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): Premedication Use Prior to Injection

The decision whether to premedicate a patient should be made at the discretion of the prescribing physician.

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

  • mild-to-moderate skin rashes

  • mild-to-moderate generalized pruritus or urticaria, and

  • mild-to-moderate ISRs (eg, injection-site erythema, injection-site pruritus, etc).1,2

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.

References

1. 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

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

3. Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

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

axSpA = axial spondyloarthritis

ISR = injection site reaction

nr-axSpA = nonradiographic axial spondyloarthritis

Date of Last Review: September 25, 2020


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