Тебериф

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Тебериф

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Treatment option: Multiple Sclerosis

Medically reviewed

Rosario Oropesa

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 Тебериф

Property Description
Active ingredient Peginterferon beta-1a (INN)
Form Solution for subcutaneous injection
Pharmacological class Immunomodulator / Pegylated Interferon
Common use Managing Relapsing-Remitting Multiple Sclerosis (RRMS)
Distinctive Feature Extended dosing interval (once every two weeks)

Defining a Treatment for Multiple Sclerosis

Тебериф is a clinically recognized disease-modifying therapy (DMT) used for the long-term management of relapsing forms of multiple sclerosis (MS). It is classified as an immunomodulator, specifically a pegylated interferon beta-1a derivative. The drug's purpose is to influence the immune system's activity to help reduce the severity and frequency of disease flare-ups.

Composition and Formulation

The active ingredient is peginterferon beta-1a, which is a chemically modified form of the human protein, Interferon beta-1a. This modification, known as pegylation, is a key feature of the medicine. The pegylation process allows the active substance to stay in the body longer, resulting in a less frequent dosing schedule. Тебериф is supplied as a sterile solution for injection for subcutaneous administration.

Primary Therapeutic Role

Тебериф's main role is to reduce the frequency of clinical relapses and slow the progression of physical disability in adult patients with relapsing-remitting multiple sclerosis (RRMS). Interferon beta products are used to decrease the number of relapses and slow the worsening of physical problems associated with MS. As a DMT, it acts proactively to dampen the abnormal immune activity and inflammation within the central nervous system.

Regulatory References

  1. U.S. National Library of Medicine’s resource, MedlinePlus

What side effects are possible with Тебериф?

Possible Side Effects and Safety Information

The safety profile for Peginterferon beta-1a (Тебериф) is derived from authoritative governmental regulatory documents, classifying known risks and safety constraints.

Frequency-Classified Adverse Reactions

Adverse reactions are classified by their likelihood of occurrence:

  • Very Common (Applies to 1 in 10 people or more): Headache, flu-like symptoms (e.g., fever, chills, myalgia, asthenia), arthralgia, and injection site reactions (pain, erythema, pruritus).
  • Common (Applies to less than 1 in 10 people): Nausea, vomiting, depression, and alopecia (hair loss).
  • Uncommon (Applies to less than 1 in 100 people): Seizure, angioedema, urticaria, and thrombocytopenia.

Flu-like symptoms are often most prominent at the initiation of therapy and tend to decrease with continued use.


Serious Adverse Reactions and Safety Constraints

The regulatory label highlights several serious, though rare, adverse reactions, often affecting specific organ systems:

  • Hepatic (Liver) Risk: Severe hepatic injury, including autoimmune hepatitis and rare cases of severe hepatic failure, has been documented. Routine monitoring of liver function tests is required.
  • Psychiatric Risk: The medication is formally contraindicated in patients with current severe depression and/or suicidal ideation. Caution is advised for those with a history of depressive disorders.
  • Vascular and Hematologic Risks: Reports include Thrombotic Microangiopathy (TMA) and Pulmonary Arterial Hypertension (PAH).
  • Allergic Reactions: Serious allergic reactions, including anaphylaxis, have been reported.

Routine monitoring of complete blood counts is also required due to the potential for hematologic issues, such as thrombocytopenia. Safety information also notes that interferon beta products may cause fetal harm based on animal data, a key consideration for use during pregnancy.

Overdose and Emergency Response

The official regulatory documents for Peginterferon beta-1a (Тебериф), such as those issued by the FDA and EMA, define the management of an overdose based on required emergency actions rather than specific symptomatic manifestations. Clinical experience with acute overdose is limited, and the dedicated Overdosage sections in the regulatory labels do not list specific symptoms or clinical signs to watch for. This absence of a documented clinical profile for acute overdose means regulators mandate that any suspected overdose requires immediate action.

Patients should contact a Poison Control Center or seek emergency medical care immediately, even if no symptoms are apparent. This procedural requirement is in place because the situation demands prompt clinical observation and professional triage under controlled conditions.

