REVOLADE

What it is

REVOLADE contains eltrombopag olamine and is available as film-coated tablets. Each tablet contains eltrombopag olamine equivalent to either 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag as eltrombopag free acid. This medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information.

Approved indications REVOLADE is indicated for the treatment of:

— Paediatric patients with chronic immune thrombocytopaenia (ITP) who have failed other treatments and either need an increased platelet concentration for a planned procedure or are at high risk of bleeding. — Adult patients with ITP who have had an inadequate response or are intolerant to corticosteroids and immunoglobulins. — Thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. — Severe aplastic anaemia (SAA) in combination with standard immunosuppressive therapy for first-line treatment of adult and paediatric patients 2 years and older. — Adult patients with SAA who have had an insufficient response to immunosuppressive therapy.

Dosing overview

REVOLADE dosing regimens must be individualised based on the patient's platelet counts. Dosing varies by indication. For chronic ITP in adults and paediatric patients aged 6 to 17 years, the recommended starting dose is 50 mg once daily. For patients of East-/Southeast-Asian ancestry in this age group, REVOLADE should be initiated at a reduced dose of 25 mg once daily. For paediatric patients aged 1 to 5 years with chronic ITP, the recommended starting dose is 25 mg once daily. The maximum dose in chronic ITP does not exceed 75 mg daily. For chronic hepatitis C thrombocytopenia in adults, REVOLADE is initiated at a dose of 25 mg once daily. The maximum dose for hepatitis C does not exceed 100 mg REVOLADE once daily. For first-line severe aplastic anaemia in adult and adolescent patients aged 12 to 17 years, the recommended initial dose is 150 mg once daily for 6 months. For paediatric patients aged 6 to 11 years, the recommended initial dose is 75 mg once daily for 6 months. For refractory severe aplastic anaemia in adults, REVOLADE is initiated at a dose of 50 mg once daily. The maximum dose for refractory severe aplastic anaemia does not exceed 150 mg daily.

Key safety warnings

REVOLADE administration can cause hepatobiliary laboratory abnormalities, severe hepatotoxicity, and potentially fatal liver injury. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin should be monitored prior to initiation of REVOLADE, every 2 weeks during the dose adjustment phase and monthly following establishment of a stable dose. REVOLADE should be discontinued if ALT levels increase to ≥3 times the upper limit of normal in patients with normal liver function and are progressive, persistent for ≥4 weeks, accompanied by increased direct bilirubin, or accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation. Platelet counts above the normal range present a theoretical risk for thrombotic/thromboembolic complications. Thromboembolic events were observed at low and normal platelet counts in REVOLADE clinical studies in ITP. Caution should be used when administering REVOLADE to patients with known risk factors for thromboembolism, such as advanced age, prolonged immobilisation, malignancies, contraceptives and hormone replacement therapy, surgery/trauma, obesity, smoking, Factor V Leiden, antithrombin III deficiency, and antiphospholipid syndrome. Platelet counts must be monitored weekly for 4 weeks following discontinuation of REVOLADE. Thrombopoietin receptor (TPO-R) agonists, including REVOLADE, may increase the risk for development or progression of reticulin fibres within the bone marrow. Biennial bone marrow examinations are recommended while patients are receiving eltrombopag treatment.

Contraindications

REVOLADE is contraindicated in patients with hypersensitivity to the active substance eltrombopag olamine or to any of the excipients.

PBS listing

In November 2023, REVOLADE was recommended for listing for severe aplastic anaemia as first-line treatment in combination with anti-thymocyte globulin and ciclosporin, and as second-line treatment.

Regulatory history

REVOLADE eltrombopag 25 mg film-coated tablets were first listed on the ARTG on 16 July 2010, followed by the 50 mg strength on the same date, the 75 mg strength on 5 September 2013, and the 12.5 mg strength on 30 March 2016. The TGA approved REVOLADE for the treatment of adult patients with severe aplastic anaemia who have had an insufficient response to immunosuppressive therapy on 7 December 2015. In November 2023, PBAC recommended listing for severe aplastic anaemia as first-line treatment in combination with anti-thymocyte globulin and ciclosporin, and as second-line treatment.