Ixekizumab

Ixekizumab is a humanized IgG4 monoclonal antibody that selectively binds with the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.

• TALTZ ® is a humanized interleukin-17A antagonist indicated for the treatment of: patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ( 1.1 ) adults with active psoriatic arthritis.ICD-10: L40.50, L40.9

• TALTZ is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients [see Warnings and Precautions ( 5.3 )] . Serious hypersensitivity reaction to ixekizumab or to any of the excipients.contraindicated

Administer by subcutaneous injection. Adult Plaque Psoriasis ( 2.2 ) Recommended dosage is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks. Pediatric Plaque Psoriasis ( 2.3 ) For patients weighing greater than 50 kg, recommended dosage is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks. For patients weighing 25-50 kg, recommended dosage is 80 mg at Week 0, followed by 40 mg every 4 weeks. For patients weighing less than 25 kg, recommended dosage is 40 mg at Week 0, followed by 20 mg every 4 weeks. Psoriatic Arthritis ( 2.4 ) Recommended dosage is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks. For psoriatic arthritis patients with coexistent moderate-to-severe plaque psoriasis, use the dosing regimen for adult plaque psoriasis. ( 2.2 ) TALTZ may be administered alone or in combination with a conventional DMARD (e.g., methotrexate). Ankylosing Spondylitis ( 2.5 ) Recommended dosage is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks. Non-radiographic Axial Spondyloarthritis ( 2.6 ) Recommended dosage is 80 mg by subcutaneous injection every 4 weeks. 2.1 Testing and Procedures Prior to Treatment Initiation Perform the following evaluations prior to TALTZ initiation: Evaluate patients for tuberculosis (TB) infection. TALTZ initiation is not recommended in patients with active TB infection.

Infections : 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. ( 5.1 ) Tuberculosis (TB) : Evaluate for TB prior to initiating treatment. ( 5.2 ) Hypersensitivity : If a serious allergic reaction occurs, discontinue TALTZ immediately and initiate appropriate therapy. ( 5.3 ) Eczematous Eruptions: In the postmarketing setting, cases of severe eczematous eruptions were reported in patients receiving TALTZ. Treatment may need to be discontinued to resolve the eczematous eruption. ( 5.4 ) Inflammatory Bowel Disease : Crohn's disease and ulcerative colitis, including exacerbations, occurred during clinical trials. Monitor closely when prescribing TALTZ to patients with inflammatory bowel disease (IBD). Discontinue TALTZ and initiate appropriate medical management if IBD develops. ( 5.5 ) Immunizations : Avoid use of live vaccines. ( 5.6 ) 5.1 Infections TALTZ may increase the risk of infection. In clinical trials in adult patients with plaque psoriasis, the TALTZ group had a higher rate of infections than the placebo group (27% vs. 23%). Upper respiratory tract infections, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in the TALTZ group than in the placebo group.

The following adverse drug reactions are discussed in greater detail in other sections of the label: Infections [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] Eczematous Eruptions [see Warnings and Precautions ( 5.4 )] Inflammatory Bowel Disease [see Warnings and Precautions ( 5.5 )] Most common (≥1%) adverse reactions associated with TALTZ treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-545-5979 (1-800-LillyRx) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Plaque Psoriasis Weeks 0 to 12 : Three placebo-controlled trials in subjects with plaque psoriasis were integrated to evaluate the safety of TALTZ compared to placebo for up to 12 weeks. A total of 1167 subjects (mean age 45 years; 66% men; 94% White) with plaque psoriasis received TALTZ (160 mg at Week 0, 80 mg every 2 weeks [Q2W] for 12 weeks) subcutaneously. In two of the trials, the safety of TALTZ (use up to 12 weeks) was also compared with an active comparator, U.S. approved etanercept [see Clinical Studies ( 14 )] .