In managing a suspected overdose, the official prescribing information directs that treatment must be primarily supportive and symptomatic, to address any clinical issues that may arise. Furthermore, regulatory documents confirm that no specific antidote for Peginterferon beta-1a overdose is currently known or available. The mandated management, therefore, focuses heavily on continuous clinical monitoring of the patient’s status and providing necessary supportive care, as determined by a healthcare professional, aligning with the procedural guidelines found in official prescribing information.

Therapeutic Uses of Тебериф

The primary role of Тебериф is to offer focused, symptomatic relief across therapeutic domains marked by heightened discomfort and acute manifestations. The primary therapeutic benefit of this medication is aligned with the approved indications and clinical contexts. It may be part of symptomatic management to provide essential supportive relief that helps patients cope more steadily with difficult episodes.

Supporting Management of Acute Symptomatic Episodes

This treatment is commonly used across conditions presenting with acute episodes and is applied in clinical settings that involve acute or unstable symptom patterns. It helps address symptom clusters that may appear suddenly or intensify quickly, leading to noticeable functional strain. The key benefit here is offering short-term symptomatic assistance and temporary stabilization to help ease the overall symptom load of a difficult episodic flare-up.

Easing the Burden of Distressing Manifestations

Тебериф is considered relevant when symptoms that interfere with daily functioning become sufficiently pronounced to disrupt routine stability. It provides support that helps ease the overall symptom burden and is used in contexts where additional management of discomfort is required. This supports patients during episodes of heightened discomfort and helps improve day-to-day comfort during symptomatic periods.


Quick Fact: Is relevant for easing symptoms related to heightened physiological activity.


Regulatory References

  1. European Medicines Agency (EMA) therapeutic overview

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Тебериф — Official Regulatory Information

Eligibility scope

Category Official Regulatory Status/Statement
Populations for whom use is allowed Adult patients (aged 18 years and older) with relapsing forms of Multiple Sclerosis (MS).
Populations for whom use is not recommended Pediatric patients (under 18 years) because safety and efficacy are not established. Use in patients with hepatic impairment has not been studied.
Populations for whom use is contraindicated Patients with a history of hypersensitivity to peginterferon, interferon beta, or any component of the formulation. Patients with current severe depression and/or suicidal ideation (EMA).
Age-related eligibility rules Adults are the approved group. Use is not established for pediatric patients and not sufficiently studied in geriatric patients ( ge 65 years).
Condition-specific eligibility rules Renal Impairment: No dosage adjustment is necessary for any severity of renal impairment.
Pregnancy and lactation eligibility status Initiation of treatment is contraindicated during pregnancy (EMA). Lactation: It is not known whether the drug is excreted in human milk.
Eligibility-related restrictions Caution is required for patients with a seizure disorder, pre-existing significant cardiac disease, or a history of depressive disorders.

Eligibility classifications (high-level)

Category Classification Details (As Defined in Official Documents)
Eligibility severity classification Contraindicated (Hypersensitivity, Severe Depression, Pregnancy initiation - EMA); Not Recommended (Pediatric use); Caution Required (Seizure Disorder, Cardiac Disease).
Regulatory basis EMA Summary of Product Characteristics (SmPC), U.S. FDA Prescribing Information.
Eligibility-context constraints Use is constrained to the approved adult age group and disease status. Contraindications impose absolute exclusions based on hypersensitivity or certain pre-existing psychiatric conditions.

Resulting eligibility structure

Official eligibility statements:

  • The medicine is approved only for adult patients (ge 18 years of age).
  • Use is contraindicated in patients with known hypersensitivity to interferons, and in the presence of current severe depression or suicidal ideation (EMA).
  • Initiation of treatment is contraindicated during pregnancy (EMA).
  • Caution is explicitly required for patients with a seizure disorder or pre-existing significant cardiac disease.

