Revolade Eltrombopag Olamine Tablets

Basic Drug Information
Generic Name‌: eltrombopag olamine
Brand Name‌: REVOLADE
Dosage Form & Strength‌: film coated tablet; 12.5mg/25mg/50mg/75mg (counted as eltrombopag)
Marketing Authorizer‌: Novartis
Mechanism of Action: oral thrombopoietin receptor (TPO-R) agonist
Indications and Usage

Revolade is indicated for:

Treatment of ‌chronic immune (idiopathic) thrombocytopenia (ITP)‌ in adult and pediatric patients 6 years of age and older who have had an inadequate response to corticosteroids, immunoglobulins, or splenectomy, to increase platelet counts and reduce or prevent bleeding.
It is only indicated for patients with ITP where the degree of thrombocytopenia and clinical situation increases the risk of bleeding. It is not intended to normalize platelet counts.
Dosage and Administration
Recommended Initial Dosage for Adults‌: 50 mg once orally; for East Asian patients or patients with moderate to severe hepatic impairment, initial dosage is 25 mg once daily.
Administration Requirements‌: Take on an empty stomach, at least 2 hours before or 4 hours after food/medications/supplements containing polyvalent cations (aluminum, calcium, iron, magnesium, selenium, zinc). Do not split, chew, crush tablets or mix with food/liquid.
Dosage Adjustment‌: Adjust dose based on platelet count response, to maintain platelet count ≥ 50×10⁹/L. Maximum daily dose is 75 mg. Discontinue therapy if no hematologic response after 16 weeks of treatment.
Dosage Forms and Strengths

Tablet specifications (eltrombopag equivalent): 12.5mg (white, imprinted GS MZ1 12.5), 25mg (white, imprinted GS NX3 25), 50mg (brown, imprinted GS UFU 50), 75mg (pink, imprinted GS FSS 75), all supplied in packs of 28 tablets.

Contraindications

Hypersensitivity to eltrombopag olamine or any excipients of the product is contraindicated.

Warnings and Precautions
Hepatotoxicity‌: May cause severe life-threatening hepatotoxicity, monitor liver function regularly. Discontinue treatment if significant liver test abnormalities occur.
Thrombosis/Thromboembolism‌: Increased risk when platelet count is above normal range, use with caution in patients with existing thrombotic risk factors.
Bleeding after Discontinuation‌: Platelet count usually returns to baseline within 2 weeks after stopping treatment, which increases bleeding risk.
Bone Marrow Reticulin Fibrosis‌: May increase the risk of reticulin fiber formation and progression in bone marrow.
Overdosage

In case of overdose, orally administer a preparation containing metal cations (such as calcium, aluminum, or magnesium preparations) to chelate eltrombopag and limit absorption. Closely monitor platelet counts. Hemodialysis is not expected to effectively enhance elimination because Revolade is not significantly renally excreted and is highly bound to plasma proteins.