Eltrombopag Dosage

Usual Adult Dose for Thrombocytopenia Idiopathic

Initial dose: Oral: 50 mg once daily on an empty stomach
Maximum dose: Oral: 75 mg once daily on an empty stomach

Patients of East Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean): Initial dose: 25 mg orally once daily on an empty stomach.

Use the lowest dose of eltrombopag to achieve and maintain a platelet count greater than or equal to 50 X 10^9/L as necessary to reduce the risk of bleeding. Dose adjustments are based upon the platelet count response. Eltrombopag should not be used in an attempt to normalize platelet counts.

Renal Dose Adjustments

Use caution when administering eltrombopag to patients with renal dysfunction.

Liver Dose Adjustments

Mild liver impairment: No adjustment required.

Moderate or severe liver impairment: Initiate dose at 25 mg orally once daily on an empty stomach. Monitor patient carefully.

Dose Adjustments

Use the lowest dose of eltrombopag to achieve and maintain a platelet count greater than or equal to 50 x 10^9/L as necessary to reduce the risk for bleeding. Dose adjustments are based upon the platelet count response. Do not exceed a dose of 75 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy and modify the dosage regimen based on platelet counts. Monitor CBCs, including platelet count and peripheral blood smears weekly until a stable platelet count has been achieved. Obtain CBCs including platelet counts and peripheral blood smears monthly thereafter.

Recommended dose adjustments are as follows:

-Platelet count less than 50 X 10^9/L following at least 2 weeks of eltrombopag therapy: Increase daily dose by 25 mg to a maximum of 75 mg daily.

-Platelet count greater than or equal to 200 X 10^9/L to less than or equal to 400 X 10^9/L at any time: Decrease the daily dose by 25 mg. Wait 2 weeks to assess the effects of any dose adjustments.

-Platelet count greater than 400 X 10^9/L: Stop eltrombopag; increase the frequency of platelet monitoring to twice weekly. Once the platelet count is less than 150 X 10^9/L, reinstate therapy at a daily dose reduced by 25 mg.

-Platelet count greater than 400 X 10^9/L after 2 weeks of therapy at lowest dose of eltrombopag: Permanently discontinue eltrombopag.

Modify the dosage regimen of concomitant ITP medications, as medically appropriate, to avoid excessive increases in platelet counts during therapy with eltrombopag.

Precautions

Do not administer more than one dose of eltrombopag within any 24-hour period.

Eltrombopag chelates polyvalent cations (such as iron, calcium, aluminum, magnesium, selenium, and zinc) in foods, mineral supplements, and antacids. Eltrombopag should not be taken within 4 hours of any medications or products containing polyvalent cations such as antacids, dairy products, and mineral supplements to avoid significant reduction in eltrombopag absorption due to chelation.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for eltrombopag. This includes a medication guide, elements to assure safe use, and an implementation system. Additional information is available at www.fda.gov/Drugs/DrugSafety/postmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

Eltrombopag should be administered on an empty stomach (1 hour before or 2 hours after meals).

Measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin prior to initiation of eltrombopag, every 2 weeks during the dose adjustment phase, and monthly following establishment of a stable dose. If bilirubin is elevated, perform fractionation.

ECG effects: There is no indication of a QT/QTc prolonging effect of eltrombopag in doses up to 150 mg daily for 5 days.

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