Connection to the overall eligibility profile

Regulatory documents strictly define who can and cannot use Тебериф by establishing mandatory exclusion criteria, primarily hypersensitivity and certain psychiatric conditions. Eligibility is confined to the adult age group, with use in all other age groups categorized as not established or insufficiently studied. Furthermore, official labeling restricts use or mandates special monitoring for patients with specific comorbidities such as cardiac disease.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Тебериф (Peginterferon beta-1a) focuses primarily on a pharmacokinetic caution related to the potential impact of interferon products on drug metabolism. Interferons have been reported to reduce the activity of Cytochrome P450 (CYP)-dependent hepatic enzymes.

This effect results in an interaction constraint regarding co-administration with other medicinal products whose clearance is highly reliant on the CYP system and which possess a narrow therapeutic index. For such substances, co-administration may lead to reduced clearance and consequently increased systemic exposure of the co-administered drug. The label notes that drug classes like certain antiepileptics may be affected, and the metabolism of specific medicines, such as Aminophylline, may be decreased.

Concerning substance interactions, regulatory documents highlight that the co-administration of Тебериф with ethanol (alcohol) may increase the risk of liver-related problems. In contrast, the concurrent or prophylactic use of common analgesic, anti-inflammatory, and/or antipyretic treatments is permissible for managing treatment-related symptoms. No mandatory timing separation rules for co-administered medicines are documented.

Finally, while not a drug-drug interaction, a population-specific pharmacokinetic note exists: patients with severe renal impairment experience increased systemic exposure to Тебериф itself, a factor that requires monitoring.

Mechanism of Action

Тебериф (Teriflunomide) is an immunomodulatory agent that acts by reversibly inhibiting the mitochondrial enzyme dihydroorotate dehydrogenase (DHODH). DHODH is a critical enzyme in the de novo pyrimidine synthesis pathway. This mechanism causes selective cellular accumulation in certain tissues.

Inhibition of DHODH effectively limits the pyrimidine nucleotide supply required for the rapid proliferation of activated T- and B-lymphocytes. This selective action suppresses the replication of these cells. As these lymphocytes are key components of the immune system's activation, this suppression restricts the ability of the system to rapidly expand the population of activated immune cells.

The resulting reduction in the activated lymphocyte population shifts the overall immunological balance. This modulation subsequently influences downstream immunological processes that are involved in neural inflammation.

Dosage and Administration Information

Тебериф (Interferon beta-1b) is a prescription medication that must be administered under the guidance of a healthcare professional experienced in the treatment of multiple sclerosis.

Dosing and Administration

The medication is supplied as a lyophilized powder and a diluent for subcutaneous (under the skin) injection. The recommended dose is 250 micrograms (0.25 mg), contained in 1.0 ml of the reconstituted solution, injected every other day.

To minimize potential side effects, treatment is generally initiated using a dose escalation, or titration, schedule over the first six weeks. Patients start with a lower dose and gradually increase to the full recommended dose. This titration schedule should be determined by your prescribing physician.

Week(s) Dose Volume
1–2 62.5 mcg 0.25 ml
3–4 125 mcg 0.5 ml
5–6 187.5 mcg 0.75 ml
7 and thereafter 250 mcg 1.0 ml

Injection Procedure

  1. Reconstitution: Before injection, the powder must be reconstituted by slowly injecting the diluent into the Тебериф vial. Gently swirl the vial until the powder is dissolved, and do not shake. The reconstituted solution is colorless to light yellow and slightly opalescent. Do not use the solution if it is discolored or contains particulate matter.
  2. Injection Site: Injections should be given into areas of loose subcutaneous tissue, such as the abdomen, hips, thighs, or the back of the upper arms. Injection sites must be rotated with each dose to reduce the risk of severe injection site reactions, including potential necrosis.

Missed Dose

If a dose is missed, administer the injection as soon as it is remembered. The subsequent dose should then be taken approximately 48 hours later. Do not inject Тебериф on two consecutive days to make up for a missed dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Тебериф

Evidence for Use in Relapsing-Remitting Multiple Sclerosis (RRMS)

The primary research for Тебериф (peginterferon beta-1a) was conducted on adults who have Relapsing-Remitting Multiple Sclerosis (RRMS), a condition characterized by conditions presenting with cycles of stability and flare-ups. These evaluations mostly involve large, Phase III RCTs where researchers divided patients into groups to research examining temporary physiological imbalance by comparing outcomes in those who received Тебериф against those who received a dummy treatment (placebo) over a defined time interval, typically around two years.

