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
• PsA
• AS/r-axSpA, and
• nr-axSpA.1

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

The following adverse reactions have been identified during post-approval use of ixekizumab. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to ixekizumab exposure.1

• Infections: bacterial, viral, and fungal opportunistic infections, including cryptococcal meningoencephalitis, esophageal and disseminated mucocutaneous candidiasis, pulmonary tuberculosis, toxoplasmosis, varicella zoster virus reactivation, cytomegalovirus colitis, pulmonary aspergillosis.1

In the postmarketing setting, serious bacterial, viral, and fungal opportunistic infections have been reported in patients receiving interleukin-17 inhibitors including ixekizumab.1

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

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.1

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

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

Spontaneous reporting of adverse events can be highly variable and is not controlled clinical information on which to assess causality of a drug to an adverse event. Spontaneous reporting has limitations due to bias in reporting including incomplete information concerning the patient. In addition, the Global Patient Safety (GPS) spontaneous database may include reports of adverse events for products that are available from a variety of manufacturers. When verification of product manufactured by Eli Lilly and Company is not obtainable, these cases are included in the spontaneous database.