Treosulfan Pregnancy and Breastfeeding Warnings

Brand names: Grafapex

Medically reviewed by Drugs.com. Last updated on Mar 24, 2025.

Treosulfan Pregnancy Warnings

According to some authorities: Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk summary: Based on the mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

Comments:
-Negative pregnancy status should be verified in females of childbearing potential within 7 days prior to initiating therapy.
-This drug is genotoxic and affects dividing cells, which may cause embryotoxicity and teratogenicity.
-Pregnant personnel should be excluded from handling this drug.
-Advise pregnant women of the potential harm to the fetus.
-According to some authorities, use is not recommended unless clearly needed.
-Females of childbearing potential should use effective contraception during therapy and for 6 months after the last dose.
-Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months (some authorities suggest 6 months) after the last dose.
-Based on findings in animal studies, this drug can impair fertility in females and males, and may cause temporary or permanent infertility.
-Males of reproductive potential should seek advice on cryo-conservation of sperm before treatment.
-Ovarian suppression and amenorrhea with menopausal symptoms may occur in pre-menopausal women.
-This drug is used in combination with fludarabine, with or without thiotepa. Consult the manufacturer product information of fludarabine and thiotepa for more information.
-If the patient becomes pregnant during or after treatment with this drug, consulting a genetic specialist should be considered.

Specific animal studies on embryo-fetal developmental toxicity have not been reported. However, during chronic oral toxicity tests, this drug significantly affected spermatogenesis and ovarian function in rats. Based on cytotoxicity and genotoxicity studies, this drug may potentially cause fetal toxicity and teratogenicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Treosulfan Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 1 week after the last dose.
-According to some authorities: Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-According to some authorities, breastfeeding should be discontinued during therapy and for at least 6 months after the last dose.
-There is no data on the effects of this drug on the breastfed infant or its impact on milk production.
-This drug is used in combination with fludarabine, with or without thiotepa. Consult the manufacturer product information of fludarabine and thiotepa for more information.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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