Bioferon (Interferon Alfa-2b)

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Bioferon (Interferon Alfa-2b)

Quick Facts

Property Description
Active ingredient Interferon Alfa-2b
Form Solution for injection or Powder for solution
Pharmacological class Biological Response Modifier
Common purpose Antiviral and Immunomodulatory
Origin Recombinant (synthetic human protein)

What Type of Medicine is Bioferon (Interferon Alfa-2b)?

Bioferon is a Biological Response Modifier and Immunomodulator that contains the recombinant human protein known as Interferon Alfa-2b. This drug is classified as a Type I Cytokine, functioning as a pharmaceutical imitation of the potent protein that human cells naturally generate when responding to viral threats and cellular abnormalities. The active substance, Interferon Alfa-2b, is produced synthetically using sophisticated recombinant DNA technology, ensuring it is a highly purified, single-component product structurally identical to the natural Interferon Alpha found in the body. Its core purpose is fundamentally antiviral and growth-regulating, distinguishing it from traditional small-molecule drugs. Interferon Alfa-2b is classified as an Immunological agent. This classification confirms the medicine works by altering or modulating the body's natural immune responses.

The Composition and Form of Interferon Alfa-2b

The active ingredient of this medication is the Interferon Alfa-2b protein, which is prepared for parenteral administration as a sterile solution for injection or as a powder for solution housed in vials or multidose pens. Since the protein component would be rapidly inactivated by the digestive system, it must be delivered directly into the body using the parenteral route. The preparation consists of the active water-soluble protein stabilized within an aqueous base or buffer system, which ensures the protein's stability and proper physiological function. Although Bioferon is a specific trade name, the active ingredient is also found in other well-known preparations such as Intron A and Roferon-A, all sharing the same fundamental recombinant protein structure and necessary injectable formulation.

What is the General Purpose of Bioferon?

The general purpose of Bioferon is to leverage the body's natural defense systems to establish an effective protective state against pathogens and abnormal cell growth. The Interferon Alfa-2b protein acts as a signal, binding to specific cell receptors to initiate powerful immunomodulatory changes that increase the overall activity of the host's immune cells. This mechanism provides a dual benefit: it directly inhibits the replication and spread of viruses, and simultaneously, it exerts an antiproliferative or growth-regulating effect, helping to restrain the multiplication of abnormal, rapidly dividing cells in the body. This approach is clinically recognized for its usefulness in managing conditions where immune system support and viral control are paramount.

Regulatory References

  1. Recombinant Interferon Alfa-2b Definition (NCI)

What side effects are possible with Bioferon (Interferon Alfa-2b)?

Possible Side Effects and Safety Information

The safety profile of Interferon Alfa-2b is defined by effects reflecting its classification as a Biological Response Modifier, involving systemic immune activation. Adverse reactions are classified by frequency and grouped according to the physiological system affected, based on official regulatory documents.


Adverse Reactions Classified by Frequency

The most frequent effects, often experienced at the initiation of therapy, are generally those associated with an acute immune response, which may diminish with continued exposure.

Classification Examples of Officially Documented Effects
Very Common (ge 1/10) Influenza-like symptoms (fever, fatigue, headache, chills, myalgia), Depression, Anorexia, Nausea, Alopecia, and Injection site reactions.
Common (ge 1/100 to < 1/10) Blood disorders (e.g., leukopenia, thrombocytopenia), Anxiety, Insomnia, Dizziness, Diarrhea, Vomiting, Hypotension, and elevated Liver enzymes.

Documented Serious Safety Concerns

Official prescribing information includes warnings regarding potentially serious adverse reactions that have been observed in clinical use:

  • Neuropsychiatric Effects: Including severe depression, suicide ideation, and suicidal behavior. These events may persist up to six months following treatment cessation.
  • Autoimmune and Endocrine Events: The development or exacerbation of autoimmune disorders and thyroid dysfunction (hypo- or hyperthyroidism) are documented risks.
  • Cardiovascular Events: The risk of events such as arrhythmias, angina, and, rarely, myocardial infarction is documented, particularly in patients with pre-existing cardiac disease.

Safety-Related Restrictions

The label defines specific constraints for use. The medicine is contraindicated in individuals with a history of severe pre-existing psychiatric conditions and those with uncontrolled severe cardiac disease.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for Interferon Alfa-2b (Bioferon) notes that experience with overdosage is limited.

Documented Manifestations and Serious Outcomes

Overdose effects are generally consistent with an exacerbation of the known primary effects of the medicine. The administration of a single dose as great as 10 times the recommended amount has been documented. Due to the nature of the drug, high-dose exposure is associated with the risk of severe, life-threatening systemic events.

