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Абаджио

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Абаджио

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Treatment option: Multiple Sclerosis

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.

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Overview of Абаджио

Quick Facts

Property Description
Active ingredient Teriflunomide
Form Oral tablet (Film-coated)
Pharmacological class Immunomodulatory agent
General purpose Disease-modifying regulation of immune activity
Origin Synthetic (Metabolite of Leflunomide)

What Type of Drug is Абаджио?

Абаджио is a synthetic, prescription-only medication utilized as a Disease-Modifying Drug (DMD), containing the active ingredient Teriflunomide. It is classified as an Immunomodulatory agent (Immunomodulator) because its core action is to selectively regulate aspects of the body's overactive immune system. The distinctive feature of Абаджио is its simple oral administration as an oral tablet (film-coated tablet), distinguishing it from numerous DMDs that necessitate injection or infusion.

Teriflunomide is chemically distinct in its origin; it is the principal active metabolite of Leflunomide, a chemically related drug traditionally used for rheumatoid arthritis. This DMD functions as a selective immunosuppressant, setting it apart from older, more generalized immunosuppressants by focusing its action on the specific immune cells driving the disease process. The drug's development has been clinically recognized for its ability to modify the course of the underlying neurological condition.


Teriflunomide: A Selective Approach to Immune Regulation

The general purpose of Абаджио is to modify the course of neurological disturbances by effectively controlling the underlying inflammatory processes. It achieves this by acting as an inhibitor of the enzyme Dihydroorotate Dehydrogenase (DHODH), a crucial step in pyrimidine synthesis, which is required for the DNA and RNA of rapidly dividing cells.

By inhibiting DHODH, the medicine specifically limits the rapid proliferation of T- and B-lymphocytes (key immune cells) that are responsible for inflammation and tissue damage in the central nervous system. This targeted, enzyme-specific blockade helps to provide a controlled anti-inflammatory effect aimed at reducing the frequency and severity of immune attacks, thereby intending to stabilize the patient's condition and help manage its progression.

Regulatory References

  1. Teriflunomide MedlinePlus Drug Information
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What side effects are possible with Абаджио?

Possible Side Effects and Safety Information

The safety profile of Абаджио (Teriflunomide) is based on data documented in official government regulatory sources, such as the FDA Prescribing Information and the European Summary of Product Characteristics (SmPC). The following information covers officially classified adverse reactions, serious risks, and regulatory constraints.

Frequency-Classified Adverse Reactions

Adverse reactions are classified by frequency as reported in clinical trials:

Classification Common Examples Affected System-Organ Class (SOC)
Very Common (ge 10%) Headache, Diarrhea, Alopecia (Hair Thinning), Nausea, Elevated Alanine aminotransferase (ALT) levels Nervous System, Gastrointestinal, Skin, Hepatobiliary
Common (1% - 10%) Hypertension (Increased Blood Pressure), Neutropenia, Paresthesia Vascular, Blood and Lymphatic, Nervous System

Serious Safety Risks and Constraints

Regulatory documents emphasize specific risks that may be serious or clinically significant:

  • Hepatotoxicity: Severe liver injury, including rare cases of fatal liver failure, is a major documented risk. ALT levels must be monitored periodically.
  • Embryofetal Toxicity: The medication is Contraindicated in Pregnancy due to the high potential for fetal harm and major birth defects. An Accelerated Elimination Procedure is recommended prior to conception for both men and women.
  • Severe Cutaneous Reactions (SCARs): Serious skin reactions such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been documented.
  • Population Restrictions: The drug is Contraindicated in patients with severe hepatic impairment and severe hypoproteinaemia. Treatment initiation may be delayed in the presence of severe active infections.

Time-Related Safety Patterns

Some adverse effects show specific patterns over time. For example, elevations in ALT levels are documented as occurring mostly within the first six months of treatment initiation.

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Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information for Abacavir (a component of products like Abagio/Ziagen) indicates that there are no specific signs or symptoms of acute overdose documented from clinical studies. Even high single doses and elevated total daily doses were administered to patients without identifying unexpected adverse effects directly attributable to an acute overdose event.

Required Emergency Actions

Management of Abacavir overexposure is focused on general supportive care, as no specific antidote is known to exist. The effectiveness of removal methods such as hemodialysis or peritoneal dialysis has not been established in regulatory documentation.

Management Action Required Status (Regulatory)
Specific Antidote Not known to exist
Dialysis Efficacy Not studied/established
Overdose Treatment General supportive measures

When to Seek Immediate Medical Help

If an overdose is suspected, immediate medical attention is required. The official guidance mandates contacting a Poison Control Center or proceeding directly to the nearest hospital emergency room for assessment. Treatment will consist of supportive measures, including close monitoring of the patient's vital signs and overall clinical status as necessary.

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Therapeutic Uses of Абаджио

What Абаджио Treats: Main Uses and Benefits

This medication is used as a foundational part of therapy to manage underlying neurological conditions. It is applied across domains where additional symptomatic support is needed to address the core illness. This medicine is used to help manage the disease's activity. The primary use is to support the management of symptoms related to systemic imbalance caused by the condition, which is the underlying cause of states marked by increased physiological stress.

