(rituximab-pvvr)

Prescribing Information
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2 DOSAGE AND ADMINISTRATION

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing Information

Administer only as an intravenous infusion [see Dosage and Administration (2.9)]. Do not administer as an intravenous push or bolus.

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 [see Warnings and Precautions (5.1)].

Premedicate before each infusion [see Dosage and Administration (2.8)].

Prior to First Infusion

Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with RUXIENCE [see Warnings and Precautions (5.3)]. Obtain complete blood counts (CBC) including platelets prior to the first dose.

During RUXIENCE Therapy

In patients with lymphoid malignancies, during treatment with RUXIENCE monotherapy, obtain complete blood counts (CBC) with differential and platelet counts prior to each RUXIENCE course. During treatment with RUXIENCE and chemotherapy, obtain CBC with differential and platelet counts at weekly to monthly intervals and more frequently in patients who develop cytopenias [see Adverse Reactions (6.1)]. In patients with RA, GPA or MPA, obtain CBC with differential and platelet counts at two to four month intervals during RUXIENCE therapy. Continue to monitor for cytopenias after final dose and until resolution.

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First Infusion
Standard Infusion: Initiate infusion at a rate of 50 mg/hour. In the absence of infusion toxicity, increase infusion rate by 50 mg/hour increments every 30 minutes, to a maximum of 400 mg/hour.
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Subsequent Infusions
Standard Infusion: Initiate infusion at a rate of 100 mg/hour. In the absence of infusion toxicity, increase rate by 100 mg/hour increments at 30-minute intervals, to a maximum of 400 mg/hour.
For Previously Untreated Follicular NHL and DLBCL Adult 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 at a rate of 20% of the total dose given in the first 30 minutes and the remaining 80% of the total dose given over the next 60 minutes. If the 90-minute infusion is tolerated in Cycle 2, the same rate can be used when administering the remainder of the treatment regimen (through Cycle 6 or 8).
Patients who have clinically significant cardiovascular disease or who have a circulating lymphocyte count greater than or equal to 5,000/mm3 before Cycle 2 should not be administered the 90-minute infusion [see Clinical Studies (14.4)].
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Interrupt the infusion or slow the infusion rate for infusion-related reactions [see Boxed Warning, Warnings and Precautions (5.1)]. Continue the infusion at one-half the previous rate upon improvement of symptoms.

2.2 Recommended Dose for Non-Hodgkin's Lymphoma (NHL)

The recommended dose is 375 mg/m2 as an intravenous infusion according to the following schedules:

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Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL
Administer once weekly for 4 or 8 doses.
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Retreatment for Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL
Administer once weekly for 4 doses.
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Previously Untreated, Follicular, CD20-Positive, B-Cell NHL
Administer on Day 1 of each cycle of chemotherapy for up to 8 doses. In patients with complete or partial response, initiate RUXIENCE maintenance eight weeks following completion of a rituximab product in combination with chemotherapy. Administer RUXIENCE as a single agent every 8 weeks for 12 doses.
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Non-progressing, Low-Grade, CD20-Positive, B-Cell NHL, after first-line CVP chemotherapy
Following completion of 6–8 cycles of CVP chemotherapy, administer once weekly for 4 doses at 6-month intervals to a maximum of 16 doses.
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Diffuse Large B-Cell NHL
Administer on Day 1 of each cycle of chemotherapy for up to 8 infusions.

2.3 Recommended Dose for Chronic Lymphocytic Leukemia (CLL)

The recommended dose is 375 mg/m2 the day prior to the initiation of FC chemotherapy, then 500 mg/m2 on Day 1 of Cycles 2–6 (every 28 days).

2.4 Recommended Dose as a Component of Zevalin® for Treatment of NHL

When used as part of the Zevalin therapeutic regimen, infuse 250 mg/m2 in accordance with the Zevalin package insert. Refer to the Zevalin package insert for full prescribing information regarding the Zevalin therapeutic regimen.

