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Doxorubicin liposomal Pregnancy and Breastfeeding Warnings

Doxorubicin liposomal is also known as: Doxil, Lipodox, Lipodox 50

Doxorubicin liposomal Pregnancy Warnings

The following information regarding doxorubicin in pregnancy was not from use of the liposomal form. Doxorubicin crosses the human placenta. Several cases of birth defects have been associated with the use of doxorubicin during pregnancy. These birth defects have included imperforate anus, rectovaginal fistula, brachycephaly, hypoplasia of the anterior cranial base and face, synostoses of cranial sutures, hypoplastic digits, and fetal maceration. Fetal death has been reported 36 hours after treatment with doxorubicin and other neoplastic agents. Doxorubicin may cause reversible testicular and ovarian dysfunction or menstrual abnormalities. Most men who have received doxorubicin regain spermatogenesis and sperm motility. Some women who were previously treated with doxorubicin have subsequently had normal pregnancies. Development of sterility may depend on the dose, duration of therapy, and the pretreatment state of gonadal function. Pregnancy outcome in women who received doxorubicin for malignancy in childhood has been reported to generally be favorable. Those with baseline left ventricular dysfunction should be considered at increased risk for worse pregnancy outcome and further deterioration in myocardial function. Peripartum heart failure has been reported years after doxorubicin therapy. Pregnancy, preeclampsia, anemia, or overhydration are possible precipitating factors in the emergence of heart failure in patients who have received doxorubicin.

Doxorubicin liposomal has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryotoxicity and abortifacient activity. Several cases of birth defects have been associated with the use of doxorubicin. There are no controlled data in human pregnancy. Women should be advised to avoid pregnancy. The prolonged half-life of doxorubicin liposomal should be considered if a woman becomes pregnant in the first few months following treatment.

See references

Doxorubicin liposomal Breastfeeding Warnings

There are no data on the excretion of doxorubicin liposomal into human milk. However, conventional doxorubicin is excreted into and accumulates in human milk. Side effects, including immune suppression, carcinogenesis, neutropenia, and unknown effects on growth are possible in nursing infants. The manufacturer recommends discontinuing nursing during treatment with doxorubicin liposomal. The American Academy of Pediatrics considers the use of doxorubicin to be contraindicated during breast-feeding.

See references

References for pregnancy information

  1. Pratt CB, Rivera G, Shanks E "Osteosarcoma during pregnancy." Obstet Gynecol 50(1 Suppl) (1977): s24-6
  2. Awidi AS, Tarawneh MS, Shubair KS, Issa AA, Dajani YF "Acute leukemia in pregnancy: report of five cases treated with a combination which included a low dose of adriamycin." Eur J Cancer Clin Oncol 19 (1983): 881-4
  3. Lendon M, Hann IM, Palmer MK, Shalet SM, Jones PH "Testicular histology after combination chemotherapy in childhood for acute lymphoblastic leukaemia." Lancet 2 (1978): 439-41
  4. "Product Information. Doxil (doxorubicin liposomal)." Sequis Pharmaceuticals Inc, Menlo Park, CA.
  5. "Product Information. Adriamycin PFS (doxorubicin)." Pharmacia and Upjohn, Kalamazoo, MI.
  6. Fassas A, Kartalis G, Klearchou N, Tsatalas K, Sinacos Z, Mantalenakis S "Chemotherapy for acute leukemia during pregnancy. Five case reports." Nouv Rev Fr Hematol 26 (1984): 19-24
  7. Turchi JJ, Villasis C "Anthracyclines in the treatment of malignancy in pregnancy." Cancer 61 (1988): 435-40
  8. Khurshid M, Saleem M "Acute leukemia in pregnancy." Lancet 2 (1978): 534-5
  9. Broadbent NR, Brown GE "Adriamycin and soft tissue injury." N Z Med J 98 (1985): 71
  10. Dobbing J "Pregnancy and leukemia." Lancet 1 (1977): 1155
  11. Newcomb M, Balducci L, Thigpen JT, Morrison FS "Acute leukemia in pregnancy. Successful delivery after cytarabine and doxorubicin." JAMA 239 (1978): 2691-2
  12. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  13. Karp GI, von Oeyen P, Valone F, Khetarpal VK, Israel M, Mayer RJ, Frigoletto FD, Garnick MB "Doxorubicin in pregnancy: possible transplacental passage." Cancer Treat Rep 67 (1983): 773-7

References for breastfeeding information

  1. "Product Information. Adriamycin PFS (doxorubicin)." Pharmacia and Upjohn, Kalamazoo, MI.
  2. Egan PC, Costanza ME, Dodion P, Egorin MJ, Bachur NR "Doxorubicin and cisplatin excretion into human milk." Cancer Treat Rep 69 (1985): 1387-89
  3. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  4. "Product Information. Doxil (doxorubicin liposomal)." Sequis Pharmaceuticals Inc, Menlo Park, CA.

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