The Basics

What is Cladribine?

Used to treat hairy cell leukemia (cancer of a certain type of white blood cell).

Brand names for Cladribine

Leustatin

How Cladribine is classified

Antineoplastic Agents, Immunosuppressive Agents

Cladribine During Pregnancy

Cladribine pregnancy category

Category DNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Cladribine while pregnant

LEUSTATIN can cause fetal harm when administered to a pregnant woman. Although there is no evidence of teratogenicity in humans due to LEUSTATIN, other drugs which inhibit DNA synthesis have been reported to be teratogenic in humans. Cladribine is teratogenic in animals. Advise females of reproductive potential to use highly effective contraception during treatment with LEUSTATIN. If LEUSTATIN 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. Cladribine is teratogenic in mice and rabbits and consequently has the potential to cause fetal harm when administered to a pregnant woman. A significant increase in fetal variations was observed in mice receiving 1.5 mg/kg/day (4.5 mg/m2) and increased resorptions, reduced litter size and increased fetal malformations were observed when mice received 3.0 mg/kg/day (9 mg/m2). Fetal death and malformations were observed in rabbits that received 3.0 mg/kg/day (33.0 mg/m2). No fetal effects were seen in mice at 0.5 mg/kg/day (1.5 mg/m2) or in rabbits at 1.0 mg/kg/day (11.0 mg/m2).

Taking Cladribine While Breastfeeding

What are recommendations for lactation if you're taking Cladribine?

Because there is no published experience with cladribine during breastfeeding, it should be avoided during breastfeeding, especially while nursing a newborn or preterm infant.[1][2] One group of authors recommends withholding breastfeeding for at 48 hours after a dose and longer in patients with impaired kidney function.[2] Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.[3] Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.[4]

Maternal / infant drug levels

Because there is no published experience with cladribine during breastfeeding, it should be avoided during breastfeeding, especially while nursing a newborn or preterm infant.[1][2] One group of authors recommends withholding breastfeeding for at 48 hours after a dose and longer in patients with impaired kidney function.[2] Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.[3] Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.[4]

Possible effects of Cladribine on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Cladribine

(Multiple Sclerosis) Glatiramer, Immune Globulin, Interferon Beta, Methylprednisolone.

List of References

Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Cree BA. Update on reproductive safety of current and emerging disease-modifying therapies for multiple sclerosis. Mult Scler. 2013;19:835-43. PMID: 23319073
2. Almas S, Vance J, Baker T et al. Management of multiple sclerosis in the breastfeeding mother. Mult Scler Int. 2016;2016:6527458. PMID: 26966579
3. Urbaniak C, McMillan A, Angelini M et al. Effect of chemotherapy on the microbiota and metabolome of human milk, a case report. Microbiome. 2014;2:24. PMID: 25061513
4. Stopenski S, Aslam A, Zhang X et al. After chemotherapy treatment for maternal cancer during pregnancy, is breastfeeding possible? Breastfeed Med. 2017;12:91-7. PMID: 28170295

Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

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