Romiplate

Romiplate

romiplostim

Manufacturer:

Kyowa Kirin

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Romiplostim
Indications/Uses
Adult chronic ITP patients refractory to other treatments (eg, corticosteroids, Ig). Adults w/ aplastic anemia refractory to conventional therapy.
Dosage/Direction for Use
SC Administer once wkly. Adult chronic ITP Initially 1 mcg/kg. May increase once wkly dose by increments of 1 mcg/kg until patient achieves platelet count of ≥50 x 109/L. Max: 10 mcg/kg once wkly. Platelet count >200 x 109/L for 2 consecutive wk Decrease once wkly dose by 1 mcg/kg, <50 x 109/L Increase once wkly dose by 1 mcg/kg. Aplastic anemia refractory to conventional therapy Adult Initially 10 mcg/kg. May adjust dose w/ increments of 5 mcg/kg. Max: 20 mcg/kg wkly.
Contraindications
Hypersensitivity to romiplostim or E. coli-derived proteins.
Special Precautions
Discontinue treatment if loss of efficacy & abnormal peripheral blood smear is observed; if platelet counts are excessively increased. Suspend treatment in patients w/ >400 x 109/L platelet count. Not to be used in attempt to normalize platelet counts. Recurrence of thrombocytopenia & bleeding after cessation of treatment. Cases of thromboembolic events, including portal vein thrombosis in patients w/ chronic liver disease. Increased bone marrow reticulin; transient blast cell increases in patients w/ myelodysplastic syndrome (MDS); progression of existing haematopoietic malignancies or MDS & to AML. Loss of response & failure to maintain platelet response. Concurrent anemia & leucocytosis (w/in 4-wk window). Patients w/ known risk factors for thromboembolism eg, inherited (factor V Leiden) or acquired (eg, antithrombin III deficiency, antiphospholipid syndrome), advanced age, prolonged periods of immobilisation, malignancies, contraceptives & HRT, surgery/trauma, obesity & smoking. Closely monitor patients for decrease in platelet count. Perform exam for cellular morphological abnormalities using peripheral blood smear & CBC prior to & during treatment; physical exam & bone marrow biopsy w/ appropriate staining for reticulin. Monitor splenectomy status in patients who had prior splenectomy; CBCs including platelet counts & peripheral blood smears (to establish baseline extent of RBC & WBC abnormalities) prior to initiation, throughout, & following discontinuation of therapy. Obtain CBCs including platelet counts & peripheral blood smears wkly during dose adjustment phase, & then mthly following establishment of stable dose; CBCs including platelet counts wkly for at least 2 wk following treatment discontinuation. Consider bone marrow test (including chromosomal evaluation) if immature cells & morphological abnormalities are found. May affect ability to drive or use machines. Hepatic & renal impairment. Not to be used during pregnancy. Lactation. Not recommended in childn <18 yr. Elderly ≥65 yr.
Adverse Reactions
Headache. Bone marrow disorder, thrombocytopenia; hypersensitivity; insomnia; dizziness, migraine, paraesthesia; flushing; pulmonary embolism; nausea, diarrhoea, abdominal pain, constipation, dyspepsia; pruritus, ecchymosis, rash; arthralgia, myalgia, muscle spasm, pain in extremity, back & bone; fatigue, inj site bruising, pain, haematoma & swelling, peripheral oedema, flu-like illness, pain, asthenia, pyrexia, chills; contusion.
Drug Interactions
Concomitant use w/ corticosteroids, danazol, &/or azathioprine, IVIg, & anti-D Ig.
MIMS Class
Haemostatics
ATC Classification
B02BX04 - romiplostim ; Belongs to the class of other systemic hemostatics. Used in the treatment of hemorrhage.
Presentation/Packing
Form
Romiplate powd for inj 250 mcg/0.5 mL
Packing/Price
5 mL x 1's
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