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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.
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
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),
|
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.
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.
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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