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Taltz ® (ixekizumab) injection
80 mg/mLThis information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
TALTZ® (ixekizumab): Hypersensitivity Reactions in the Pediatric Psoriasis Clinical Trial
Ixekizumab is contraindicated in patients with known serious hypersensitivity to ixekizumab or to any of the excipients. In the all exposure population of IXORA-PEDS, 16 patients reported a nonanaphylactic allergic reaction/hypersensitivity TEAE.
US_cFAQ_IXE359_HYPERSENSITIVITY_REACTION_PEDS
en-US
Hypersensitivity-Related Label Information
IXORA-PEDS is an ongoing, multicenter, randomized, double-blind, placebo-controlled phase 3 study designed to evaluate the efficacy and safety of ixekizumab in pediatric patients aged 6 to <18 years with moderate-to-severe plaque psoriasis.1
Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the ixekizumab group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post marketing use with ixekizumab. If a serious hypersensitivity reaction occurs, discontinue ixekizumab immediately and initiate appropriate therapy.2
Ixekizumab is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.2
Allergic Reaction/Hypersensitivity Treatment-Emergent Adverse Events in IXORA-PEDS
A summary of allergic reaction/hypersensitivity TEAEs are provided in IXORA-PEDS: Allergic Reaction/Hypersensitivity Treatment-Emergent Adverse Events in the Double-Blind Treatment Period and Combined Treatment Periods. All TEAEs were nonanaphylactic in nature.3
In the double-blind treatment period of IXORA-PEDS, 6 (5.2%) ixekizumab-treated patients and 1 (1.8%) patient in the placebo arm reported an allergic reaction/hypersensitivity TEAE. There were no severe or serious allergic reaction/hypersensitivity AEs. No patients discontinued study drug due to an allergic reaction/hypersensitivity AE.3
In the all ixekizumab exposure population, as of the November 25, 2019 database lock, 16 (8.2%) patients reported a total of 17 allergic reaction/hypersensitivity TEAEs. There were no allergic reaction/hypersensitivity SAEs. No patients discontinued study treatment due to an allergic reaction/hypersensitivity AE.3
Across 14 pooled psoriasis trials including 13 adult trials and IXORA-PEDS (N=6091, accounting for 17,499.3 PYs of total ixekizumab exposure),
- there were no confirmed cases of anaphylaxis, and
- the IR of hypersensitivity was 5.1 per 100 PYs.3
|
12-Week Double-Blind Treatment Period |
Combined Treatment Periods |
|
|
Placebo |
Ixekizumab Q4W |
Total Ixekizumab |
Urticaria |
0 |
2 (1.7) |
3 (1.5) |
Bronchospasm |
0 |
1 (0.9) |
1 (0.5) |
Dermatitis atopic |
0 |
1 (0.9) |
4 (2.0) |
Eczema |
0 |
1 (0.9) |
1 (0.5) |
Rash maculo-papular |
0 |
1 (0.9) |
1 (0.5) |
Rash pustular |
1 (1.8) |
0 |
0 |
Dermatitis |
0 |
0 |
1 (0.5) |
Drug eruption |
0 |
0 |
1 (0.5) |
Eye edema |
0 |
0 |
1 (0.5) |
Injection related reaction |
0 |
0 |
1 (0.5) |
Rash |
0 |
0 |
1 (0.5) |
Skin Reaction |
0 |
0 |
1 (0.5) |
Swelling of eyelid |
0 |
0 |
1 (0.5) |
Abbreviations: PY = patient-years; Q4W = every 4 weeks.
aIncludes induction, maintenance, and extension periods through the 48-week database lock (253.9 total PY of ixekizumab exposure), including patients switched to ixekizumab from placebo or etanercept following the double-blind induction treatment period.
Enclosed Prescribing Information
References
1Paller AS, Seyger MMB, Magariños GA, et al. Efficacy and safety of ixekizumab in a phase 3, randomized, double-blind, placebo-controlled study in pediatric patients with moderate-to-severe plaque psoriasis. Talk presented at: 28th Annual Meeting of the European Academy of Dermatology and Venereology; October 9-13, 2019; Madrid, Spain.
2Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021.
3Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
AE = adverse event
IR = incidence rate
PY = patient-years
SAE = serious adverse event
TEAE = treatment-emergent adverse event
Date of Last Review: March 26, 2020
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