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Enfiera (100mg / 500mg) - Rituximab Injection

Enfiera (100mg / 500mg) - Rituximab Injection

Enfiera contains Rituximab, a monoclonal antibody used to treat B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia, and autoimmune diseases like rheumatoid arthritis. It targets the CD20 protein on B lymphocytes, helping destroy abnormal or overactive B cells.

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Description Product Details
General Information:
Generic Name: Rituximab
Brand Name: Enfiera
Packing: Single-use glass vial
Strength: 100 mg/10 mL and 500 mg/50 mL
Manufacturer: Zydus Cadila
Form: Intravenous infusion solution
Category: Monoclonal antibody, Antineoplastic, Immunosuppressant
Product Intro:
Enfiera is an anti-CD20 monoclonal antibody that binds specifically to the CD20 antigen on the surface of B-cells. It is available in two strengths (100 mg and 500 mg) as a sterile solution for intravenous infusion and is used in oncology and immunology treatment protocols.
Uses (Indications):
  1. Non-Hodgkin's lymphoma (NHL), especially CD20-positive B-cell types
  2. Chronic lymphocytic leukemia (CLL)
  3. Rheumatoid arthritis (in combination with methotrexate)
  4. Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)
  5. Pemphigus vulgaris (a rare autoimmune blistering disorder)
  6. Off-label use in other autoimmune disorders (under medical supervision)
Storage Instructions:
  1. Store between 2°C to 8°C in a refrigerator
  2. Do not freeze
  3. Protect from light by keeping it in the original carton
  4. Do not shake the vial
  5. Discard any unused portion after opening or dilution
How It Works (Mechanism of Action):
Rituximab is a chimeric monoclonal antibody that targets the CD20 antigen found on the surface of pre-B and mature B lymphocytes. Binding to CD20 causes B-cell lysis through multiple mechanisms including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC), and apoptosis, reducing both cancerous and autoimmune B-cell populations.
Side Effects:
Common Side Effects:
  1. Infusion-related reactions (fever, chills, rigors)
  2. Headache
  3. Fatigue
  4. Nausea
  5. Low white blood cell counts
  6. Rash or itching
Serious Side Effects:
  1. Severe infusion reactions including hypotension and bronchospasm
  2. Progressive multifocal leukoencephalopathy (PML – rare but fatal brain infection)
  3. Tumor lysis syndrome (especially in high tumor burden patients)
  4. Severe infections including hepatitis B reactivation
  5. Severe mucocutaneous reactions (e.g., Stevens-Johnson Syndrome)
  6. Cardiac arrhythmias and hypotension during infusion
Dosage (Typical Recommended Dose):
  1. Non-Hodgkin’s lymphoma: 375 mg/m² IV once weekly for 4–8 weeks
  2. CLL: 375 mg/m² on day 1, followed by 500 mg/m² on day 1 of cycles 2–6 (with chemotherapy)
  3. Rheumatoid arthritis: 1000 mg IV on days 1 and 15 (usually with methotrexate)
  4. GPA/MPA: 375 mg/m² once weekly for 4 weeks
  5. Dosing may vary based on indication, body surface area, and combination regimens
  6. Premedication with antihistamines, acetaminophen, and corticosteroids is standard
Method of Administration:
  1. Administered via intravenous infusion only – not for IV push or IM injection
  2. Infuse in a hospital or infusion center under medical supervision
  3. First infusion is started at a slow rate (50 mg/hr), then increased gradually if tolerated
  4. Observe closely for at least 1–2 hours post-infusion for any reactions
  5. Premedication is strongly recommended to reduce risk of infusion-related events
Precautions:
  1. Screen for hepatitis B virus (HBV) before starting treatment
  2. Monitor for infusion reactions during and after treatment
  3. Use caution in patients with heart disease or arrhythmias
  4. Avoid live vaccines during and after treatment
  5. Monitor complete blood counts regularly
  6. Ensure contraception during and for at least 12 months after last dose in women of childbearing age
Drug Interactions:
  1. Immunosuppressants (e.g., methotrexate, cyclophosphamide) – increased infection risk
  2. Live vaccines – avoid due to immunosuppressive effects
  3. Concomitant biologics (e.g., TNF inhibitors) – increased immunosuppression
  4. Drugs affecting bone marrow – may cause additive myelosuppression
  5. No major cytochrome P450 interactions, but always consult physician before combining with other therapies
Allergies (Warnings for Allergic Reactions): 
  1. Hypersensitivity reactions may occur during infusion
  2. Symptoms include rash, itching, fever, hypotension, breathing difficulty
  3. Discontinue infusion immediately and treat symptoms if allergic reaction develops
  4. Risk is higher during first infusion; close monitoring is essential
Overdose Information:
  1. No specific antidote for rituximab overdose
  2. May cause severe B-cell depletion, neutropenia, or prolonged immunosuppression
  3. Supportive care and monitoring of immune status, blood counts, and infection markers required
  4. Seek immediate emergency care if overdose is suspected
Missed Dose Instructions:
  1. If a scheduled dose is missed, contact the healthcare provider to reschedule
  2. Do not self-administer or adjust the schedule independently
  3. Regular dosing and timing are important to maintain therapeutic effect
Additional Notes:
  1. Patients should carry a card or wear a medical alert for rituximab use
  2. Avoid close contact with individuals who have infections, especially viral
  3. May affect vaccine response – consult doctor before any vaccinations
  4. Repeat courses may be given after B-cell recovery if clinically necessary
  5. Discuss fertility preservation if applicable, as rituximab may impair reproductive function

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