Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Taltz® (ixekizumab): Vad är rekommendationen vid missad dos vid axiell spondyloartrit?

Taltz produktresumé innehåller inga specifika rekommendationer om hur man ska gå tillväga vid missad dos. Se ytterligare information i svaret nedan.

Additional Information

The US Taltz package insert states that if a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.1

In the ixekizumab clinical development program, ixekizumab was administered at approximately the same time each day, as much as possible.2,3

For the pivotal COAST-V AS/r-axSpA clinical trial, injections not administered on the scheduled day were to be administered

  • within 3 days of the scheduled day from week 0 to week 16, and

  • within 5 days of the scheduled day after week 16.3

For the pivotal COAST-W AS/r-axSpA clinical trial, the missed injection was to be administered as soon as possible but not within 5 days of the next scheduled dose. Injections were to be at least 5 days apart and subsequent study visits were not to be modified according to this delay.3

For the pivotal COAST-X nr-axSpA clinical trial, the missed injection was to be administered as soon as possible but not within 5 days of the next scheduled dose. Injections were to be at least 5 days apart and subsequent study visits were not to be modified according to this delay.3

References

1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.

2. Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711

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

Glossary

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

nr-axSpA = nonradiographic axial spondyloarthritis

Datum fӧr senaste ӧversyn 2020 M04 15


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