Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® ▼ (baricitinib): Reproduktiv risk hos män

Djurstudier tyder på att behandling med baricitinib har ingen effekt på manlig spermatogenes (Olumiant produktresumé). Det finns emellertid en potential att minska fertiliteten.

Combined Male and Female Animal Fertility Study

Male rats were treated with 0, 5, 15, or 50 mg/kg of BARI daily for 6 weeks including 4 weeks prior to cohabitation with female rats treated with 0, 5, 25, or 100 mg/kg.1

Effects on Reproductive Organs and Sperm

Histologic studies found no change in male reproductive organs, and no effects on sperm motility, concentration, and morphology at any BARI dose level.1

Effects on Fertility and Early Embryonic Development

Results by Doses

At doses of 50 and 100 mg/kg/day, reproductive performance was unaffected in males and females. However, fertility was reduced in BARI-treated females compared to control females. Non-gravid rates were

  • 7 of 19 (36.8%) in BARI-treated females, and

  • 1 of 19 (5.3%) in control females.1

At doses of 15 mg/kg and 25 mg/kg, fertility was unaffected in male and female rats. However, maintenance of pregnancy was adversely affected at these doses based upon findings of

  • increased post-implantation losses (early resorptions), and

  • decreased numbers of mean viable embryos per litter.1

At doses of 5mg/kg/day, the number of viable embryos was unaffected in BARI-treated female rats that were mated to BARI-treated males.1

Potential Cause of Decreased Fertility

Based on the study design, it could not be determined if fertility results were attributable to toxicities in one sex or both. However, since there were no effects on spermatogenesis or semen/sperm endpoints in male rats, the decreased overall mating performance was likely the result of fertility effects in female rats including

  • decreased corpora lutea and implantation sites,

  • increased pre-implantation loss, and

  • adverse effects on intrauterine survival.2

Contraceptive Criteria in Clinical Trial Protocols

In BARI rheumatoid arthritis clinical trials, male patients agreed to use 2 forms of highly effective birth control while engaging in sexual intercourse with female partners of childbearing potential during the trial and for 28 days after the last dose of study medication.1

References

1. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2. Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

BARI = baricitinib

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2018 M03 26

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