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Revolade

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Active Substance: eltrombopag olamine
Common Name: eltrombopag
ATC Code: B02BX05
Marketing Authorisation Holder: Novartis Europharm Limited
Active Substance: eltrombopag olamine
Status: Authorised
Authorisation Date: 2010-03-11
Therapeutic Area: Purpura, Thrombocytopenic, Idiopathic
Pharmacotherapeutic Group: Antihaemorrhagics

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Revolade is indicated for chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients aged 1 year and above who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).

Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4.4 and 5.1).

Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.1).

How is Revolade used?

Revolade(Eltrombopag) is available as tablets (12.5, 25, 50 and 75 mg) and as a powder (25 mg) to prepare a suspension (a liquid to be taken by mouth). The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in treating blood diseases or chronic hepatitis C and its complications.

The dose depends on the patient’s age and the disease Revolade is being used to treat; it is adjusted as needed to maintain the appropriate platelet level. For ITP and aplastic anaemia, a lower starting dose may be needed in patients of East Asian descent (such as Chinese, Japanese, Korean or Taiwanese).

Patients should not take any antacids, dairy products or mineral supplements in the four hours before and in the two hours after taking Revolade. For more information, see the package leaflet.

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