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ABOUT TALTZ

mechanism of action

Taltz is designed to specifically target IL-17A1,3*

Taltz pharmacology

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

Pathophysiology of the skin and joint symptoms of plaque psoriasis and psoriatic arthritis2,4-6

In skin

IL-17A can cause hyperproliferation of keratinocytes and trafficking of neutrophils into the skin.

In joints

IL-17A increases inflammation and mediates bone and cartilage damage.

IL-17A upregulates RANK ligand on osteoblasts, leading to increased expression of the RANK ligand receptor on pre-osteoclasts. The RANK ligand receptor induces osteoclast formation and secretion of bone-degrading enzymes.

RANK=receptor activator of nuclear factor ϰB.

See how Taltz works in plaque psoriasis

Taltz is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Select 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.

DOSING

Taltz dosing for patients with moderate to severe plaque psoriasis1

The dosing regimen is the same for adult patients with moderate to severe plaque psoriasis, and for adult patients with psoriatic arthritisƚ and coexistent moderate to severe plaque psoriasis1

Taltz Dosing Dosing Taltz Taltz Dosing Taltz Dosing Dosing Taltz

*Every 4 weeks.

For patients who have psoriatic arthritis without coexistent moderate to severe plaque psoriasis, follow the psoriatic arthritis dosing on the PsA tab.

If patients forget to take their Taltz dose, instruct them to inject a dose as soon as they remember; then to take their next dose at the regularly scheduled time.

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.

Taltz dosing for patients with psoriatic arthritis1

Taltz Dosing Taltz Dosing

For patients with psoriatic arthritis and coexistent moderate to severe plaque psoriasis, follow the plaque psoriasis dosing

If patients forget to take their Taltz dose, instruct them to inject a dose as soon as they remember; then to take their next dose at the regularly scheduled time.

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. For additional administration information, refer to the Instructions for Use included with the device.

SELECT IMPORTANT ADMINISTRATION 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 mind7

At first use, over 94% of patients with moderate to severe plaque psoriasis 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.

Device Study Trial Design Trial Design Arrow

References

  1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
  2. Martin DA, et al. The emerging role of IL-17 in the pathogenesis of psoriasis: preclinical and clinical findings. J Invest Dermatol. 2013:133:17-26.
  3. Kirkham BW, Kavanaugh A, Reich K. Interleukin-17A: a unique pathway in immune-mediated diseases: psoriasis, psoriatic arthritis and rheumatoid arthritis. Immunology. 2013;141:133-142.
  4. Miossec P, Kolls JK. Targeting IL-17 and TH17 cells in chronic inflammation. Nat Rev Drug Discov. 2012;11:763-776.
  5. Ritchlin CT, Colbert RA, Gladman DD. Psoriatic arthritis. N Engl J Med. 2017; 376:957-970.
  6. Speeckaert R, Lambert J, Grine L, Van Gele M, De Schepper S, van Geel N. The many faces of interleukin-17 in inflammatory skin diseases. Br J Dermatol. 2016;175:892-901.
  7. 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

Psoriatic Arthritis:

Taltz is indicated for the treatment of adult patients with active psoriatic arthritis.

Plaque Psoriasis:

Taltz is indicated for the treatment of adult patients 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. 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. 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 group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis.

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 profile observed in patients with psoriatic arthritis was consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis.

Please click to access the Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

IX HCP ISI 01DEC2017