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Taltz ® (ixekizumab) injection
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.
Does Taltz® (ixekizumab) have any safety warnings or precautions?
Information on warnings and precautions from Taltz USPI is summarized below.
Indications and Usage
Ixekizumab is indicated for the treatment of
- patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
- adults with active psoriatic arthritis (PsA)
- adults with active ankylosing spondylitis/radiographic axial spondyloarthritis (AS/r-axSpA), and
- adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.1
Warnings and Precautions
Ixekizumab may increase the risk of infection. In clinical trials in patients with plaque psoriasis, the rate of infections was
- 27% in the ixekizumab groups, and
- 23% in the placebo group.1
Infections that occurred more frequently in the ixekizumab group than in the placebo group were
- upper respiratory tract infection
- oral candidiasis
- conjunctivitis, and
- tinea infections.1
A similar increase in risk of infection was seen in placebo-controlled trials in patients with
- pediatric psoriasis
- AS/r-axSpA, and
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 ixekizumab to patients with active TB infection. Initiate treatment of latent TB prior to administering ixekizumab. Consider anti-TB therapy prior to initiation of ixekizumab in patients with a 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
Serious hypersensitivity reactions occurred in the ixekizumab group in clinical trials.1
- Both angioedema and urticaria occurred at a rate of ≤0.1% each.
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
Inflammatory Bowel Disease
Patients treated with ixekizumab may be at an 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 in the placebo group. During ixekizumab treatment, monitor for onset or exacerbation of IBD. If IBD occurs, discontinue ixekizumab and initiate appropriate medical management.1
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
Enclosed Prescribing Information
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.
Date of Last Review: October 11, 2023