COSENTYX 25 mg/mL
secukinumab · INJECTION, SOLUTION, CONCENTRATE · Novartis Pharmaceuticals Corporation
COSENTYX is a injection, solution, concentrate containing secukinumab at 25 mg/mL, taken intravenous. Manufactured by Novartis Pharmaceuticals Corporation.
Key Facts
- Brand Name
- COSENTYX
- Generic Name
- secukinumab
- NDC Code (Product)
0078-1168- Manufacturer
- Novartis Pharmaceuticals Corporation
- Strength
- 25 mg/mL
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761349
- Drug Class
- Interleukin-17A Antagonist [EPC]
- Marketing Start
- 10/06/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 1.2 ) active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. ( 1.3 ) active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. ( 1.4 ) active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. ( 1.5 ) moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. ( 1.6 ) 1.1 Plaque Psoriasis COSENTYX ® is 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. 1.2 Psoriatic Arthritis COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. 1.3 Ankylosing Spondylitis COSE…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 lo…
Contraindications
4 CONTRAINDICATIONS 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)] . Serious hypersensitivity to secukinumab or any excipients in COSENTYX. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Certain CYP450 Substrates Increased concentrations of cytokines (e.g., IL-17) during chronic inflammation associated with certain diseases including PsO, PsA, AS, nr-axSpA, ERA, and HS may suppress the formation of CYP enzymes. Upon initiation or discontinuation of COSENTYX in patients who are receiving concomitant CYP450 substrates, particularly those where minimal decreases in the concentration may reduce CYP substrate effectiveness or minimal increases in the concentration may increase CYP substrate adverse reactions, consider monitoring for therapeutic effect or concentration of the CYP substrate and consider dosage adjustment of the CYP substrate as needed [see Clinical Pharmacology (12.3)] .
Adverse Reactions
6 ADVERSE REACTIONS 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 …
Frequently Asked Questions
What is COSENTYX used for?
COSENTYX contains secukinumab. It is a injection, solution, concentrate taken intravenous. Consult your doctor for specific uses.
Is COSENTYX a controlled substance?
COSENTYX is not classified as a controlled substance by the DEA.
What is the generic name for COSENTYX?
The generic name for COSENTYX is secukinumab. There are no other listed brand versions of secukinumab.
What is the NDC code for COSENTYX 25 mg/mL?
The NDC (National Drug Code) for COSENTYX 25 mg/mL is 0078-1168, listed by Novartis Pharmaceuticals Corporation.
Other COSENTYX Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)