Elbonix (Eltrombopag) 25 mg

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Product Overview:

Elbonix 25 mg is a readily absorbable, compact molecule that serves as a thrombopoietin (TPO) receptor agonist. It engages with the transmembrane domain of the TPO receptor in humans, triggering signaling pathways that promote the growth and maturation of bone marrow stem cells. Elbonix is presented in the form of tablets for oral consumption.

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    Composition:

    Elbonix 25 tablet: Each film-coated tablet is formulated with Eltrombopag Olamine INN, equating to 25 mg of Eltrombopag.

    Therapeutic Classification:

    Blood Formation Agent

    Pharmacological Profile

    Action Mechanism:

    Eltrombopag, available for oral administration, is a TPO-receptor agonist that binds to the receptor’s transmembrane domain, initiating signaling pathways that stimulate bone marrow progenitor cell growth and maturation.

    Pharmacokinetics:

    Absorption: Maximum concentration of Eltrombopag is reached 2-6 hours post-administration. The drug demonstrates at least 52% oral absorption from a single 75-mg dose.
    Distribution: Eltrombopag’s blood cell concentration is 50% to 79% of its plasma concentration. It is highly plasma protein-bound (>99%) and metabolized by BCRP, not by P-gp or OATP1B1.
    Metabolism: Extensively metabolized through cleavage, oxidation, and conjugation. CYP1A2 and CYP2C8 are primary enzymes for oxidative metabolism, with UGT1A1 and UGT1A3 handling glucuronidation.
    Elimination: Mainly excreted via feces (59%) and urine (31%), with about 20% of the dose excreted unchanged in feces. Eltrombopag’s plasma elimination half-life ranges from 21 to 32 hours.

    Dosage and Administration:

    Chronic Immune (Idiopathic) Thrombocytopenia (ITP)

    Administer the lowest effective dose to maintain a platelet count above 50 x 10^9/L to minimize bleeding risk. Adjust dose based on platelet response, aiming for a gradual increase within 1-2 weeks of treatment initiation.

    Initial Dosage: For adults and children over 6 years with ITP, start at 25 mg daily, adjusted based on patient response and specific conditions such as ethnicity or liver impairment.
    Dose Adjustment and Monitoring: Adjust the dose to maintain desired platelet counts, with regular blood count and liver function monitoring.

    Use in Specific Populations

    Pregnancy: Category C. Assess the benefit-risk ratio before administration.
    Nursing Mothers: Consider discontinuing the drug or breastfeeding due to potential adverse effects.
    Pediatric Use: Established safety and efficacy for chronic ITP in patients 1 year and older. The appropriate starting dose is 25 mg daily.
    Geriatric Use: No significant differences in safety or effectiveness observed between older and younger patients.
    Hepatic Impairment: Initial dose adjustment recommended.
    Renal Impairment: No adjustment needed in the initial dose.
    Ethnic Considerations: Dose adjustments may be necessary for patients of East Asian ancestry due to higher exposures.

    Warnings and Precautions

    Monitor for hepatotoxicity and thrombotic/thromboembolic complications. Regularly check liver function and platelet counts.

    Side Effects:

    Common side effects include nausea, diarrhea, upper respiratory infections, and increased liver enzymes.

    Contraindications:

    There are no known contraindications.

    Drug Interactions:

    Avoid intake within 2 hours before or 4 hours after consuming products containing polyvalent cations.

    Overdose Management:

    Monitor platelet counts closely and consider chelation therapy in cases of significant overdose.

    Pharmaceutical Information:

    Storage:

    Store in a cool, dry place away from light. Keep out of reach of children.

    Packaging:

    Elbonix 25 Tablet: Packaged in 28-tablet Alu-Alu blister packs.

    Product Name

    Elbonix

    Generic Name

    Eltrombopag Olamine

    Formulation

    Tablet

    Available Pack Size

    4×7 ’s and 4×7’s

    Available Strengths

    25 mg and 50 mg