following a full submission:
romiplostim (Nplate) is accepted for restricted use within NHSScotland for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Romiplostim is also accepted for restricted use as second line treatment for adult non-splenectomised patients where surgery is contra-indicated. Romiplostim is restricted to use in patients with severe symptomatic ITP or patients with a high risk of bleeding.
Romiplostim was significantly better than placebo in maintaining platelets at (or above) a minimum target level in previously treated patients with ITP.
Download detailed advice103KB (PDF)
Medicine details
- Medicine name:
- romiplostim (Nplate)
- SMC ID:
- 553/09
- Indication:
- Idiopathic (immune) thrombocytopenic purpura (ITP)
- Pharmaceutical company
- Amgen Ltd
- BNF chapter
- Nutrition and blood
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 12 October 2009
The marketing authorisation for romiplostim was extended to include use in adult non-splenectomised patients where surgery is not contra-indicated in January 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.