Eltrombopag Tablets Technical Specification

Posted on by Pharmacist
Eltrombopag Tablets Technical Specification

Eltrombopag Tablets are widely recognized for their role in managing chronic immune thrombocytopenia (ITP) and related conditions where platelet levels drop due to autoimmune destruction. This detailed technical guide provides an in-depth overview of the product specifications, indications, therapeutic use, precautions, regulatory profile, and essential patient care instructions.

Introduction to Eltrombopag Tablets

Eltrombopag is an orally administered thrombopoietin receptor agonist used for patients with persistently low platelet counts. It works by stimulating platelet production in the bone marrow, helping reduce the risk of excessive bleeding associated with ITP.

Available as film-coated tablets, the product is designed for patient compliance, efficacy, and stability.

Product Overview

Commercial & Pharmaceutical Details

  • Product Name: Eltrombopag Tablets
  • Brand Name: Eltrombopag
  • Strengths Available: 12.5 mg, 25 mg, 50 mg, 75 mg, 100 mg
  • Dosage Form: Film-coated Tablet
  • Packing Options: 7s, 28s, 30s
  • Route of Administration: Oral use only

These strengths allow physicians to tailor treatment precisely based on platelet response and clinical condition.

Qualitative & Quantitative Composition

Eltrombopag Tablets 12.5mg

Each film-coated tablet contains:

  • Eltrombopag Olamine equivalent to Eltrombopag … 12.5 mg
  • Excipients … q.s.
  • Color: Titanium Dioxide

The excipient profile is optimized for stability, dissolution, and patient acceptability.

Therapeutic Classification

Eltrombopag belongs to the Anti-Cancer and Hematology Supportive Care category.
While not a cytotoxic agent itself, it is essential in managing complications associated with hematological disorders.

Therapeutic Use

Eltrombopag is used primarily for:

  • Chronic Immune Thrombocytopenia (ITP):
    Helps increase platelet counts in patients unresponsive to corticosteroids, immunoglobulins, or splenectomy.
  • Thrombocytopenia Associated with Hepatitis C Therapy:
    Supports continued antiviral treatment by preventing treatment interruptions.
  • Severe Aplastic Anemia (SAA):
    Promotes multilineage hematopoiesis in refractory or relapsed SAA.

Why Eltrombopag is Used

Eltrombopag is prescribed to:

  • Enhance platelet production when natural count is inadequate.
  • Reduce risk of spontaneous bleeding.
  • Improve quality of life in patients with chronic low platelet levels.
  • Support continuation of other vital therapies such as antiviral or cancer treatment.

Its targeted mechanism of action makes it an essential medication in hematology.

Indications

Eltrombopag is indicated for:

  • Adults and pediatric patients with chronic immune thrombocytopenia (ITP).
  • Patients who did not respond adequately to first-line therapy.
  • Maintenance of platelet levels to avoid severe bleeding episodes.

How Eltrombopag Works (Mechanism of Action)

Eltrombopag is a thrombopoietin (TPO) receptor agonist.
It binds to the TPO receptor (c-Mpl) on hematopoietic stem cells in the bone marrow and:

  • Stimulates megakaryocyte proliferation.
  • Promotes platelet production.
  • Increases circulating platelet levels in a controlled manner.

How to Take Eltrombopag (Important Patient Instructions)

Patients must follow physician guidance strictly.
General medication-related instructions include:

  • Must be swallowed whole — do not crush, chew, or break the tablet.
  • Take on an empty stomach, either:
    • 1 hour before meals OR
    • 2 hours after meals
  • Avoid dairy, calcium-rich foods, supplements, and antacids within the restricted timing window, as they may reduce absorption.
  • Use only as directed by a qualified Hematologist or Oncologist.
  • Do not change your dose without consulting a healthcare provider.

These instructions ensure optimal bioavailability and therapeutic effect.

Mandatory Precautions & Safety Information

Key Precautions

  • Monitor liver function regularly due to risk of hepatic toxicity.
  • Do not use in uncontrolled liver disease.
  • Inform physicians about any history of cataracts—periodic eye exams are recommended.
  • Avoid interacting drugs such as strong chelators or polyvalent cation supplements near dose timing.

Mandatory Safety & Caution Information

  • “It is dangerous to take this preparation except under medical supervision.”
  • Cytotoxic-related Warning: Must be dispensed only on prescription of specialists such as Hematologist, Oncologist, or General Medicine experts.
  • Federal regulations require dispensing with the Medication Guide.
  • Do not use the product if the safety seal is missing or broken.
  • Keep out of reach of children.
  • Use safety closures when dispensing.

Regulatory & Documentation Support

Each batch of Eltrombopag Tablets is backed by comprehensive regulatory documentation:

  • COA – Certificate of Analysis
  • MOA – Method of Analysis
  • COPP – Certificate of Pharmaceutical Product
  • FSC – Free Sale Certificate
  • Stability Studies – Real-time & Accelerated
  • GMP Compliance
  • CTD Dossier – Module 1 to Module 5

These documents support international registration, quality assurance, and global distribution.

Storage Requirements

  • Store at 20°C to 25°C (68°F to 77°F).
  • Temperature excursions allowed: 15°C to 30°C (59°F to 86°F).
  • Do not remove desiccant from the container.
  • Keep tightly closed to protect from moisture.
  • Store in the original packaging until ready for use.

Proper storage ensures product stability and therapeutic reliability.

Dosage Administration

  • Dosage must be individualized and determined only by a Hematologist or Oncologist.
  • Regular monitoring of platelet counts is essential to adjust dosing safely.
  • Not to be used without professional supervision.
  • Always refer to the package insert and SmPC for detailed prescribing information.

Patient Information Leaflet & SmPC

Eltrombopag Tablets come with:

  • PIL – Patient Information Leaflet
  • SmPC – Summary of Product Characteristics

These documents provide validated, regulatory-approved instructions for safe and effective use

Eltrombopag Tablets are a critical therapy in managing chronic immune thrombocytopenia and related platelet disorders. With proven efficacy, precise dosing strengths, and strong regulatory backing, they remain a vital pharmaceutical product in hematology. Strict adherence to medical supervision, safety guidelines, and storage instructions ensures optimal patient outcomes.