Indicated for:

Plaque Psoriasis:

• The treatment of patients 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Psoriatic Arthritis:

• The treatment of adult patients with active psoriatic arthritis.

TALTZ may be administered alone or in combination with a conventional disease modifying antirheumatic drug (cDMARD) (e.g., methotrexate).

Ankylosing Spondylitis:

• The treatment of adult patients with active ankylosing spondylitis.

Non-Radiographic Axial Spondyloarthritis:

• The treatment of adult patients with active non-radiographic axial spondyloarthritis (nraxSpA) with objective signs of inflammation.

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. Consider anti-TB therapy prior to initiating TALTZ in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving TALTZ should be monitored closely for signs and symptoms of active TB during and after treatment.

TALTZ may increase the risk of infection. In clinical trials in adult patients with plaque psoriasis, the TALTZ group had a higher rate of infections than the placebo group. Upper respiratory tract infections, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in the TALTZ 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 non-radiographic axial spondyloarthritis.

Patients treated with TALTZ may be at 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 control group.

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.

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.

TALTZ, an antagonist of IL-17A, could normalize the formation of CYP450 enzymes. Therefore, upon initiation or discontinuation of TALTZ in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.

There are no available data on TALTZ use in pregnant women to inform any drug associated risks. Human IgG is known to cross the placental barrier; therefore, TALTZ may be transmitted from the mother to the developing fetus.

There are no data on the presence of ixekizumab in human milk, the effects on the breastfed infant, or the effects on milk production. Ixekizumab was detected in the milk of lactating cynomolgus monkeys.

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• Use in patients under the age of 6. GoToSource

• Pyoderma gangrenosum. GoToSource

Eczema (inflammatory skin condition), seborrheic dermatitis (inflammatory skin condition) and urticaria (hives). GoToSource

Fungal infections (including pneumocystis, jirovecii pneumonia, histoplasmosis, and candidiasis). GoToSource

Paradoxical reactions (including palmoplantar pustular and psoriasiform reactions, psoriatic arthritis, hidradenitis, uveitis, pyoderma gangrenosum, granulomatous reactions and vasculitis). GoToSource

Nasopharyngitis, upper respiratory tract infection, injection-site reaction, pruritus (severe itching), crohn’s disease, ulcerative colitis, cellulitis (bacterial skin infection), oral candidiasis (yeast infection of mouth and throat) and neutropenia (low level of neutrophils a type of white blood cell). GoToSource

Lawsuits filed for immune related reactions, upper respiratory tract infections and fungal infections.