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Cladribine Pregnancy and Breastfeeding Warnings

Cladribine is also known as: Cladribine Novaplus, Leustatin

Medically reviewed on September 22, 2017

Cladribine Pregnancy Warnings

Animal data have revealed evidence of teratogenicity, embryotoxicity, fetotoxicity, increased resorptions, reduced litter size, and fetal death at doses equivalent to the recommended dose in humans. 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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

IV Formulation:
-AU: Use is contraindicated.
-UK, US: Use is not recommended.
Oral Formulation:
-AU, UK: Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: D

Comments:
-This drug can cause fetal harm when administered to a pregnant woman.
-Women of childbearing potential should use effective contraception during therapy and for 6 months after the last dose.
-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 hazard to the fetus.
-Men being treated with this drug should be advised not to father a child up to 6 months after the last dose.

See references

Cladribine Breastfeeding Warnings

Because there is no published experience with this drug during breastfeeding, it should be avoided, especially while nursing a newborn or preterm infant. Some experts recommend withholding breastfeeding for at 48 hours after a dose and longer in patients with impaired kidney function. Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk. Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.

IV Formulation:
-AU: Use is contraindicated.
-UK, US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Oral formulation:
-AU, UK: Use is contraindicated.

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

Comment:
-Because this drug may be excreted into human milk in human milk and because there is potential for serious adverse reactions in nursing infants, breastfeeding should not be undertaken during therapy and for 6 months after the last dose.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Leustatin (cladribine)." Ortho Biotech Inc, Raritan, NJ.
  3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

References for breastfeeding information

  1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Leustatin (cladribine)." Ortho Biotech Inc, Raritan, NJ.

Further information

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

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