Альфарекин

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Альфарекин

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Альфарекин

Quick Facts

Property Description
Active Ingredient Interferon Alfa-2b
Pharmacological Class Immunostimulant, Biological Response Modifier
Forms Lyophilizate (for solution), Rectal Suppositories
Origin Synthetic Recombinant Protein
Patient Group Adults and Children (including newborns)

Definition, Class, and Active Substance

Альфарекин is a high-purity, single-agent medicinal product identified by the active substance Interferon Alfa-2b, which is consistently classified as a Biological Response Modifier and a potent Immunostimulant. This substance is a natural cytokine—a Type I Interferon—that is integral to the body’s intrinsic immune signaling. Its utility in modulating the immune system and providing a broad defensive function is centered on its role in regulating immune responses. This established recognition confirms the medicine helps the body's natural defenses manage a variety of cellular and infectious threats.

The Interferon Alfa-2b component is a recombinant protein produced using sophisticated gene-engineering technology, not derived directly from human blood products. This process yields a non-glycosylated protein that is structurally identical to the natural human protein, ensuring a highly standardized and consistent biological preparation.

Differentiating Forms and Compositional Features

The drug offers a unique differentiation through its available pharmaceutical presentations: a sterile lyophilizate (a powder) for preparing an injectable solution and rectal suppositories. The inclusion of suppositories is a distinguishing feature, enabling administration through an alternative route particularly relevant for use in certain patient groups, including young children and newborns.

This single-agent formulation is composed of the pure recombinant protein and an aqueous solution base containing buffering salts, such as sodium phosphates, to ensure stability. The application of Interferon Alfa-2b extends to various conditions where immune enhancement or control of cell proliferation is required. This confirms the substance has an established application in supporting the body's response mechanisms across different therapeutic areas.

General Purpose: Immune Enhancement and Regulation

The overall general purpose of Альфарекин is to actively engage and strengthen the body's internal defense systems. Its core function involves stimulating a powerful antiviral state within cells, making them resistant to viral replication, and exhibiting a robust immunomodulating activity to enhance the function of key immune components. Crucially, the substance also provides a recognized antiproliferative action, which assists in slowing or regulating the uncontrolled, rapid multiplication of cells. This combined ability to directly fight pathogens and regulate abnormal cell growth defines its foundational role as a biological therapeutic agent.

Regulatory References

  1. NIH: Interferon Alfa-2b

What side effects are possible with Альфарекин?

Possible Side Effects and Safety Information

The safety profile for Interferon Alfa-2b is documented in official regulatory sources, classifying potential effects by frequency and the body systems involved. The most frequently documented adverse effects are often systemic and constitutional.


Adverse Reaction Scope

Classification Examples of Officially Listed Reactions
Very Common Influenza-like symptoms (e.g., fever, fatigue, chills, headache), musculoskeletal pain, and decreases in white blood cell counts (leukopenia) [EMA/FDA].
Common Anxiety, depression, insomnia, gastrointestinal issues (e.g., nausea, diarrhea, anorexia), mild injection site reactions, and elevated liver enzymes [EMA/FDA].
System-Organ Class Reactions are officially grouped across multiple systems, including Blood and Lymphatic, Psychiatric, Nervous System, and Gastrointestinal Disorders [FDA].

Serious Safety Considerations

Serious adverse reactions are formally identified in labeling and include fatal or life-threatening neuropsychiatric disorders (such as severe depression, suicidal ideation, and psychosis), autoimmune phenomena, cardiotoxicity (e.g., arrhythmias), and severe retinal disorders [FDA].

Time-Related Safety Patterns: The commonly noted influenza-like symptoms are generally more frequent at the initiation of therapy and may lessen with continued exposure. Some disorders, such as certain endocrine or autoimmune conditions, are associated with long-term exposure.

Safety-Related Restrictions: The official label contraindicates use in individuals with severe pre-existing psychiatric disorders, decompensated cardiac disease, or severe hepatic disease. Specific population-specific safety notes advise caution for patients with a history of significant cardiac or pre-existing psychiatric conditions [EMA/FDA].

The regulatory structure mandates close monitoring, including periodic clinical and laboratory evaluations, to observe for persistently severe or worsening signs of these documented conditions.

Overdose and Emergency Response

The official regulatory profile for Interferon Alfa-2b overdose focuses on the potential for excessive exposure to intensify the risk of specific severe, life-threatening systemic disorders. These are the primary documented manifestations of overdose or severe toxicity.

