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Taltz ® (ixekizumab)
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What to do, when a Taltz® (ixekizumab) dose is missed?
The Taltz label does not contain a specific recommendation about what to do when a patient forgets a dose of ixekizumab.
Table of Contents
Information from the U.S. label
The U.S. Taltz package insert states that if a dose is missed, the dose should be administered as soon as possible. Thereafter, resume dosing at the regular scheduled time.1
After how many days was it still possible to make up for a missed dose in the clinical trials?
The following information describes the procedure in the clinical trials with ixekizumab. The treatment decision remains at the discretion of the treating physician.
Plaque Psoriasis
For the pivotal UNCOVER adult psoriasis clinical trials, injections not administered on the scheduled day were to be administered
- within 1 to 3 days of the scheduled day during the induction period (week 0-12), and
- within 5 days of the scheduled day after week 12.2
For the IXORA-PEDS pediatric psoriasis clinical trial, injections not administered on the scheduled day were to be administered within 5 days of the originally scheduled day. Dates of subsequent study visits were not to be modified according to the delay.3
Psoriatic Arthritis
For the pivotal SPIRIT psoriatic arthritis clinical trials, injections not administered on the scheduled day were to be administered
- within 3 to 4 days of the scheduled day from week 0 to week 24, and
- within 4 to 5 days of the scheduled day after week 24.3
Radiographic axial Spondyloarthritis
For the COAST-V ankylosing spondylitis/radiographic axial spondyloarthritis (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
Non-radiographic axial Spondyloarthritis
For the COAST-X nonradiographic axial spondyloarthritis (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
1Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.
2Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1, UNCOVER-2, and UNCOVER-3 Study Groups. 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
3Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: 18 April 2023