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Taltz ® (ixekizumab) injection
80 mg/mL
This 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.
What are the most common side effects in patients treated with Taltz® (ixekizumab)?
Most common side effects and safety information from the ixekizumab label are summarized below.
Content Overview
- What are the contraindications for ixekizumab?
- What are the warnings and precautions for ixekizumab?
- What adverse reactions were reported in ixekizumab clinical trials?
- Reference
What are the contraindications for ixekizumab?
Ixekizumab is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.1
What are the warnings and precautions for ixekizumab?
Infections: Ixekizumab may increase the risk of infection. In clinical trials in adult patients with plaque psoriasis, the ixekizumab group had a higher rate of infections than the placebo group (27% vs 23%). Upper respiratory tract infections, oral candidiasis, conjunctivitis, and tinea infections occurred more frequently in the ixekizumab group than in the placebo group. A similar increase in risk of infection was seen in placebo-controlled trials in patients with pediatric psoriasis, psoriatic arthritis, ankylosing spondylitis, and nonradiographic axial spondyloarthritis.1
In the postmarketing setting, serious bacterial, viral, and fungal opportunistic infections have been reported in patients receiving interleukin-17 inhibitors including ixekizumab. Instruct patients treated with ixekizumab to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy, monitor the patient closely and discontinue ixekizumab until the infection resolves.1
Pretreatment Evaluation for Tuberculosis: Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ixekizumab. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering ixekizumab. Consider anti-TB therapy prior to initiating ixekizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ixekizumab should be monitored closely for signs and symptoms of active TB during and after treatment.1
Hypersensitivity: 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 postmarketing use with ixekizumab. If a serious hypersensitivity reaction occurs, discontinue ixekizumab immediately and initiate appropriate therapy.1
Eczematous Eruptions: In the postmarketing setting, cases of severe eczematous eruptions, including atopic dermatitis–like eruptions, dyshidrotic eczema, and erythroderma were reported in patients receiving ixekizumab; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of ixekizumab. Treatment may need to be discontinued to resolve the eczematous eruption. Some patients with limited psoriasis treatment options were successfully treated for eczema while continuing ixekizumab.1
Inflammatory Bowel Disease: Patients treated with ixekizumab may be at increased risk of inflammatory bowel disease (IBD). In clinical trials, Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the ixekizumab group than the placebo control group. During ixekizumab treatment, monitor for onset or exacerbation of IBD and if IBD occurs, discontinue ixekizumab and initiate appropriate medical management.1
Immunizations: Prior to initiating therapy with ixekizumab, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with ixekizumab. No data are available on the response to live vaccines.1
What adverse reactions were reported in ixekizumab clinical trials?
Adult Plaque Psoriasis
Data from 3 placebo-controlled trials in subjects with plaque psoriasis were integrated to evaluate the safety of ixekizumab compared to placebo for up to 12 weeks. A total of 1167 subjects (mean age 45 years; 66% men; 94% White) with plaque psoriasis received ixekizumab (160 mg at week 0, 80 mg every 2 weeks [Q2W] for 12 weeks) subcutaneously. In 2 of the trials, the safety of ixekizumab (use up to 12 weeks) was also compared with an active comparator, US-approved etanercept.1
Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the ixekizumab group than in the placebo group during the 12-week placebo-controlled period of the pooled clinical trials.1
Adverse Reactionsa |
Ixekizumab 80 mg Q2W |
Etanerceptb |
Placebo |
|---|---|---|---|
Injection site reactions |
196 (17) |
32 (11) |
26 (3) |
Upper respiratory tract infectionsc |
163 (14) |
23 (8) |
101 (13) |
Nausea |
23 (2) |
1 (<1) |
5 (1) |
Tinea infections |
17 (2) |
0 (0) |
1 (<1) |
Abbreviations: N = number of patients in the treatment group; Q2W = every 2 weeks.
a Data are presented as n (%).
b US-approved etanercept.
c Upper respiratory tract infections cluster includes nasopharyngitis and rhinovirus infection.
