Effects on Fertility: Although no studies have been conducted with Pharmorubicin, it may be expected, like doxorubicin, to cause infertility during the period of drug administration. In women, Pharmorubicin may cause amenorrhoea. After termination of therapy, ovulation and menstruation may be expected to return in a few months, often accompanied by normal fertility. Premature menopause may also occur.
In male patients, oligospermia or azoospermia may be permanent, although fertility may return several years after ceasing therapy. Given the mutagenic potential of Pharmorubicin, the drug could induce chromosomal damage in human spermatozoa; therefore, males undergoing Pharmorubicin treatment should be advised to use effective contraceptive methods during treatment and for at least 3.5 months after the last dose.
Use in Pregnancy - Category D: Women of child-bearing potential should be advised to avoid becoming pregnant during treatment and to use effective contraceptive methods during treatment and for at least 6.5 months after last dose.
There is no specific information available at present concerning the use of Pharmorubicin in human pregnancy. However, as it has been shown to be embryotoxic and fetotoxic in animals, it should not be used in patients who are pregnant or are likely to become pregnant.
If epirubicin 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. There have been sporadic reports of fetal and/or neonatal transient ventricular hypokinesia, transient elevation of cardiac enzymes, and of fetal death from suspected anthracycline induced cardiotoxicity following in utero exposure to epirubicin in 2nd and/or 3rd trimesters (see Precautions). Monitor the fetus and/or neonate for cardiotoxicity and perform testing consistent with community standards of care.
Use in Lactation: It is likely that Pharmorubicin is excreted in breast milk, therefore, it is not recommended for nursing mothers unless the expected benefit outweighs any potential risk. Because of the potential for serious adverse reactions in nursing infants from epirubicin, lactating women should be advised not to breastfeed during treatment with epirubicin and for at least 7 days after last dose.