ELBONIX (ELTROMBOPAG) 50MG TABLETS 28's

ELBONIX 50 mg contains eltrombopag olamine, a thrombopoietin receptor agonist that stimulates megakaryocyte proliferation and differentiation in the bone marrow, thereby increasing platelet production.

It is a non-peptide small molecule that activates the thrombopoietin receptor (c-Mpl) via a transmembrane domain distinct from endogenous thrombopoietin.

The 50 mg tablet is the standard therapeutic dose for most adult patients with chronic immune thrombocytopenia (ITP).

Uses:

·       chronic ITP in adults and children (1 year and above) refractory to other treatments

·       thrombocytopenia associated with hepatitis C (to allow interferon-based therapy)

·       severe aplastic anaemia refractory to immunosuppressive therapy.

The 50 mg formulation allows single-tablet daily dosing for most patients, improving convenience and adherence compared to taking two 25 mg tablets.

ELBONIX 50 mg must be taken on an empty stomach (at least 30 minutes before or 2 hours after food, especially calcium-containing foods and dairy products).

Standard Dosing (Adults and Adolescents 12 years, non-East Asian)

•       Starting dose: 50 mg once daily (one 50 mg tablet).

•       Dose adjustment: based on platelet response, adjust by 25 mg increments every 2 weeks using 25 mg or 50 mg tablets as appropriate.

•       Maximum dose: 75 mg once daily.

East Asian Patients

•       Start at 25 mg once daily due to higher drug exposure — use the 25 mg tablet formulation.

Hepatitis C Thrombocytopenia

•       Starting dose: 25 mg once daily, increasing to 50 mg at week 2 if platelet count remains below 50 x 10^9/L. Maximum: 100 mg once daily in this indication.

The platelet count target is not normal range but a level sufficient to reduce clinically significant bleeding risk (generally at or above 50 x 10^9/L). Regular monitoring and dose adjustments are required throughout therapy.

The side effect profile of the 50 mg tablet is identical to the 25 mg formulation (see ELBONIX 25 mg entry for full details).

Common Side Effects

•       Nausea, headache, upper respiratory infections, nasopharyngitis.

•       Elevated liver enzymes (ALT, AST).

Serious Side Effects

•       Hepatotoxicity — yellowing of skin/eyes, dark urine (stop and seek assessment).

•       Thromboembolic events — DVT, PE, portal vein thrombosis (especially when platelet count is above 200 x 10^9/L).

•       Bone marrow reticulin formation and potential myelofibrosis with prolonged use.

•       Rebound thrombocytopenia following discontinuation.

•       Cataracts with long-term use.

Hepatotoxicity — Monitoring Essential

Liver function tests (ALT, AST, bilirubin) must be monitored before treatment, every 2 weeks during dose adjustment, and monthly once stable. Discontinue if ALT exceeds 3x ULN with symptoms or bilirubin elevation.

Thromboembolism Prevention

Do not allow platelet counts to exceed 200 x 10^9/L. Adjust dose downward promptly if this threshold is approached. Patients with hepatic cirrhosis (e.g., hepatitis C patients) are at increased risk of portal vein thrombosis.

Dietary Separation — Calcium-Rich Foods

Take ELBONIX at least 30 minutes before eating. Wait at least 4 hours after taking ELBONIX before consuming dairy products, antacids, or mineral supplements containing calcium, magnesium, aluminium, iron, selenium, or zinc — these chelate eltrombopag and reduce absorption by up to 70%.

Long-term Haematological Monitoring

Annual bone marrow biopsy may be considered for patients on prolonged therapy to assess for reticulin deposition. Peripheral blood film review every 6 months to detect early dysplastic changes, especially in aplastic anaemia patients.

•       Polyvalent cation-containing supplements/antacids (calcium, magnesium, aluminium, iron, zinc) — chelate eltrombopag; separate by a minimum 4 hours.

•       Rosuvastatin and other OATP1B1/OATP1B3 substrates — eltrombopag inhibits these hepatic uptake transporters; increase statin plasma levels; monitor for myopathy or reduce statin dose.

•       Organic anion transporter substrates (methotrexate, penicillins) — eltrombopag inhibits OAT1/OAT3; increased substrate plasma levels.

•       CYP1A2 and CYP2C8 substrates — eltrombopag inhibits these enzymes; increased exposure of co-administered substrates (e.g., repaglinide).

•       Store below 30 degrees Celsius.

•       Keep in original packaging, away from moisture.

•       Keep out of sight and reach of children.

•       Do not use after the expiry date.

ELBONIX 50 mg is a prescription-only medicine (POM) in Kenya, regulated by the Pharmacy and Poisons Board (PPB). It must be initiated and supervised by a consultant haematologist or specialist physician.

Due to complex monitoring requirements (liver function, platelet counts, peripheral blood films), ongoing specialist oversight is essential throughout treatment.

Monitoring Protocol (same for both strengths)

•       Platelet count: weekly until stable dose established for 4 weeks, then monthly.

•       LFTs: every 2 weeks during titration, monthly once stable.

•       Peripheral blood film: every 6 months.

•       Ophthalmic review: annually.

Statin Interaction — Action Required

Eltrombopag inhibits OATP1B1/OATP1B3 and can raise statin plasma levels substantially. If a patient is already on rosuvastatin, consider switching to a statin with lower OATP dependence (e.g., pravastatin at low dose) or reduce the rosuvastatin dose by 50% and monitor for myopathy with CK measurements.

What is the difference between the 25 mg and 50 mg ELBONIX tablets?

The 50 mg tablet contains double the dose of the 25 mg tablet. The 50 mg tablet is typically the standard starting and maintenance dose for most adult ITP patients of non-East Asian heritage. The 25 mg tablet is used for starting therapy in East Asian patients, for dose adjustments in 25 mg increments, and for patients with liver problems. Both tablets contain the same active ingredient (eltrombopag) and have the same clinical indications.

Can I split the 50 mg tablet to get a 25 mg dose?

No — ELBONIX tablets should not be split, crushed, or chewed. For a 25 mg dose, use the dedicated 25 mg tablet formulation. Splitting may affect how the medicine is absorbed and lead to inaccurate dosing.

What happens if my platelet count goes too high on ELBONIX?

If your platelet count rises above 200 x 10^9/L, the dose needs to be reduced or temporarily stopped to prevent blood clotting (thromboembolism). Your haematologist will adjust your dose based on regular platelet count monitoring. Never take more than your prescribed dose, and always attend your blood test appointments.