Last update June 11, 2026

Белимумаб

Compatible

Safe product and/or breastfeeding is the best option.

Human IgG1λ monoclonal antibody. Indicated for the treatment of systemic lupus erythematosus. Administered intravenously every 2 to 4 weeks.

Its extremely high molecular weight explains the negligible transfer into breast milk observed (Higuchi 2025, Blomjous 2024, Saito 2024 and 2020) and calculated (Stratigakis 2023), as molecules larger than 800–1,000 Da have difficulty being excreted into breast milk. (Hale, Almas 2016, Anderson 2016). The concentration in breast milk is 200 to 500 times lower than that in maternal plasma. (Stratigakis 2023, Saito 2020)

No problems have been observed in infants of mothers treated with belimumab. (Oaklander 2024, Saito 2020, Danve 2014)

Due to its protein nature, it is inactivated in the gastrointestinal tract and is not absorbed (oral bioavailability is practically zero), which hinders or prevents its passage into the infant’s plasma from ingested breast milk (Lactmed, Hale, Anderson 2021), except in preterm infants and during the immediate neonatal period, when there may be increased intestinal permeability (Sammaritano 2020). Waiting two weeks after delivery before resuming treatment allows the newborn’s plasma levels to drop from their intrauterine levels and also minimizes transmission to the baby. (Krysko 2023) 

Expert authors and medical rheumatology associations consider its use during breastfeeding to be safe. (Rüegg 2025, Pluma 2025, Russell 2023)


See below the information of this related product:

  • Lupus (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)

Alternatives

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

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Other names

Белимумаб is Belimumab in Cyrillic.

Is written in other languages:

Groups

Белимумаб belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Белимумаб in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. ≈ 0 %
Molecular weight 147.000 daltons
VD 0.076 l/Kg
T½ 466 hours
M/P ratio 0.002 - 0.004 -
Theoretical Dose 0.018 - 0.026 mg/Kg/d
Relative Dose < 4 %

References

  1. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on April 16, 2024 Full text (link to original source)
  2. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 Full text (link to original source)
  3. Higuchi A, Saito J, Fujimori K, Ishikawa T, Kawasaki H, Miyagawa E, Abe S, Kohno C, Takai C, Wada YS, Kawai T, Murashima A, Kaneko K. Placental and breast milk transfer of belimumab in three patients with systemic lupus erythematosus treated throughout pregnancy. Mod Rheumatol Case Rep. 2025 Jul 25;9(2). pii: rxaf038. Abstract
  4. Rüegg L, Pluma A, Hamroun S, Cecchi I, Perez-Garcia LF, Anderson PO, Andreoli L, Wirström SB, Boyadhzieva V, Chambers C, Costedoat-Chalumeau N, Dolhain RJEM, Fischer-Betz R, Giles I, Gøtestam-Skorpen C, Hoeltzenbein M, Marchiori F, Mayer-Pickel K, Molto A, Nelson-Piercy C, Nielsen OH, Tincani A, et al. EULAR recommendations for use of antirheumatic drugs in reproduction, pregnancy, and lactation: 2024 update. Ann Rheum Dis. 2025 Jun;84(6):910-926. Abstract Full text (link to original source)
  5. Pluma A, Hamroun S, Rüegg L, Cecchi I, Kramer M, Perez-Garcia LF, Rivero T, Finckh A, Meissner Y, Förger F. Antirheumatic drugs in reproduction, pregnancy, and lactation: a systematic literature review informing the 2024 update of the EULAR recommendations. Ann Rheum Dis. 2025 Sep;84(9):1561-1590. Abstract Full text (link to original source)
  6. Oaklander AL, Allen J, Dietliker N, Wilder-Smith EP. Relapsing-Remitting Immunotherapy Responsive Small-Fiber Neuropathy: Longitudinal Tracking Through 10 Years Including Pregnancies. Neurol Neuroimmunol Neuroinflamm. 2024 Sep;11(5):e200286. Abstract Full text (link to original source)
  7. Blomjous BS, de Boer MA, van Weissenbruch MM, Laan KCJ, Rispens T, Voskuyl AE, Bultink IEM. Concentrations of subcutaneously administered belimumab in human breast milk of a woman with systemic lupus erythematosus: a case report. Lupus Sci Med. 2024 Mar 18;11(1). Abstract Full text (link to original source)
  8. Saito J, Yakuwa N, Hosokawa Y, Hamada H, Suzuki T, Sago H, Kaneko K, Yamatani A, Murashima A. 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. 2024 Jan;90(1):146-157. Abstract Full text (link to original source)
  9. Stratigakis A, Paty D, Zou P, Zhao Z, Li Y, Zhang T. A regression approach for assessing large molecular drug concentration in breast milk. Reprod Breed 2023;3:199-207. Full text (link to original source) Full text (in our servers)
  10. Russell MD, Dey M, Flint J, Davie P, Allen A, Crossley A, Frishman M, Gayed M, Hodson K, Khamashta M, Moore L, Panchal S, Piper M, Reid C, Saxby K, Schreiber K, Senvar N, Tosounidou S, van de Venne M, Warburton L, Williams D, Yee CS, et al. British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2023 Apr 3;62(4):e48-e88. Abstract Full text (link to original source)
  11. Krysko KM, Dobson R, Alroughani R, Amato MP, Bove R, Ciplea AI, Fragoso Y, Houtchens M, Jokubaitis VG, Magyari M, Abdelnasser A, Padma V, Thiel S, Tintore M, Vukusic S, Hellwig K. Family planning considerations in people with multiple sclerosis. Lancet Neurol. 2023 Apr;22(4):350-366. Abstract
  12. Anderson PO. Monoclonal Antibodies During Breastfeeding. Breastfeed Med. 2021 Aug;16(8):591-593. Abstract
  13. Saito J, Yakuwa N, Ishizuka T, Goto M, Yamatani A, Murashima A. Belimumab Concentrations in Maternal Serum and Breast Milk During Breastfeeding and the Safety Assessment of the Infant: A Case Study. Breastfeed Med. 2020 Jul;15(7):475-477. Abstract
  14. Sammaritano LR, Bermas BL, Chakravarty EE, Chambers C, Clowse MEB, Lockshin MD, Marder W, Guyatt G, Branch DW, Buyon J, Christopher-Stine L, Crow-Hercher R, Cush J, Druzin M, Kavanaugh A, Laskin CA, Plante L, Salmon J, Simard J, Somers EC, Steen V, Tedeschi SK, et al. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol. 2020 Apr;72(4):529-556. Abstract Full text (link to original source)
  15. Almas S, Vance J, Baker T, Hale T. Management of Multiple Sclerosis in the Breastfeeding Mother. Mult Scler Int. 2016;2016:6527458. Abstract Full text (link to original source) Full text (in our servers)
  16. Anderson PO. Monoclonal Antibodies. Breastfeed Med. 2016 Apr;11:100-1. Abstract
  17. Danve A, Perry L, Deodhar A. Use of belimumab throughout pregnancy to treat active systemic lupus erythematosus: a case report. Semin Arthritis Rheum. 2014 Oct;44(2):195-7. Abstract

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