Indication:Chronic immune thrombocytopenic purpura
1.1 Romiplostim is recommended as an option for treating adults with chronic immune (idiopathic) thrombocytopenic purpura, within its marketing authorisation (that is, in adults who have had a splenectomy and whose condition is refractory to other treatments, or as a second-line treatment in adults who have not had a splenectomy because surgery is contraindicated), only if:
* their condition is refractory to standard active treatments and rescue therapies, or
* they have severe disease and a high risk of bleeding that needs frequent courses of rescue therapies
* if the manufacturer makes romiplostim available with the discount agreed in the patient access scheme.
1.2 People currently receiving romiplostim whose disease does not meet the criteria in 1.1 should be able to continue treatment until they and their clinician consider it appropriate to stop.
* Portal venous thrombosis has occurred in patients with thrombocytopenia associated with cirrhosis and hepatic insufficiency who were treated with thrombopoietin (TPO) agonists.
* Platelet count thresholds at which romiplostim dose should be reduced and interrupted have been lowered to >150×109/L for two consecutive weeks and >250×109/L, respectively in order to minimise the risk of thrombotic/thromboembolic events.
* Romiplostim should not be used in patients with moderate to severe hepatic impairment (cirrhosis, Child-Pugh score 7 or greater) unless the expected benefit outweighs the identified risk of portal venous thrombosis in patients with thrombocytopenia associated to hepatic insufficiency treated with TPO agonists.
* Following initiation of Nplate treatment, platelet counts should be assessed weekly until a stable platelet count ( 50 or greaterx 109/L for at least 4 weeks without dose adjustment) has been achieved (as described in the SmPC). Platelet counts should be assessed monthly thereafter.
* If the platelet count is >150 x 109/L for two consecutive weeks (instead of >200 x 109/L as previously recommended), then the once weekly dose of Nplate should be decreased by 1 microgram/kg
* If the platelet count is >250 x 109/L (instead of >400 x 109/L as previously recommended), then treatment should be discontinued and the platelet count should be assessed weekly.
* After the platelet count has fallen to < 150 x 109/L, then once weekly treatment with the dose reduced by 1 microgram per kg should be resumed. * Due to the interindividual variable platelet response, in some patients platelet count may abruptly fall below 50 x 109/L after dose reduction or treatment discontinuation. In these cases, if clinically appropriate, higher cut-off levels of platelet count for dose reduction (200 x 109/L) and treatment interruption (400 x 109/L) may be considered according to medical judgement. European Medicines Agency Amgen: Dear healthcare professional letter 17/12/2010