Is imatinib safe during pregnancy?
Department of Hematology, All India Institute of Medical Sciences (AIIMS), New Delhi, India.Leukemia research (Impact Factor: 2.35). 10/2008; 33(4):572-3. DOI: 10.1016/j.leukres.2008.08.002
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ABSTRACT: The development of imatinib as a therapeutic agent targeting BCR-ABL has increased the treatment options for chronic myeloid leukemia (CML) by significantly impacting outcomes, and imatinib is recommended by treatment guidelines as the first-line therapy. However, treatment of maternal CML with imatinib during gestation is not recommended because of the potential risk to the fetus. We describe the clinical presentation, course and outcome of one pregnant patient with CML who was treated with imatinib. We review all pregnancies associated with imatinib documented in the literature. A 27-year-old pregnant patient was diagnosed to have Philadelphia chromosome positive chronic phase CML in August 2007. Imatinib was administered (400 mg/day) between the 21st and 39th weeks of gestation. The patient tolerated the drug well and achieved complete hematological and cytogenetic remission. There were no imatinib-related maternal complications during the pregnancy. Fetal growth remained normal as well as amniotic fluid volume estimation. Labor was induced at the 39th gestational week, resulting in the uneventful vaginal delivery of a healthy male infant without any congenital anomaly. Umbilical cord blood and infant peripheral blood were collected at delivery. No postnatal complications occurred; however, imatinib was present in the umbilical cord blood (338 ng/mL) and in the infant's peripheral blood (478 ng/mL). Breast milk was collected on different postpartum days, and concentrations of imatinib were detected. At 10 months of age, the baby had normal growth and development. In light of reported cases and our experience, treatment of CML during the second and third trimesters of gestation and breast feeding seems to be safe, but the data are still limited and the effects of chronic exposure of infants to imatinib are not known. We think that each case should be examined and considered independently, and decisions should be individualized.Archives of Gynecology 08/2009; 280(2):169-75. DOI:10.1007/s00404-008-0861-7 · 1.36 Impact Factor
Article: CML in pregnancy and childhood[Show abstract] [Hide abstract]
ABSTRACT: With the improved survivals offered by the tyrosine kinase inhibitors has come the necessity to address issues relating to quality of life and one such area is that of fertility and parenting. Animal data suggest that imatinib at standard dosages is unlikely to impair fertility in either adult males or females but human data remain limited. Children born to men who are actively taking imatinib at the time of conception appear healthy and current advice is not to discontinue treatment. In contrast the data relating to children born to women exposed to imatinib during pregnancy are less encouraging. Although numbers are small there has been a disturbing cluster of rare congenital malformations such that imatinib cannot be safely recommended, particularly during the period of organogenesis. The appropriate management of children with CML has also been radically changed by the advent of imatinib. The features of the disease at presentation, the natural history and the response to therapy seem to be identical in children to that seen in adults. Now that imatinib has been in clinical use for almost ten years without severe long-term side effects, most physicians are now comfortable advising a trial of imatinib prior to consideration of transplant. Data relating to the efficacy and safety of second generation tyrosine kinase inhibitors in childhood is entirely absent and transplant remains the first choice for patients failing imatinib and perhaps also for young patients with sub-optimal responses.Best practice & research. Clinical haematology 09/2009; 22(3):455-74. DOI:10.1016/j.beha.2009.09.008 · 2.12 Impact Factor
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ABSTRACT: The introduction of tyrosine kinase inhibitors into clinical practice now offers most patients with chronic myelogenous leukemia lengthy remissions and the possibility of normal life expectancies. These improved survivals have resulted in the need to address issues relating to quality of life, including fertility and procreation. Treatment may require lifelong daily therapy with drugs that might inhibit proteins essential to gonadal function, implantation, and embryogenesis. Animal data suggest that imatinib at standard dosages is unlikely to impair fertility in either adult male or female animals. However, human data remain limited, particularly in children and adolescents. Children born to men who are actively taking imatinib at conception seem healthy, and current advice is not to discontinue treatment. In contrast, data are less encouraging for children born to women exposed to imatinib during pregnancy. Although numbers are small, a disturbing cluster of rare congenital malformations has prevented imatinib from being recommended safely, particularly during the period of organogenesis. Alternative strategies for managing pregnancy in chronic myelogenous leukemia include one or both of regular leukapheresis and interferon-alpha. Pregnancy in advanced-phase disease presents particular problems.Journal of the National Comprehensive Cancer Network: JNCCN 11/2009; 7(10):1050-8. · 4.18 Impact Factor
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