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FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Dermatology efficacy taltz header

Trial design


SELECT IMPORTANT SAFETY INFORMATION
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 exacerbation of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.


References: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020. 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: NCT03573323. 9. ClinicalTrials.gov Identifier: NCT02561806. 10. ClinicalTrials.gov Identifier: NCT01597245. 11. ClinicalTrials.gov Identifier: NCT01646177. 12. ClinicalTrials.gov Identifier: NCT03151551. 13. Data on file. Lilly USA, LLC. DOF-IX-US-0167. 14. Data on file. Lilly USA, LLC. DOF-IX-US-0006. 15. Data on file. Lilly USA, LLC. DOF-IX-US-0121. 16. 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. 17. 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. 18. Data on file. Lilly USA, LLC. TAL20171127A. 19. Data on file. Lilly USA, LLC. DOF-IX-US-0125. 20. 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. 21. Data on file. Lilly USA, LLC. TAL20170829F. 22. 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. 23. Data on file. Lilly USA, LLC. TAL20170829B. 24. 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. 25. Data on file. Lilly USA, LLC. DOF-IX-US-0014. 26. 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. 27. Data on file. Lilly USA, LLC. TAL20170829D. 28. Data on file. Lilly USA, LLC. TAL20171219A. 29. Data on file. Lilly USA, LLC. DOF-IX-US-0010. 30. Data on file. Lilly USA, LLC. DOF-IX-US-0141.

Indications and Important Safety Information
Indications

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
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 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.

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
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.

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 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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IX HCP ISI 26MAR2020