Overdose Risk & Manifestations Official Guidance
Life-Threatening Systemic Disorders Overdose is associated with the potential to cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders.
Documented Toxicity Manifestations include severe hematologic toxicity (e.g., leukopenia, thrombocytopenia) and persistent, significant elevation of liver enzymes (hepatic toxicity).
Population-Specific Note The prescribing information notes that suicidal ideation or attempts occurred more frequently in pediatric patients, particularly adolescents, compared to adults.

Immediate Emergency Actions

Regulatory documents state that if an overdose is suspected, a healthcare provider or doctor must be called right away. Immediate medical attention is required upon the observation of severe symptoms such as chest pain, irregular heartbeat, confusion, or changes in mood or behavior.

The documented management for severe, worsening signs involves mandatory withdrawal from therapy and is symptomatic and supportive, as no specific antidote is officially listed. Close clinical and laboratory monitoring is required until symptoms stabilize.

Therapeutic Uses of Альфарекин

What Альфарекин Treats: Main Uses and Benefits

Альфарекин (Interferon Alfa-2b) is commonly used to help with conditions across domains of viral disease management and certain oncology contexts. The medication is commonly used to help with conditions that involve persistent viral infections and specific types of cell growth.


Therapeutic Scope and Symptom Relief

Альфарекин is commonly used in situations involving symptoms related to long-standing viral threats, such as Chronic Viral Hepatitis (types B and C), and is applied when appropriate for specific malignancies including certain leukemias, lymphomas, and Malignant Melanoma. It helps address symptom clusters that may become intense or disruptive in chronic conditions and may assist with managing symptoms that interfere with daily functioning that arise from conditions marked by increased physiological stress.

In clinical scenarios, it is often used when symptoms intensify and supportive relief is needed, such as when applied in scenarios where additional management of discomfort is required after initial treatment. The medication supports the body's natural defense system and contributes to easing the overall symptom load associated with persistent cellular or viral challenges.


Quick Fact: Relief for Persistent Symptoms
Primary Symptom Focus Symptoms related to systemic imbalance that may appear suddenly or intensify over time.
Main Clinical Context Chronic disease management and adjuvant therapy for high-risk conditions.
Patient Benefit Helps ease the overall symptom burden and assists with maintaining functional stability.

Regulatory References

  1. NIH MedlinePlus overview on Interferon Alfa-2b

Eligibility and Restrictions for Use

Who can and cannot use Альфарекин? (Interferon Alfa-2b)

Official regulatory documents define strict criteria for patient eligibility and exclusion, focusing primarily on pre-existing medical conditions, organ function, and age.

Contraindicated Populations (Must Not Use):

  • Patients with Autoimmune Hepatitis or decompensated liver disease.
  • Individuals with a history of severe psychiatric disorders, including severe depression or suicidal ideation.
  • Those with severe pre-existing cardiovascular disease (e.g., uncontrolled hypertension, recent stroke/MI).
  • Patients with a known hypersensitivity to alpha interferons or excipients.

Age and Reproductive Eligibility:

  • Pediatric Use: Established for Chronic Hepatitis B in children 1 year of age or older and Chronic Hepatitis C (in combination) in children 3 years of age or older.
  • Pregnancy/Lactation: Use is contraindicated in combination therapy with ribavirin due to fetal risk. Monotherapy use is restricted, requiring effective contraception for both female patients and male partners.

Conditional Use (Requires Caution):

Use requires special monitoring or control in patients with pre-existing conditions like uncontrolled thyroid disease, diabetes mellitus, renal impairment, or certain autoimmune disorders.

What should I know about interactions with other medicines?

Official Interaction Profile

The interaction profile of Альфарекин (Interferon Alfa-2b) is primarily characterized by two documented patterns: the modulation of metabolic enzymes and the risk of additive toxicities with co-administered medicines, as stated in regulatory labeling.

Exposure-Modifying Interactions

Interferon Alfa-2b is documented to possess the potential to indirectly reduce the activity of the liver’s cytochrome P450 (CYP) enzyme system. This reduction may slow the metabolic clearance of other co-administered medicinal products that are substrates for these enzymes.

  • Theophylline: Co-administration may increase the plasma concentration of Theophylline, a drug cleared in part by CYP1A2. Regulatory documents advise that therapeutic drug monitoring and potential dose adjustment of Theophylline are necessary when co-administered.
  • Methadone: Increased exposure to Methadone may occur due to inhibited clearance, which is a recognized risk.

