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Does cosentyx have any adverse effects on female fertility?

See the DrugPatentWatch profile for cosentyx

Does Cosentyx Affect Female Fertility?

Cosentyx (secukinumab), an IL-17A inhibitor for psoriasis, psoriatic arthritis, and ankylosing spondylitis, shows no evidence of impairing female fertility in animal studies or human data. Clinical trials and post-marketing reports do not indicate fertility issues in women of childbearing potential.[1][2]

What Animal Studies Say

In female rats and cynomolgus monkeys, secukinumab had no adverse effects on fertility, estrus cycles, or reproductive performance at doses up to 50 times the human equivalent. No impacts on oocyte quality or implantation rates appeared.[3]

Evidence from Human Trials and Pregnancy Registries

Phase 3 trials excluded pregnant women but monitored reproductive-aged females; no fertility signals emerged. The Secukinumab Pregnancy Exposure Registry (ongoing since 2015) tracks outcomes in exposed women, with no fertility-related adverse events reported to date. Over 1,000 pregnancies monitored show standard miscarriage and malformation rates, unrelated to preconception use.[1][4]

FDA and EMA Labeling on Fertility

US prescribing information states animal data reveal no fertility impairment, and human relevance is unknown but unlikely based on mechanism (IL-17A targets inflammation, not reproductive organs). No warnings for women planning pregnancy. EMA summary similarly notes no effects in preclinical fertility studies.[2][5]

What If You're Planning Pregnancy?

Discontinue Cosentyx if pregnancy is confirmed, per label, due to limited human data (not fertility-specific). Use effective contraception during treatment and 20 weeks after last dose, as it crosses the placenta late-term. No fertility recovery period needed post-treatment.[1]

Related Patient Concerns: Male Fertility and Breastfeeding

Male fertility is unaffected in animal studies; human data limited but reassuring. Cosentyx passes into breast milk in low amounts; benefits likely outweigh risks for nursing, but monitor infant.[1][2]

[1]: Cosentyx US Prescribing Information (Novartis, 2023)
[2]: Drugs.com - Cosentyx Side Effects and Safety
[3]: EMA Product Information - Cosentyx
[4]: MotherToBaby Fact Sheet - Secukinumab (2023)
[5]: FDA Label - Cosentyx (Secukinumab)



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