Cyclophos Use In Pregnancy & Lactation

500 mg: Women of childbearing potential: Girls treated with Cyclophosphamide during pre-pubescence generally develop secondary sexual characteristics normally and have regular menses.
Girls treated with Cyclophosphamide during pre-pubescence subsequently have conceived.
Girls treated with Cyclophosphamide who have retained ovarian function after completing treatment are at increased risk of developing premature menopause (cessation of menses before age of 40 years).
Contraception in males and females: Women should not become pregnant during the treatment and for a period of 12 months following discontinuation of the therapy.
Men should not father a child during the treatment and for a period of 6 months following discontinuation of the therapy.
Sexually active women and men should use effective methods of contraception during these periods of time.
Pregnancy: There are very limited data from the use of Cyclophosphamide in pregnant women. There are reports of serious multiple congenital aberrations after use during the first trimester.
Animal studies have shown teratogenicity and other reproduction toxicity.
Considering the data from human case reports, animal studies and the mechanism of action of Cyclophosphamide, its use during pregnancy, in particular during the first trimester, is not recommended.
In each individual case the potential benefit of the treatment should be weighed against the potential risk for the foetus.
Breastfeeding: Cyclophosphamide is excreted into the breast milk and can cause neutropenia, thrombocytopenia, low haemoglobin, and diarrhoea in children. Cyclophosphamide is contraindicated during breastfeeding.
Fertility: Cyclophosphamide interferes with oogenesis and spermatogenesis. It may cause sterility in both sexes. In women Cyclophosphamide may cause transient or permanent amenorrhea, and in boys treated with Cyclophosphamide during pre-pubescence, oligospermia or azoospermia. Men treated with Cyclophosphamide may develop oligospermia or azoospermia. Prior to treatment of men with Cyclophosphamide, they should be informed of the possibility to store and keep viable sperm collected before treatment.
1 g: Pregnancy: Cyclophosphamide is contraindicated in pregnancy. Cyclophosphamide crosses the placental barrier. Treatment with Cyclophosphamide has a genotoxic effect and may cause fetal damage when administered to pregnant women. Both women and men should wait at least 6 to 12 months after stopping Cyclophosphamide before attempting to conceive or father a child.
Malformations have been reported in children born to mothers treated with Cyclophosphamide during the first trimester of pregnancy. However, there are also reports of children without malformations born to women exposed during the first trimester.
Exposure to Cyclophosphamide in utero may cause miscarriage, fetal growth retardation, and foetotoxic effects manifesting in the newborn, including leukopenia, anaemia, pancytopenia, severe bone marrow hypoplasia, and gastroenteritis.
Animal data suggest that an increased risk of failed pregnancy and malformations may persist after discontinuation of Cyclophosphamide as long as oocytes/follicles exist that were exposed to Cyclophosphamide during any of their maturation phases.
If Cyclophosphamide is used during pregnancy, or if the patient becomes pregnant while taking this drug or after treatment, the patient should be apprised of the potential hazard to a fetus.
Breastfeeding: Cyclophosphamide is passed into the breast milk. Neutropenia, thrombocytopenia, low hemoglobin, and diarrhea have been reported in children breast fed by women treated with Cyclophosphamide. Women must not breastfeed during treatment with Cyclophosphamide.
Fertility: Cyclophosphamide interferes with oogenesis and spermatogenesis. It may cause sterility in both sexes.
Development of sterility appears to depend on the dose of Cyclophosphamide, duration of therapy, and the state of gonadal function at the time of treatment.
Cyclophosphamide-induced sterility may be irreversible in some patients.
Sexually active women and men should use effective methods of contraception during these periods of time.
Female patients: Amenorrhea, transient or permanent, associated with decreased estrogen and increased gonadotrophin secretion develops in a significant proportion of women treated with Cyclophosphamide.
For older women, in particular, amenorrhea may be permanent.
Oligomenorrhea has also been reported in association with Cyclophosphamide treatment.
Girls treated with Cyclophosphamide during prepubescence generally develop secondary sexual characteristics normally and have regular menses.
Girls treated with Cyclophosphamide during prepubescence subsequently have conceived.
Girls treated with Cyclophosphamide who have retained ovarian function after completing treatment are at increased risk of developing premature menopause (cessation of menses before age of 40 years).
Male patients: Men treated with Cyclophosphamide may develop oligospermia or azoospermia, which are normally associated with increased gonadotrophin but normal testosterone secretion.
Sexual potency and libido generally are unimpaired in these patients.
Boys treated with Cyclophosphamide during prepubescence may develop secondary sexual characteristics normally, but may have oligospermia or azoospermia.
Some degree of testicular atrophy may occur.
Cyclophosphamide-induced azoospermia is reversible in some patients, though the reversibility may not occur for several years after cessation of therapy.