Pharmacodynamic and Toxicity Interactions

Specific pharmacodynamic interactions leading to additive toxicity are officially noted for certain drug classes:

  • Myelosuppressive Agents: Co-administration carries an additive risk of hematological toxicity, including severe neutropenia and thrombocytopenia.
  • CNS-Active Medicines: There is a heightened potential for neuropsychiatric adverse events when co-administered with other medicines that affect the central nervous system, requiring caution.
  • Hepatotoxic Agents: The risk of liver injury is increased when Альфарекин is co-administered with other agents known to be toxic to the liver, particularly in patients with hepatic impairment.

No mandatory timing separation rules are universally documented in regulatory labels; constraints center on monitoring and adjusting co-administered drug doses to manage increased exposure or additive toxicities.

Mechanism of Action

Initiating the JAK-STAT Signal Transduction

The drug's action begins by the Interferon Alfa-2b substance acting as an agonist for the IFNAR (Interferon-alpha/beta Receptor), which is the primary biological target on the cell surface. This molecular interaction activates receptor-associated kinases, JAK1 and TYK2, launching the highly specific JAK-STAT signaling cascade which drives the transcription of hundreds of genes associated with cellular defense mechanisms.


Inducing the Cellular Defense State

The activation of the signaling cascade leads to the expression of Interferon-Stimulated Genes (ISGs), the effector molecules of the mechanism. These ISGs encode defensive proteins like PKR and the OAS/RNase L system that halt protein synthesis and degrade RNA, establishing a state of cellular non-permissiveness for viral replication and molecular intrusion. Furthermore, the mechanism induces Cyclin-Dependent Kinase (CDK) Inhibitors to influence the regulation of cell multiplication and promote apoptosis.


Modulating Immune and Antiproliferative Functions

The mechanism influences immune functions, including the enhancement of Natural Killer (NK) cell cytotoxicity and the upregulation of MHC Class I molecules, while concurrently contributing to the regulation of cellular proliferation. This collective action profile encompasses both the initiation of host defense mechanisms and the modulation of cellular growth regulation.

Dosage and Administration Information

Administration Guidelines

Альфарекин (Interferon Alfa-2b) is administered according to precise, standardized regimens, with doses typically measured in Millions of International Units (MIU).

Administration Scope Label Instructions
Route of Administration Subcutaneous (SC) or Intramuscular (IM) injection are standard. Intravenous (IV) infusion is used for specific high-dose regimens, and Intralesional (IL) injection for localized treatments. Regional formulations may include Rectal suppositories.
Dosing Schedule Dosage is often determined by Body Surface Area (m^2). Regimens vary significantly, such as 2 MIU/m^2 three times a week for Hairy Cell Leukemia, or a two-phase schedule for Malignant Melanoma: 20 MIU/m^2 daily for induction followed by 10 MIU/m^2 three times a week for maintenance.
Frequency and Timing Administration is frequently scheduled three times a week (on alternate days) or daily (five consecutive days per week) for certain induction courses. Duration is typically fixed, ranging from 16 weeks up to 48 weeks or more, depending on the indication.

Preparation and Procedural Rules

The powder formulation (lyophilizate) must be reconstituted with the provided diluent by gentle swirling; shaking is to be avoided. For IV administration, the calculated dose is added to 0.9% sodium chloride solution and administered as a 20-minute infusion. Subcutaneous injection sites must be rotated to minimize local effects.

Population-Specific Rules

Guidelines approve use in the pediatric population (ge 3 years old) for certain conditions, with dosing calculated based on m^2. Instructions also detail objective criteria for dose reduction or temporary withholding of treatment, which is based on pre-defined laboratory parameter changes (e.g., changes in white blood cell or platelet counts).

Recent Clinical Evidence

Research Evidence / Overview of Studies for Альфарекин

This summary details the clinical research conducted on the medicine, outlining the types of studies performed, the findings reported by researchers, and the limitations documented in the scientific literature. Research does not determine whether an individual will respond similarly, but findings describe group patterns, not personal outcomes.


Evidence for Use in Chronic Viral Hepatitis

Research for chronic viral hepatitis, particularly Hepatitis C, was primarily conducted using Randomized Controlled Trials (RCTs) and systematic reviews that monitored patient outcomes over defined time intervals. Studies explored outcomes related to systemic or functional imbalance, such as measuring the decrease in viral markers and the normalization of liver enzyme levels. Research highlights changes measured during the study period, reporting that patients treated over longer courses—sometimes 12 to 24 months—were associated with a higher frequency of sustained virological response compared to shorter courses. Long-term effects for certain complications are not fully established.


