Effects on Fertility: Doxorubicin may cause infertility during the time of drug administration. In women, doxorubicin may cause amenorrhea. Although ovulation and menstruation appear to return after termination of therapy, premature menopause can occur.
Doxorubicin was toxic to male reproductive organs in animal studies, producing testicular atrophy, diffuse degeneration of the seminiferous tubules, and hypospermia.
Doxorubicin is mutagenic and can induce chromosomal damage in human spermatozoa. Oligospermia or azoospermia may be permanent; however, sperm counts have been reported to return to normospermic levels in some instances. This may occur several years after the end of therapy. Men undergoing treatment with doxorubicin should use effective contraceptive measures. Both men and women should seek advice on fertility preservation before treatment.
Use in Pregnancy - Category D: There is no information on the drug's use in pregnancy; therefore, the drug should not be used in pregnant women or those likely to become pregnant unless the expected benefit outweighs any potential risk. If a woman receives doxorubicin during pregnancy or becomes pregnant while taking the drug, she should be apprised of the potential hazard to the fetus.
Although animal studies have not demonstrated teratogenic activity due to doxorubicin treatment, an embryotoxic action is evident. Studies with rabbits and rats have revealed a decreased weight gain and a higher incidence of resorbed fetuses. No greater incidence of gross, visceral or skeletal malformations or of post-natal deaths has been observed.
Dose-related mutagenic effects of doxorubicin have been reported to produce severe chromosomal aberrations in in vitro studies. In view of this activity, the use of this drug in pregnant women is not recommended.
Women of Childbearing Potential/Contraception in Males and Females: Women of childbearing potential should be advised to avoid becoming pregnant during treatment and to use effective contraceptive methods during treatment and for at least 6 months and 10 days after last dose. Men with female partners of childbearing potential should be advised to use effective contraception during treatment with doxorubicin and for at least 3 months and 10 days after last dose.
Use in Lactation: Doxorubicin is secreted in breast milk. Because of the potential for serious reactions in nursing infants from doxorubicin, women should be instructed not to breast-feed while undergoing treatment with doxorubicin and for at least 10 days after last dose.