The Basics

What is Dasatinib?

Used to treat certain cases of chronic myelogenous leukemia and acute lymphoblastic leukemia.

Brand names for Dasatinib

Sprycel

How Dasatinib is classified

Antineoplastic Agents, Enzyme Inhibitors, Protein Kinase Inhibitors, Signal Transduction Inhibitors, Tyrosine Kinase Inhibitors

Dasatinib During Pregnancy

Dasatinib pregnancy category

Category DNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Dasatinib while pregnant

SPRYCEL may cause fetal harm when administered to a pregnant woman. There are noadequate and well-controlled studies of SPRYCEL in pregnant women. Women ofchildbearing potential should be advised of the potential hazard to the fetus and to avoidbecoming pregnant. If SPRYCEL is used during pregnancy, or if the patient becomespregnant while taking SPRYCEL, the patient should be apprised of the potential hazardto the fetus.In nonclinical studies, at plasma concentrations below those observed in humansreceiving therapeutic doses of dasatinib, embryo-fetal toxicities were observed in rats andrabbits. Fetal death was observed in rats. In both rats and rabbits, the lowest doses ofdasatinib tested (rat: 2.5 mg/kg/day [15 mg/m2/day] and rabbit: 0.5 mg/kg/day[6 mg/m2/day]) resulted in embryo-fetal toxicities. These doses produced maternal AUCsof 105 ng•hr/mL (0.3-fold the human AUC in females at a dose of 70 mg twice daily) and44 ng•hr/mL (0.1-fold the human AUC) in rats and rabbits, respectively. Embryo-fetaltoxicities included skeletal malformations at multiple sites (scapula, humerus, femur,radius, ribs, clavicle), reduced ossification (sternum; thoracic, lumbar, and sacralvertebrae; forepaw phalanges; pelvis; and hyoid body), edema, and microhepatia.

Taking Dasatinib While Breastfeeding

What are recommendations for lactation if you're taking Dasatinib?

Although one breastfed infants apparently experienced no adverse effects during maternal use of dasatinib, no long-term data are available. Because dasatinib and its metabolite are more than 90% bound to plasma proteins, the amounts in milk are likely to be low. However, there is little published experience with dasatinib during breastfeeding, and an alternate drug may be preferred, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during dasatinib therapy and for 2 weeks after the last dose.

Maternal / infant drug levels

Although one breastfed infants apparently experienced no adverse effects during maternal use of dasatinib, no long-term data are available. Because dasatinib and its metabolite are more than 90% bound to plasma proteins, the amounts in milk are likely to be low. However, there is little published experience with dasatinib during breastfeeding, and an alternate drug may be preferred, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during dasatinib therapy and for 2 weeks after the last dose.

Possible effects of Dasatinib on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Dasatinib

Imatinib.

List of References

Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Alizadeh H, Jaafar H, Kajtar B. Outcome of 3 pregnancies in a patient with chronic myeloid leukemia who received 3 types of tyrosine kinase inhibitors each in different pregnancy: Follow-up of the case with a review of published reports. Ann Saudi Med. 2015;35:468-71. PMID: 26657232

Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

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