Pediatric Safety


Safety profile of Taltz in IXORA-PEDS is consistent with adult psoriasis trials: no new safety signals observed1,2

Clinically relevant adverse events of special interest through week 121,2

Safety adverse 12 week

List is not all-inclusive.

Overall, the safety profile observed in pediatric patients with PsO treated with Taltz every 4 weeks is consistent with the safety profile in adult patients with PsO, with the exception of the frequencies of conjunctivitis (3%), influenza (2%), and urticaria (2%) in the pediatric population.

Crohn’s disease occurred at a greater frequency in the Taltz group (0.9%) than the placebo group (0%) during the 12-week, placebo-controlled period. Crohn’s disease occurred in a total of 4 Taltz treated subjects (2.0%) through 48 weeks.

*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 Taltz.

References: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020. 2. Data on file. Lilly USA, LLC. DOF-IX-US-0217.

Indications and Important Safety Information

Taltz is indicated for patients as young as age 6 with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. Taltz is also indicated for adult patients with active psoriatic arthritis (PsA). Taltz is also indicated for adult patients with active ankylosing spondylitis (AS).

Important Safety Information
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

Taltz may increase the risk of infection. In clinical trials of adult patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of adult patients with psoriatic arthritis and ankylosing spondylitis, and pediatric patients with plaque psoriasis. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

Pre-Treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Closely monitor patients receiving Taltz for signs and symptoms of active TB during and after treatment.

Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the Taltz group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post-marketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inflammatory Bowel Disease
Patients treated with Taltz may be at an increased risk of inflammatory bowel disease. In clinical trials, Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group than the placebo group. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.

Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.

Most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profiles observed in adult patients with psoriatic arthritis and ankylosing spondylitis and pediatric patients with plaque psoriasis were consistent with the safety profile in adult patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis and conjunctivitis, influenza, and urticaria in pediatric psoriasis.

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