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TALTZ during pregnancy. Pregnant women exposed to TALTZ are encouraged to enroll in the TALTZ Pregnancy Registry by calling 1-800-284-1695. Contact information for the registry is also available on http://www.pregnancyregistry.lilly.com. Risk Summary Available data from the published literature and the pharmacovigilance database with TALTZ use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Human IgG is known to cross the placental barrier; therefore, TALTZ may be transmitted from the mother to the developing fetus. An embryofetal development study conducted in pregnant monkeys during organogenesis at doses up to 19 times the maximum recommended human dose (MRHD) revealed no evidence of harm to the developing fetus. When dosing was continued until parturition, neonatal deaths were observed at 1.9 times the MRHD [see Data] . The clinical significance of these nonclinical findings is unknown. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

The pharmacokinetic (PK) properties of ixekizumab were similar across the adult plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis indications. Absorption Following a single subcutaneous dose of 160 mg in subjects with plaque psoriasis, ixekizumab reached peak mean (±SD) serum concentrations (C max ) of 16.2 ±6.6 mcg/mL by approximately 4 days post dose.

• Mar 22, 2016BLABLA125521Eli Lilly And Co

1. 1Injection Site Pain3,86611%
2. 2Drug Ineffective3,2178.9%
3. 3Psoriasis3,2058.8%
4. 4Injection Site Erythema2,1786.0%
5. 5Injection Site Reaction1,7734.9%
6. 6Injection Site Swelling1,6374.5%
7. 7Incorrect Dose Administered1,1653.2%
8. 8Product Dose Omission Issue9402.6%
9. 9Covid-199202.5%
10. 10Pain8912.5%
11. 11Arthralgia8742.4%
12. 12Therapy Interrupted8262.3%
13. 13Diarrhoea8172.3%
14. 14Rash8142.2%
15. 15Injection Site Pruritus7882.2%

The 10 most recently updated of 75 ClinicalTrials.gov registrations naming Ixekizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA)
  Recruiting · Phase 4 · Interventional · 200 enrolled · Eli Lilly and Company
  NCT06864026updated 2026-06-11
• Psoriasis Longitudinal Assessment and Registry
  Active not recruiting · Observational · 15,849 enrolled · Janssen Scientific Affairs, LLC
  NCT00508547updated 2026-06-05
• Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
  Not yet recruiting · Phase 4 · Interventional · 10 enrolled · University of California, San Francisco
  NCT07352566updated 2026-06-03
• A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
  Recruiting · Phase 4 · Interventional · 200 enrolled · Eli Lilly and Company
  NCT06857942updated 2026-06-03
• Effects of Interleukin (IL)-17A Inhibition on Idiopathic Subglottic Stenosis
  Completed · Phase 2 · Interventional · 10 enrolled · Yale University
  NCT05309616updated 2026-05-29
• Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight
  Completed · Phase 3 · Interventional · 279 enrolled · Eli Lilly and Company
  NCT06588296updated 2026-05-13
• Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis
  Recruiting · Interventional · 45 enrolled · NHS Greater Glasgow and Clyde
  NCT07443956updated 2026-05-04
• Ixekizumab Diabetes Intervention Trial (I-DIT)
  Active not recruiting · Phase 2 · Interventional · 127 enrolled · Göteborg University
  NCT04589325updated 2026-04-27
• A Study of Switching to Picankibart in Chinese Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy
  Active not recruiting · Phase 3 · Interventional · 308 enrolled · Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
  NCT06945107updated 2026-03-25
• A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
  Active not recruiting · Phase 3 · Interventional · 101 enrolled · Eli Lilly and Company
  NCT04527380updated 2026-03-19

Frequently asked questions

How does Ixekizumab work?

Ixekizumab is a humanized IgG4 monoclonal antibody that selectively binds with the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.

What is Ixekizumab used for?

According to FDA labeling, Ixekizumab carries indications including: TALTZ ® is a humanized interleukin-17A antagonist indicated for the treatment of: patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ( 1.1 ) adults with active psoriatic arthritis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ixekizumab?

Ixekizumab is classified as Interleukin inhibitors, Interleukin-17A Antagonist, Interleukin-17A Antagonists.

What are the brand names for Ixekizumab?

Ixekizumab is marketed under brand names including Taltz.

What are the contraindications for Ixekizumab?

Ixekizumab labeling lists contraindications including: TALTZ is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients [see Warnings and Precautions ( 5.3 )] . Serious hypersensitivity reaction to ixekizumab or to any of the excipients.. Always consult the full prescribing information and a clinician.