The central benefit is that it helps manage disease control, which supports maintaining functional stability. The medication is relevant for addressing symptom clusters that may become intense or disruptive, such as persistent fatigue, general ill feeling, and malaise. The medication is applied across therapeutic domains where additional support is needed for the body's natural response, contributing to immune support during periods of heightened systemic burden. The medication is commonly used across therapeutic domains where symptom management is appropriate to ease distress. The overall benefit supports improved comfort and assists patients with coping more steadily with symptom fluctuations.

Quick Fact: Supports Management of Chronic Systemic Symptoms

Regulatory References

  1. NIH MedlinePlus Drug Information
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Eligibility and Restrictions for Use

Official Eligibility and Contraindications for Абаджио (Teriflunomide)

Regulatory agencies define specific population rules for the use of Teriflunomide, ensuring patient safety is managed, particularly concerning teratogenicity and liver risk.

Category Regulatory Status (Mandatory Rules)
Absolute Contraindications Pregnancy or females of childbearing potential not using reliable contraception. Patients with severe hepatic impairment (Child-Pugh Class C). Patients with a history of hypersensitivity to Teriflunomide or its parent compound, Leflunomide.
Special Conditions Patients with severe immunodeficiency states (e.g., AIDS), severe active infections, or significantly impaired bone marrow function are contraindicated. Co-administration with Leflunomide is prohibited.

Age-Related Eligibility

  • Adults are the standard approved population. The medicine is also approved for pediatric patients aged 10 years and older in certain regions. Safety and efficacy have not been established in children below 10 years of age.
  • Geriatric patients (65 years and over) should use the drug with caution due to generally insufficient data on safety and efficacy in this age group.

Hepatic and Renal Limitations

The medicine is contraindicated in severe hepatic impairment. For renal impairment, use is contraindicated in patients with severe renal impairment undergoing dialysis due to lack of sufficient clinical experience.

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What should I know about interactions with other medicines?

Aubagio (teriflunomide) can interact with many other medicines, which may increase the risk of side effects or reduce the effectiveness of one or both drugs. It is crucial to inform your healthcare provider about all prescription, over-the-counter medications, vitamins, and herbal supplements you are taking.

Potential Drug Interactions

1. Drugs That May Have Increased Effects (requiring monitoring):

Drug Type Examples Potential Result
Statins Atorvastatin, Rosuvastatin Increased risk of statin side effects (e.g., muscle problems), Rosuvastatin dose limit recommended.
Oral Contraceptives Ethinyl estradiol-containing products Increased levels of oral contraceptive hormones, potentially increasing side effects.
Certain Diabetes Drugs Repaglinide, Pioglitazone Increased effects and risk of side effects from these drugs.
Others Warfarin May reduce the effectiveness of warfarin (blood thinner); require close monitoring of INR.

2. Drugs That May Have Decreased Effects (requiring monitoring):

Aubagio can decrease the effectiveness of certain drugs, including those metabolized by the CYP1A2 enzyme, such as Duloxetine (used for depression/pain) and Tizanidine (a muscle relaxant).

3. Other Important Interactions:

  • Leflunomide: Coadministration with leflunomide is contraindicated due to the risk of severe side effects, especially liver toxicity.
  • Hepatotoxic Drugs: Using Aubagio with other drugs that can cause liver damage (hepatotoxic drugs) may increase the risk of serious liver injury. Close monitoring of liver enzymes is essential.
  • Live Vaccines: Live vaccines (e.g., Yellow Fever, MMR, Nasal Flu) should be avoided immediately before or during Aubagio treatment due to the immunosuppressive effect, which increases the risk of vaccine-related infection. Non-live vaccines may be used, but their effectiveness might be reduced.

Accelerated elimination procedures using cholestyramine or activated charcoal can significantly decrease the level of Aubagio in the body, typically considered in cases of serious side effects, significant overdose, or before becoming pregnant.

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Mechanism of Action

Selective Metabolic Blockade (DHODH Inhibition)

This mechanism focuses on the active ingredient's role as a selective, reversible inhibitor of the mitochondrial enzyme Dihydroorotate Dehydrogenase (DHODH), which controls a critical, rate-limiting step in the de novo​ pyrimidine synthesis pathway. The resulting deficiency in nucleic acid building blocks (pyrimidines) acts as a metabolic bottleneck, reducing the ability of rapidly proliferating immune cells to divide and expand.

️ Targeted Control of Autoimmune Lymphocyte Expansion

By selectively targeting the proliferation of activated T and B lymphocytes—cells that are metabolically reliant on the DHODH pathway—the drug exerts a cytostatic effect. This localized suppression curtails the clonal growth of autoreactive immune cells, thereby influencing the systemic immune response by reducing the total number of activated lymphocytes.

Modulation of CNS Immune Infiltration

The mechanism's primary physiological consequence is the diminished presence of activated lymphocytes. As fewer activated cells are produced in the periphery, the pool available to traverse the blood-brain barrier is reduced. This reduction in the number of activated lymphocytes entering the CNS compartment correlates with a dampened immune response within the neurological system.

