Summary of Use during Lactation

Data in one patient indicates that the drug is rapidly eliminated over 24 hours and undetectable at 48 hours after a dose. It is suggested that breastfeeding be withheld for at least 48 hours after a dose of cladribine and perhaps up to a week,[1,2] although the manufacturers recommends a 7-day (Europe) or 10-day (US) abstinence period. 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]

Drug Levels

Maternal Levels. A woman with multiple sclerosis who was 4 months postpartum began cladribine. In her second course of therapy, 5 weeks after the first course, she received 20 mg cladribine once daily by mouth on days 1 to 3 and 10 mg on days 4 and 5. On day 3, the patient collected samples at 0, 1, 2, 4, 6, 8, 12, and 24 hours after a 20 mg dose. The highest milk level was 281 mcg/L at 1 hour after the dose. Levels declined rapidly over 12 to 24 hours, to undetectable (<1.5 mcg/L) levels at 48 hours and beyond. The average milk level was 44 mcg/L over the 24 hour period. The authors calculated that a fully breastfed infant would receive a dose of 6.6 mcg/kg daily, which corresponds to a weight-adjusted dose of 3.1% of the maternal dose.[5]

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

Effects in Breastfed Infants

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

Effects on Lactation and Breastmilk

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

Alternate Drugs to Consider

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

References

1.

Almas S, Vance J, Baker T, et al. Management of multiple sclerosis in the breastfeeding mother. Mult Scler Int. 2016;2016:6527458. [PMC free article: PMC4757692] [PubMed: 26966579]

2.

Canibaño B, Deleu D, Mesraoua B, et al. Pregnancy-related issues in women with multiple sclerosis: an evidence-based review with practical recommendations. J Drug Assess. 2020;9:20–36. [PMC free article: PMC7034025] [PubMed: 32128285]

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. [PMC free article: PMC4109383] [PubMed: 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. [PubMed: 28170295]

5.

Datta P, Ciplea AI, Rewers-Felkins K, et al. Cladribine transfer into human milk: A case report. Mult Scler. 2021;27:799–801. [PubMed: 32507055]

Substance Name

Cladribine

CAS Registry Number

4291-63-8

Drug Class

Breast Feeding

Lactation

Antineoplastic Agents

Immunosuppressive Agents