Research in High-Risk Malignant Melanoma

The research in high-risk melanoma was evaluated in large RCTs that compared the high-dose regimen to an observation period following surgery. These studies primarily measured two critical endpoints: Relapse-Free Survival (RFS) and Overall Survival (OS). Findings from the pivotal trials indicate that the treatment was associated with an extension of RFS compared to observation. However, research describes that high rates of required dose reduction or discontinuation due to patient tolerance challenges was observed in studies. Subgroup findings remain uncertain concerning the OS endpoint across different scientific reviews.


Evidence in Special Patient Populations and Gaps

The medicine was evaluated in pediatric patients for chronic viral hepatitis, where monitored developmental metrics were a key focus. Data for certain groups remain insufficient regarding the use of the drug alone for other oncology indications in pediatric patients. The evidence is also limited for historical uses in hematologic malignancies, and comparative evidence is lacking against currently available treatment options in melanoma.

Key Studies & References

  1. Sustained Virological Response to Interferon-α Is Associated with Improved Outcome in HCV-related Cirrhosis: A Retrospective Study
  2. Interferon Alfa-2b Injection: MedlinePlus Drug Information (used for standard indication list and general context)

Frequently Asked Questions (FAQ)

Common questions about Альфарекин (FAQ)

Q: Why is Альфарекин officially indicated for multiple different health conditions?

Regulatory authorities indicate this medicine for multiple conditions because of its three primary roles: it acts as an immunostimulant, a modifier of biological responses, and has potent antiproliferative action (it helps regulate cell multiplication) and antiviral action. This combination of effects on the immune system and cell growth defines its application across different therapeutic areas.

Q: Can people with certain autoimmune conditions use Альфарекин, based on official descriptions?

Official prescribing information indicates that the medicine is contraindicated (use is restricted) in patients with Autoimmune Hepatitis. For individuals with other types of autoimmune disorders, regulatory agencies advise that special monitoring and caution are required, as described in regulatory documentation.

Q: What are the considerations for older patients regarding the use of Альфарекин?

Official guidance does not set specific upper age limits for the use of this medicine. However, regulatory documentation indicates closer monitoring may be necessary due to the potential for co-existing medical conditions that could influence treatment. Decisions about dosage and use are always individualized, not based on age alone.

Q: What is the general guidance if a scheduled application of Альфарекин is missed?

According to regulatory patient information, if an application is missed, the information typically recommends administering it as soon as it is remembered. However, if it is almost time for the next scheduled application, the recommendation is to skip the missed one entirely. The label strongly cautions against taking a double dose to make up for the one that was missed.

Q: Does official information note common interactions between Альфарекин and over-the-counter pain relievers?

Official patient guidance suggests the use of acetaminophen (paracetamol) to help manage the flu-like symptoms that commonly occur with this medicine. Regulatory guidance requires that the use of all over-the-counter pain relievers be discussed with a healthcare provider.

Q: Can a patient take vitamin supplements while undergoing treatment with Альфарекин?

Official patient guidance emphasizes the necessity for patients to inform their healthcare provider of all medicines, herbs, non-prescription drugs, and dietary supplements being used. This is important because even if specific supplements are not listed in the warnings, potential interactions with the medicine may occur.

Q: What are the signs of a serious, though rare, allergic reaction to Альфарекин?

Regulatory documents list signs of a serious allergic reaction, which can include symptoms like trouble breathing, severe itching (hives), or swelling of the face, throat, or tongue (anaphylaxis). Regulatory information notes that these signs indicate a medical emergency and require immediate professional attention.

Q: Does the timing of the day when Альфарекин is applied generally affect the outcome?

Patient guidance indicates that administering the medicine at the same time of day on each scheduled day of application is commonly recommended. It is often advised to apply the injection in the late afternoon or evening, as this timing can help patients manage the common flu-like side effects by sleeping through the peak effects.

Q: Do official documents provide information about changes to diet while using Альфарекин?

Official guidance notes that simple dietary adjustments are sometimes advised, such as avoiding heavy or spicy foods to help lessen nausea, or consuming bland, low-fiber foods to manage diarrhea. These non-clinical suggestions help in managing certain common side effects.

Q: Is it true that patients using Альфарекин might experience temporary hair thinning?

According to official regulatory adverse reaction lists, hair thinning (alopecia) is noted as a potential side effect of Interferon Alfa-2b treatment. This is considered a potential consequence that may occur during the course of therapy.

Q: What is the definition of a 'contraindication' for the use of Альфарекин?

