Chronic ITP splenectomised adult patients who are refractory to other treatments (eg, corticosteroids, Ig). 2nd-line treatment for adult non-splenectomised patients where surgery is contraindicated. Adults w/ moderate to severe aplastic anaemia refractory to conventional therapies.
SC Chronic ITP Initially 1 mcg/kg once wkly. May be increased by increments of 1 mcg/kg until the patient achieves a platelet count ≥50 x 109/L. Max: 10 mcg/kg once wkly. Aplastic anaemia Initially 10 mcg/kg once wkly. May be adjusted w/ increments of 5 mcg/kg. Consider dose increase in cases where platelet count has not risen (eg, increase by ≥20 × 109/L from baseline or increase to ≥10 × 109/L & ≥100% increase from baseline w/ blood transfusion independence) though the same dose has been administered for 4 consecutive wk. Max: 20 mcg/kg once wkly.
Reocurrence of thrombocytopenia & bleeding after cessation of treatment; closely monitor patients for decreased platelet count & medically manage to avoid bleeding upon discontinuation; restart ITP treatment if romiplostim is discontinued. Increased bone marrow reticulin; perform exam for cellular morphological abnormalities using peripheral blood smear & CBC prior to & during treatment. Patients w/ known risk factors for thromboembolism (eg, Factor V Leiden) or acquired risk factors (eg, ATIII deficiency, antiphospholipid syndrome), advanced age, prolonged periods of immobilisation, malignancies, contraceptives & HRT, surgery/trauma, obesity & smoking. Possible thromboembolic events including portal vein thrombosis in patients w/ chronic liver disease. Possible medication errors including overdose & underdose; monitor platelet counts. Possible myelodysplastic syndromes (MDS) disease progression to AML. Not to be used for thrombocytopenia due to MDS or any other cause of thrombocytopenia other than ITP. Possible chromosome abnormalities after Romiplate administration in patients w/ aplastic anaemia refractory to conventional therapy. Search for causative factors including immunogenicity & increased bone marrow reticulin if there is loss of response or failure to maintain a platelet response w/ romiplostim. Monitor CBCs including platelet counts & peripheral blood smears prior to initiation, throughout & following discontinuation of therapy; examine peripheral blood differential to establish baseline extent of RBC & WBC abnormalities prior to initiation of therapy. Possible mild to moderate, transient bouts of dizziness may moderately influence ability to drive & use machines. Moderate to severe hepatic impairment. Renal impairment. Not recommended during pregnancy & in women of childbearing potential not using contraception. Lactation. Not recommended for use in childn <18 yr. Elderly ≥65 yr.
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