In these studies, researchers monitored several key measures related to the disease. The primary outcomes describing episodic or acute changes were the Annualized Relapse Rate (ARR), which calculates the average number of symptom flare-ups a patient has each year. Another important measurement was Confirmed Disability Progression (CDP), a measure that was studied for tracking whether a patient’s physical challenges increased and remained stable over several months, as scored on functional scales. The research also examined changes on MRI scans, specifically monitoring lesions that were used as markers in the study.

Study Focus: Outcomes Measured in Clinical Trials

Besides the clinical assessments of relapses and disability, the studies also focused on neuroradiological activity, which means changes seen on brain images. Researchers used MRI to monitor the number of Gadolinium-enhancing (Gd+) T1 lesions (markers linked to acute inflammatory or irritative states) and tracked new or enlarging T2 hyperintense lesions. The initial findings describe how the measurements of these neurological endpoints differed between the groups receiving the treatment and the placebo groups in the short-term trials.

Understanding Long-Term Evidence and Follow-Up

While the core regulatory evidence comes from the two-year randomized trials, long-term outcomes are not fully established by the same high-certainty research standards. Long-term observations (up to six years) were obtained through Open-Label Extension Studies (OLEX), where all participants received the study medication. These studies, which are subject to patient self-selection and observation bias, lack the double-blind, placebo-controlled design of the initial trials. Research highlights what is known — and what is still uncertain — about the durability of the treatment over many years.

Frequently Asked Questions (FAQ)

Common questions about Тебериф (FAQ)

Q: How quickly can a person expect Тебериф to start working?

A: Studies and official information indicate that Тебериф is a long-term therapy designed to manage multiple sclerosis over time. While the drug’s mechanism, which involves suppressing the proliferation of activated immune cells, begins shortly after treatment starts, the effects on major clinical outcomes—like the reduction of relapses and slowing of disability progression—are measured over the course of two-year clinical trials.

Q: What should I do if I miss a dose of Тебериф?

A: According to the official product information, if a dose is missed, the injection should be administered as soon as it is remembered. The label specifies the timing for the subsequent dose should be adjusted accordingly. Official documentation states that the medication should not be injected on two consecutive days to account for a missed dose.

Q: Does Тебериф interact with common pain relievers?

A: Yes, official regulatory documents state that the concurrent use of common analgesic, anti-inflammatory, and/or antipyretic treatments is permissible. These are often used for managing treatment-related side effects, such as flu-like symptoms.

Q: Can Тебериф be used by older adults?

A: The medication is officially approved for use in adult patients aged 18 years and older with relapsing forms of multiple sclerosis. However, official information notes that its use in geriatric patients (age 65 and older) has not been sufficiently studied, and safety and efficacy are not established in the pediatric population (under 18 years).

Q: What is the standard duration of treatment with Тебериф?

A: Тебериф is classified as a Disease-Modifying Therapy (DMT) intended for the long-term management of relapsing forms of multiple sclerosis. Clinical trials supporting its use typically track patient outcomes over periods of up to two years and beyond.

Q: Is it possible to take Тебериф with alcohol (informational query)?

A: Official regulatory documents highlight a caution regarding the co-administration of this medication with ethanol (alcohol). This combination may increase the risk of developing liver-related problems, a known concern documented in the product’s safety profile.

Q: Are there specific symptoms that mean Тебериф is working?

A: Clinical studies measure effectiveness through objective metrics rather than immediate patient-perceptible symptoms. The key outcomes tracked are the reduction in the Annualized Relapse Rate (ARR) and the slowing of Confirmed Disability Progression (CDP), as well as positive changes on MRI scans.

Q: Is Тебериф the same as other similar medicines I've seen advertised?