A contraindication is a term used in official prescribing information to identify a medical reason or condition where the risks of taking the medicine are considered too high. In cases of a contraindication, the medicine is not to be used by the patient.

Q: Why do some regulatory sources mention the need to monitor thyroid function while on Альфарекин?

Regulatory sources advise that thyroid function should be monitored because Interferon Alfa-2b has been associated with the potential development or worsening of thyroid disorders. This is a particular concern for patients undergoing long-term exposure to the medicine.

Q: Are there specific laboratory tests generally required before a patient starts using Альфарекин?

Regulatory guidance requires certain laboratory tests to be performed at baseline, before treatment begins, including checks of blood cell counts (WBC, platelets), liver function, and thyroid function (TSH). The requirement for testing also continues periodically throughout the course of treatment, as clinically determined.

Q: What is the process for safely transporting Альфарекин internationally?

The official storage requirements mandate that the medicine must be kept continuously refrigerated between 2 C to 8 C and must not be frozen. Regulatory documentation requires that a continuous cold chain be maintained during transportation, often necessitating the use of a validated travel cooler with ice packs.

Q: Is Альфарекин classified as a drug that poses a risk of dependence or addiction?

The medicine itself is not classified as a controlled substance that poses a risk of dependence or addiction. However, regulatory warnings caution that Interferon Alfa-2b therapy has been associated with the relapse of drug addiction in patients with a history of substance abuse.

Q: What is the factual reason for the official recommendation to check liver function during Альфарекин therapy?

Official information states that liver function is monitored because Interferon Alfa-2b may potentially cause or worsen liver injury. This is particularly relevant when the medicine is used alongside other medicines known to be toxic to the liver.

Q: What is the expected frequency for follow-up appointments and check-ins during Альфарекин treatment?

Regulatory guidance mandates that patients receive periodic clinical and laboratory evaluations throughout the course of therapy. The frequency of these check-ups is determined by the healthcare provider based on the patient's individual needs and response to therapy, but they are typically more frequent at the start of therapy.

Q: Does official guidance state that Альфарекин can impair the ability to drive or operate complex machinery?

Official guidance indicates that restrictions on driving or operating complex machinery may be required if patients experience certain side effects. These include feeling dizzy, confused, or somnolent (sleepy), as these effects can impair concentration and motor skills.

Q: What official safety rating or category is generally applied to Альфарекин?

The medicine is formally classified within the regulatory system as an Immunostimulant. This means it works by engaging the immune system. It is also designated as a product available only by prescription.

Q: Is there factual information about potential concerns if Альфарекин treatment is suddenly discontinued?

Official guidance outlines specific criteria, such as changes in laboratory results, for when treatment should be temporarily withheld or permanently discontinued. Regulatory documentation indicates that discontinuation of therapy is a clinical decision that must occur under the direct supervision of a healthcare provider.

Q: Is the use of Альфарекин documented in the treatment protocols for any rare or orphan diseases?

Official regulatory documents confirm that the medicine has approved indications for certain diseases that are classified as rare. Examples include its use in treating Hairy Cell Leukemia and specific high-risk types of Malignant Melanoma.

Q: What is the general scientific meaning of the 'alpha' designation in Interferon Alpha-2b (Альфарекин)?

The term 'Alpha' in Interferon Alfa-2b refers to the Type I Interferon class of proteins. These are natural signaling proteins, known as cytokines, that play a key role in the body's internal immune signaling and defensive mechanisms.

Q: What does official regulatory information state regarding the management of an overdose of Альфарекин?

Official patient information notes that if an overdose is suspected, immediate contact with a poison control center or emergency room is required for medical guidance. The patient should report the situation for appropriate medical management.

How should Альфарекин be stored and disposed of?

Storage and Disposal Requirements

Official regulatory guidelines strictly define the conditions necessary to store and dispose of Альфарекин (Interferon Alfa-2b) to maintain its stability.

Storage Conditions

Requirement Specifics
Temperature Store in the refrigerator between 2 C to 8 C (36 F to 46 F).
Protection Keep in the original container to protect it from light. The product must not be frozen and should be kept away from heat.
Child Safety Store the medicine and all related supplies out of the reach of children and pets.
Stability Reconstituted solution must be used or discarded within 24 hours if stored in the refrigerator. Multi-dose presentations must be discarded after one month of first use.

Disposal Instructions

Used syringes and needles must be placed immediately in an FDA-cleared sharps disposal container. Any unused or expired medicine and the full sharps container must be disposed of according to local community guidelines for medical waste.

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

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