ponatinib (Iclusig)
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Introduction
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]
More general terms
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: https://www.ncbi.nlm.nih.gov/pubmed/23190221
- ↑ 3.0 3.1 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 - ↑ 4.0 4.1 4.2 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