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Cyclophosphamide Pregnancy and Breastfeeding Warnings

Cyclophosphamide is also known as: Cytoxan, Cytoxan Lyophilized, Neosar

Cyclophosphamide Pregnancy Warnings

Cyclophosphamide has been assigned to pregnancy category D by the FDA. While normal newborns have been delivered to women who were exposed to cyclophosphamide during pregnancy, human data have revealed evidence of embryotoxicity and fetotoxicity. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving 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 during therapy. The use of cyclophosphamide during pregnancy is contraindicated.

The use of cyclophosphamide during human pregnancy has resulted in severe and multiple abnormalities, including facial and palate defects, absent fingers and toes, absence of some coronary arteries, imperforate ani, hernias, growth retardation, multiple eye defects, microcephaly, hypotonia, and pancytopenia. Normal pregnancies and infantile development have resulted despite the use of cyclophosphamide during pregnancy. Use of this drug during the second and third trimesters does not seem to place the fetus at risk for congenital abnormalities. Nevertheless, use of cyclophosphamide during pregnancy is contraindicated.

See references

Cyclophosphamide Breastfeeding Warnings

Cyclophosphamide has been found in human milk up to 6 hours after a single 500 mg IV dose. Absolute neutropenia has been described in a nursing infant whose mother received 800 mg of cyclophosphamide, along with vincristine and prednisone therapy. Neutropenia and thrombocytopenia were observed in another nursing infant whose mother received 6 mg/kg/day of cyclophosphamide IV. After the third dose, the nursing infants leukocyte an platelet counts fell from pretreatment values of 4,800/mm3 and 270,000/mm3 to 3,200/mm3 and 47,000/mm3, respectively.

Cyclophosphamide is excreted into human milk. Neutropenia, thrombocytopenia, and immune suppression have been observed in infants whose mothers were receiving this drug during lactation. The drug also has an unacceptable risk of carcinogenesis. The American Academy of Pediatrics considers the use of cyclophosphamide to be contraindicated during breast-feeding.

See references

References for pregnancy information

  1. Zemlickis D, Lishner M, Erlich R, Koren G "Teratogenicity and carcinogenicity in a twin exposed in utero to cyclophosphamide." Teratogenesis Carcinog Mutagen 13 (1993): 139-43
  2. Fraiser LH, Kanekal S, Kehrer JP "Cyclophosphamide toxicity: characterising and avoiding the problem." Drugs 42 (1991): 781-95
  3. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  4. Anderson D, Bishop JB, Garner RC, Ostrosky-Wegman P, Selby PB "Cyclophosphamide: review of its mutagenicity for an assessment of potential germ cell risks." Mutat Res 330 (1995): 115-81
  5. Watson AR, Rance CP, Bain J "Long term effects of cyclophosphamide on testicular function." Br Med J 291 (1985): 1457-60
  6. "Product Information. Cytoxan (cyclophosphamide)." Bristol-Myers Squibb, Princeton, NJ.

References for breastfeeding information

  1. Wiernik PH, Duncan JH "Cyclophosphamide in human milk." Lancet 1 (1971): 912
  2. "Product Information. Cytoxan (cyclophosphamide)." Bristol-Myers Squibb, Princeton, NJ.
  3. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  4. Amato D, Niblett JS "Neutropenia from cyclophosphamide in breast milk." Med J Aust 03/12/77 (1977): 383-4

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