Classification Manifestation/Outcome
Primary Manifestation Exacerbation of therapeutic effects (e.g., flu-like symptoms)
Life-Threatening Risks Myocardial infarction, Renal failure, Hemorrhage, Hepatic enzyme abnormalities, Aggravation of neuropsychiatric disorders

Required Emergency Actions

Management of overdosage is defined as symptomatic and supportive treatment, as no specific antidote is known. The regulatory guidance mandates specific actions in the event of suspected overdose or severe toxicity:

  • You must call a healthcare provider right away if you take too much medication.
  • Seek immediate medical attention for persistently severe or worsening symptoms.
  • The healthcare provider may perform a closer examination and blood tests for monitoring the effects.
  • Therapy may require withdrawal or discontinuation for persistently severe reactions that do not abate.

Therapeutic Uses of Bioferon (Interferon Alfa-2b)

What Bioferon (Interferon Alfa-2b) Treats: Main Uses and Benefits

This medicine is used to provide additional therapeutic support against specific types of persistent viral threats and patterns of uncontrolled cell growth in the body. It is clinically utilized for established, chronic conditions where additional management of discomfort is required to help manage disease progression. Its applications generally fall into three major therapeutic domains.


This medicine is applied across therapeutic domains involving chronic viral disease, blood disorders, and specific tumors. The common indications include Chronic Hepatitis B and Chronic Hepatitis C; hematologic malignancies like Hairy Cell Leukemia and Follicular Non-Hodgkin Lymphoma; certain solid tumors such as Malignant Melanoma (in the high-risk adjuvant setting); and AIDS-related Kaposi's Sarcoma and Condylomata Acuminata (Genital Warts).

For these conditions, the therapy contributes to easing the overall symptom load.

“...Interferon Alfa-2b is relevant for managing specific disease states where long-term immunomodulatory assistance is appropriate.”


Quick Fact: Relief for Chronic Disease Activity
This medicine is commonly used to help manage persistent viral activity and uncontrolled cellular proliferation, supporting the patient in maintaining a stable state during long-term disease management.

Therapeutic Scope and Benefits

The core benefit for patients with chronic viral hepatitis is relevant for easing symptoms related to systemic imbalance by helping to manage viral activity. This may help limit the progression of tissue damage and contributes to easing the overall risk of long-term complications like cirrhosis. For oncology uses, the goal is to address the uncontrolled cell growth. This may assist with the reduction of tumor burden and can support the improvement of related symptoms, which supports patients during episodes of heightened discomfort.

Eligibility and Restrictions for Use

Interferon Alfa-2b eligibility is strictly defined by regulatory documents, focusing on excluding patients with specific health conditions where the risks are highest.

Absolute Contraindications

Use of this medicine is strictly contraindicated in patients with certain pre-existing conditions:

  • Severe Psychiatric Disorders: Individuals with a current or past history of severe depression, suicidal ideation, or suicide attempts.
  • Severe Organ Dysfunction: Patients with decompensated liver disease (Child-Pugh B or C) or severe, pre-existing cardiovascular disease (e.g., recent heart attack or stroke, unstable angina).
  • Autoimmune Status: Those with active, serious, or untreated autoimmune diseases, including autoimmune hepatitis, or who are immunosuppressed transplant recipients.

Age and Conditional Restrictions

Population Group Eligibility Status (Regulatory)
Adults Generally approved for use (age 18 and older).
Children Permitted for specific combination therapies only if 3 years of age or older.
Pregnancy Contraindicated in combination with ribavirin; Not Recommended for monotherapy use. Females of reproductive potential must use effective contraception.
Renal Function Contraindicated in severe renal dysfunction ( CrCl < 50 mL/min) when used with ribavirin.

Patients with pre-existing conditions like thyroid disease or diabetes mellitus must have these conditions well-controlled with conventional treatment to be eligible for use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information describes several categories of medically significant interactions for Bioferon (Interferon Alfa-2b). These constraints are primarily structured around the drug’s effect on liver enzyme metabolism and the potential for additive adverse effects with other medicines.

Interferon Alfa-2b is an inhibitor of the CYP1A2 hepatic enzyme, which can increase the systemic exposure and effects of co-administered medicines metabolized by this enzyme, such as theophylline and aminophylline. The use of Interferon Alfa-2b with fezolinetant, a drug that is a sensitive CYP1A2 substrate, is contraindicated due to this pharmacokinetic interaction.