Adverse reactions that occurred at rates less than 1% in the ixekizumab group and more frequently than in the placebo group during the 12-week induction period included
- rhinitis
- oral candidiasis
- urticaria
- influenza
- conjunctivitis
- inflammatory bowel disease, and
- angioedema.1
Pediatric Plaque Psoriasis
Ixekizumab was evaluated in a placebo-controlled trial in pediatric subjects with moderate-to-severe psoriasis 6 to less than 18 years of age. A total of 171 subjects were studied (115 subjects on ixekizumab and 56 subjects on placebo).1
Overall, the safety profile observed in pediatric subjects with plaque psoriasis treated with ixekizumab every 4 weeks is consistent with the safety profile in adult subjects with plaque psoriasis with the exception of the frequencies of
- conjunctivitis (2.6%)
- influenza (1.7%), and
- urticaria (1.7%).1
Psoriatic Arthritis
Ixekizumab was studied in 2 placebo-controlled trials in patients with psoriatic arthritis. A total of 678 patients were studied (454 patients on ixekizumab and 224 on placebo). A total of 229 patients in these trials received ixekizumab 160 mg at week 0, followed by 80 mg every 4 weeks (Q4W). Overall, the safety profile observed in patients with psoriatic arthritis treated with ixekizumab Q4W is consistent with the safety profile in adult patients with plaque psoriasis with the exception of the frequencies of influenza (1.3%) and conjunctivitis (1.3%).1
Ankylosing Spondylitis
Ixekizumab was studied in 2 placebo-controlled trials in patients with ankylosing spondylitis. A total of 566 patients were studied (376 patients on ixekizumab and 190 on placebo). A total of 195 patients in these trials received ixekizumab 80 or 160 mg at week 0, followed by 80 mg Q4W. Overall, the safety profile observed in patients with ankylosing spondylitis treated with ixekizumab Q4W is consistent with the safety profile in adult patients with plaque psoriasis.1
In adult patients with ankylosing spondylitis, Crohn’s disease and ulcerative colitis, including exacerbations, occurred in 2 patients (1.0%) and 1 patient (0.5%), respectively, in the ixekizumab 80 mg Q4W group and 1 patient (0.5%) and 0%, respectively, in the placebo group during the 16-week, placebo-controlled period in clinical trials. Of these patients, serious events occurred in 1 patient in the ixekizumab 80 mg Q4W group and 1 patient in the placebo group.1
Nonradiographic Axial Spondyloarthritis
Ixekizumab was studied in a placebo-controlled trial in patients with nonradiographic axial spondyloarthritis. A total of 303 patients were studied (198 patients on ixekizumab and 105 on placebo). A total of 96 patients in this trial received ixekizumab 80 or 160 mg at week 0, followed by 80 mg Q4W. Overall, the safety profile observed in patients with nonradiographic axial spondyloarthritis treated with ixekizumab 80 mg Q4W up to week 16 is consistent with the previous experience of ixekizumab in other indications.1
Injection Site Reactions
In the adult plaque psoriasis trials, the most frequent injection site reactions were erythema and pain. Most injection site reactions were mild to moderate in severity and did not lead to discontinuation of ixekizumab.1
Laboratory Assessment of Neutropenia
Over the entire treatment period (weeks 0 to 60), neutropenia occurred in 11% of subjects treated with ixekizumab (0.24 per subject-year of follow-up) compared to 3% of subjects treated with placebo (0.14 per subject-year of follow-up). In subjects treated with ixekizumab, the incidence rate of neutropenia during weeks 13 to 60 was lower than the incidence rate during weeks 0 to 12.1
In the 12-week, placebo-controlled period, neutropenia ≥ Grade 3 (<1,000 cells/mm3) occurred in 0.2% of the ixekizumab group (0.007 per subject-year of follow-up) compared to 0.1% of the placebo group (0.006 per subject-year of follow-up). The majority of cases of neutropenia were either Grade 2 (2% for ixekizumab 80 mg Q2W versus 0.3% for placebo; ≥1,000 to <1,500 cells/mm3) or Grade 1 (7% for ixekizumab 80 mg Q2W versus 3% for placebo; ≥1,500 cells/mm3 to <2,000 cells/mm3). Neutropenia in the ixekizumab group was not associated with an increased rate of infection compared to the placebo group.1
Immunogenicity
Adult Plaque Psoriasis: By week 12, approximately 9% of adult subjects treated with ixekizumab Q2W developed antibodies to ixekizumab. Approximately 22% of subjects treated with ixekizumab at the recommended dosing regimen developed antibodies to ixekizumab during the 60-week treatment period. The clinical effects of antibodies to ixekizumab are dependent on the antibody titer; higher antibody titers were associated with decreasing drug concentration and clinical response.1
Of the adult subjects who developed antibodies to ixekizumab during the 60-week treatment period, approximately 10%, which equates to 2% of subjects treated with ixekizumab at the recommended dosing regimen, had antibodies that were classified as neutralizing. Neutralizing antibodies were associated with reduced drug concentrations and loss of efficacy.1
Psoriatic Arthritis: For subjects treated with ixekizumab 80 mg Q4W for up to 52 weeks (SPIRIT-P1), 11% developed antidrug antibodies, and 8% had confirmed neutralizing antibodies.1
Ankylosing Spondylitis: For patients treated with ixekizumab 80 mg Q4W for up to 16 weeks (COAST-V, COAST-W), 5.2% developed antidrug antibodies, and 1.5% had neutralizing antibodies.1
Nonradiographic Axial Spondyloarthritis: Of patients treated with ixekizumab 80 mg Q4W for up to 52 weeks (COAST-X), 8.9% developed antidrug antibodies, all of which were low titer. No patient had neutralizing antibodies.1
Pediatric Plaque Psoriasis: In pediatric psoriasis subjects treated with ixekizumab at the recommended dosing regimen up to 12 weeks, 21 subjects (18%) developed antidrug antibodies, and 5 subjects (4%) had confirmed neutralizing antibodies associated with low drug concentrations. No conclusive evidence could be obtained on the potential association of neutralizing antibodies and clinical response and/or adverse events due to the small number of pediatric subjects in the study.1
Enclosed Prescribing Information
TALTZ® (ixekizumab) injection, for subcutaneous use, Lilly
Reference
- Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
Date of Last Review: July 09, 2026