Taltz ® (ixekizumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Taltz Summary of Product Characteristics (SmPC)

Taltz® (ixekizumab): What is the recommendation, when a dose is missed by patients with axial spondyloarthritis?

The Taltz Summary of Product Characteristics does not contain any specific recommendation on how to proceed when a dose is missed. Please refer to the additional information provided in the response below.

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

Date of Last Review: April 15, 2020


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