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FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Dermatology efficacy taltz header

Trial design


SELECT IMPORTANT SAFETY INFORMATION
HYPERSENSITIVITY

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.


References: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019. 2. Data on file. Lilly USA, LLC. TAL20160223C. 3. Data on file. Lilly, USA, LLC. TAL20160328C. 4. Data on File. Lilly USA, LLC. TAL20160222D. 5. Data on File. Lilly USA, LLC. TAL20160222A. 6. Data on File. Lilly USA, LLC. TAL20160222E. 7. Data on File. Lilly USA, LLC. TAL20160222B. 8. ClinicalTrials.gov Identifier: NCT03151551. 9. ClinicalTrials.gov Identifier: NCT02561806. 10. ClinicalTrials.gov Identifier: NCT03573323. 11. Data on file. Lilly USA, LLC. DOF-IX-US-0006. 12. Data on file. Lilly USA, LLC. DOF-IX-US-0121. 13. Mease PJ, van der Heijde D, Ritchlin CT, et al; on behalf of SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017;76:79-87. 14. Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389:2317-2327. Supplementary appendix. 15. Data on file. Lilly USA, LLC. TAL20171127A. 16. Data on file. Lilly USA, LLC. DOF-IX-US-0125. 17. Reich K, Leonardi C, Lebwohl M, et al. Sustained response with ixekizumab treatment of moderate-to-severe psoriasis with scalp involvement: results from three phase trials (UNCOVER-1, UNCOVER-2, UNCOVER-3). J Dermatolog Treat. 2017;28:282-287. 18. Data on file. Lilly USA, LLC. TAL20170829F. 19. Dennehy EB, Zhang L, Amato D, Goldblum O, Rich P. Ixekizumab is effective in subjects with moderate to severe plaque psoriasis with significant nail involvement: results from UNCOVER 3. J Drugs Dermatol. 2016;15:958-961. 20. Data on file. Lilly USA, LLC. TAL20170829B. 21. Ryan C, Menter A, Guenther L, et al; on behalf of IXORA-Q Study Group. Efficacy and safety of ixekizumab in a randomized, double-blinded, placebo-controlled phase 3b study of patients with moderate-to-severe genital psoriasis [published online ahead of print May 10, 2018]. Br J Dermatol. 2018. doi:10.1111/bjd.16736. 22. Data on file. Lilly USA, LLC. DOF-IX-US-0014. 23. Menter A, Warren RB, Langley RG, et al. Efficacy of ixekizumab compared to etanercept and placebo in patients with moderate-to-severe plaque psoriasis and non-pustular palmoplantar involvement: results from three phase 3 trials (UNCOVER-1, UNCOVER-2 and UNCOVER-3). J Eur Acad Dermatol Venereol. 2017;31:1686-1692. 24. Data on file. Lilly USA, LLC. TAL20170829D. 25. Data on file. Lilly USA, LLC. TAL20171219A. 26. Data on file. Lilly USA, LLC. DOF-IX-US-0010.

Indications and Important Safety Information
Indications

Taltz is indicated for your adult patients with active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).

Taltz is also indicated for your adult patients with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

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

WARNINGS AND PRECAUTIONS
Infections
Taltz may increase the risk of infection. In clinical trials of 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 patients with psoriatic arthritis and ankylosing spondylitis. 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.

Hypersensitivity
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
During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease. Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz 80 mg Q2W group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis and in the Taltz Q4W group in ankylosing spondylitis trials (Crohn’s disease 1.0% [2 patients], ulcerative colitis 0.5% [1 patient]) than in the placebo group (Crohn’s disease 0.5% [1 patient], ulcerative colitis 0%). In the ankylosing spondylitis trials, serious events occurred in 1 patient in the Taltz group and 1 patient in the placebo group.

Immunizations
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.

ADVERSE REACTIONS
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 patients with psoriatic arthritis and ankylosing spondylitis were consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis.

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IX HCP ISI 23AUG2019