Omacetaxine mepesuccinate

Generic Medicine Info
Indications and Dosage
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.
Add 1 mL of NaCl 0.9% to a vial labelled as containing 3.5 mg. Swirl gently until a clear solution is obtained.
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.
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.
Symptoms: Gastrointestinal disorders, gingival haemorrhage, alopecia, neutropenia, thrombocytopenia. Management: Supportive treatment.
Drug Interactions
Increased risk of haemorrhage with anticoagulants, aspirin, and other NSAIDS.
Mechanism of Action: 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.
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, (accessed on Jan. 22, 2020)

Store between 20-25°C. Protect from light.
This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01XX40 - omacetaxine mepesuccinate ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
Anon. Omacetaxine Mepesuccinate. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. Accessed 04/05/2018.

Anon. Omacetaxine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 04/05/2018.

Buckingham R (ed). Omacetaxine Mepesuccinate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 04/05/2018.

Synribo Injection, Powder, Lyophilized, for Solution (Cephalon, Inc.). DailyMed. Source: U.S. National Library of Medicine. Accessed 04/05/2018.

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