA and MPA in combination with glucocorticoids is 375 mg/m2 once weekly for 4 weeks. The follow up dose for adult patients with GPA and MPA who have achieved disease control with induction treatment, in combination with glucocorticoids is two 500 mg intravenous infusions separated by two weeks, followed by a 500 mg intravenous infusion every 6 months thereafter based on clinical evaluation (2.6).
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The dose for PV is two-1,000 mg intravenous infusions separated by 2 weeks in combination with a tapering course of glucocorticoids, then a 500 mg intravenous infusion at Month 12 and every 6 months thereafter or based on clinical evaluation. Dose upon relapse is a 1,000 mg intravenous infusion with considerations to resume or increase the glucocorticoid dose based on clinical evaluation. Subsequent infusions may be no sooner than 16 weeks after the previous infusion (2.7). Methylprednisolone 100 mg intravenous or equivalent glucocorticoid is recommended 30 minutes prior to each infusion (2.8).

DOSAGE FORMS AND STRENGTHS

Injection: 100 mg/10 mL (10 mg/mL) and 500 mg/50 mL (10 mg/mL) solution in single-dose vials (3).

CONTRAINDICATIONS

None (4).

WARNINGS AND PRECAUTIONS

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Tumor lysis syndrome: Administer aggressive intravenous hydration, anti-hyperuricemic agents, monitor renal function (5.5).
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Infections: Withhold RUXIENCE and institute appropriate anti-infective therapy (5.6).
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Cardiac adverse reactions: Discontinue infusions in case of serious or life-threatening events (5.7).
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Renal toxicity: Discontinue in patients with rising serum creatinine or oliguria (5.8).
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Bowel obstruction and perforation: Consider and evaluate for abdominal pain, vomiting, or related symptoms (5.9).
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Immunizations: Live virus vaccinations prior to or during RUXIENCE treatment are not recommended (5.10).
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Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception (5.11).

ADVERSE REACTIONS

Most common adverse reactions in clinical trials were:

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NHL (greater than or equal to 25%): infusion-related reactions, fever, lymphopenia, chills, infection and asthenia (6.1).
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CLL (greater than or equal to 25%): infusion-related reactions and neutropenia (6.1).
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RA (greater than or equal to 10%): upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis (other important adverse reactions include infusion-related reactions, serious infections, and cardiovascular events) (6.1).
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GPA and MPA (greater than or equal to 15%): infections, nausea, diarrhea, headache, muscle spasms, anemia, peripheral edema, infusion-related reactions (6.1).
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PV (greater than or equal to 15%): infusion-related reactions, depression, upper respiratory tract infection/nasopharyngitis, headache (other important adverse reactions include infections) (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

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

USE IN SPECIFIC POPULATIONS

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Lactation: Advise not to breastfeed (8.2).
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Geriatric Use: In CLL patients older than 70 years of age, exploratory analyses suggest no benefit with the addition of rituximab to FC (8.5).

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.


*
Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of RUXIENCE has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.

Revised: 4/2026

Medication Guide

MEDICATION GUIDE

This Medication Guide has been approved by the U.S. Food and Drug Administration     Revised: 4/2026

MEDICATION GUIDE
RUXIENCE® (RUKSee-ents)
(rituximab-pvvr)
injection

What is the most important information I should know about RUXIENCE?
RUXIENCE can cause serious side effects that can lead to death, including:

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Infusion-related reactions. Infusion-related reactions are very common side effects of RUXIENCE treatment. Serious infusion-related reactions can happen during your infusion or within 24 hours after your infusion of RUXIENCE. Your healthcare provider should give you medicines before your infusion of RUXIENCE 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 RUXIENCE:
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hives (red itchy welts) or rash
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itching
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swelling of your lips, tongue, throat or face
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sudden cough
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shortness of breath, difficulty breathing, or wheezing
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weakness
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dizziness or feel faint
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palpitations (feel like your heart is racing or fluttering)
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chest pain
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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 RUXIENCE:
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painful sores or ulcers on your skin, lips or in your mouth
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blisters
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peeling skin
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rash
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pustules
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Hepatitis B virus (HBV) reactivation. Before you receive your RUXIENCE 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 RUXIENCE 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 RUXIENCE 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 RUXIENCE.
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 RUXIENCE.
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Progressive Multifocal Leukoencephalopathy (PML). PML is a rare, serious brain infection caused by a virus that can happen in people who receive RUXIENCE. 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:
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confusion
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dizziness or loss of balance
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difficulty walking or talking
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decreased strength or weakness on one side of your body
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vision problems

See "What are the possible side effects of RUXIENCE?" for more information about side effects.

