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Taltz ® (ixekizumab)
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Taltz® (ixekizumab): Can the Patient use Premedication before Injection?
The prescribing physician decides whether to premedicate a patient.
Table of Contents
Protocols for Premedication in the Clinical Trials
According to the protocols for psoriasis and psoriatic arthritis, and axSpA (including AS/r-axSpA and nr-axSpA) trials, if a patient experienced an acute allergic/hypersensitivity reaction after injection of investigational product, consideration for any premedication for future injections was agreed upon between the investigator and sponsor and/or its designee.
- Medications considered appropriate for premedication included but were not restricted to acetaminophen/paracetamol up to 1000 mg and antihistamines (for example, oral diphenhydramine 50 mg), given 30 to 60 minutes prior to investigational product injection.
- Patients were permitted to self-premedicate at home prior to administration of investigational product as directed by the investigator.1,2
Examples of potential allergic/hypersensitivity reactions that might merit premedication included
Please note that ixekizumab is contraindicated in patients with serious hypersensitivity to the active substance or to any of the excipients.3
Premedication in Clinical Trials
Of patients experiencing an ISR during the induction period of UNCOVER-1, -2, and -3, one patient who received ixekizumab used premedication for ISR when taking future injections.2
No patients who received ixekizumab during the 24-week double-blind treatment periods of SPIRIT-P1 and SPIRIT-P2 used premedication for ISR with future injections.2
No analysis has been conducted on patients who used premedication for ISR with future injections in axSpA trials.
1Gordon 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
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland
AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis
axSpA = axial spondyloarthritis
ISR = injection site reaction
nr-axSpA = nonradiographic axial spondyloarthritis
Date of Last Review: 25 September 2020