A: Тебериф is a pegylated interferon beta-1a, which is a specialized form of the human protein Interferon beta-1a. The process of pegylation is a key feature that allows the drug to stay in the body longer, resulting in a less frequent dosing schedule compared to non-pegylated interferon products for the same condition.

Q: Can Тебериф affect my sleep?

A: Official safety data lists adverse events related to the nervous system, including headache and depression. Although not a direct effect on sleep, reports also mention somnolence (sleepiness) as a symptom that can be associated with some of the documented, more serious adverse reactions like liver problems.

Q: Is it normal to feel tired when taking Тебериф?

A: Yes, fatigue or asthenia (weakness) is listed as a Very Common side effect in the product's safety information. This tiredness is often experienced as part of the flu-like symptoms that are most noticeable when beginning therapy, but which typically lessen with continued use.

Q: Does Тебериф interact with vitamins or supplements?

A: Official documents focus on interactions with prescription medications whose clearance relies heavily on the Cytochrome P450 (CYP) system in the liver. No specific mandatory warnings or interactions are documented in the labeling for vitamins or common supplements.

Q: Why is Тебериф sometimes mentioned alongside other medicines for the same condition?

A: Тебериф is part of a group of treatments called Disease-Modifying Therapies (DMTs) used for the long-term management of relapsing multiple sclerosis. It is one of several approved treatments in the pharmacological class of immunomodulators that are used to influence the immune system's activity.

Q: How does Тебериф affect the body differently than other medicines?

A: It works as an immunomodulator by acting on the immune system to limit the ability of certain immune cells (T- and B-lymphocytes) to proliferate quickly. This is achieved through inhibiting an enzyme called dihydroorotate dehydrogenase (DHODH), which is crucial for these cells to multiply.

Q: What research supports the use of Тебериф?

A: The use of the drug is supported by large-scale, controlled Phase III clinical trials involving adults with Relapsing-Remitting Multiple Sclerosis (RRMS). These studies demonstrated the medicine's effects on the Annualized Relapse Rate (ARR) and slowing the progression of physical disability compared to a placebo.

Q: Does Тебериф affect blood pressure?

A: The official label notes that caution is required for patients with pre-existing significant cardiac disease. Furthermore, reports include the potential for Pulmonary Arterial Hypertension (PAH), which is a rare but serious condition involving high blood pressure in the arteries of the lungs.

Q: Is Тебериф used only for serious conditions?

A: Yes, the medication is specifically indicated for the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS). This is a chronic, neurological disease that is considered serious and requires long-term management.

Q: Are there any restrictions on activity while using Тебериф?

A: Official documents do not impose general restrictions on activity. However, official documentation describes the potential for low platelet counts, which may increase the risk of bleeding and bruising. This is a factor to consider in relation to high-risk activities.

Q: What is the experience of people using Тебериф in clinical trials?

A: Clinical trial results describe the frequency of side effects, with most patients experiencing Very Common events like flu-like symptoms (fever, chills, myalgia) and reactions at the injection site (pain, redness). These effects are typically mild to moderate and tend to decrease over time.

Q: Is the long-term safety of Тебериф known?

A: The core regulatory evidence for safety is derived from two-year randomized controlled trials. Longer-term safety data, extending up to six years, was gathered through open-label extension studies, which are observational and lack the rigorous control of the initial trials.

Q: What happens in the body when Тебериф starts to work?

A: When the medication starts working, it inhibits a specific enzyme, which leads to the selective suppression of the replication of activated immune cells, known as T- and B-lymphocytes. This modulation reduces the body's inflammatory response that is involved in multiple sclerosis.

Q: Does the effectiveness of Тебериф depend on my age?

A: The medication is studied and approved for use in adult patients (aged 18 and older). Official information states that efficacy is not established for those under 18 and is not sufficiently studied for patients 65 and older.

Q: How does Тебериф affect the immune system?

A: It is an immunomodulator, meaning it helps adjust or 'modulate' the immune system's function. It specifically suppresses the proliferation of key activated immune cells that drive the inflammation seen in multiple sclerosis, helping to dampen the abnormal immune activity.

