following a full submission:
eltrombopag (Revolade) is accepted for restricted use within NHS Scotland.
Indication under review: Eltrombopag is indicated for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Eltrombopag may be considered as second-line treatment for adult non splenectomised patients where surgery is contraindicated.
SMC restriction: in both the splenectomised and non-splenectomised patient populations, restricted to use in patients with severe symptomatic ITP or a high risk of bleeding.
Eltrombopag has been shown to be significantly more effective than placebo in raising and maintaining platelet counts at (or above) a minimum target level in previously treated patients with ITP.
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Medicine details
- Medicine name:
- eltrombopag (Revolade)
- SMC ID:
- 625/10
- Indication:
- Adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
- Pharmaceutical company
- GlaxoSmithKline UK Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 09 August 2010
The marketing authorisation for eltrombopag was extended to include use in adult non-splenectomised patients where surgery is not contra-indicated in February 2016. This minor licence change will not be assessed. The restriction to use in patients with severe symptomatic ITP or a high risk of bleeding still applies regardless of spleen status.