Search
ponatinib (Iclusig)
Marketing suspended October 31, 2013 due to serious risk of venous thromboembolism. [4]
Indications:
- treatment of chronic myeloid leukemia (CML)
- treatment of Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
Dosage: once daily
Adverse effects:
- venous thromboembolism, arterial thrombosis [3]
- hepatotoxicity
- hypertension
- headache
- fever
- fatigue
- xerosis
- rash
- nausea
- constipation
- abdominal pain
- arthralgia
Mechanism of action:
- targets CML cells with the T315I mutation, presumably the t(9;22)(q34.1;q11.2) BCR/ABL fusion product of the Philadelphia chromosome
Notes:
- marketing suspended Dec 2013 until manufacturer addresses life-threatening thromboses and blood-vessel narrowing [4]
General
small inhibitory antineoplastic agent (ib drug)
References
- FDA News Release: Dec. 14, 2012
FDA approves Iclusig to treat two rare types of leukemia
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332252.htm
- Cortes JE et al.
Ponatinib in refractory Philadelphia chromosome-positive
leukemias.
N Engl J Med 2012 Nov 29; 367:2075.
PMID: 23190221
- FDA MedWatch. October 11,2013
Inclusig (Ponatinib): Drug Safety Communication - Increased
Reports Of Serious Blood Clots In Arteries And Veins.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370971.htm
- FDA MedWatch. October 31,2013
Iclusig (Ponatinib): Drug Safety Communication - Increased
Reports Of Serious Blood Clots In Arteries And Veins.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370971.htm
- FDA Drug Safety Communication: Dec 20, 2013
FDA requires multiple new safety measures for leukemia drug
Iclusig; company expected to resume marketing.
http://www.fda.gov/Drugs/DrugSafety/ucm379554.htm