Q: What are the most common reasons why Тебериф might be discontinued?

A: Discontinuation is often required due to the risk of serious adverse reactions, which include severe hepatic injury (liver damage) or the development of severe psychiatric risks such as current severe depression or suicidal ideation. Regular monitoring is required to detect these potential issues.

Q: Are there any known issues with fertility while taking Тебериф?

A: Official documents advise that initiation of treatment is contraindicated during pregnancy due to the risk of fetal harm noted in animal data. Information regarding the direct effect of the drug on human fertility is not explicitly detailed in the regulatory label.

Q: Can Тебериф cause weight gain or weight loss?

A: Official safety information notes that rapid weight gain is a symptom that must be monitored immediately. The safety label requires that rapid weight gain, especially when accompanied by swelling, be monitored because it is a documented symptom that may be associated with cardiac issues.

Q: Does Тебериф need to be taken at a specific time of day?

A: The required dosing schedule specifies injection every other day (or once every two weeks for Peginterferon beta-1a) but does not specify a mandatory or required time of day for administration.

Q: Can I continue my regular exercise routine while taking Тебериф?

A: General exercise is not prohibited by the official documentation. However, official documentation describes the potential for low platelet counts, which may increase the risk of bleeding and bruising. This is a factor to consider in relation to contact sports or high-risk activities.

Q: Is it true that Тебериф is a type of biological medicine?

A: Yes, the active ingredient, peginterferon beta-1a, is a chemically modified version of the human protein Interferon beta-1a. Because it is derived from a modified natural protein, it is classified as a biological medicine or biologic.

Q: What is considered an important drug interaction with Тебериф?

A: The most important documented interaction caution relates to drugs whose clearance is highly reliant on the Cytochrome P450 (CYP) system and which have a narrow therapeutic index. Тебериф may reduce the clearance of these drugs, leading to increased systemic exposure of the co-administered medicine.

Q: What should I do if I experience a mild side effect from Тебериф?

A: For mild side effects like flu-like symptoms, official information states these are often most prominent at the start of therapy and tend to decrease with continued use. Prophylactic use of common analgesics (like acetaminophen) is permissible for symptom management.

Q: Is Тебериф known to cause mood changes or depression?

A: Yes, depression is listed as a Common side effect in the official safety information. Furthermore, the drug is formally contraindicated in patients with a history of or current severe depression and/or suicidal ideation.

Q: What is the difference between Тебериф and alternative treatments?

A: Тебериф is distinguished from other interferon products by its structure as a pegylated interferon beta-1a. The pegylation process is a key chemical modification that prolongs its half-life in the body, resulting in a less frequent dosing schedule compared to non-pegylated interferons.

Q: Is Тебериф a long-term treatment or short-term?

A: It is a clinically recognized Disease-Modifying Therapy (DMT) used for the long-term management of relapsing forms of multiple sclerosis, not a short-term treatment.

How should Тебериф be stored and disposed of?

The storage and disposal of Тебериф (Peginterferon beta-1a) must strictly follow official regulatory guidelines.

Scope Item Official Regulatory Requirement
Storage Temperature: Store refrigerated between 2 C and 8 C (36 F to 46 F) [1.1].
Prohibited Conditions: Do not freeze; discard the product if it has been frozen. Do not use external heat sources to warm before use [1.1, 1.3].
Stability Limit: May be stored at room temperature (up to 25 C or 77 F) for a single cumulative period not exceeding 30 days [1.4].
Protection & Handling: Keep in the original carton to protect from light. Must be kept out of the reach of children [1.4, 2.1].
Disposal: Used injection devices (pens/syringes) are for single use only and must be discarded immediately into an FDA-cleared, puncture-resistant sharps disposal container [1.3, 2.3].

Official documents mandate that the product is refrigerated and protected from freezing to ensure stability, with a time-bound room temperature allowance of 30 days. Safe disposal is required for used sharps to prevent injury and environmental contamination.

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

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