Romiplostim


Concise Prescribing Info
Indications/Uses
Idiopathic thrombocytopenic purpura.
Dosage/Direction for Use
Adult : SC In patients with increased risk of bleeding who have had inadequate response to corticosteroids, immunoglobulins, or splenectomy: Initial: 1 mcg/kg once a week. Adjust dose at weekly interval by increments of 1 mcg/kg to achieve and maintain a platelet count of ≥50 x 109 cells/L. Max: 10 mcg/kg/week. Dose may be increased, reduced, withheld or discontinued based on patient’s platelet response.
Dosage Details
Subcutaneous
Idiopathic thrombocytopenic purpura
Adult: In patients with increased risk of bleeding who have had inadequate response to corticosteroids, immunoglobulins, or splenectomy: Initially, 1 mcg/kg once a week, adjust at weekly interval by increments of 1 mcg/kg to achieve and maintain a platelet count of ≥50 x 109 cells/L. Max: 10 mcg/kg per week. Adjust dose based on patient’s platelet count response. If <50 x 109 cells/L, increase by 1 mcg/kg. If >150 x 109 cells/L for 2 consecutive weeks, decrease by 1 mcg/kg. If >250 x 109 cells/L, withhold the dose and monitor platelet count weekly; once <150 x 109 cells/L is achieved, resume at a dose reduced by 1 mcg/kg. Higher cut-off levels of platelet count for dose reduction (200 x 109 cells/L) and treatment interruption (400 x 109 cells/L) may be considered according to clinical judgment. Discontinue if platelet count is not raised sufficiently after 4 weeks of treatment at Max dose.
Reconstitution
Add 0.72 or 1.2 mL of preservative-free sterile water for injection to a vial containing 250 mcg or 500 mcg, respectively. Gently swirl and invert the vial to wet the powder. Do not shake or agitate the vial during and after reconstitution.
Special Precautions
Patient with or with history of cerebrovascular disease, risk factors for thromboembolism (e.g. advanced age, prolonged periods of immobilisation, malignancies, surgery/trauma, bleeding, obesity, smoking, contraceptives and hormone replacement therapy). Renal and hepatic impairment (including chronic liver disease). Pregnancy and lactation. Not intended for use to normalise platelet count. Not indicated for treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any other cause.
Adverse Reactions
Significant: Thromboembolic events (e.g. portal vein thrombosis), rebound thrombocytopenia, increased bone marrow reticulin, anaemia, leucocytosis, haematopoietic malignancies progression (e.g. MDS, acute myeloid leukaemia).
Cardiac disorders: Palpitations.
Gastrointestinal disorders: Gastroenteritis, nausea, diarrhoea, constipation, abdominal pain, dyspepsia.
General disorders and administration site conditions: Fatigue, pyrexia, chills, peripheral oedema, injection site reactions.
Immune system disorders: Hypersensitivity reactions (e.g. angioedema, urticaria).
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia, pain in the extremities, abdomen, back, or shoulder.
Nervous system disorders: Headache, dizziness, paraesthesia.
Psychiatric disorders: Insomnia.
Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection.
Skin and subcutaneous tissue disorders: Pruritus, ecchymosis, rash.
Vascular disorders: Flushing.
Parenteral/SC: C
Patient Counseling Information
This drug may cause dizziness or fatigue, if affected, do not drive or operate machinery.
MonitoringParameters
Assess CBC with differential, platelet count, peripheral blood smear, cellular morphologic abnormalities, prior to initiation of therapy, then monitor weekly during dose adjustments, then monthly during stable therapy, and at least 2 weeks after cessation of therapy.
Action
Description: Romiplostim, a biosynthetic (recombinant DNA-derived) Fc-peptide fusion protein, is a thrombopoietin (TPO) receptor agonist. It binds to the human TPO receptor (cMp1) and activates intracellular transcriptional pathways to stimulate platelet production.
Pharmacokinetics:
Absorption: Slowly absorbed. Time to peak plasma concentration: 7-50 hours (median: 14 hours).
Excretion: Elimination half-life: 1-34 days (median: 3.5 days).
Storage
Store between 2-8°C. Do not freeze. Protect from light.
MIMS Class
ATC Classification
B02BX04 - romiplostim ; Belongs to the class of other systemic hemostatics. Used in the treatment of hemorrhage.
Disclaimer: This information is independently developed by MIMS based on Romiplostim from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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