Pharmacodynamic interactions require caution with agents that share similar toxicity profiles. Concomitant use with myelosuppressive agents (e.g., deferiprone, acalabrutinib) or immunosuppressive agents (e.g., ponesimod) requires close patient monitoring for excessive myelosuppression and infection risk, respectively. Similarly, co-administration with narcotics, hypnotics, or sedatives should be avoided or closely monitored for excessive central nervous system toxicity.

Patients with impaired renal function require special consideration, as reduced clearance may increase the risk of interferon toxicity, necessitating close monitoring and potential dose adjustment.

Mechanism of Action

Bioferon, a recombinant Type I interferon, functions as a cytokine agonist. Its biological target is the cell-surface Type I interferon receptor (IFNAR), a heterodimer composed of IFNAR1 and IFNAR2 subunits. Binding of Interferon Alfa-2b induces a conformational change in the receptor complex, leading to the trans-phosphorylation and activation of the constitutively associated Janus kinase (JAK) family members: Tyrosine Kinase 2 (TYK2), associated with IFNAR1, and JAK1, associated with IFNAR2.

Activated JAK1 and TYK2 phosphorylate specific tyrosine residues on the cytoplasmic tails of the IFNAR subunits. These phosphotyrosine residues then serve as docking sites for the latent cytoplasmic transcription factors STAT1 and STAT2. The STAT proteins are subsequently phosphorylated by the JAKs, resulting in the formation of an active cytoplasmic heterotrimer complex, ISGF3 (Interferon-Stimulated Gene Factor 3), which includes phosphorylated STAT1, STAT2, and IRF9 (Interferon Regulatory Factor 9).

This ISGF3 complex translocates into the cell nucleus, where it binds to specific promoter sequences termed Interferon-Stimulated Response Elements (ISREs). This DNA binding initiates the transcription of hundreds of Interferon-Stimulated Genes (ISGs), which encode effector proteins involved in modulation of cell proliferation and immune function.

Dosage and Administration Information

Administration Methods

Bioferon (Interferon Alfa-2b) is typically administered via injection. The specific method of delivery depends on the condition being addressed and the requirements of the treatment plan. Common administration routes include subcutaneous (under the skin), intramuscular (into the muscle), or intralesional (directly into a lesion) injections. In certain clinical settings, it may also be administered intravenously.

Preparation for Use

The medication often comes in a powder form that requires reconstitution with a sterile diluent or as a pre-mixed solution. When preparing the medication, it is important to inspect the vial for any discoloration or particulate matter. The solution should generally appear clear and colorless.

Handling and Disposal

Because this medication is biological in nature, proper handling is necessary to maintain its stability. This includes adhering to specific temperature requirements for storage and avoiding vigorous shaking of the vial, which can degrade the protein.

All components used for the injection, including syringes and needles, are intended for single use only. Proper disposal in a designated sharps container is a standard part of the administration process to ensure environmental safety and prevent accidental needle sticks.

Rotation of Injection Sites

For treatments requiring multiple doses over time, it is standard practice to rotate the site of injection. Common areas for subcutaneous injection include the thighs, abdomen (excluding the area around the navel), and the outer surface of the upper arms. Rotating these sites helps to maintain skin integrity and ensures consistent absorption of the medication.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Bioferon (Interferon Alfa-2b)


Evidence for Use in Chronic Hepatitis B and C

Research for Interferon Alfa-2b in Chronic Hepatitis B and Chronic Hepatitis C was initially established through numerous Randomized Controlled Trials (RCTs). These studies compared Interferon Alfa-2b, alone or sometimes in combination with other agents, against control groups. Studies monitored outcomes that included measurements of viral components (viral DNA or RNA) and key liver enzymes in the blood. Researchers also explored changes in the condition of liver tissue by monitoring histological outcomes through biopsies in the observed populations.

Studies reported patterns observed in the measurement of viral markers and liver enzyme levels during the study period. The research highlights changes measured during the study period, including the rate at which viral markers were kept low after treatment was stopped, which researchers term a sustained virological response.

However, certainty remains low regarding the very long-term effects. Long-term outcomes are not fully established concerning the ultimate prevention of cirrhosis or liver cancer. Furthermore, much of this foundational evidence was collected before the development of newer oral antiviral drugs, meaning modern comparative evidence against today's standard treatments is lacking.


