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Taltz ® (ixekizumab)
This information is intended for UK registered healthcare professionals only in response to your search for information. For current information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk
Medication for injection site reactions with Taltz® (ixekizumab)
In the psoriasis trials, 5 % of patients who experienced injection site reactions with the original ixekizumab formulation reported receiving a concomitant medication for injection site reactions.
Content overview
Injection Site Reactions as a Side Effect of Ixekizumab
Injection site reactions (ISR) were one of the most frequently reported side effects with Ixekizumab. The most frequent injection site reactions observed were erythema and pain. These reactions were predominantly mild to moderate in severity and did not lead to discontinuation of Taltz.1
These results were obtained with the original formulation of Taltz that contained citrate. Meanwhile, a citrate-free formulation is available. In a single-blinded, randomised cross-over study in 45 healthy subjects comparing the original formulation with the revised, citrate-free formulation, statistically significantly lower pain scores were obtained with the citrate-free vs. the original formulation during injection.1
Of note, the ixekizumab injection sites may be altered. If possible, areas of the skin that show psoriasis should be avoided as injection sites.1
For complete information, please refer to the Taltz Summary of Product Characteristics, in particular the section
- 4.2 Posology and method of administration
- 4.8 Undesirable effects
Detailed instructions on choosing the injection sites are provided in the Instructions of Use for the Taltz pre-filled pen or pre-filled syringe, which comes with the device, in particular the section2,3
- Section 1 Get ready
Below, you may find further information on the type of concomitant medications that patients who experienced injection site reactions used. A description of the clinical studies is available in section 5.1 of the Summary of Product Characteristics.
Detailed information on the medication for injection site reactions after administration of ixekizumab
The information regarding injection site reactions (ISRs) and concomitant treatment for ISRs included in this response is from trials using the original formulation of ixekizumab that contained citrate. No information is available regarding concomitant medications used to treat ISRs in studies of the currently marketed citrate-free formulation of ixekizumab.
The information included in this response is specific to medications that were used to treat ISRs that were reported from an overall psoriasis safety database across 18 clinical trials in adult and pediatric patients. The information provided is for reference only and does not constitute a treatment recommendation. Health care decisions to use concomitant medications in patients who experience ISRs with the use of ixekizumab should be based on the best clinical judgment of the prescribing health care practitioner.
Treatment-emergent adverse events (TEAEs) were evaluated using Medical Dictionary for Regulatory Activities (MedDRA) terms. These were defined as events that first occurred or worsened in severity, relative to baseline, at any time during a clinical study. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a TEAE of the type listed. Adverse events (AEs) reported during the studies were not necessarily caused by the therapy and the frequencies do not reflect investigator assessment of causality.
Treatment of injection site reactions in the psoriasis clinical trials
One of the most commonly reported AEs with the commercial ixekizumab formulation was ISRs. Injection site reactions were predominantly mild-to-moderate in severity and did not lead to discontinuation of ixekizumab.4
Concomitant Medications Allowed for the Treatment of ISRs in the Psoriasis Clinical Trials
In the ixekizumab trials, patients were allowed to use over-the-counter
- analgesics,
- antihistamines,
- topical antihistamines and
- topical steroids.5
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.6
Among those who received treatment, the majority received antihistamines.6
In an analysis of patients across 18 psoriasis trials, 55 of the 1096 patients (5.0%) who experienced a treatment-emergent ISR were reported to have received a concomitant medication to treat the ISR.4 Concomitant Medications Provided for Treatment-Emergent ISRs Across 18 Psoriasis Clinical Trials summarizes the concomitant medications used to treat ISRs in the all psoriasis ixekizumab safety population (N=7088 total patients) across 18 clinical trials in adult and pediatric patients with psoriasis.4
|
n (%) |
Total patients with treatment-emergent ISR (N=1096) |
|
Patients with at least 1 concomitant medication for indication of ISR |
55 (5.0) |
Patients treated with concomitant medications for indication of ISR (N=55)a |
|
Diphenhydramine |
14 (25.5) |
Cetirizine |
13 (23.6) |
Loratadine/Desloratidineb |
7 (12.7) |
Paracetamol |
5 (9.1) |
Topical corticosteroidc |
6 (10.9) |
Topical antihistamined |
5 (9.1) |
Abbreviation: ISR = injection site reaction.
aConcomitant medications listed reflect those reported as ISR for indication in at least 5 patients. Values reflect percentages of patients who reported use of at least one concomitant medication for ISR. Patients may have received greater than one concomitant medication for ISR.
bDesloratidine (n=3), loratidine (n=3), loratidine with pseudoephedrine (n=1).
cTopical 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: Potent - betamethasone valerate, fluocinolone acetonide, fluocinonide, methylprednisolone aceponate; Very potent - clobetasol propionate; Weak - hydrocortisone.
dDimetindene maleate (n=3), diphenhydramine hydrochloride (n=1), fenistil (n=1).
References
1Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland [UK]
2Taltz syringe [instructions for use]. Eli Lilly and Company (Ireland) Limited, Ireland [UK]
3Taltz autoinjector [instructions for use]. Eli Lilly and Company (Ireland) Limited, Ireland [UK]
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5Gordon 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
6Shear 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
Links to references and third-party websites are provided solely for your convenience and to facilitate easy access to the sources cited.
Date of Last Review: 31 May 2024