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RUXIENCE
Rituximab
$370.00
100mg/10ml · 2 vial
BrandBranded medicine· By Pfizer
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100mg/10ml
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FDA boxed warningFatal infusion-related reactions, severe mucocutaneous reactions, hepatitis b virus reactivation and progressive multifocal leukoencephalopathy
Infusion-Related Reactions Administration of rituximab products can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RUXIENCE infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions.
Severe Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products.
Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RUXIENCE. Discontinue RUXIENCE and concomitant medications in the event of HBV reactivation.
Progressive Multifocal Leukoencephalopathy (PML) Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products.
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.
Severe mucocutaneous reactions, some with fatal outcomes.
Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death.
Progressive multifocal leukoencephalopathy (PML) resulting in death.
About RUXIENCE
Overview
RUXIENCE (rituximab-pvvr) is a monoclonal antibody medicine given by intravenous infusion. It treats certain CD20-positive non-Hodgkin lymphomas and chronic lymphocytic leukemia in adults, either alone or with other medicines depending on the condition. It also treats adults with moderately to severely active rheumatoid arthritis after an inadequate response to one or more TNF antagonists, granulomatosis with polyangiitis, microscopic polyangiitis, or moderate to severe pemphigus vulgaris; rheumatoid arthritis treatment includes methotrexate, while treatment for the two forms of vasculitis includes glucocorticoids. It works by attaching to a protein called CD20 on certain B cells, leading to their destruction.
What it treats
• Certain CD20-positive B-cell non-Hodgkin’s lymphomas in adults, including low-grade or follicular lymphoma and previously untreated diffuse large B-cell lymphoma. Used alone, as maintenance treatment, or with chemotherapy, depending on the type and treatment history. • Previously untreated or previously treated CD20-positive chronic lymphocytic leukemia in adults, with fludarabine and cyclophosphamide. • Moderately to severely active rheumatoid arthritis in adults who have had an inadequate response to one or more TNF antagonist therapies, with methotrexate. • Granulomatosis with polyangiitis and microscopic polyangiitis in adults, with glucocorticoids. • Moderate to severe pemphigus vulgaris in adults.
Safety information
Side effects
Common side effects vary by the condition being treated. They include reactions during an infusion, infections, fever, chills, weakness, low levels of certain white blood cells, nausea, diarrhea, headache, muscle spasms, anemia, swelling of the hands or feet, and depression. Reported infections include upper respiratory tract infections, nose and throat infections, urinary tract infections, and bronchitis. Contact a doctor promptly for reactions during an infusion or suspected serious side effects. These include severe skin and mouth reactions; reactivation of hepatitis B with severe liver inflammation; progressive multifocal leukoencephalopathy, a serious brain infection; tumor lysis syndrome, caused by the breakdown of tumor cells; serious infections; heart problems; kidney damage; and bowel blockage or perforation. Abdominal pain, vomiting, or a marked decrease in urine output require prompt medical assessment. RUXIENCE can harm an unborn baby. Effective contraception is advised for people who can become pregnant. Live virus vaccines are not recommended before or during treatment.
FDA boxed warning
Fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis b virus reactivation and progressive multifocal leukoencephalopathy
Infusion-Related Reactions Administration of rituximab products can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RUXIENCE infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions.
Severe Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products.
Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RUXIENCE. Discontinue RUXIENCE and concomitant medications in the event of HBV reactivation.
Progressive Multifocal Leukoencephalopathy (PML) Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products.
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.
Severe mucocutaneous reactions, some with fatal outcomes.
Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death.
Progressive multifocal leukoencephalopathy (PML) resulting in death.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The supplied FDA label lists no formal contraindications for RUXIENCE. However, important warnings and precautions apply. RUXIENCE can harm an unborn baby. People who could become pregnant should use effective contraception. Breastfeeding is not advised. Live virus vaccines are not recommended before or during treatment. Other conditions requiring caution include: • Infections: treatment should be withheld and appropriate anti-infective treatment started. • Tumor lysis syndrome: preventive treatment and kidney function monitoring are needed. • Serious or life-threatening heart reactions: the infusion must be stopped. • Kidney toxicity: treatment must be stopped if blood creatinine rises or urine output becomes very low. • Possible bowel blockage or perforation: abdominal pain, vomiting or related symptoms need medical assessment.
Interactions
Tell your doctor if you are receiving cisplatin, as using it with RUXIENCE can cause kidney toxicity. Formal interaction studies have not been performed with rituximab products. In patients with chronic lymphocytic leukaemia (CLL), rituximab did not change exposure to fludarabine or cyclophosphamide. In rheumatoid arthritis (RA) trials, methotrexate or cyclophosphamide did not change how rituximab was processed in the body.
Using RUXIENCE
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label RUXIENCE (RITUXIMAB-PVVR) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] (DailyMed, retrieved 19 September 2026).
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