Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

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Taltz® ▼ (ixekizumab): Kliniska prövningar om reproduktionsrisker hos män med psoriasis, psoriasisartrit och axial spondyloartrit

Det finns begränsade säkerhetsdata om gravida kvinnor som exponeras för ixekizumab via en manlig partner som fått ixekizumab.

Short Answer Summary

The effect of ixekizumab on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.1

There are limited safety data on pregnant women exposed to ixekizumab via a male partner who received ixekizumab.2

All men agreed to use a reliable method of birth control during ixekizumab clinical trials.3,4

Information regarding pregnancy, lactation, and fertility in female patients is available in the Taltz summary of product characteristics.1

Psoriasis and Psoriatic Arthritis Trials

Out of 4517 male patients exposed to ixekizumab in 16 PsO and PsA clinical trials through September 20, 2018, 76 cases of paternal exposure were identified and the outcome is known for 64 of the pregnancies.4

Information on these cases is summarized in Table 1.

Table 1. Cumulative Summary of Pregnancies: Potential Fetal Exposures via Fathers Exposed to Ixekizumab4

 

Paternal Exposures to Ixekizumab in RCTs
(N=4517)

Pregnancies, n (%)

76 (1.7)

Pregnancies with known outcomea, n

64

Live birthb, n (%)

51 (79.7)

Spontaneous abortion, n (%)

10 (15.6)

Induced abortion, n (%)

3 (4.7)

Abbreviation: RCTs = randomized controlled trial.

a There were 5 cases of congenital malformations reported, including 1 case each of heart abnormality, multiple gestation (triplets) with low birth weight, abnormal growth on ultrasound, webbed finger, and widening of the right pelvis.

b Of the 51 live births, 44 (86.3%) were full term, 5 (9.8%) were premature, and details were unknown for the remaining 2 (3.9%) patients.

Axial Spondyloarthritis Trials

In partners of male patients exposed to ixekizumab during their participation in ixekizumab studies, 5 pregnancies occurred as of April 1, 2019. As of the data cutoff date for the 5 reported cases (numbers 1-5 below represent separate cases):

  1. Partner of the patient did not consent to follow-up.

  2. No complications related to the pregnancy were reported. 

  3. No complications related to the pregnancy were reported.

  4. Lost to follow-up as patient did not agree to provide further information about the pregnancy as of April 1, 2019.

  5. No AEs were reported for the male patient, the female partner of the patient, the fetus, or related to the pregnancy.2

References

1. Taltz [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. Feldman SR, Pangallo BA, Xu W, et al. Ixekizumab and pregnancy outcome. Poster presented at: 75th Annual Meeting of the American Academy of Dermatology; March 3-7, 2017; Orlando, FL. https://www.aad.org/eposters/Submissions/getFile.aspx?id=4532&type=sub

4. Egeberg A, Kimball AB, Feldman SR, et al. Ixekizumab and pregnancy outcomes in patients with psoriasis or psoriatic arthritis. Poster presented at: 28th European Academy of Dermatology and Venereology Congress; October 9-13, 2019; Madrid, Spain.

Glossary

AE = adverse event

AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis

IgG = immunoglobulin G

IgG4 = immunoglobulin G subclass 4

nr-axSpA = nonradiographic axial spondyloarthritis

PsA = psoriatic arthritis

PsO = psoriasis

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 2020 M03 18


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