Secukinumab

Secukinumab is a human IgG1 monoclonal antibody that selectively binds to 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.

• COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. ( 1.1 ) active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older.ICD-10: L40.50, L40.9

• COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis and angioedema have been reported during treatment with COSENTYX [see Warnings and Precautions (5.2)] .contraindicated

Prior to COSENTYX initiation, complete all age-appropriate vaccinations, evaluate patients for tuberculosis (TB). ( 2.1 ) See Full Prescribing Information for instructions on preparation and administration of COSENTYX. ( 2.2 , 2.11 , 2.12 ) Administration of Intravenous Formulation: COSENTYX for intravenous use must be diluted prior to administration. Administer as an intravenous infusion after dilution over a period of 30 minutes. ( 2.12 ) Plaque Psoriasis: Subcutaneous Dosage in Adults: Recommended dosage is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. For some patients, a dose of 150 mg may be acceptable. ( 2.3 ) Subcutaneous Dosage in Pediatric Patients 6 Years and Older: Recommended weight-based dosage is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. For patients < 50 kg, the dose is 75 mg. For patients ≥ 50 kg, the dose is 150 mg. ( 2.3 ) Psoriatic Arthritis: Adult Patients Subcutaneous Dosage: For PsA patients with coexistent moderate to severe PsO, use the dosage and administration for PsO. ( 2.3 ) For other PsA patients, administer with or without a loading dosage. With a loading dosage : 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter Without a loading dosage : 150 mg every 4 weeks If a patient continues to have active PsA, consider a dosage of 300 mg every 4 weeks. ( 2.4 ) Intravenous Dosage: The recommended intravenous dosages are: With a loading dosage : 6 mg/kg given at Week 0 as a loading dose, followed by 1.75 mg/kg every 4 weeks thereafter (max.

Infections : Serious infections have occurred. Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection. If a serious infection develops, discontinue COSENTYX until the infection resolves. ( 5.1 ) Hypersensitivity Reactions : If an anaphylactic reaction or other serious allergic reaction occurs, discontinue COSENTYX immediately and initiate appropriate therapy. ( 5.2 ) Tuberculosis (TB) : Prior to initiating treatment with COSENTYX, evaluate for TB. ( 5.3 ) Inflammatory Bowel Disease (IBD) : Cases of IBD were observed in clinical trials. Exercise caution when prescribing COSENTYX to patients with IBD. ( 5.4 ) Eczematous Eruptions : Cases of severe eczematous eruptions have occurred in patients receiving COSENTYX. ( 5.5 ) Immunizations : Avoid use of live vaccines in patients treated with COSENTYX. ( 5.7 ) 5.1 Infections COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in COSENTYX treated subjects compared to placebo-treated subjects. In placebo-controlled clinical trials in subjects with moderate to severe PsO, higher rates of common infections, such as nasopharyngitis (11.4% versus 8.6%), upper respiratory tract infection (2.5% versus 0.7%) and mucocutaneous infections with candida (1.2% versus 0.3%) were observed in subjects treated with COSENTYX compared to placebo-treated subjects. A similar increase in risk of infection in subjects treated with COSENTYX was seen in placebo-controlled trials in subjects with PsA, AS and nr-axSpA.

The following adverse reactions are discussed in greater detail elsewhere in the labeling: Infections [see Warnings and Precautions (5.1)] Hypersensitivity Reactions [see Warnings and Precautions (5.2)] Inflammatory Bowel Disease [see Warnings and Precautions (5.4)] Eczematous Eruptions [see Warnings and Precautions (5.5)] Most common adverse reactions (> 1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 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. Adverse Reactions in Clinical Trials of Subcutaneous COSENTYX Adverse Reactions from Clinical Trials in Adults with PsO A total of 3,430 adult subjects with PsO were treated with COSENTYX in controlled and uncontrolled clinical trials. Of these, 1,641 subjects were treated with COSENTYX for at least 1 year. Four placebo-controlled Phase 3 trials in PsO subjects (Trials PsO1, PsO2, PsO3, and PsO4) were pooled to evaluate the safety of COSENTYX in comparison to placebo up to 12 weeks after treatment initiation. In total, 2,077 subjects were evaluated (691 in the COSENTYX 300 mg group, 692 in the COSENTYX 150 mg group, and 694 in the placebo group).

