SubcutaneousChronic idiopathic thrombocytopenic purpuraAdult: In patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins, splenectomy): Initially, 1 mcg/kg once weekly, may be increased by increments of 1 mcg/kg until a platelet count of ≥50 x 109/L is achieved and maintained. Max: 10 mcg/kg once weekly. Adjust dose based on patient's platelet count response. If <50 x 109/L, increase once weekly dose by 1 mcg/kg. If >150 x 109/L for 2 consecutive weeks, decrease once weekly dose by 1 mcg/kg. If >250 x 109/L, withhold the dose and monitor platelet count weekly; once <150 x 109/L is achieved, resume dosing with once weekly dose reduced by 1 mcg/kg. Discontinue use if platelet count is not raised sufficiently after 4 weeks of treatment at Max dose. Recommendations on dosage adjustments and treatment indications may vary among countries and individual products. Refer to specific product guidelines.
Child: ≥1 year Same as adult dose.
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Reconstitute with 0.44 mL (for 125 mcg vial), 0.72 mL (for 250 mcg vial), or 1.2 mL (for 500 mcg vial) sterile water for inj to yield a final concentration of 500 mcg/mL. Gently swirl and invert to dissolve the contents. Do not shake or vigorously agitate the vial. If the calculated dose is <23 mcg, further dilute solution with 1.38 mL (for 125 mcg vial), 2.25 mL (for 250 mcg vial), or 3.75 mL (for 500 mcg vial) NaCl 0.9% solution for inj to a final concentration of 125 mcg/mL.
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Patient with known risk factors for thromboembolism (e.g. Factor V Leiden, antiphospholipid syndrome, antithrombin III deficiency, prolonged periods of immobilisation, malignancy, surgery or trauma, contraceptives and hormone replacement therapy, obesity, smoking). Not recommended for treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP. Renal and moderate to severe hepatic (Child-Pugh score ≥7) impairment. Not indicated for use to normalise platelet counts. Children and elderly. Pregnancy and lactation.
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Significant: Thromboembolic events (e.g. portal vein thrombosis), reoccurrence of thrombocytopenia and bleeding (upon discontinuation), increased risk for bone marrow reticulin fibre deposition, anaemia, leucocytosis, progression from MDS to acute myeloid leukaemia.
Cardiac disorders: Palpitations.
Ear and labyrinth disorders: Ear infection.
Gastrointestinal disorders: Abdominal or upper abdominal pain, gastroenteritis, nausea, diarrhoea, constipation, dyspepsia.
General disorders and administration site conditions: Fatigue, pain, pyrexia, peripheral oedema, influenza-like illness, chills, asthenia, inj site reactions.
Immune system disorders: Hypersensitivity, angioedema.
Injury, poisoning and procedural complications: Contusion.
Musculoskeletal and connective tissue disorders: Back pain, bone pain, arthralgia, myalgia, muscle spasms, pain in extremities.
Nervous system disorders: Headache, dizziness, paraesthesia, migraine.
Psychiatric disorders: Insomnia.
Respiratory, thoracic and mediastinal disorders: URTI, rhinitis, sinusitis, oropharyngeal pain.
Skin and subcutaneous tissue disorders: Rash, pruritus, ecchymosis.
Vascular disorders: Flushing.
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This drug may cause dizziness, if affected, do not drive or operate machinery.
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Monitor CBC with differential and platelets at baseline, weekly during dose adjustment phase, then monthly, and weekly for at least 2 weeks after treatment discontinuation or completion.
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Symptoms: Excessive increase in platelet counts, which may result in thrombotic/thromboembolic complications. Management: Discontinue treatment and monitor platelet counts. Restart treatment in accordance with appropriate dosage recommendations.
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Description:
Mechanism of Action: Romiplostim, an Fc-peptide fusion protein (peptibody), is a thrombopoietin (TPO) receptor agonist. It binds to the human TPO receptor (also known as cMp1) and activates intracellular transcriptional pathways to stimulate platelet production.
Onset: Increased platelet count: 4-9 days.
Duration: Platelet count returns to baseline by Day 28.
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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Intact vials: Store between 2-8°C. Do not freeze. Protect from light. If necessary, may also be stored at room temperature (up to 25°C) for a single period of up to 30 days; do not place back in the refrigerator once stored at room temperature. Reconstituted vials: Store at 25°C or between 2-8°C for up to 24 hours after reconstitution. Further diluted solutions may be stored in a syringe at 25°C or in the original vial between 2-8°C for no longer than 4 hours before administration. Protect from light. Do not shake.
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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 05/12/2022. Buckingham R (ed). Romiplostim. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/12/2022. Joint Formulary Committee. Romiplostim. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/12/2022. Nplate 500 micrograms Powder for Solution for Injection (Amgen Limited). MHRA. https://products.mhra.gov.uk. Accessed 05/12/2022. Nplate Injection, Powder, Lyophilized, for Solution (Amgen Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/12/2022. Romiplate 250 mcg Powder for Solution for Injection (Kyowa Kirin Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 05/12/2022.
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