Evidence for Use in Malignant Melanoma (Adjuvant Therapy)

Interferon Alfa-2b was evaluated in multiple large-scale Randomized Controlled Trials (RCTs) following surgery for high-risk malignant melanoma. The main outcomes research examined were Relapse-Free Survival (RFS) and Overall Survival (OS). Studies reported observations of a delayed time to disease recurrence (RFS) in cohorts that received Interferon Alfa-2b compared to control groups.

However, the findings related to Overall Survival (OS) were mixed across different studies and subsequent analyses. Long-term follow-up reports described patterns in the time to survival endpoints that were sometimes small in magnitude across analyses. A significant number of patients involved in these studies had to stop treatment early due to observed tolerability issues, which complicates the understanding of the full impact of the therapy.


What is Still Uncertain About the Research for Interferon Alfa-2b

The overall research landscape shows several key limitations. The findings for Overall Survival in the adjuvant melanoma setting were inconsistent across trials. For the chronic viral indications, the current evidence must be viewed in the context of the development of newer antiviral medicines. For many indications, the sample sizes were modest in early trials, and follow-up durations were limited in others, leading to evidence quality that varies across studies. Further research is needed to fully contextualize these older findings within modern treatment paradigms.

Key Studies & References

  1. Peginterferon alfa-2b plus ribavirin for treatment of chronic hepatitis C in children and adolescents: a randomized trial

Frequently Asked Questions (FAQ)

Common questions about Bioferon (Interferon Alfa-2b) (FAQ)

Q: Can I take pain relievers like Tylenol or Advil while on Bioferon?

A: Regulatory documents suggest that a fever reducer or pain reliever, such as acetaminophen (Tylenol), can sometimes be used before a dose to help manage the common, temporary flu-like symptoms. Official product information cautions against taking other medicines that may increase the risk of similar side effects, such as those that affect the central nervous system. Questions about co-administration are best addressed by a prescribing healthcare provider.


Q: Can Bioferon be used during pregnancy?

A: Official information generally does not recommend the use of this medicine during pregnancy due to the potential for adverse effects indicated in animal studies. When used in combination with ribavirin, the combination is strictly prohibited. For both men and women of reproductive potential, regulatory guidelines mandate the use of effective contraception throughout the duration of treatment.


Q: What is the connection between Interferon Alfa-2b and hepatitis C treatment?

A: Interferon Alfa-2b is officially indicated for the treatment of chronic hepatitis C, often used in combination with other medicines. However, official research documents note that much of the evidence for this use was established before the development of newer, highly effective oral antiviral drugs.


Q: Does Bioferon affect fertility in men or women?

A: Official safety documents indicate that the medicine has the potential to damage fertility or cause harm to an unborn child. Due to these potential risks, regulatory guidelines strictly mandate the use of effective birth control for all patients of reproductive potential during treatment and for a specified time after treatment is complete.


Q: Do I need to get blood tests done regularly while on Bioferon?

A: Official prescribing guidelines describe the requirement for regular monitoring with blood tests. These tests typically include checking blood counts (CBC), liver function, and thyroid function, which are evaluated at the start of treatment and at specified intervals throughout the course of therapy.


Q: Are there any foods or supplements that should be avoided while using Bioferon?

A: Official drug documents focus primarily on drug-drug interactions, particularly those involving shared side effects or metabolic inhibition. While specific prohibitions for common foods or standard dietary supplements are generally not listed, questions regarding specific supplements are best directed to a healthcare provider.


Q: Is Bioferon the same as Interferon Alfa-2a?

A: No, Bioferon contains Interferon Alfa-2b, which is a protein that is chemically distinct from Interferon Alfa-2a. Although both are classified as recombinant Type I alpha interferons with similar biological effects, they are considered separate active substances in official regulatory documents and are not interchangeable.


Q: How long do most patients typically stay on Bioferon treatment?

A: The required duration of therapy is highly specific and is determined by the medical condition being treated. According to official prescribing information, treatment can range from several months (e.g., for some viral infections) up to multiple years (e.g., for certain cancer maintenance protocols).


Q: Is weight gain or weight loss a common side effect of Bioferon?

A: Official adverse reaction lists commonly report anorexia, or a loss of appetite. This side effect may potentially lead to weight loss over time. Weight gain is not commonly or very commonly reported in the regulatory product information.


Q: Is Bioferon safe for people with a history of depression?

A: Official warnings state that this medicine is contraindicated, or should be strictly avoided, in patients with severe psychiatric disorders or a history of depression. Close neuropsychiatric monitoring is required for all patients, as severe depression, anxiety, and suicidal ideation have been observed during use.


Q: Why is Bioferon sometimes used for conditions other than cancer?

