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Enfiera 100mg - Rituximab Injection

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Enfiera 100mg - Rituximab Injection

Enfiera 100mg is a monoclonal antibody formulation containing Rituximab, used to treat various cancers such as Non-Hodgkin’s lymphoma and chronic lymphocytic leukemia, as well as autoimmune diseases like rheumatoid arthritis. It works by targeting and destroying specific B cells.

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Description Product Details
General Information:
Generic Name: Rituximab
Brand Name: Enfiera
Packing: 10ml Vial (100mg/10ml)
Strength: 100 mg
Company: Zydus Lifesciences Ltd.
Manufacturer: Hetero Biopharma Limited
Form: Injection (concentrate for intravenous infusion)
Category: Anti-cancer, Immunosuppressant, Monoclonal Antibody
Product Intro:
Enfiera 100mg is a targeted anti-CD20 monoclonal antibody injection used for the treatment of B-cell malignancies and immune-mediated conditions. It is administered as an intravenous infusion in a controlled clinical environment and helps reduce abnormal B-cell activity in the body.
Uses:
  1. Non-Hodgkin’s Lymphoma (NHL)
  2. Chronic Lymphocytic Leukemia (CLL)
  3. Rheumatoid Arthritis (RA) – in combination with methotrexate
  4. Granulomatosis with Polyangiitis (GPA)
  5. Microscopic Polyangiitis (MPA)
  6. Off-label use in lupus nephritis, multiple sclerosis, and immune thrombocytopenia (ITP)
Storage Instructions:
  1. Store in a refrigerator between 2°C to 8°C
  2. Do not freeze
  3. Protect from direct light
  4. Keep in original carton until use
  5. Discard any unused portion as per institutional protocol
How it Works (Mechanism of Action):
Rituximab is a chimeric monoclonal antibody that binds to the CD20 antigen on B lymphocytes. This binding initiates:
  1. Complement-mediated cytotoxicity (CDC)
  2. Antibody-dependent cellular cytotoxicity (ADCC)
  3. Direct induction of apoptosis (cell death)
    The result is the destruction of abnormal or autoimmune B cells, helping to treat cancers and autoimmune disorders.
Side Effects:
Common Side Effects:
  1. Fever and chills during infusion
  2. Weakness and fatigue
  3. Nausea
  4. Headache
  5. Skin rash
  6. Infections (e.g., upper respiratory tract)
Severe Side Effects:
  1. Infusion-related severe reactions (hypotension, bronchospasm)
  2. Serious infections (e.g., hepatitis B reactivation)
  3. Rare brain infection (Progressive Multifocal Leukoencephalopathy – PML)
  4. Severe neutropenia or thrombocytopenia
  5. Tumor lysis syndrome
Dosage (Typical Recommended Dose):
Non-Hodgkin’s Lymphoma:
  1. 375 mg/m² body surface area, once weekly for 4–8 weeks
  2. Dosage may vary based on combination with chemotherapy
Rheumatoid Arthritis:
  1. 1000 mg per infusion (initially two infusions two weeks apart)
  2. Repeat every 6 months or based on disease activity
Note: Enfiera 100mg is usually used to make up part of the total dose (e.g., for patients with lower body surface area or to adjust exact required volume).
Method of Administration:
  1. Intravenous infusion only – administered in a hospital or clinic
  2. Must be diluted in 0.9% sodium chloride or other suitable IV fluid
  3. Administer slowly, with careful monitoring of vital signs
  4. Premedication with acetaminophen, antihistamines, and corticosteroids is recommended
Precautions:
  1. Screen for hepatitis B virus (HBV) before starting treatment
  2. Caution in patients with heart conditions or severe infections
  3. Avoid live vaccines during and after treatment
  4. Use in pregnancy only if necessary; not advised during breastfeeding
  5. Monitor complete blood counts regularly
Drug Interactions:
  1. Chemotherapy drugs (e.g., cyclophosphamide) may increase risk of low blood counts
  2. Immunosuppressants or corticosteroids may increase infection risk
  3. May reduce the effectiveness of vaccines
  4. Avoid combining with other biologic agents unless prescribed
Allergies:
  1. Contraindicated in patients with hypersensitivity to Rituximab or murine proteins
  2. Watch for symptoms of allergic reaction: rash, swelling, difficulty breathing, or dizziness
Overdose Information:
  1. No specific antidote
  2. Overdose may cause increased risk of infections, neutropenia, or infusion reactions
  3. Treatment is supportive and symptomatic; hospital monitoring is required
Missed Dose Instructions:
  1. If a dose is missed, consult your physician immediately
  2. Treatment schedule may be adjusted based on the clinical situation and response
Additional Notes:
  1. Patients receiving Rituximab should be closely monitored during infusion and post-infusion
  2. Female patients should use effective contraception during treatment and for at least 12 months after last dose
  3. Follow all institutional handling and disposal procedures for cytotoxic drugs
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