Cladribine Pregnancy and Breastfeeding Warnings

Brand names: Cladribine Novaplus, Leustatin, Mavenclad

Medically reviewed by Drugs.com. Last updated on Aug 4, 2025.

Cladribine Pregnancy Warnings

Use is contraindicated in women and in females and males of reproductive potential who do not plan to use effective contraception.

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

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-A pregnancy exposure registry is available.
-Use of adequate methods of contraception should be encouraged.
-This drug can cause fetal harm when administered to a pregnant woman.
-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.
-Report pregnancies in women diagnosed with multiple sclerosis who were exposed to oral cladribine either during pregnancy or within six months prior to conception.
- Male patients of reproductive potential should take precautions to prevent pregnancy of their partner during treatment and for at least 6 months after the last dose.

Animal studies have revealed evidence of embryolethality and fetal harm. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling EDM Serono's Adverse Event reporting line at 1-800-283-8088 ext. 5563.
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

Cladribine Breastfeeding Warnings

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.

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.

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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