Rituxim 10 mg/ml (IV Infusion)

Indications

• Non-Hodgkin’s Lymphoma (NHL)
• Relapsed or refractory
• Low-grade or follicular
• CD20-positive
• B-cell NHL
• Previously untreated follicular
• Chronic Lymphocytic Leukemia (CLL)
• Rheumatoid Arthritis (RA)
• Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis)
• Microscopic Polyangiitis (MPA)
• Pemphigus Vulgaris (PV)

Pharmacology

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

Dosage & Administration

• Intravenous Infusion only
• Standard Infusion for first infusion
• Subsequent Infusions standard and for specific indications like NHL, CLL, RA, GPA, MPA, PV
• Recommended Dose for NHL, CLL, RA, GPA, MPA, and PV

Interaction

• Formal drug interaction studies not performed
• No alteration in systemic exposure to fludarabine or cyclophosphamide in patients with CLL

Contraindications

• Known hypersensitivity to Rituximab or any other components of this product

Side Effects

• Reactivation of hepatitis B virus
• Fever and rigors
• Pruritus and skin rashes
• Dyspnoea and bronchospasm
• Asthenia and headache
• Thrombocytopenia, neutropenia, and anaemia
• Abdominal pain, bowel obstruction, and perforation
• Exacerbation of heart failure and angina pectoris
• Reversible interstitial pneumonia and interstitial fibrosis
• Depletion of immunoglobulin concentrations

Pregnancy & Lactation

• Fetal harm when administered to a pregnant woman
• Adverse developmental outcomes including B-cell lymphocytopenia in infants exposed to Rituximab in-utero
• Advisory against breastfeeding during treatment with Rituximab and for 6 months after the last dose

Precautions & Warnings

• Severe and fatal infusion-related reactions
• Severe mucocutaneous reactions
• Progressive Multifocal Leukoencephalopathy (PML)
• Tumor Lysis Syndrome (TLS)
• Infections, including bacterial, fungal, and new or reactivated viral infections
• Storage Conditions
• Storage in a refrigerator at 2°C-8°C, protection from light, and avoidance of freezing

Therapeutic Class

• Cytotoxic immunosuppressants

Related Brands

• Mabthera 10 mg/ml (IV Infusion) - roche-bangladesh-ltd