Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant®▼ (baricitinib): Exponering under graviditet

Baricitinib är kontraindicerat under graviditet. Fertila kvinnor ska använda en effektiv preventivmetod under behandling samt i minst 1 vecka efter avslutad behandling.

Information from the label

BARI is contraindicated during pregnancy. Women of childbearing potential have to use effective contraception during and for at least 1 week after treatment. If a patient becomes pregnant while taking BARI the parents should be informed of the potential risk to the foetus.1

The JAK/STAT pathway has been shown to be involved in cell adhesion and cell polarity which can affect early embryonic development. There are no adequate data from the use of BARI in pregnant women. Studies in animals have shown reproductive toxicity. BARI was teratogenic in rats and rabbits. Animal studies indicate that BARI may have an adverse effect on bone development in utero at higher dosages.1

Studies in animals suggest that treatment with baricitinib has the potential to decrease female fertility while on treatment, but there was no effect on male spermatogenesis.1

Human Fetal Development

The effects of BARI on human fetal development are not known.2

BARI is a potent, selective, and reversible inhibitor of the JAK family of protein tyrosine kinases, specifically JAK1 and JAK2.3 The JAK/STAT pathway has been shown to be involved in cell adhesion and cell polarity, which can affect early embryonic development.2

Based on the mechanism of action and findings of maternal and embryo-fetal toxicities, including skeletal anomalies in animals dosed in excess of the maximum human exposure, BARI should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.2

Clinical Trial Criteria Related to Pregnancy

Pregnancy was a criterion for permanent discontinuation in all BARI clinical studies. Patients were excluded from participating in clinical studies if they were

  • pregnant or nursing at the time of study entry

  • women of childbearing potential who did not agree to use 2 forms of highly effective birth control when engaging in sexual intercourse while enrolled in the study and for at least 28 days following the last dose of study treatment, or

  • men who did not agree to use 2 forms of highly effective birth control while engaging in sexual intercourse with female partners of childbearing potential enrolled in the study, and for at least 28 days following the last dose of study treatment.2

Pregnancy During Clinical Study Participation

Data on fetal outcomes and breastfeeding were collected for all reported cases of pregnancy that occurred during maternal or paternal exposures to study treatment. As of 13 February 2018, 23 women had become pregnant during BARI clinical studies.2 

Fifteen of the 23 pregnancy cases involved known exposure to methotrexate or leflunomide as study drug or background therapy. Reported pregnancy outcomes included

  • 13 cases of spontaneous (n=9) or induced (n=4) abortions

  • 2 premature deliveries

  • 6 full-term pregnancies without reported abnormalities, and 

  • 2 cases with the outcome unavailable.2

Additionally, there were 3 pregnancy cases in partners of male patients exposed to BARI; all pregnancies were carried to full term without abnormality reported.2

Fertility / cross placenta Studies in Animals

In a combined male/female rat fertility study, baricitinib decreased overall mating performance (decreased fertility and conception indices). In female rats there were

- decreased numbers of corpora lutea and implantation sites,

- increased pre-implantation loss, and/or

- adverse effects on intrauterine survival of the embryos.1

Since there were no effects on spermatogenesis (as assessed by histopathology) or semen/sperm endpoints in male rats, the decreased overall mating performance was likely the result of these female effects.1

It is unknown if BARI crosses the human placenta. In animal studies, following a 25-mg/kg dose of radioactivity-labeled [14C]-BARI in pregnant rats, radioactivity was widely distributed to both maternal and fetal tissues, confirming transfer of [14C]-BARI across the placenta in pregnant rats.2

Detailed Information

Summary of Product Characteristics


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

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

3. Fridman JS, Scherle PA, Collins R, et al. Selective inhibition of JAK1 and JAK2 is efficacious in rodent models of arthritis: preclinical characterization of INCB028050. J Immunol. 2010;184(9):5298-5307. http://dx.doi.org/10.4049/jimmunol.0902819


BARI = baricitinib

JAK = Janus kinase

STAT = signal transducers and activators of transcription

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 2019 M05 28

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