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ABOUT TALTZ

Mechanism of Action

Taltz is designed to specifically target IL-17A1,2*

Elevated levels of IL-17A have been implicated in the pathogenesis of psoriasis

  • IL-17A is a protein that plays a role in driving underlying inflammation in psoriasis
  • No formal pharmacodynamic studies of Taltz have been conducted

Taltz pharmacology

  • A humanized immunoglobulin G4 (IgG4) monoclonal antibody
  • Mean half-life (t½) is 13 days

*The relationship between the mechanism of action and clinical outcomes has not been determined.

Dosing

Once-monthly* maintenance dosing after the first 12 weeks1

Taltz Dosing Dosing Taltz Taltz Dosing

*Every 4 weeks.

For detailed administration instructions, please have patients read the Instructions for Use included with the device.

SELECT IMPORTANT ADMINISTRATION INFORMATION

Patients may self-inject after training in subcutaneous injection technique. Instruct patients to inject the full amount and not to inject where the skin is tender, bruised, red, thick, or affected by psoriasis.

Select Important Safety Information

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.

Devices

Designed with patients in mind3,4

At first use, over 94% of patients agreed the Taltz autoinjector was “easy to use” and were confident in their ability to use it.

Taltz Autoinjector and Prefilled Syringe Taltz Autoinjector and Prefilled Syringe

Please see Instructions for Use included with the device.

Trial A (N=204) was a phase 3, 12-week, multicenter, randomized, open-label trial in patients with moderate to severe plaque psoriasis. All patients received Taltz 80 mg every 2 weeks following a 160 mg starting dose. The primary objective was to evaluate the effect of the drug delivery device (prefilled syringe or autoinjector) on the pharmacokinetics of Taltz. Assessment of ease of administration was performed with the 12-item Subcutaneous Administration Assessment Questionnaire (SQAAQ) at weeks 0, 4, and 8.

References

  1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2016.
  1. Krueger JG, Fretzin S, Suárez-Fariñas M, et al. IL-17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis. J Allergy Clin Immunol. 2012;130:145-154.
  1. Data on file. Lilly USA, LLC. TAL20160201B.
  1. Callis Duffin K, Bukhalo M, Bobonich MA, et al. Usability of a novel disposable autoinjector device for ixekizumab: results from a qualitative study and an open-label clinical trial, including patient-reported experience. Med Devices (Auckl). 2016;9:361-369.

References

  1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2016.
  1. Krueger JG, Fretzin S, Suárez-Fariñas M, et al. IL-17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis. J Allergy Clin Immunol. 2012;130:145-154.
  1. Data on file. Lilly USA, LLC. TAL20160201B.
  1. Callis Duffin K, Bukhalo M, Bobonich MA, et al. Usability of a novel disposable autoinjector device for ixekizumab: results from a qualitative study and an open-label clinical trial, including patient-reported experience. Med Devices (Auckl). 2016;9:361-369.
Indication and Important Safety Information

Taltz is indicated for the treatment of adults with moderate to severe plaque psoriasis 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. The Taltz group had a higher rate of infections than the placebo group (27% vs 23%). 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. Patients receiving Taltz should be monitored closely 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. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inflammatory Bowel Disease

Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease.

Immunizations

Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Live vaccines should not be given 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.

Please see full Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

IX HCP ISI 22MAR2016