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Dosage and Administration Information

General Principles of Administration

Абаджио is administered orally for the management of relapsing forms of multiple sclerosis. The medication is available as a film-coated tablet, which facilitates consistent daily dosing. Administration is flexible and may occur with or without food.

Official Dosing Regimens

The standard daily dose is either 7 mg or 14 mg taken orally. The dose is determined based on the specific clinical requirements of the treatment protocol.

  • Standard Regimen: One tablet taken once daily at approximately the same time each day.

Contextual Use Instructions

Usage Constraint Official Requirement
Dose Modification No dose adjustment is generally required for patients with renal impairment.
Hepatic Impairment The medication is not recommended for individuals with severe hepatic impairment.
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Swallowing Difficulty Tablets should be swallowed whole; they are typically not crushed or chewed to ensure the integrity of the film coating.

The drug is intended for continuous, non-cyclical use as a foundational element of the chronic treatment protocol. Its management after any therapy interruption requires the availability of medical supervision.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Абаджио (Teriflunomide)


Evidence for Use in Relapsing Forms of Multiple Sclerosis (RMS)

Research into Teriflunomide for Relapsing Forms of Multiple Sclerosis (RMS) was primarily conducted through large-scale, international Randomized Controlled Trials (RCTs). These studies were applied in adults diagnosed with conditions like Relapsing-Remitting MS (RRMS) or Active Secondary Progressive MS (aSPMS). The core research explored the medicine in adults and focused on the evaluation of two main measures: the measurement of the Annualized Relapse Rate (ARR) and assessing the time to sustained Confirmed Disability Progression (CDP) using standardized functional scales.

The studies monitored how these measures evolved over defined periods, typically lasting around two to three years. Data describe patterns related to both the frequency of relapses and the incidence of sustained disability progression measured during the study period. Additionally, long-term studies resulting from Open-Label Extensions (OLEs) provide insight into observed patterns of disease activity over several years.

Certain aspects of the evidence remain limited. Comparative evidence against other treatments is lacking. Furthermore, findings were sometimes mixed when researchers examined certain patient-reported outcomes, such as fatigue, and research into the contribution to understanding some aspects of daily functioning remains uncertain.


Evidence for Use in Clinically Isolated Syndrome (CIS)

The medicine was evaluated in studies involving adults presenting with a single, first-time neurological episode suggestive of MS, a condition known as Clinically Isolated Syndrome (CIS). Research examined patients with CIS in dedicated Randomized Controlled Trials.

The study’s primary endpoint was the measurement of the time elapsed until a second clinical event, which serves as the basis for a formal MS diagnosis. Researchers also studied changes in the accumulation of new MRI lesions. Studies monitored patterns related to the rate of transitioning to clinically definite MS in the observed populations. The follow-up durations for these specific trials were limited, meaning the long-term outcomes are not fully established.

Key Studies & References

  1. Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis (TEMSO)
  2. Teriflunomide for treating relapsing–remitting multiple sclerosis (NICE Technology Appraisal Guidance 303)
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Frequently Asked Questions (FAQ)

Common questions about Абаджио (FAQ)

Q: What is Абаджио used for?

Абаджио (Teriflunomide) is approved for the treatment of relapsing forms of multiple sclerosis (MS) in adults. It is intended to help reduce the frequency of relapses and delay the progression of physical disability.

Q: How does Абаджио affect the immune system?

Абаджио is classified as a pyrimidine synthesis inhibitor. It is thought to work by reducing the number of activated lymphocytes (a type of white blood cell) in the central nervous system, which are believed to contribute to the damage seen in MS.

Q: What are the most common side effects of Абаджио?

The most frequently reported side effects associated with Абаджио include headache, diarrhea, nausea, and hair thinning (alopecia). Patients should discuss all potential side effects and concerns with their healthcare provider.

Q: Can I stop taking Абаджио if my symptoms improve?

It is important that patients do not stop taking Абаджио or change the dose without first consulting the prescribing healthcare provider. Treatment for MS is typically long-term, and stopping the medication may allow the condition to worsen.

Q: Is it safe to use alcohol while taking Абаджио?

Due to the potential for Абаджио to cause liver problems, the product label often advises caution regarding alcohol consumption. Patients should discuss their alcohol use with a healthcare professional to understand the potential risks in their specific situation.

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How should Абаджио be stored and disposed of?

Storage Conditions

Labeled Storage Temperature Requirements: Store at controlled room temperature (20 C to 25 C / 68 F to 77 F), with excursions allowed up to 30 C.
Handling and Protection Requirements: Must be kept away from excess moisture and excess heat. Do not freeze. Store in the original container, which must be kept tightly closed.
Child-Protection Storage Requirements: Keep out of the sight and reach of children.

Official Disposal Protocol

Disposal Instructions: The best option for unused or expired tablets is an authorized drug take-back program (e.g., pharmacy drop-off).
Alternative Disposal (if no take-back): Mix the uncrushed tablets with an unappealing substance (like used coffee grounds or cat litter), seal the mixture in a bag or container, and discard it in the household trash.
Regulatory Requirement: All disposal must conform to applicable regional, national, and local laws and regulations.

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

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