Eli Lilly and Company announced the availability of a new, citrate-free formulation of Taltz(R) (ixekizumab) injection 80 mg/mL. The new formulation, which was recently approved by The U.S. Food and Drug Administration in May 2022, includes the same active ingredient as the original formulation. The new Taltz formulation significantly reduced injection site pain experienced by some people immediately following injection as shown by an 86% decrease in a visual analog scale (VAS) of pain versus the original formulation.

Taltz is approved to treat adults and children six years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, adults with active psoriatic arthritis, active ankylosing spondylitis (AS) and active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. Taltz citrate-free demonstrated a safety profile consistent with the original formulation. Existing Taltz patients will not need a new prescription, nor should they experience a gap in their therapy.

The new formulation is currently being shipped across the U.S. with anticipated broad availability for both new and existing Taltz patients by the end of the month. In the interim, the original formulation of Taltz continues to be available until it is replaced by the citrate-free formulation. The citrate-free formulation of Taltz was approved by the European Medicines Agency in December 2021 with several markets launching now and many more anticipated in the coming months.

Lilly is committed to improving experiences for people treated with Taltz, providing the same active ingredient in a new citrate-free formulation. Lilly's investment into patient-centric research is evident as Taltz has been studied in more than 10,000 people in clinical trials globally and has been available in most markets for more than five years. In the U.S., more people living with psoriasis are treated with Taltz compared to any other IL-17A antagonist, adding to the nearly 130,000 people in the U.S. who have been treated with the medicine.

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 Precaution: 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.

The citrate-free injection pain study (N=70) was a subject-blind, randomized, crossover study in healthy participants ages 18-75 years to determine injection site pain differences between Taltz citrate-free formulation compared to the original formulation of Taltz. The primary endpoint, pain intensity on injection, was measured by the Visual Analog Scale (VAS) of pain 0-100mm.