Rituximab-pvvr
Generic Name: rituximab-pvvr
Brand Names:
Ruxience
11 DESCRIPTION Rituximab-pvvr is a genetically engineered chimeric murine/human monoclonal IgG 1 kappa antibody directed against the CD20 antigen. Rituximab-pvvr has an approximate molecular weight of 145 kD. Rituximab-pvvr is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RUXIENCE (rituximab-pvvr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish-yellow solution for intravenous infusion.
Overview
11 DESCRIPTION Rituximab-pvvr is a genetically engineered chimeric murine/human monoclonal IgG 1 kappa antibody directed against the CD20 antigen. Rituximab-pvvr has an approximate molecular weight of 145 kD. Rituximab-pvvr is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RUXIENCE (rituximab-pvvr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish-yellow solution for intravenous infusion.
Uses
1 INDICATIONS AND USAGE RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: • 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. o 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. o 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.
Dosage
2 DOSAGE AND ADMINISTRATION • Administer only as an intravenous infusion ( 2.1 ). • Do not administer as an intravenous push or bolus ( 2.1 ). • 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 ). • The dose for adult B-cell NHL is 375 mg/m 2 ( 2.2 ). • The dose for CLL is 375 mg/m 2 in the first cycle and 500 mg/m 2 in Cycles 2–6, in combination with FC, administered every 28 days ( 2.3 ). • The dose as a component of Zevalin ® (ibritumomab tiuxetan) Therapeutic Regimen is 250 mg/m 2 ( 2.4 ).
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Infusion-related reactions [see Warnings and Precautions (5.1) ] • Severe mucocutaneous reactions [see Warnings and Precautions (5.2) ] • Hepatitis B reactivation with fulminant hepatitis [see Warnings and Precautions (5.3) ] • Progressive multifocal leukoencephalopathy [see Warnings and Precautions (5.4) ] • Tumor lysis syndrome [see Warnings and Precautions (5.5) ] • Infections [see Warnings and Precautions (5.6) ] • Cardiovascular adverse reactions [see Warnings and Precautions (5.7) ] • Renal toxicity [see Warnings and Precautions (5.8) ] • Bowel obstruction and perforation [see Warnings and Precautions (5.9) ] Most common adverse reactions in...
Interactions
7 DRUG INTERACTIONS Formal drug interaction studies have not been performed with rituximab products. In patients with CLL, rituximab 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 ).
Warnings
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. 5 WARNINGS AND PRECAUTIONS • Tumor lysis syndrome: Administer aggressive intravenous hydration, anti-hyperuricemic agents, monitor renal function ( 5.5 ). • Infections: Withhold RUXIENCE and institute appropriate anti-infective therapy ( 5.6 ). • Cardiac adverse reactions: Discontinue infusions in case of serious or life-threatening events ( 5.7 ). • Renal toxicity: Discontinue in patients with rising serum creatinine or oliguria ( 5.8 ). • Bowel obstruction and perforation: Consider and evaluate for abdominal pain, vomiting, or related symptoms ( 5.9 ). • Immunizations: Live virus vaccinations prior to or during RUXIENCE treatment are not recommended ( 5.10 ). • Embryo-Fetal toxicity: Can cause fetal harm. 4 CONTRAINDICATIONS None. None ( 4 ).
Pregnancy
8.1 Pregnancy Risk Summary Based on human data, rituximab products can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed in-utero (see Clinical Considerations ) . In animal reproduction studies, intravenous administration of rituximab to pregnant cynomolgus monkeys during the period of organogenesis caused lymphoid B-cell depletion in the newborn offspring at doses resulting in 80% of the exposure (based on AUC) of those achieved following a dose of 2 grams in humans. Advise pregnant women of the risk to a fetus.
Storage
Store RUXIENCE vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton. RUXIENCE vials should be protected from direct sunlight. Do not freeze or shake.
Frequently Asked Questions
What is Rituximab-pvvr used for?▼
1 INDICATIONS AND USAGE RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: • 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. o 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. o 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.
What are the side effects of Rituximab-pvvr?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Infusion-related reactions [see Warnings and Precautions (5.1) ] • Severe mucocutaneous reactions [see Warnings and Precautions (5.2) ] • Hepatitis B reactivation with fulminant hepatitis [see Warnings and Precautions (5.3) ] • Progressive multifocal leukoencephalopathy [see Warnings and Precautions (5.4) ] • Tumor lysis syndrome [see Warnings and Precautions (5.5) ] • Infections [see Warnings and Precautions (5.6) ] • Cardiovascular adverse reactions [see Warnings and Precautions (5.7) ] • Renal toxicity [see Warnings and Precautions (5.8) ] • Bowel obstruction and perforation [see Warnings and Precautions (5.9) ] Most common adverse reactions in...
Can I take Rituximab-pvvr during pregnancy?▼
8.1 Pregnancy Risk Summary Based on human data, rituximab products can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed in-utero (see Clinical Considerations ) . In animal reproduction studies, intravenous administration of rituximab to pregnant cynomolgus monkeys during the period of organogenesis caused lymphoid B-cell depletion in the newborn offspring at doses resulting in 80% of the exposure (based on AUC) of those achieved following a dose of 2 grams in humans. Advise pregnant women of the risk to a fetus.
What are the important warnings for Rituximab-pvvr?▼
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. 5 WARNINGS AND PRECAUTIONS • Tumor lysis syndrome: Administer aggressive intravenous hydration, anti-hyperuricemic agents, monitor renal function ( 5.5 ). • Infections: Withhold RUXIENCE and institute appropriate anti-infective therapy ( 5.6 ). • Cardiac adverse reactions: Discontinue infusions in case of serious or life-threatening events ( 5.7 ). • Renal toxicity: Discontinue in patients with rising serum creatinine or oliguria ( 5.8 ). • Bowel obstruction and perforation: Consider and evaluate for abdominal pain, vomiting, or related symptoms ( 5.9 ). • Immunizations: Live virus vaccinations prior to or during RUXIENCE treatment are not recommended ( 5.10 ). • Embryo-Fetal toxicity: Can cause fetal harm. 4 CONTRAINDICATIONS None. None ( 4 ).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.