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Daunorubicin Pregnancy and Breastfeeding Warnings

Daunorubicin is also known as: Cerubidine

Daunorubicin Pregnancy Warnings

There is little evidence that daunorubicin is fetotoxic or teratogenic when given after 10 to 20 weeks' gestation, but the data are inadequate. There has been general acceptance of intensive chemotherapy when leukemia occurs in the second and third trimesters, although such treatment has been associated with intrauterine growth retardation (which may also have possibly been due to underlying leukemia), fetal myelosuppression, abortion, and teratogenicity. Limited data have shown that it is possible to give a single very high dose of chemotherapy for acute myeloid leukemia in younger women without compromising fertility. No congenital defects were observed among 22 live births (one set of twins) after the use of daunorubicin during the first trimester in 29 women. One of these 22 infants was anemic, hypoglycemic, and had multiple serum electrolyte abnormalities. Another 1 of the 22 developed severe, transient, drug-induced myelosuppression after in utero exposure to daunorubicin and 5 other antineoplastic agents. Of the 8 remaining pregnancies, there were 3 elective abortions, 3 intrauterine deaths, 1 stillborn with diffuse myocardial necrosis, and 1 maternal death. One of the intrauterine deaths was associated with severe pregnancy-induced hypertension. In one case, chromosomal abnormalities of unknown significance (gaps and a ring chromosome) were observed in a healthy female infant whose mother had received daunorubicin for 3 weeks, beginning at 22 weeks' gestation. In general, data have shown that 40% of the infants exposed to antineoplastic agents are of low birth weight, regardless of time of intrauterine exposure. Limited data from two cases suggest paternal exposure to daunorubicin may result in congenital defects, including Fallot's tetralogy, syndactyly, anencephaly, and stillbirth. Animal data have revealed evidence of clastogenic effects from daunorubicin. Use of daunorubicin in one human male who fertilized during treatment resulted in a normal and healthy infant.

Daunorubicin has been assigned to pregnancy category D by the FDA. Animal data have revealed evidence of teratogenicity, fetotoxicity, and decreased post-delivery growth rate. Daunorubicin may cause fetal harm when administered to a pregnant woman because of its teratogenic potential. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. Use of daunorubicin during pregnancy is considered contraindicated.

See references

Daunorubicin Breastfeeding Warnings

There are no data on the excretion of daunorubicin into human milk.

See references

References for pregnancy information

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  11. Salooja N, Chatterjee R, McMillan AK, Kelsey SM, Newland AC, Milligan DW, Franklin IM, Hutchinson RM, Linch DC, Goldstone AH "Successful pregnancies in women following single autotransplant for acute myeloid leukemia with a chemotherapy ablation protocol." Bone Marrow Transplant 13 (1994): 431-5
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  15. Tobias JS, Bloom HJ "Doxorubicin in pregnancy." Lancet 1 (1980): 776
  16. Nicholson HO "Cytotoxic drugs in pregnancy: review of reported cases." J Obstet Gynaecol Br Commonw 75 (1968): 307-12
  17. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  18. Matthews JH, Wood JK "Male fertility during chemotherapy for acute leukemia." N Engl J Med 303 (1980): 1235
  19. Schleuning M, Clemm C "Chromosomal aberrations in a newborn whose mother received cytotoxic treatment during pregnancy." N Engl J Med 317 (1987): 1666-7
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  21. Artlich A, Moller J, Tschakaloff A, Schwinger E, Kruse K, Gortner L "Teratogenic effects in a case of maternal treatment for acute myelocytic leukaemia--neonatal and infantile course." Eur J Pediatr 153 (1994): 488-91
  22. Okun DB, Groncy PK, Sieger L, Tanaka KR "Acute leukemia in pregnancy: transient neonatal myelosuppression after combination chemotherapy in the mother." Med Pediatr Oncol 7 (1979): 315-9
  23. "Product Information. Cerubidine (daunorubicin)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  24. Kamiguchi Y, Tateno H, Iizawa Y, Mikamo K "Chromosome analysis of human spermatozoa exposed to antineoplastic agents in vitro." Mutat Res 326 (1995): 185-92
  25. Feliu J, Juarez S, Ordonez A, Garcia-Paredes ML, Gonzalez-Baron M, Montero JM "Acute leukemia and pregnancy." Cancer 61 (1988): 580-4
  26. Russell JA, Powles RI, Oliver RT "Conception and congenital abnormalities after chemotherapy of acute myelogenous leukemia in two men." Br Med J 1 (1976): 1508
  27. Schafer AI "Teratogenic effects of antileukemic chemotherapy." Arch Intern Med 141 (1981): 514-5
  28. Sanz MA, Rafecas FJ "Successful pregnancy during chemotherapy for acute promyelocytic leukemia." N Engl J Med 306 (1982): 939
  29. Hamer JW, Beard ME, Duff GB "Pregnancy complicated by acute myeloid leukemia." N Z Med J 89 (1979): 212-3
  30. Lowenthal RM, Marsden KA, Newman NM, Baikie MJ, Campbell SN "Normal infant after treatment of acute myeloid leukaemia in pregnancy with daunorubicin." Aust N Z J Med 8 (1978): 431-2
  31. Morishita S, Imai A, Kawabata I, Tamaya T "Acute myelogenous leukemia in pregnancy: fetal blood sampling and early effects of chemotherapy." Int J Gynaecol Obstet 44 (1994): 273-7

References for breastfeeding information

  1. "Product Information. Cerubidine (daunorubicin)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

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