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Indications and Dosage
Subcutaneous
Chronic myeloid leukaemia Adult: Chronic or accelerated phase: Induction: 1.25 mg/m2 bid at approx 12-hour intervals for 14 consecutive days of a 28-day cycle, repeated every 28 days until haematological response is achieved. Maintenance: 1.25 mg/m2 bid for 7 consecutive days of a 28-day cycle, repeated as long as there is clinical benefit. Dose modifications may be required if toxicity occur.
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Reconstitution
Add 1 mL of NaCl 0.9% to a vial labelled as containing 3.5 mg. Swirl gently until a clear solution is obtained.
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Contraindications
Pregnancy.
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Special Precautions
Patient with diabetes or risk factors for diabetes. Lactation.
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Adverse Reactions
Significant: Gastrointestinal haemorrhage, glucose intolerance, hyperglycaemia.
Blood and lymphatic system disorders: Lymphopenia, bone marrow failure, febrile neutropenia. Gastrointestinal disorders: Diarrhoea, nausea, vomiting, constipation, abdominal pain. General disorders and administration site conditions: Asthenia, fatigue, pyrexia, injection site reactions. Metabolism and nutrition disorders: Anorexia, peripheral oedema. Musculoskeletal and connective tissue disorders: Arthralgia, back pain, myalgia, pain in extremity. Nervous system disorders: Headache. Psychiatric disorders: Insomnia. Respiratory, thoracic and mediastinal disorders: Cough, epistaxis. Skin and subcutaneous tissue disorders: Alopecia, rash. Potentially Fatal: Severe anaemia, neutropenia, and thrombocytopenia; cerebral haemorrhage. |
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Parenteral/SC: D
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Patient Counseling Information
This drug may cause fatigue, if affected, do not drive or operate machinery.
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Monitoring Parameters
Monitor CBC during induction and initial maintenance therapy then every 2 weeks thereafter or as clinically indicated; blood glucose frequently; signs of bleeding or infection.
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Overdosage
Symptoms: Gastrointestinal disorders, gingival haemorrhage, alopecia, neutropenia, thrombocytopenia. Management: Supportive treatment.
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Drug Interactions
Increased risk of haemorrhage with anticoagulants, aspirin, and other NSAIDS.
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Action
Description: Omacetaxine mepesuccinate is a semisynthetic formulation of homoharringtonine, an alkaloid derived from Cephalotaxus harringtonia. It reversibly inhibits protein synthesis by binding to the A-site cleft of the ribosomal subunit.
Synonym: homoharringtonine. Pharmacokinetics: Absorption: Rapidly absorbed. Time to peak plasma concentration: Approx 30 minutes. Distribution: Plasma protein binding: ≤50%. Metabolism: Hydrolysed by plasma esterases to 4’-DMHHT. Minimal hepatic microsomal oxidative or esterase-mediated metabolism. Excretion: Via urine (approx 37%) and faeces (approx 44%). Terminal elimination half-life: 14.6 hours. |
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Chemical Structure
 Source: National Center for Biotechnology Information. PubChem Database. Omacetaxine mepesuccinate, CID=285033, https://pubchem.ncbi.nlm.nih.gov/compound/Omacetaxine-mepesuccinate (accessed on Jan. 22, 2020) |
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Storage
Store between 20-25°C. Protect from light.
This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal. |
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MIMS Class
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ATC Classification
L01XX40 - omacetaxine mepesuccinate ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
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References
Anon. Omacetaxine Mepesuccinate. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 04/05/2018. Anon. Omacetaxine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/05/2018. Buckingham R (ed). Omacetaxine Mepesuccinate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/05/2018. Synribo Injection, Powder, Lyophilized, for Solution (Cephalon, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 04/05/2018.
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