💉 DESCRIPTION
Rituximab Injection 10 mg/mL is a monoclonal antibody used to treat certain hematologic cancers and autoimmune diseases. It specifically targets CD20-positive B-cells.
- Generic Name: Rituximab
- Strength: 10 mg/mL
- Available Vial Sizes: Commonly in 10 mL (100 mg) and 50 mL (500 mg) vials
- Route: Intravenous (IV) infusion only
- Drug Class: Anti-CD20 monoclonal antibody (Chimeric monoclonal IgG1)
✅ ADVANTAGES
- Targets CD20 antigen on B-cells, enabling selective immune modulation
- Used in both oncology and autoimmune indications
- Helps reduce need for chemotherapy in some regimens
- May induce long-lasting remission in lymphomas
- Suitable for combination therapy with CHOP and other regimens
- Approved for use in both adults and children (certain indications)
🧬 NATURE / MECHANISM OF ACTION
- Rituximab binds to the CD20 antigen found on B lymphocytes (normal and malignant).
- Mechanisms of action:
- Antibody-dependent cellular cytotoxicity (ADCC)
- Complement-dependent cytotoxicity (CDC)
- Direct apoptosis induction
- Results in depletion of circulating and tissue B-cells
💊 INDICATIONS
- Hematologic cancers:
- Non-Hodgkin’s lymphoma (NHL) – CD20-positive
- Chronic lymphocytic leukemia (CLL)
- Autoimmune diseases:
- Rheumatoid arthritis (with methotrexate)
- Granulomatosis with polyangiitis
- Microscopic polyangiitis
- Pemphigus vulgaris (off-label)
⚠️ PRECAUTIONS
- Infusion-related reactions common (fever, chills, bronchospasm, hypotension) – especially during 1st dose
- Serious mucocutaneous reactions may occur (SJS, TEN)
- Hepatitis B reactivation – screen all patients prior to treatment
- May cause progressive multifocal leukoencephalopathy (PML)
- Monitor CBC, liver/kidney function, and infection signs
- Use with extreme caution in cardiovascular or respiratory patients
🧊 STORAGE
- Refrigerate at 2°C–8°C (Do not freeze)
- Keep vial in outer carton to protect from light
- After dilution:
- Stable for up to 24 hours at 2–8°C
- Must be used within 6 hours if kept at room temperature
- Do not shake
👨⚕️ PATIENT ADVICE
- Inform doctor of any past infections, especially hepatitis
- Report fever, chills, rash, trouble breathing immediately
- Avoid live vaccines during and after treatment
- Maintain regular blood tests to monitor blood counts
- Women should avoid pregnancy during and 12 months after last dose
- Hair loss is rare but fatigue, nausea, and body aches are possible
📦 PACKAGING
- Glass vials with clear, colorless solution
- Common pack sizes:
- 100 mg/10 mL vial
- 500 mg/50 mL vial
- Each vial sealed with rubber stopper and flip-off aluminum cap
- Cytotoxic handling precautions apply
- Supplied in a carton box with leaflet