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Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-.
CASRN: 143090-92-0
Drug Levels and Effects
Summary of Use during Lactation
Anakinra is the pharmaceutical name for recombinant human interleukin-1 receptor antagonist (IL-1Ra). IL-1Ra is a normal component of human milk where it may play a role as an anti-inflammatory agent. Several infants have been breastfed during maternal anakinra therapy with no obvious adverse effects. If anakinra is required by the mother, it is not a reason to discontinue breastfeeding.[1,2]
Drug Levels
Maternal Levels. The concentration of IL-1Ra in colostrum in 88 normal mothers was 672 ng/L, which was higher than the plasma concentration. Mature milk levels were lower than those in colostrum. Samples collected over a period of 2 to 6 months postpartum indicated that mothers continued to excrete IL-1Ra during this time.[3] Mothers with acute mastitis had slightly higher average levels of IL-1Ra than levels after recovery, but the median values were the same. The levels found in these mothers were the same as those of control mothers.[4]
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
A woman was receiving anakinra 100 mg daily for adult-onset Still's disease during pregnancy and lactation. Her breastfed (extent not stated) infant gained wight and appeared to have normal psychomotor development during an unspecified follow-up period.[5]
Among a cohort of 18 women with term pregnancies treated with anakinra for cryopyrin-associated periodic syndromes during pregnancy, 3 of the women breastfed their infants (extent not stated) for periods of <1 month, 3 months and 1 year. No adverse neonatal outcomes were reported.[6]
In an international multicenter study of mothers exposed to interleukin-1 receptor antagonists, 10 babies were breastfed (extent not stated) by mothers receiving anakinra for up to 10 months. No infections or developmental abnormalities were reported.[7] Three of the cases had been reported previously in reference[6].
Of 5 women who took anakinra during pregnancy, two breastfed their infants while continuing to receive anakinra 100 mg daily. No serious infections were reported and development was normal.[8]
A woman was treated with anakinra 100 mg subcutaneously and oral colchicine 1 mg twice daily during pregnancy and postpartum for familial Mediterranean fever while she breastfed her infant (extent not specified). At 9 months of age, the infant’s development was within normal range. The routine vaccination schedule for the baby was being performed on time and there was no history of infection in the infant.[9]
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.
- 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]
- 2.
- 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]
- 3.
- Buescher ES, Malinowska I. Soluble receptors and cytokine antagonists in human milk. Pediatr Res. 1996;40:839–44. [PubMed: 8947960]
- 4.
- Buescher ES, Hair PS. Human milk anti-inflammatory component contents during acute mastitis. Cell Immunol. 2001;210:87–95. [PubMed: 11520075]
- 5.
- Berger CT, Recher M, Steiner U, et al. A patient's wish: Anakinra in pregnancy. Ann Rheum Dis. 2009;68:1794–5. [PubMed: 19822718]
- 6.
- Chang Z, Spong CY, Jesus AA, et al. Anakinra use during pregnancy in patients with cryopyrin-associated periodic syndromes (CAPS). Arthritis Rheumatol. 2014;66:3227–32. [PMC free article: PMC4323990] [PubMed: 25223501]
- 7.
- Youngstein T, Hoffmann P, Gul A, et al. International multi-centre study of pregnancy outcomes with interleukin-1 inhibitors. Rheumatology (Oxford). 2017;56:2102–8. [PMC free article: PMC6251516] [PubMed: 28968868]
- 8.
- Smith CJF, Chambers CD. Five successful pregnancies with antenatal anakinra exposure. Rheumatology (Oxford). 2018;57:1271–5. [PMC free article: PMC7191889] [PubMed: 29660063]
- 9.
- Duman NC, Goren MZ, Karaalp A. Anakinra use during pregnancy and lactation: A case report. Reprod Toxicol 2019;88:139-40. Abstract. doi:10.1016/j.reprotox.2019.05.029. [CrossRef]
Substance Identification
Substance Name
Anakinra
CAS Registry Number
143090-92-0
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- PASylation of IL-1 receptor antagonist (IL-1Ra) retains IL-1 blockade and extends its duration in mouse urate crystal-induced peritonitis.[J Biol Chem. 2020]PASylation of IL-1 receptor antagonist (IL-1Ra) retains IL-1 blockade and extends its duration in mouse urate crystal-induced peritonitis.Powers NE, Swartzwelter B, Marchetti C, de Graaf DM, Lerchner A, Schlapschy M, Datar R, Binder U, Edwards CK 3rd, Skerra A, et al. J Biol Chem. 2020 Jan 17; 295(3):868-882. Epub 2019 Dec 9.
- Review [Interleukin-1 receptor antagonist anakinra (Kineret) for treatment of rheumatic arthritis].[Z Rheumatol. 2003]Review [Interleukin-1 receptor antagonist anakinra (Kineret) for treatment of rheumatic arthritis].Rubbert-Roth A, Perniok A. Z Rheumatol. 2003 Aug; 62(4):367-77.
- A comparative study of the inhibitory effects of interleukin-1 receptor antagonist following administration as a recombinant protein or by gene transfer.[Arthritis Res Ther. 2003]A comparative study of the inhibitory effects of interleukin-1 receptor antagonist following administration as a recombinant protein or by gene transfer.Gouze JN, Gouze E, Palmer GD, Liew VS, Pascher A, Betz OB, Thornhill TS, Evans CH, Grodzinsky AJ, Ghivizzani SC. Arthritis Res Ther. 2003; 5(5):R301-9. Epub 2003 Aug 1.
- Review Is IL-1 a good therapeutic target in the treatment of arthritis?[Best Pract Res Clin Rheumatol....]Review Is IL-1 a good therapeutic target in the treatment of arthritis?Burger D, Dayer JM, Palmer G, Gabay C. Best Pract Res Clin Rheumatol. 2006 Oct; 20(5):879-96.
- Topical administration of interleukin-1 receptor antagonist as a therapy for aqueous-deficient dry eye in autoimmune disease.[Mol Vis. 2013]Topical administration of interleukin-1 receptor antagonist as a therapy for aqueous-deficient dry eye in autoimmune disease.Vijmasi T, Chen FY, Chen YT, Gallup M, McNamara N. Mol Vis. 2013; 19:1957-65. Epub 2013 Sep 19.
- Anakinra - Drugs and Lactation Database (LactMed)Anakinra - Drugs and Lactation Database (LactMed)
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