2.5 Recommended Dose for Rheumatoid Arthritis (RA)

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Administer RUXIENCE as two-1,000 mg intravenous infusions separated by 2 weeks.
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Glucocorticoids administered as methylprednisolone 100 mg intravenous or its equivalent 30 minutes prior to each infusion are recommended to reduce the incidence and severity of infusion-related reactions.
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Subsequent courses should be administered every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks.
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RUXIENCE is given in combination with methotrexate.

2.6 Recommended Dose for Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)

     

Induction Treatment of Adult Patients with Active GPA/MPA

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Administer RUXIENCE as a 375 mg/m2 intravenous infusion once weekly for 4 weeks for patients with active GPA or MPA.
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Glucocorticoids administered as methylprednisolone 1,000 mg intravenously per day for 1 to 3 days followed by oral prednisone as per clinical practice. This regimen should begin within 14 days prior to or with the initiation of RUXIENCE and may continue during and after the 4 week induction course of RUXIENCE treatment.

Follow up Treatment of Adult Patients with GPA/MPA who have Achieved Disease Control with Induction Treatment

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Administer RUXIENCE as two 500 mg intravenous infusions separated by two weeks, followed by a 500 mg intravenous infusion every 6 months thereafter based on clinical evaluation.
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If induction treatment of active disease was with a rituximab product, initiate follow up treatment with RUXIENCE within 24 weeks after the last induction infusion with a rituximab product or based on clinical evaluation, but no sooner than 16 weeks after the last induction infusion with a rituximab product.
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If induction treatment of active disease was with other standard of care immunosuppressants, initiate RUXIENCE follow up treatment within the 4 week period that follows achievement of disease control.

2.7 Recommended Dose for Pemphigus Vulgaris (PV)

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Administer RUXIENCE as two-1,000 mg intravenous infusions separated by 2 weeks in combination with a tapering course of glucocorticoids.
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Maintenance treatment
Administer RUXIENCE as a 500 mg intravenous infusion at Month 12 and every 6 months thereafter or based on clinical evaluation.
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Treatment of relapse
Administer RUXIENCE as a 1,000 mg intravenous infusion on relapse, and consider resuming or increasing the glucocorticoid dose based on clinical evaluation.

Subsequent infusions of RUXIENCE may be administered no sooner than 16 weeks following the previous infusion.

2.8 Recommended Dose for Premedication and Prophylactic Medications

Premedicate with acetaminophen and an antihistamine before each infusion of RUXIENCE. For adult patients administered RUXIENCE according to the 90-minute infusion rate, the glucocorticoid component of their chemotherapy regimen should be administered prior to infusion [see Clinical Studies (14.4)].

For RA, GPA and MPA, and PV patients, methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each infusion.

Provide prophylaxis treatment for Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections for patients with CLL during treatment and for up to 12 months following treatment as appropriate [see Warnings and Precautions (5.6)].

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

PCP prophylaxis should be considered for patients with PV during and following RUXIENCE treatment.

2.9 Administration and Storage

Use appropriate aseptic technique. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. RUXIENCE should be a clear to slightly opalescent, colorless to pale brownish-yellow liquid. Do not use vial if particulates or discoloration is present.

Administration

Use a sterile needle and syringe to prepare RUXIENCE. Withdraw the necessary amount of RUXIENCE and dilute to a final concentration of 1 mg/mL to 4 mg/mL in an infusion bag containing either 0.9% Sodium Chloride Injection or 5% Dextrose Injection. Gently invert the bag to mix the solution. Do not mix or dilute with other drugs. Discard any unused portion left in the vial.

Storage

If not used immediately, store diluted RUXIENCE solutions as shown in the table below.

Diluted RUXIENCE Solution Storage Conditions

Diluent Used to Prepare Solution for Infusion

Diluted RUXIENCE Solution Storage Conditions

0.9% Sodium Chloride Injection, USP

Store RUXIENCE solution diluted in 0.9% Sodium Chloride Injection, USP refrigerated at 2°C to 8°C (36°F to 46°F) for up to 16 days after preparation.

5% Dextrose Injection, USP

Store RUXIENCE solution diluted in 5% Dextrose Injection, USP refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours after preparation.

No incompatibilities between RUXIENCE and polyvinylchloride bags have been observed.

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:

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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
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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:
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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
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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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