Interferon alfa-2b

Summary

Interferon alfa-2b (IFN-α2b) is a recombinant human interferon approved for a broad range of indications including chronic hepatitis B, chronic hepatitis C, hairy cell leukemia, malignant melanoma, follicular lymphoma, AIDS-related Kaposi's sarcoma, and condylomata acuminata. It exerts antiviral, antiproliferative, and immunomodulatory actions through the JAK-STAT pathway.

Mechanism of Action

Binds to type I interferon receptors (IFNAR1/IFNAR2) on cell surfaces, activating the JAK-STAT signaling pathway, leading to transcription of interferon-stimulated genes (ISGs) that produce antiviral, antiproliferative, and immunomodulatory effects; enhances NK cell and macrophage activity and upregulates MHC class I expression.

Routes of Administration

Goals & Uses

• AIDS-Related Kaposi's SarcomaOncology / Infectious DiseaseModerate
• Chronic Hepatitis C treatmentAntiviralHigh
• Chronic Hepatitis B treatmentAntiviralHigh
• Hairy cell leukemia treatmentOncologyHigh
• Follicular non-Hodgkin lymphomaOncology / HematologyModerate
• Malignant melanoma adjuvant therapyOncologyHigh

Contraindications

• Neonates and Infants (benzyl alcohol-containing formulations)PediatricHigh
• Concurrent use of telbivudineDrug InteractionHigh
• Autoimmune hepatitisHepatic / AutoimmuneHigh
• Decompensated liver diseaseHepatic ImpairmentHigh
• Hypersensitivity to interferon alfa or any componentImmunologicHigh
• Severe psychiatric disorders (untreated)PsychiatricHigh

Adverse Effects

• Neutropenia and thrombocytopeniaHematologicCommon
• Depression and neuropsychiatric effectsNeuropsychiatricCommon
• Injection site reactionsLocalCommon
• Thyroid dysfunctionEndocrineUncommon
• Elevated liver enzymes / hepatotoxicityHepaticUncommon
• Flu-like syndrome (fever, chills, myalgia, fatigue)SystemicCommon

Drug Interactions

• Zidovudine (AZT)Moderate
• Theophylline / AminophyllineModerate
• TelbivudineHigh
• RibavirinLow
• ClozapineHigh
• MethadoneModerate

Population Constraints

• PregnancyReproductive SafetyRelative
• Severe renal impairment (CrCl <50 mL/min)Renal ImpairmentRelative
• Pediatric patients (<1 year)AgeAbsolute
• Pre-existing autoimmune diseaseAutoimmuneRelative
• Elderly patients (>65 years)AgeRelative
• Severe cardiovascular diseaseCardiovascularRelative

Regulatory Status

• European UnionApprovedApproved: Chronic hepatitis B, Chronic hepatitis C, Hairy cell leukemia, Follicular lymphoma, Malignant melanoma, Kaposi's sarcoma, Condylomata acuminata, Multiple myeloma, Carcinoid tumorApproved by EMA; available as Intron A. Carcinoid and multiple myeloma indications differ from US label.
• United StatesApprovedApproved: Hairy cell leukemia, Chronic hepatitis B, Chronic hepatitis C (with/without ribavirin), Malignant melanoma (adjuvant), Follicular lymphoma, AIDS-related Kaposi's sarcoma, Condylomata acuminataApproved since 1986 under brand name Intron A (Merck/Schering-Plough). Some HCV indications now largely superseded by DAAs.
• United KingdomApprovedApproved: Chronic hepatitis B, Chronic hepatitis C, Hairy cell leukemia, Follicular lymphoma, Malignant melanoma, Kaposi's sarcoma, Condylomata acuminataAvailable via MHRA approval; broadly aligned with EU indications post-Brexit.

Approved by FDA (Intron A, Schering-Plough/Merck) since 1986. Multiple indications approved across US, EU, and UK. Largely supplanted in hepatitis C by direct-acting antivirals (DAAs). Pegylated form (peginterferon alfa-2b) has extended half-life and is also approved.

Evidence & Sources

No sources recorded yet.