Recelbia 10 mg/ml (IV Infusion)

Indications

• Non-Hodgkin’s Lymphoma (NHL)
• Chronic Lymphocytic Leukemia (CLL)
• Rheumatoid Arthritis (RA)
• Granulomatosis with Polyangiitis (GPA)
• Microscopic Polyangiitis (MPA)
• Pemphigus Vulgaris (PV)

Dosage & Administration

• Intravenous Infusion
• First Infusion
• Subsequent Infusions
• Recommended Dose for Non-Hodgkin’s Lymphoma (NHL)
• Recommended Dose for Chronic Lymphocytic Leukemia (CLL)
• Recommended Dose for Rheumatoid Arthritis (RA)
• Recommended Dose for Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)
• Recommended Dose for Pemphigus Vulgaris (PV)

Pharmacology

• Genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody
• Binding affinity for the CD20 antigen of approximately 8.0 nM
• Approximate molecular weight of 145 kD

Interaction

Formal drug interaction studies have not been performed

Contraindications

Known hypersensitivity to Rituximab or any other components

Side Effects

• Reactivation of hepatitis B virus
• Fever and rigors
• Pruritus, skin rashes
• Bronchospasm
• Thrombocytopenia
• Neutropenia
• Abdominal pain

Pregnancy & Lactation

• Can cause fetal harm when administered to a pregnant woman
• Adverse developmental outcomes in infants exposed to Rituximab in-utero
• Reported to be excreted at low concentrations in human breast milk

Precautions & Warnings

• Can cause severe, including fatal, infusion-related reactions
• Severe Mucocutaneous Reactions
• Progressive Multifocal Leukoencephalopathy (PML)
• Tumor Lysis Syndrome (TLS)
• Serious, including fatal, bacterial, fungal, and new or reactivated viral infections

Therapeutic Class

Cytotoxic immunosuppressants

Storage Conditions

• Store the vial in original carton at 2°C-8°C in a refrigerator
• Do not freeze
• Protect from light
• Keep out of the reach of children

Related Brands

• Ritumab 10 mg/ml (IV Infusion) - drug-international-ltd
• Mabrix 10 mg/ml (IV Infusion) - aci-limited