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).

How can injection site reactions with Taltz® (ixekizumab) be managed?

There is no specific recommendation for the treatment of Injection Site Reactions.

UK_cFAQ_IXE410_ISR_ISR_TREATMENT_CONCOMITANT_MEDS_PsO_CITRATE_FREE
UK_cFAQ_IXE410_ISR_ISR_TREATMENT_CONCOMITANT_MEDS_PsO_CITRATE_FREE
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 ixekizumab 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

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

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 18 Psoriasis Clinical Trials summarizes the concomitant medications.

Concomitant Medications Provided for Treatment-Emergent ISRs Across 18 Psoriasis Clinical Trials4


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)

Loratidine/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).

What is the Best Way to Administer the Ixekizumab Injection?

  • Ixekizumab is for subcutaneous injection.1

    • Injection sites may be alternated.1
    • The recommended places for injection of ixekizumab are the abdomen, thigh, or back of arm.4
    • If possible, areas of the skin that show psoriasis should be avoided as injection sites.1

The package leaflet and the user manual give further comprehensive instructions for administration.1

What Does Eli Lilly and Company Recommend?

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.

Original and Citrate-free Ixekizumab Formulation

The information regarding injection site reactions (ISRs) and concomitant treatment for ISRs included in this response is from trials using the commercial formulation of ixekizumab. No information is available regarding concomitant medications used to treat ISRs in studies of the citrate-free formulation 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: 15 December 2021


Contact Lilly

Call or Email us

If you want to ask a Medical Information question or you want to report an adverse event or product complaint you can call us or email us at ukmedinfo@lilly.com

Available Mon - Fri, 10am - 4pm, excluding Bank Holidays

Or you can

Chat with Us

Click to Chat is Offline

If you have a question, you can chat online with a Lilly Medical Information professional.

Submit a request