What is RUXIENCE?
RUXIENCE is a prescription medicine used to treat:

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Adults with Non-Hodgkin's Lymphoma (NHL): alone or with other chemotherapy medicines.
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Adults with Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide.
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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.
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Adults with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA): with glucocorticoids, to treat GPA and MPA.
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Adults with Pemphigus Vulgaris (PV): to treat moderate to severe PV.

RUXIENCE is not indicated for treatment of children.

Before you receive RUXIENCE, tell your healthcare provider about all of your medical conditions, including if you:

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have had a severe reaction to RUXIENCE or another rituximab product
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have a history of heart problems, irregular heart beat or chest pain
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have lung or kidney problems
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have an infection or weakened immune system
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have or have had any severe infections including:
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Hepatitis B virus (HBV)
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Hepatitis C virus (HCV)
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Cytomegalovirus (CMV)
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Herpes simplex virus (HSV)
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Parvovirus B19
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Varicella zoster virus (chickenpox or shingles)
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West Nile Virus
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have had a recent vaccination or are scheduled to receive vaccinations. You should not receive certain vaccines before or during treatment with RUXIENCE.
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are pregnant or plan to become pregnant. Talk to your healthcare provider about the risks to your unborn baby if you receive RUXIENCE during pregnancy.
Females who are able to become pregnant:
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Your healthcare provider should do a pregnancy test to see if you are pregnant before starting RUXIENCE.
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You should use effective birth control (contraception) during treatment with RUXIENCE and for 12 months after your last dose of RUXIENCE. Talk to your healthcare provider about effective birth control.
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Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with RUXIENCE.
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are breastfeeding or plan to breastfeed. RUXIENCE may pass into your breast milk. Do not breastfeed during treatment and for 6 months after your last dose of RUXIENCE.

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

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a Tumor Necrosis Factor (TNF) inhibitor medicine
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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 RUXIENCE?

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RUXIENCE is given by infusion through your central catheter or through a needle placed in a vein (intravenous infusion), in your arm. Talk to your healthcare provider about how you will receive RUXIENCE.
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Your healthcare provider may prescribe medicines before each infusion of RUXIENCE to reduce infusion side effects such as fever and chills.
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Your healthcare provider should do blood tests regularly to check for side effects to RUXIENCE.
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Before each RUXIENCE 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 RUXIENCE?
RUXIENCE can cause serious side effects, including:

•
See "What is the most important information I should know about RUXIENCE?"
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Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have:
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kidney failure and the need for dialysis treatment
o
abnormal heart rhythm
 
TLS can happen within 12 to 24 hours after an infusion of RUXIENCE. 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:
o
nausea
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vomiting
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diarrhea
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lack of energy
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Serious infections. Serious infections can happen during and after treatment with RUXIENCE, and can lead to death. RUXIENCE 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 RUXIENCE include bacterial, fungal, and viral infections. After receiving RUXIENCE, 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 RUXIENCE. Tell your healthcare provider right away if you have any symptoms of infection:
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fever
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cold symptoms, such as runny nose or sore throat that do not go away
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flu symptoms, such as cough, tiredness, and body aches
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earache or headache
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pain during urination
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cold sores in the mouth or throat
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cuts, scrapes or incisions that are red, warm, swollen or painful
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Heart problems. RUXIENCE may cause chest pain, irregular heartbeats, and heart attack. Your healthcare provider may monitor your heart during and after treatment with RUXIENCE if you have symptoms or 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 RUXIENCE.
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Kidney problems, especially if you are receiving RUXIENCE for NHL. RUXIENCE can cause severe kidney problems that lead to death. Your healthcare provider should do blood tests to check how well your kidneys are working.
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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 RUXIENCE with chemotherapy medicines. Tell your healthcare provider right away if you have any severe stomach-area (abdomen) pain or repeated vomiting during treatment with RUXIENCE.

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

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infusion-related reactions (see "What is the most important information I should know about RUXIENCE?")
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infections (may include fever, chills)
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body aches
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tiredness
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nausea

In adults with GPA or MPA the most common side effects of RUXIENCE also include:

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low white and red blood cells
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swelling
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diarrhea
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muscle spasms

Other side effects with RUXIENCE include:

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aching joints during or within hours of receiving an infusion
o
more frequent upper respiratory tract infection

These are not all of the possible side effects with RUXIENCE.
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 RUXIENCE.
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 RUXIENCE that is written for healthcare providers.

What are the ingredients in RUXIENCE?
Active ingredient: rituximab-pvvr
Inactive ingredients: edetate disodium dihydrate, L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection.

Manufactured by Pfizer Ireland Pharmaceuticals Unlimited Company, Cork, Ireland, P43 X336

U.S. License No. 2060
Distributed by Pfizer Labs Division of Pfizer Inc. New York, NY 10001
LAB-1274-7.0

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For more information, go to www.pfizer.com or call 1-800-438-1985.

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