Omacetaxine mepesuccinate Brand Name– SYNRIBO
What is Omacetaxine mepesuccinate
Omacetaxine mepesuccinate is a cephalotaxine ester that inhibits protein synthesis by binding to the A-site in the peptidyl-transferase center of the large ribosomal subunit. It reduces protein levels of Bcr-Abl and Mcl-1 independent of direct Bcr-Abl binding.
Omacetaxine mepesuccinate is indicated for treatment of chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) that is resistant and/or intolerant to 2 or more tyrosine kinase inhibitors (TKI).
In a pooled analysis of 2 studies, treatment with omacetaxine resulted in a major cytogenic response rate of 18.4% in patients with CP-CML (n = 76) and a complete hematologic response rate or no evidence of leukemia (composite endpoint) of 14.3% in patients with AP-CML (n = 35).
Omacetaxine mepesuccinate has demonstrated efficacy in CML patients with the T315I mutation who had failed previous TKI therapy in a phase II study (n = 62).
Omacetaxine (Synribo) was approved by the FDA in October 2012.
Indications
- chronic myelogenous leukemia (CML)
For the treatment of chronic myelogenous leukemia (CML)
NOTE: The FDA has designated omacetaxine as an orphan drug for the treatment of CML.
for the treatment of chronic or accelerated phase CML with resistance and/or intolerance to 2 or more tyrosine kinase inhibitors
Side Effects
- abdominal pain
- agitation
- alopecia
- anemia
- anemia
- angina
- anorexia
- anorexia
- anxiety
- arthralgia
- arthralgia
- asthenia
- asthenia
- back pain
- back pain
- bleeding
- blurred vision
- bone pain
- bradycardia
- cataracts
- chest pain (unspecified)
- chills
- confusion
- conjunctivitis
- constipation
- cough
- cough
- dehydration
- depression
- diabetes mellitus
- diarrhea
- diarrhea
- diplopia
- dizziness
- dysgeusia
- dyspepsia
- dysphagia
- dysphonia
- dyspnea
- dyspnea
- dysuria
- ecchymosis
- edema
- elevated hepatic enzymes
- epistaxis
- epistaxis
- erythema
- fatigue
- fatigue
- fever
- fever
- gastritis
- gastroesophageal reflux
- GI bleeding
- gingivitis
- gout
- headache
- headache
- hematoma
- hemoptysis
- hemorrhoids
- hot flashes
- hyperbilirubinemia
- hyperglycemia
- hyperhidrosis
- hypertension
- hyperthermia
- hyperuricemia
- hypoesthesia
- hypoglycemia
- hypotension
- infection
- infection
- influenza
- infusion-related reactions
- injection site reaction
- insomnia
- intracranial bleeding
- lacrimation
- lethargy
- leukopenia
- lymphopenia
- lymphopenia
- malaise
- musculoskeletal pain
- myalgia
- nasal congestion
- nausea
- nausea
- neutropenia
- neutropenia
- night sweats
- ocular hemorrhage
- ocular pain
- oral ulceration
- palpitations
- paresthesias
- peripheral edema
- petechiae
- pruritus
- purpura
- rash
- rhinorrhea
- seizures
- sinus tachycardia
- skin hyperpigmentation
- skin ulcer
- stomatitis
- thrombocytopenia
- thrombocytopenia
- tinnitus
- tremor
- vomiting
- vomiting
- weakness
- xerophthalmia
- xerosis
- xerostomia
Monitoring Parameters
- blood glucose
- CBC with differential
- pregnancy testing
Contraindications
- anemia
- bleeding
- breast-feeding
- contraception requirements
- diabetes mellitus
- geriatric
- GI bleeding
- hyperglycemia
- hyperosmolar hyperglycemic state (HHS)
- infection
- infertility
- intracranial bleeding
- male-mediated teratogenicity
- neutropenia
- pregnancy
- pregnancy testing
- reproductive risk
- thrombocytopenia
Interactions
- Acetaminophen; Aspirin, ASA; Caffeine
- Amlodipine; Celecoxib
- Anticoagulants
- Aspirin, ASA
- Aspirin, ASA; Butalbital; Caffeine
- Aspirin, ASA; Butalbital; Caffeine; Codeine
- Aspirin, ASA; Caffeine; Dihydrocodeine
- Aspirin, ASA; Caffeine; Orphenadrine
- Aspirin, ASA; Carisoprodol
- Aspirin, ASA; Carisoprodol; Codeine
- Aspirin, ASA; Citric Acid; Sodium Bicarbonate
- Aspirin, ASA; Dipyridamole
- Aspirin, ASA; Omeprazole
- Aspirin, ASA; Oxycodone
- Aspirin, ASA; Pravastatin
- Celecoxib
- Clozapine
- Diclofenac
- Diclofenac; Misoprostol
- Diflunisal
- Diphenhydramine; Ibuprofen
- Diphenhydramine; Naproxen
- Esomeprazole; Naproxen
- Etodolac
- Famotidine; Ibuprofen
- Fenoprofen
- Flurbiprofen
- Hydrocodone; Ibuprofen
- Ibuprofen
- Ibuprofen; Oxycodone
- Ibuprofen; Pseudoephedrine
- Indomethacin
- Ketoprofen
- Ketorolac
- Lansoprazole; Naproxen
- Meclofenamate Sodium
- Mefenamic Acid
- Meloxicam
- Nabumetone
- Naproxen
- Naproxen; Pseudoephedrine
- Naproxen; Sumatriptan
- Nonsteroidal antiinflammatory drugs
- Oxaprozin
- Palifermin
- Penicillamine
- Piroxicam
- Rofecoxib
- Sulindac
- Tolmetin
- Tuberculin Purified Protein Derivative, PPD
- Valdecoxib
