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Daunorubicin liposomal Pregnancy and Breastfeeding Warnings

Daunorubicin liposomal is also known as: DaunoXome

Daunorubicin liposomal Pregnancy Warnings

Daunorubicin liposomal 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. Literature reports have described the use of conventional daunorubicin during pregnancy with no congenital defects; however, there were instances of chromosomal aberration, anemia, hypoglycemia, electrolyte abnormalities, transient neutropenia, and transient myelosuppression. In one case a neonate had brachycephaly, hypoplasia of the cranial base and midface, synostosis, hypoplastic thumbs, and four-finger hands, after maternal chemotherapy with multiple agents including daunorubicin and doxorubicin during the first trimester. 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.

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.

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Daunorubicin liposomal Breastfeeding Warnings

There are no data on the excretion of daunorubicin into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions due to daunorubicin in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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References for pregnancy information

  1. Matthews JH, Wood JK "Male fertility during chemotherapy for acute leukemia." N Engl J Med 303 (1980): 1235
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  3. O'Donnell R, Costigan C, O'Connell LG "Two cases of acute leukaemia in pregnancy." Acta Haematol 61 (1979): 298-300
  4. Lilleyman JS, Hill AS, Anderton KJ "Consequences of acute myelogenous leukemia in early pregnancy." Cancer 40 (1977): 1300-3
  5. Alegre A, Chunchurreta R, Rodriguez-Alarcon J, Cruz E, Prada M "Successful pregnancy in acute promyelocytic leukemia." Cancer 49 (1982): 152-3
  6. Estiu M "Successful pregnancy in leukemia." Lancet 1 (1977): 433
  7. 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
  8. Sears HF, Reid J "Granulocytic sarcoma: local presentation of a systemic disease." Cancer 37 (1976): 1808-13
  9. Volkenandt M, Buchner T, Hiddemann W, van de Loo J "Acute leukaemia during pregnancy." Lancet 2 (1987): 1521-2
  10. Dobbing J "Pregnancy and leukemia." Lancet 1 (1977): 1155
  11. 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
  12. Hamer JW, Beard ME, Duff GB "Pregnancy complicated by acute myeloid leukemia." N Z Med J 89 (1979): 212-3
  13. Valemzuela PL, Montalban C, Matorras R, Nieto A, Gonzales A, Perera S "Pregnancy and relapse of peripheral T cell lymphoma. A case report." Gynecol Obstet Invest 32 (1991): 59-61
  14. "Product Information. Cerubidine (daunorubicin)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  15. 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
  16. 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
  17. Griffiths M "Acute leukaemia during pregnancy." Lancet 1 (1988): 586
  18. Cantini E, Yanes B "Acute myelogenous leukemia in pregnancy." South Med J 77 (1984): 1050-2
  19. Sanz MA, Rafecas FJ "Successful pregnancy during chemotherapy for acute promyelocytic leukemia." N Engl J Med 306 (1982): 939

References for breastfeeding information

  1. "Product Information. Cerubidine (daunorubicin)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  2. "Product Information. Daunoxome (daunorubicin liposomal)." Nexstar Pharmaceuticals Inc, Boulder, CO.

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