Summary of Use during Lactation

Abatacept is a large fusion protein that interferes with T-cell activation. It has a molecular weight of 92,000, so only small amounts are expected to enter breastmilk and absorbed by the infant.[1] One case report indicates that amounts in milk are very low and do not appear to affect the breastfed infant. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[2] Some professional guidelines consider abatacept to be acceptable during breastfeeding.[3,4] However, until more information is available an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. A woman with rheumatoid arthritis resumed weekly doses of abatacept 125 mg subcutaneously 2 days after delivery. Maternal serum and breastmilk samples were obtained after the 9th and 10th doses. Peak abatacept concentrations in milk occurred at about 3 days after each dose at 256 mcg/L. Prior to the next dose, the trough concentration was 170 mcg/L. The authors estimated the daily infant dose to be between 25 and 38 mcg/kg, which translates into a weight-adjusted percent of maternal dosage of 1 to 1.5% (median 1.3%).[5]

Two lactating women who were receiving abatacept for rheumatoid arthritis donated milk samples for analysis. The first, who was receiving a subcutaneous dose of 125 mg once weekly, had a peak milk level of about 200 mcg/L at 3 days after the dose and a level of about 100 mcg/L at 7 days after the dose. The second, who was receiving an intravenous dose of 500 mg every 2 weeks, had a peak milk level of about 100 mcg/L at 3 days after the dose and a level of about 50 mcg/L at 7 days after the dose.[6]

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

Effects in Breastfed Infants

A woman with rheumatoid arthritis resumed weekly doses of abatacept 125 mg subcutaneously 2 days after delivery. Her infant was exclusively breastfed, reportedly up until 12 months of age. Her infant had no adverse effects and developed normally during this time. She also received routine childhood vaccinations at 3 months of age as well as rotavirus and BCG vaccination at 6 months of age. No infections or adverse immune reactions were seen following the vaccinations.[5]

Effects on Lactation and Breastmilk

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

Alternate Drugs to Consider

(Rheumatoid Arthritis) Adalimumab, Certolizumab Pegol, Etanercept, Infliximab, Tocilizumab

References

1.

Sammaritano LR, Bermas BL, Chakravarty EE, et al. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol 2020;72:529-56. [PubMed: 32090480]

2.

Krysko KM, Dobson R, Alroughani R, et al. Family planning considerations in people with multiple sclerosis. Lancet Neurol 2023;22:350-66. [PubMed: 36931808]

3.

Götestam Skorpen C, Hoeltzenbein M, Tincani A, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis 2016;75:795-810. [PubMed: 26888948]

4.

Russell MD, Dey M, Flint J, et al. British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: Immunomodulatory anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford) 2023;62:e48-e88. [PMC free article: PMC10070073] [PubMed: 36318966]

5.

Saito J, Yakuwa N, Takai C, et al. Abatacept concentrations in maternal serum and breast milk during breastfeeding and an infant safety assessment: A case study. Rheumatology (Oxford) 2019;58:1692-4. [PubMed: 31323087]

6.

Saito J, Yakuwa N, Hosokawa Y, et al. Establishment of a measurement system to evaluate breast milk transfer of biological agents using dry filter paper: a multi-institutional study. Br J Clin Pharmacol 2023. [PubMed: 37548054]

Substance Name

Abatacept

CAS Registry Number

332348-12-6

Drug Class

Breast Feeding

Lactation

Milk, Human

Antirheumatic Agents