A: The medicine is classified as a Biological Response Modifier that has both antiviral (virus-fighting) and antiproliferative (growth-regulating) effects. Because of this dual mechanism, its official indications include the treatment of certain chronic viral infections, such as hepatitis B and C, in addition to certain cancers.


Q: Does Bioferon affect the immune system?

A: Yes, Bioferon is explicitly classified as an Immunomodulator. It functions by binding to specific cell receptors to activate the body's natural defense pathways, leading to the transcription of many genes that modulate and strengthen immune function.


Q: How do doctors monitor the effectiveness of Bioferon treatment?

A: The effectiveness of the treatment is monitored by measuring specific laboratory and clinical markers that relate to the condition being treated. For viral infections, this includes measuring viral markers. For cancer treatments, this includes assessing the disease response and tracking survival endpoints as described in the official protocols.


Q: Is it possible to develop a tolerance to Bioferon over time?

A: Official safety data suggests that patients may often develop a tolerance to the acute side effects, such as the initial flu-like symptoms, over several months of continued treatment. The regulatory labels do not specifically address whether therapeutic tolerance, or a loss of primary effectiveness, develops over time.


Q: What official studies support the use of Bioferon for melanoma?

A: The use of the medicine as an adjuvant therapy for malignant melanoma is supported by evidence from multiple large-scale Randomized Controlled Trials (RCTs). These studies, cited in the Clinical Studies section of the prescribing information, provided observations regarding outcomes like the time to disease recurrence and overall survival.


Q: What are the long-term effects of taking Bioferon?

A: Documented long-term risks include severe effects like neuropsychiatric disorders that can persist for up to six months after treatment stops, and the potential to develop or worsen autoimmune conditions or thyroid dysfunction. Official research also notes that certain very long-term outcomes for diseases, such as the prevention of cirrhosis, are not fully established.


Q: Are there specific vaccines to avoid while receiving Bioferon?

A: Official documents recommend that caution be used with the concomitant administration of certain vaccines. Specifically, live vaccines are often advised against during treatment due to the medicine's effects as an immunomodulator.


Q: Can Bioferon cause elevated liver enzymes?

A: Yes, regulatory documents list elevated liver enzymes (ALT/AST) as a Common adverse effect of the medicine. Because of this documented risk, official guidelines mandate the regular monitoring of liver function tests throughout the course of treatment.


Q: Are the initial side effects of Bioferon worse than later ones?

A: Official information indicates that the most frequent side effects, particularly the flu-like symptoms, are often experienced at the initiation of therapy. These effects may lessen in severity with continued exposure, suggesting that the initial treatment phase may be the most challenging for some patients.


Q: Can Bioferon interact with herbal supplements like St. John's Wort?

A: Official prescribing information states that this medicine acts as an inhibitor of the CYP1A2 liver enzyme. Because certain herbal supplements, such as St. John's Wort, are known to affect this same enzyme, a potential interaction could exist, and caution is needed with the use of such supplements.


Q: Why do some people stop using Bioferon after starting?

A: The regulatory label outlines several non-personal reasons for stopping treatment. These include the patient developing a persistent intolerance to side effects, the occurrence of serious adverse events (such as severe depression), or the disease failing to respond to the medicine within a specific timeframe.


Q: What should I do if my side effects from Bioferon feel unmanageable?

A: Official protocols for managing severe intolerance include reducing the dose, temporarily withholding the dose, or permanently discontinuing the medicine. The documentation specifies that severe or unmanageable effects warrant immediate notification to a prescribing healthcare provider.

How should Bioferon (Interferon Alfa-2b) be stored and disposed of?

Storage and Disposal of Interferon Alfa-2b

The storage and disposal instructions for Interferon Alfa-2b products are defined by regulatory documents to maintain drug stability and ensure safety.

Storage Category Official Regulatory Requirements
Temperature Store in the refrigerator between 2 C to 8 C (36 F to 46 F). Do not freeze the product.
Protection Keep the medicine in the original carton to protect the solution from light.
Stability After first use (multi-dose) or reconstitution (powder), the solution must be used within a specific time, such as 24 hours or 28 days, while still refrigerated.
Disposal Used needles and syringes must be immediately placed in an FDA-cleared sharps disposal container. Unused or expired medication should be disposed of via local pharmaceutical take-back programs; do not flush down the toilet or throw into household trash.
Child Safety Keep the product out of the reach and sight of children.

The regulatory profile mandates continuous cold storage and strict protection from light to preserve the protein's integrity. Safe disposal requires separating used injection materials into approved sharps containers and utilizing designated channels for unused product.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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