The Basics
What is Imatinib?
Used to treat chronic myelogenous leukemia (CML), gastrointestinal stromal tumors (GISTs) and more.
Brand names for Imatinib
Gleevec
How Imatinib is classified
Antineoplastic Agents, Enzyme Inhibitors, Protein Kinase Inhibitors, Signal Transduction Inhibitors, Tyrosine Kinase Inhibitors
Imatinib During Pregnancy
Imatinib pregnancy category
Category N/ANote 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 Imatinib while pregnant
Gleevec can cause fetal harm when administered to a pregnant woman based on human and animal data. There are no clinical studies regarding use of Gleevec in pregnant women. There have been postmarket reports of spontaneous abortions and congenital anomalies from women who have been exposed to Gleevec during pregnancy. Reproductive studies in rats have demonstrated that imatinib mesylate induced teratogenicity and increased incidence of congenital abnormalities following prenatal exposure to imatinib mesylate at doses equal to the highest recommended human dose of 800 mg/day based on body surface area. Advise women to avoid pregnancy when taking Gleevec. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus. The background risk of major birth defects and miscarriage for the indicated population is not known; however, in the U.S. general population, the estimated background risk of major birth defects of clinically recognized pregnancies is 2-4% and of miscarriage is 15%-20%.
Taking Imatinib While Breastfeeding
What are recommendations for lactation if you're taking Imatinib?
Limited information indicates that maternal doses of imatinib up to 400 mg daily produce low levels of the drug and its active metabolite in milk. Although a few breastfed infants apparently experienced no adverse effects during maternal use of imatinib, no long-term data are available. Until more data are available, imatinib should be used only with careful monitoring during breastfeeding. The manufacturer and some authors recommend that breastfeeding be discontinued during imatinib therapy and for 1 month after therapy.[1][2]
Maternal / infant drug levels
Limited information indicates that maternal doses of imatinib up to 400 mg daily produce low levels of the drug and its active metabolite in milk. Although a few breastfed infants apparently experienced no adverse effects during maternal use of imatinib, no long-term data are available. Until more data are available, imatinib should be used only with careful monitoring during breastfeeding. The manufacturer and some authors recommend that breastfeeding be discontinued during imatinib therapy and for 1 month after therapy.[1][2]
Possible effects of Imatinib on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Imatinib
None listed
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. Pistilli B, Bellettini G, Giovannetti E et al. Chemotherapy, targeted agents, antiemetics and growth-factors in human milk: How should we counsel cancer patients about breastfeeding? Cancer Treat Rev. 2013;39:207-11. PMID: 23199900
2. Burwick RM, Kuo K, Brewer D et al. Maternal, fetal, and neonatal imatinib levels with treatment of chronic myeloid leukemia in pregnancy. Obstet Gynecol. 2017;129:831-4. PMID: 28383372
3. Gambacorti-Passerini CB, Tornaghi L, Marangon E et al. Imatinib concentrations in human milk. Blood. 2007;109:1790. PMID: 17284536
4. Russell MA, Carpenter MW, Akhtar MS et al. Imatinib mesylate and metabolite concentrations in maternal blood, umbilical cord blood, placenta and breast milk. J Perinatol. 2007;27:241-3. PMID: 17377606
5. Ali R, Ozkalemkas F, Kimya Y et al. Imatinib use during pregnancy and breast feeding: a case report and review of the literature. Arch Gynecol Obstet. 2009;280:169-75. PMID: 19083009
6. Kronenberger R, Schleyer E, Bornhauser M et al. Imatinib in breast milk. Ann Hematol. 2009;88:1265-6. PMID: 19462170
7. Gouraud A, Vial T, Ianotto JC et al. Imatinib concentration in breast milk: A case report. Fundam Clin Pharmacol. 2013;27 (Suppl 1):68. Abstract. DOI: doi:10.1111/fcp.12026
8. Chelysheva E, Aleshin S, Polushkina E et al. Breastfeeding in patients with chronic myeloid leukaemia: Case series with measurements of drug concentrations in maternal milk and literature review. Mediterr J Hematol Infect Dis. 2018;10:e2018027. PMID: 29755704
9. Jiang Q, Jiang B, Chen SS et al. [Pregnancy outcome among patients with chronic myelogenous leukemia treated with tyrosine kinase inhibitors]. Zhonghua Xue Ye Xue Za Zhi. 2012;33:6-9. PMID: 22575184
10. 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.
