BIOFERON

Interferon Alpha 2B (30%)
Price: ₹600 - ₹2100 per vial
Mfr: Biocon Ltd | Form: Injection (Powder for solution in vial)

📋 Clinical Overview

Interferon alfa-2b is a recombinant form of a naturally occurring cytokine belonging to the type I interferon family. It is a 165-amino acid glycoprotein produced by recombinant DNA technology using genetically engineered Escherichia coli. The '30%' typically refers to a specific formulation or a component of a combination product, such as with ribavirin, but as a standalone entity, it is a potent immunomodulator and antiviral agent. It exerts its effects by binding to specific cell surface receptors, leading to the activation of a complex intracellular signaling cascade (JAK-STAT pathway), resulting in the transcription of interferon-stimulated genes (ISGs). This leads to inhibition of viral replication, suppression of cell proliferation, enhanced phagocytic activity of macrophages, and augmentation of the cytotoxic activity of lymphocytes. In the Indian context, it is a critical drug for managing chronic viral hepatitis and certain malignancies, though its use has declined with the advent of direct-acting antivirals (DAAs) for Hepatitis C.

💊 Dosage & Administration

Adult: Varies widely by indication. Examples: **Chronic Hepatitis B:** 5-10 million IU SC/IM three times per week or 30-35 million IU per week for 16-24 weeks. **Chronic Hepatitis C (with ribavirin):** 3 million IU SC/IM three times per week for 24-48 weeks. **Hairy Cell Leukemia:** 2 million IU/m2 SC/IM three times per week for 6 months. **Melanoma (adjuvant):** 20 million IU/m2 IV 5 days/week for 4 weeks induction, then 10 million IU/m2 SC three times per week for 48 weeks maintenance. Dosing must be individualized.

Note: 1. Administer SC into the thigh, abdomen, or upper arm, or IM into the deltoid or thigh. Rotate injection sites. 2. Reconstitute lyophilized powder with provided sterile water for injection. Swirl gently; do not shake. Use immediately. 3. Pre-filled syringes/vials are for single use only. 4. Premedicate with oral acetaminophen (paracetamol) 500-650 mg 30 minutes before injection to reduce flu-like symptoms.

⚠️ Contraindications

  • Known hypersensitivity to interferon alfa-2b, any other interferon-alpha, or any component of the formulation
  • Autoimmune hepatitis or history of severe autoimmune disease
  • Decompensated liver disease (e.g., Child-Pugh class B or C cirrhosis) prior to or during treatment for Hepatitis C
  • Severe pre-existing cardiac disease (e.g., unstable angina, recent MI, uncontrolled CHF)
  • Severe renal impairment (CrCl < 50 mL/min) or end-stage renal disease on dialysis
  • Severe psychiatric disorders, especially severe depression, suicidal ideation, or history thereof

🔬 Mechanism of Action

Interferon alfa-2b binds to specific, high-affinity cell-surface receptors (IFNAR1 and IFNAR2) present on virtually all nucleated cells. This binding activates the receptor-associated tyrosine kinases, JAK1 and TYK2, which phosphorylate and activate signal transducer and activator of transcription (STAT) proteins, primarily STAT1 and STAT2. These activated STATs form heterodimers, translocate to the nucleus, and bind to gamma-activated sequence (GAS) elements or form interferon-stimulated gene factor 3 (ISGF3) complex with IRF9 to bind interferon-stimulated response elements (ISREs) in the promoter regions of numerous interferon-stimulated genes (ISGs). The expression of these ISGs creates an 'antiviral state' within the cell.

🤕 Side Effects

  • Flu-like syndrome (fever, chills, headache, myalgia, arthralgia, fatigue - occurs in >60%)
  • Injection site reactions (erythema, pain, swelling)
  • Anorexia, nausea
  • Alopecia (reversible)
  • Mild leukopenia, thrombocytopenia

🤰 Special Populations

Pregnancy: Pregnancy Category C (US FDA). Animal studies show abortifacient effects. No adequate human studies. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When used for Hepatitis C with ribavirin, ribavirin is Pregnancy Category X (absolute contraindication).

Driving: May cause fatigue, dizziness, and confusion. Patients should be cautioned about operating machinery or driving until they know how the drug affects them.

🔄 Drug Interactions

TheophyllineInterferon alfa-2b inhibits cytochrome P450 1A2, increasing theophylline levels and risk of toxicity.Major
Zidovudine (AZT)Increased risk of myelosuppression (neutropenia, anemia).Major
RibavirinAdditive hemolytic anemia risk. This is a therapeutic combination but requires intense monitoring.Major
Other Myelosuppressive Agents (e.g., chemotherapy, clozapine)Increased risk of severe bone marrow suppression.Major
Live Attenuated VaccinesIncreased risk of vaccine-induced infection. Avoid vaccination during therapy.Major
CNS Depressants (e.g., alprazolam, opioids)Potential additive CNS effects like drowsiness and dizziness.Moderate
Nephrotoxic Drugs (e.g., aminoglycosides, NSAIDs)Increased risk of renal dysfunction.Moderate

🔁 Alternatives to BIOFERON

Same composition (Interferon Alpha 2B (30%)), different brands:

VIRAFERON INTRON A REALFA-2B SHANFERON FERON