SubcutaneousIdiopathic thrombocytopenic purpuraAdult: 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.
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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.
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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.
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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.
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This drug may cause dizziness or fatigue, if affected, do not drive or operate machinery.
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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.
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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).
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Store between 2-8°C. Do not freeze. Protect from light.
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B02BX04 - romiplostim ; Belongs to the class of other systemic hemostatics. Used in the treatment of hemorrhage.
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Anon. Romiplostim. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/03/2018. Buckingham R (ed). Romiplostim. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/03/2018. Joint Formulary Committee. Romiplostim. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/03/2018. McEvoy GK, Snow EK, Miller J et al (eds). Romiplostim. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 09/03/2018. Nplate Injection, Powder, Lyophilized, for Solution (Amgen Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 09/03/2018.
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