8.1 Pregnancy Risk Summary Limited available human data with COSENTYX use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. In an embryo-fetal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of secukinumab during organogenesis at doses up to 30 times the maximum recommended human dose (MRHD) (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data An embryo-fetal development study was performed in cynomolgus monkeys with secukinumab. No malformations or embryo-fetal toxicity were observed in fetuses from pregnant monkeys that were administered secukinumab weekly by the subcutaneous route during the period of organogenesis at doses up to 30 times the MRHD (on a mg/kg basis at a maternal dose of 150 mg/kg). A pre- and post-natal development toxicity study was performed in mice with a murine analog of secukinumab.

Metabolism

Pharmacokinetics Following Subcutaneous Administration The observed pharmacokinetics (PK) of secukinumab administered subcutaneously in patients with PsO, PsA, AS and nr-axSpA were similar. The secukinumab PK is also similar in pediatric patients with ERA and PsO for the same weight tiered dosing regimen.

In the event of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

• Jan 21, 2015BLABLA125504Novartis Pharms Corp
• Oct 6, 2023BLABLA761349Novartis Pharms Corp

1. 1Drug Ineffective28,95018%
2. 2Psoriasis22,70914%
3. 3Pain16,38710%
4. 4Arthralgia14,6859.2%
5. 5Fatigue10,3796.5%
6. 6Psoriatic Arthropathy9,9876.3%
7. 7Pruritus9,3015.9%
8. 8Malaise9,2865.8%
9. 9Rash8,8905.6%
10. 10Condition Aggravated8,3495.3%
11. 11Diarrhoea7,8404.9%
12. 12Nasopharyngitis7,6474.8%
13. 13Pain In Extremity7,2084.5%
14. 14Headache7,1014.5%
15. 15Off Label Use6,5474.1%

The 10 most recently updated of 260 ClinicalTrials.gov registrations naming Secukinumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Effects of Different Secukinumab Maintenance Regimens on Long-Term Outcomes in Patients With Psoriasis
  Not yet recruiting · Observational · 120 enrolled · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  NCT07642544updated 2026-06-11
• Psoriasis Longitudinal Assessment and Registry
  Active not recruiting · Observational · 15,849 enrolled · Janssen Scientific Affairs, LLC
  NCT00508547updated 2026-06-05
• Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)
  Active not recruiting · Phase 3 · Interventional · 161 enrolled · Novartis Pharmaceuticals
  NCT06331312updated 2026-06-05
• IL-17 Blockade to Decrease irAEs (REPLAY)
  Recruiting · Phase 1 · Interventional · 4 enrolled · Duke University
  NCT07237594updated 2026-06-04
• 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
• Secukinumab Open Label Roll-over Extension Protocol
  Recruiting · Phase 4 · Interventional · 1,000 enrolled · Novartis Pharmaceuticals
  NCT04638647updated 2026-06-03
• Mediterranean Diet vs no Dietary Intervention for Improving Signs and Symptoms of Psoriasis in Patients Treated With Anti-IL-17 or Anti-IL-23 Inhibitors
  Recruiting · Interventional · 36 enrolled · University Hospitals Cleveland Medical Center
  NCT06399432updated 2026-06-03
• Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa
  Recruiting · Phase 4 · Interventional · 36 enrolled · Novartis Pharmaceuticals
  NCT07489573updated 2026-06-03
• A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission
  Active not recruiting · Phase 4 · Interventional · 240 enrolled · Novartis Pharmaceuticals
  NCT05622708updated 2026-06-02
• Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability up to 6 Years of Intravenous (i.v.) Secukinumab in Pediatric Participants With Juvenile Psoriatic Arthritis (JPsA).
  Recruiting · Phase 1 · Interventional · 20 enrolled · Novartis Pharmaceuticals
  NCT06751238updated 2026-06-02

Frequently asked questions

How does Secukinumab work?

Secukinumab is a human IgG1 monoclonal antibody that selectively binds to 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 Secukinumab used for?

According to FDA labeling, Secukinumab carries indications including: COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. ( 1.1 ) active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Secukinumab?

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

What are the brand names for Secukinumab?

Secukinumab is marketed under brand names including Cosentyx.

What are the contraindications for Secukinumab?

Secukinumab labeling lists contraindications including: COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis and angioedema have been reported during treatment with COSENTYX [see Warnings and Precautions (5.2)] .. Always consult the full prescribing information and a clinician.