Taltz Citrate-Free: The same active ingredient with significantly less injection site pain vs the original formulation1*
*P<.0001; 3.5 vs 25.2 based on VAS 0-100

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Rheumatology Dosing2

VAS Injection Site Pain Score Immediately Following Injection

*P<.0001; based on VAS 0-100

Taltz Citrate-Free Injection Pain Study Design

Citrate-Free Injection Pain Study (N=70) was a subject-blind, randomized, crossover study in healthy subjects age 18-75 years to determine injection site pain differences between Taltz citrate-free formulation compared to the original formulation of Taltz. The primary endpoint was pain intensity on injection, as measured by Visual Analog Scale of Pain (VAS Pain) 0-100. Subjects were randomized 1:1:1 to receive a single 1 mL subcutaneous injection of 80 mg Taltz original formulation, 80 mg Taltz citrate-free formulation 1 (CF1), or 80 mg Taltz citrate-free formulation 2 (CF2) in 1 of 3 possible treatment sequences on Days 1, 8, and 15 in a 3-period cross-over design. Injections were administered in the abdomen by a medical professional using a prefilled syringe. CF2 is not an approved formulation. Only data on the commercially available citrate-free formulation (CF1) will be presented.2

Taltz Citrate-Free Bioequivalence Study Design

The Citrate-Free Bioequivalence Study (N=245) was a 2-arm, subject-blind, parallel-design study in healthy subjects age 18-75 years to evaluate bioequivalence of Taltz citrate-free (CF) formulation compared to the original formulation of Taltz. Subjects were stratified into 1 of 3 weight categories (low: <70.0 kg; medium: 70.0-80.0 kg; high: >80.0 kg). Participants were then randomized within the 3 weight categories 1:1 to a single subcutaneous dose of either 80 mg Taltz original formulation (n=126) or 80 mg Taltz CF formulation (n=119). Subjects in each group were sub-randomized 1:1:1 to injection site (arm, thigh, or abdomen). Injections were administered by a medical professional using an autoinjector. The primary endpoint was bioequivalence as measured by maximum concentration (Cmax) of serum ixekizumab and area under the concentration versus time curve (AUC) of ixekizumab from time of injection through day 85 and time of injection through infinity.2

DOSING FOR AS AND PsA

Convenient 1-day starting dose with a once-monthly* dosing schedule2

*Every 4 weeks.

The dosing regimen is the same for adult patients with AS and for adult patients with PsA without coexistent moderate to severe PsO.

For patients with PsA and coexistent moderate to severe PsO

After the starting dose of two 80 mg injections, 1 injection every 2 weeks for 3 months (12 weeks), then once a month* thereafter.

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.

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.

DOSING FOR nr-axSpA2

Convenient once-monthly* dosing schedule

*Every 4 weeks.

Starting dose of one 80 mg injection, followed by one 80 mg injection every 4 weeks thereafter.

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.

Devices

Taltz has 2 device options, offering you the flexibility to choose the one that best suits your patients2,3

Devices designed with patients in mind

At first use, over 94% of adult patients with moderate to severe plaque psoriasis agreed the Taltz autoinjector was "easy to use" and were confident in their ability to use it.

Please see Instructions for Use included with the device.

Device study trial design

References: 1. Chabra S, Gill BJ, Gallo G, et al. Ixekizumab citrate-free formulation: results from two clinical trials. Adv Ther. 2022;Epub (Incl Suppl Inf):1-11, 1-4. https://doi.org/10.1007/s12325-022-02126-0 . 2. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021. 3. Callis Duffin K, Bagel J, Bukhalo M, et al. Phase 3, open-label, randomized study of the pharmacokinetics, efficacy and safety of ixekizumab following subcutaneous administration using a prefilled syringe or an autoinjector in patients with moderate-to-severe plaque psoriasis (UNCOVER‐A). J Eur Acad Dermatol Venereol. 2017;31:107-113.

INDICATIONS

Taltz is indicated for adults with active psoriatic arthritis (PsA), for adults with active ankylosing spondylitis (AS), and for adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. Taltz is also indicated for patients aged 6 years or older 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 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, ankylosing spondylitis, non-radiographic axial spondyloarthritis, 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, ankylosing spondylitis, non-radiographic axial spondyloarthritis, 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.

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

IX HCP ISI 07MAY2020