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Enfiera 500mg - Rituximab Injection

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Enfiera 500mg - Rituximab Injection

Enfiera 500mg is a monoclonal antibody containing Rituximab, used in the treatment of certain types of cancers and autoimmune diseases. It targets CD20-positive B cells, making it effective for conditions like Non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

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Description Product Details
General Information:
Generic Name: Rituximab
Brand Name: Enfiera
Packing: Vial of 500mg/50ml
Strength: 500 mg
Manufacturer: Emcure Pharmaceuticals
Form: Injection (solution for infusion)
Category: Monoclonal Antibody, Anticancer, Immunosuppressant
Product Intro:
Enfiera 500mg is a targeted therapy used to treat various B-cell malignancies and autoimmune disorders. As a biosimilar to Rituximab, it is administered intravenously under medical supervision and has shown high efficacy in destroying abnormal or overactive B cells in cancers and immune-related conditions.
Uses:
  1. Treatment of Non-Hodgkin’s Lymphoma (NHL)
  2. Treatment of Chronic Lymphocytic Leukemia (CLL)
  3. Used in Rheumatoid Arthritis in combination with methotrexate
  4. Treatment of Granulomatosis with polyangiitis (GPA)
  5. Treatment of Microscopic polyangiitis (MPA)
  6. Off-label uses in lupus nephritis, immune thrombocytopenia (ITP), and multiple sclerosis
Storage Instructions:
  1. Store at 2°C to 8°C in a refrigerator
  2. Do not freeze or shake
  3. Protect from light
  4. Keep out of reach of children
  5. Discard any unused solution as per hospital protocol
How it Works (Mechanism of Action):
Rituximab is a chimeric monoclonal antibody that binds specifically to the CD20 antigen on B-lymphocytes. Once bound:
  1. It triggers immune-mediated destruction of B cells through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC)
  2. Induces apoptosis (programmed cell death) in malignant B cells
  3. Reduces overactive immune responses in autoimmune disorders
Side Effects:
Common Side Effects:
  1. Infusion-related reactions (fever, chills, flushing)
  2. Fatigue
  3. Nausea
  4. Headache
  5. Low white blood cell counts (neutropenia)
  6. Respiratory tract infections
Severe Side Effects:
  1. Serious infections (e.g., pneumonia, hepatitis B reactivation)
  2. Progressive multifocal leukoencephalopathy (PML – rare brain infection)
  3. Severe infusion reactions
  4. Tumor lysis syndrome
  5. Cardiac events (especially in patients with heart disease)
Dosage (Typical Recommended Dose):
For Non-Hodgkin’s Lymphoma (NHL):
  1. 375 mg/m² IV infusion once weekly for 4–8 doses, often in combination with chemotherapy
For Rheumatoid Arthritis:
  1. Two IV infusions of 1000 mg separated by two weeks; repeated every 6 months or as needed
Note: Dose adjustments based on disease, body surface area, and clinical response
Method of Administration:
  1. Administered via intravenous (IV) infusion only
  2. Must be given under close medical supervision in a hospital or infusion center
  3. Pre-medication with acetaminophen, antihistamines, and corticosteroids is often required to minimize infusion reactions
  4. Infusion rate is gradually increased during the first dose
Precautions:
  1. Screen for hepatitis B prior to initiating therapy
  2. Monitor blood counts and signs of infection throughout treatment
  3. Avoid live vaccines during and after treatment
  4. Caution in patients with cardiac disorders or active infections
  5. Use in pregnancy only if clearly needed; not recommended during breastfeeding
Drug Interactions:
  1. Increased risk of immunosuppression with other chemotherapeutic agents
  2. May reduce efficacy of vaccines
  3. Caution with immunomodulators or corticosteroids due to infection risk
  4. Interaction with other monoclonal antibodies or biologics should be monitored closely
Allergies:
  1. Contraindicated in patients with known hypersensitivity to Rituximab or murine proteins
  2. Allergic reactions may include rash, shortness of breath, swelling of lips/tongue, or anaphylaxis
Overdose Information:
  1. Limited data on overdose
  2. Monitor for severe neutropenia, infections, or infusion reactions
  3. Supportive care and symptomatic management are essential
Missed Dose Instructions:
  1. If a dose is missed, it should be administered as soon as possible under medical guidance
  2. Subsequent doses may be rescheduled depending on the treatment protocol
Additional Notes:
  1. Patients must be monitored during and after infusion due to risk of serious side effects
  2. Female patients of childbearing age should use effective contraception during and for 12 months after the last dose
  3. Patients should report any signs of infection or neurological symptoms immediately
  4. Safe disposal protocols must be followed due to its cytotoxic nature
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