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Taltz ® (ixekizumab)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
What is Recommended to Treat Injection Site Reactions Caused by Taltz® (ixekizumab) in Psoriasis Patients?
There is no specific recommendation for the treatment of Injection Site Reactions.
UK_cFAQ_IXE410_ISR_ISR_TREATMENT_CONCOMITANT_MEDS_PsO
en-GB
Are Injection Site Reactions Common Adverse Events?
ISRs were one of the most frequently reported adverse events (AE) with ixekizumab. The most frequent injection site reactions observed were erythema and pain.1
Is it Necessary to Discontinue Ixekizumab Because of Injection Site Reactions?
ISRs were predominantly mild to moderate in severity and did not lead to discontinuation of ixekizumab.1
How were Injection Site Reactions Treated in the Psoriasis Clinical Trials?
In the clinical trials, patients were allowed to use over-the-counter
- analgesics,
- antihistamines,
- topical antihistamines and
- topical steroids.2
Does a Injection Site Reaction Need Treatment in Any Case?
Concomitant medication to treat injection site reactions (ISR) was uncommonly used. It was used in
- 1.5% of patients treated with ixekizumab every 2 weeks (Q2W) and
- 1.6% of patients treated with etanercept during the first 12 weeks of the UNCOVER studies.3
Across 7 clinical trials out of 661 patients with treatment-emergent ISR (all psoriasis ixekizumab safety population; N=4209 total patients)
- 53 (8.0%) patients received at least one concomitant medication, and
- 608 (92.0%) patients had no concomitant ISR treatment (April 2015 data cutoff).4
Which Treatment was Preferably Used in the Psoriasis Clinical Trials?
Most patients treated for ISR received antihistamines.3
Concomitant Medications Provided for Treatment-Emergent ISRs Across 7 Psoriasis Clinical Trials summarizes the concomitant medications.
Patients Treated with Concomitant Medications for Indication of ISR (N=53)b |
n (%) |
Diphenhydramine |
14 (26.4) |
Cetirizine |
13 (24.5) |
Loratidine/Desloratidinec |
6 (11.3) |
Paracetamol |
5 (9.4) |
Topical corticosteroidd |
5 (9.4) |
Topical antihistaminee |
5 (9.4) |
Abbreviation: ISR = injection site reaction.
aAll psoriasis ixekizumab safety population (N=4209 total patients); Data cutoff of April 2015.
bConcomitant medications listed reflect those reported as ISR for indication in at least 5 patients. Values reflect percentages of all patients who reported use of at least one concomitant medication for ISR. Patients may have received greater than one concomitant medication for ISR.
cDesloratidine (n=3), loratidine (n=2), loratidine with pseudoephedrine (n=1).
dTopical corticosteroids across potency classes were allowed during the open-label treatment period in the UNCOVER studies for any indication for use. The topical corticosteroids referenced in this table given for the indication of ISR (n=1 for each medication listed) consist of betamethasone valerate, fluocinonide, methylprednisolone aceponate (Potent); clobetasol propionate (Very Potent); and hydrocortisone (Weak).
eDimetindene maleate (n=4), diphenhydramine hydrochloride (n=1).
What is the Best Way to Administer the Ixekizumab Injection?
Ixekizumab is for subcutaneous injection.1
The package leaflet and the user manual give further comprehensive instructions for administration.1
What Does Eli Lilly and Company Recommend?
The information provided is for reference only and does not constitute a treatment recommendation.
It is the decision of the prescribing health care practitioner whether to use concomitant medications in patients who experience ISRs with the use of ixekizumab.
References
1Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland
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
3Shear NH, Paul C, Blauvelt A, et al. Safety and tolerability of ixekizumab: integrated analysis of injection-site reactions from 11 clinical trials. J Drugs Dermatol. 2018;17(2):200-206. http://jddonline.com/articles/dermatology/S1545961618P0200X
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: 14 May 2021
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