Omacetaxine mepesuccinate


Concise Prescribing Info
Indications/Uses
Chronic myeloid leukaemia.
Dosage/Direction for Use
Adult : SC Chronic or accelerated phase: Induction: 1.25 mg/m2 bid 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.
Dosage Details
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.
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.
Contraindications
Pregnancy.
Special Precautions
Patient with diabetes or risk factors for diabetes. Lactation.
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.
Parenteral/SC: D
Patient Counseling Information
This drug may cause fatigue, if affected, do not drive or operate machinery.
MonitoringParameters
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.
Overdosage
Symptoms: Gastrointestinal disorders, gingival haemorrhage, alopecia, neutropenia, thrombocytopenia. Management: Supportive treatment.
Drug Interactions
Increased risk of haemorrhage with anticoagulants, aspirin, and other NSAIDS.
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.
Chemical Structure

Chemical Structure Image
Omacetaxine mepesuccinate

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)

Storage
Store between 20-25°C. Protect from light.
This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal.
ATC Classification
L01XX40 - omacetaxine mepesuccinate ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
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.

Disclaimer: This information is independently developed by MIMS based on Omacetaxine mepesuccinate 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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