Adult Dosing
Chronic ITP related thrombocytopenia
- Start 50 mg PO qd, 25 mg PO qd in patients of East Asian ancestry
- Max: 75 mg/day
- Give 1 hr before or 2 hrs after meals
- At least 4 hrs interval should pass between eltrombopag and other medications, foods, or supplements containing polyvalent cations (e.g., iron, calcium, aluminum, magnesium, selenium, and zinc)
- Use lowest effective dose to achieve platelet >50 x 109/L
- Discontinue if no increase in platelet after 4 wks at maximum dose
Dose adjustment as per the platelet count
- <50 x 109/L : Increase daily dose by 25 mg to a maximum of 75 mg/day
- 200 x 109/L to 400x 109/L: Decrease the daily dose by 25 mg and monitor for two weeks for any subsequent dose adjustment
- >400 x 109/L: Stop therapy, monitor platelet twice weekly, once the platelet count is <150 x 109/L, reinitiate therapy at a daily dose reduced by 25 mg
- >400 x 109/L after 2 wks of therapy at lowest dose: Permanently discontinue therapy
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Eltrombopag may cause hepatotoxicity. Perform liver chemistries at baseline and regularly during treatment[US Black Box warning]
- Patients with chronic hepatitis C with cirrhosis have low albumin levels or with Model for End-Stage Liver Disease (MELD) score 10 at baseline may have a greater risk of hepatic decompensation and should be closely monitored
- Therapy may cause liver enzyme elevation. Monitor ALT, AST, and bilirubin prior to starting treatment, every 2 wk during the dose-adjustment phase, and monthly following a stable dose; perform fractionation if bilirubin is elevated
- Evaluate abnormal serum liver tests with repeat testing within 3 to 5 days. If the abnormalities are confirmed, monitor serum liver tests weekly until resolved. Discontinue therapy if ALT levels increase to =>3X ULN in patients with normal liver function or =>3X baseline in patients with pre-treatment elevations in transaminases and are progressively increasing, persistent for >4 weeks, accompanied by increased direct bilirubin, or accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation
- Eltrombopag should not be used to normalize platelet counts
- Excessive increases in platelet counts may cause thrombotic/thromboembolic complications, use with caution in patients at risk of thromboembolism. Do not use to normalize platelet counts, follow dose adjustments guidelines and maintain a platelet count of 50 x 109/L
- Cataracts can develop or worsened with eltrombopag, perform ocular examination at baseline and during the therapy
Cautions: Use cautiously in
- Hepatic impairment
- Renal impairment
- Hematologic malignancy
- Myelodysplastic syndromes
- Thromboembolism risk factors (Factor V leiden, ATIII deficiency, antiphospholipid syndrome)
- Bone marrow fibrosis
- Changes in smoking habit
Supplemental Patient Information
- Advise patients to inform the physician if there is any sign of liver disease like yellow skin, dark urine, tiredness
- Patients should maintain a 4-hour interval between the drug and foods, mineral supplements, and antacids which contain polyvalent cations such as iron, calcium, aluminum, magnesium, selenium, and zinc
Pregnancy Category:C
Breastfeeding: May cause fetal harm. Excretion in human milk is unknown. Manufacturer advises either to discontinue the drug or nursing depending on the importance of the drug to mother and the known benefits of nursing