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Chlorambucil Pregnancy and Breastfeeding Warnings

Brand names: Leukeran

Medically reviewed by Drugs.com. Last updated on Nov 25, 2024.

Chlorambucil Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk.

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

Risk summary: Based on its mechanism of action and effects in pregnant patients and animals, this drug can cause fetal harm when administered to a pregnant woman.

Comments:
-Women of childbearing potential should be advised to avoid becoming pregnant.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Urogenital malformations, including absence of a kidney, were found in fetuses in animal studies. Unilateral renal agenesis has been observed in 2 offspring whose mothers received this drug during the first trimester. There are no adequate and well-controlled studies in pregnant women.

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

Chlorambucil Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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


Comments:
-The effects in the nursing infant are unknown.

See references

Does Chlorambucil interact with my other drugs?

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See also

References for pregnancy information

  1. Marmor D, Grob-Menendez F, Duyck F, Delafontaine D (1992) "Very late return of spermatogenesis after chlorambucil therapy: case reports." Fertil Steril, 58, p. 845-6
  2. Steege JF, Caldwell DS (1980) "Renal agenesis after first trimester exposure to chlorambucil." South Med J, 73, p. 1414-5
  3. "Product Information. Leukeran Tablets (chlorambucil)." Glaxo Welcome, Research Triangle Pk, NC.
  4. (2023) "Product Information. Leukeran (chlorambucil)." Waylis Therapuetics LLC

References for breastfeeding information

  1. "Product Information. Leukeran Tablets (chlorambucil)." Glaxo Welcome, Research Triangle Pk, NC.

Further information

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

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