When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Section 4.4. Special warnings and precautions for use & Section 4.8 Undesirable effects
Important safety information added on the risk of disease progression to Acute Myelogenous Leukaemia (AML) with Nplate® (romiplostim) use in patients with Myelodysplastic Syndrome (MDS).
Section 10 Date of the revision of the text
Date of revision updated.
Section 4.2
Platelet count thresholds at which romiplostim dose should be reduced and interrupted have been lowered to >150x109/L for two consecutive weeks and >250x109/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 (Child-Pugh score ≥ 7) unless the expected benefit outweighs the identified risk of portal venous thrombosis in patients with thrombocytopenia associated to hepatic insufficiency treated with TPO agonists.
Section 4.4
Portal venous thrombosis has been identified in patients with thrombocytopenia associated with hepatic insufficiency that were treated with thrombopoietin (TPO) agonists.
Section 4.8
Reclassification of adverse reactions and addition of an adverse event from spontaneous reporting Section 10 Changed from 18-Oct-2010 to 26-Nov-2010
Section 4.4, sub-section Progression of existing haematopoietic malignancies or Myelodysplastic Syndromes (MDS).
Information regarding transient blast cell increases has been removed.