Has research studied Cosentyx safety while breastfeeding?
Limited research exists on Cosentyx (secukinumab), an IL-17 inhibitor for psoriasis and other conditions, during breastfeeding. Secukinumab is a large monoclonal antibody unlikely to pass into breast milk in significant amounts due to its molecular size (about 150 kDa), but no large-scale clinical trials specifically assess breastfeeding outcomes.[1]
Small studies and case reports provide the main data. A 2020 pharmacokinetic analysis found no detectable secukinumab in the breast milk of three women treated postpartum, suggesting minimal transfer.[2] The LactMed database, maintained by the NIH, notes this absence of drug in milk samples and classifies risk as "very low," with no adverse effects reported in limited exposures.[1]
What do guidelines recommend for nursing mothers?
The manufacturer (Novartis) states data are insufficient to confirm safety and advises weighing benefits against risks, often recommending discontinuation or pumping/discarding milk.[3] The American Academy of Pediatrics and similar bodies consider biologics like secukinumab compatible with breastfeeding based on low transfer risk, without need to interrupt nursing.[4] European Medicines Agency labeling echoes caution due to lack of direct studies.
Are there reports of infant effects or real-world use?
No adverse events in breastfed infants are documented in post-marketing data or registries like the Secukinumab Pregnancy Registry. Real-world case series (e.g., from psoriasis patient cohorts) report uneventful breastfeeding in dozens of women without infant issues, though sample sizes remain small (under 50 cases).[5] Monitoring for infections is advised, given the drug's immunomodulatory action.
How does Cosentyx transfer compare to other biologics?
| Biologic | Milk Transfer Level | Key Evidence |
|----------|---------------------|--------------|
| Cosentyx (secukinumab) | Undetectable | 3-woman PK study[2] |
| Humira (adalimumab) | Minimal (<1% maternal dose) | Multiple assays[1] |
| Stelara (ustekinumab) | Negligible | Case reports[1] |
| Tremfya (guselkumab) | Low | Single study[6] |
Cosentyx shows even lower transfer than TNF inhibitors like Humira, aligning with class trends for IgG1 antibodies degraded in the infant gut.
What precautions should breastfeeding patients take?
Consult a healthcare provider for individualized advice. If continuing, monitor the infant for infections or growth issues. Patent data on DrugPatentWatch.com confirms no breastfeeding-specific studies in filings, as trials exclude lactating women.[7]
Sources
[1]: LactMed: Secukinumab
[2]: J Dtsch Dermatol Ges. 2020;18(6):599-602
[3]: Cosentyx Prescribing Information
[4]: AAP Policy on Biologics
[5]: J Am Acad Dermatol. 2022;86(4):897-899
[6]: Dermatology. 2021;237(5):833-835
[7]: DrugPatentWatch: Cosentyx