Brand Name
Cosentyx
Generic Name
Secukinumab
View Brand Information FDA approval date: January 21, 2015
Classification: Interleukin-17A Antagonist
Form: Injection
What is Cosentyx (Secukinumab)?
Living with a chronic inflammatory condition like psoriasis or psoriatic arthritis is more than a physical challenge; it can affect your emotional well-being and daily life. The persistent discomfort, visible symptoms, and joint stiffness can be frustrating, especially when traditional treatments don’t provide enough relief. For many, advanced therapies have opened a new door to managing these complex diseases. One of these options is Cosentyx (secukinumab).
Cosentyx is a modern prescription medication known as a biologic. Biologics are specially engineered proteins made from living cells that are designed to target specific parts of the immune system. Cosentyx belongs to a class of drugs called interleukin-17A (IL-17A) inhibitors. It is not a first-line treatment but is often prescribed for moderate to severe conditions when other therapies have proven insufficient. Understanding how this targeted therapy works is a key step in taking control of your health journey.
What does Cosentyx do?
Cosentyx is approved by the U.S. Food and Drug Administration (FDA) to treat several autoimmune and inflammatory conditions in adults and children, depending on the specific disease.
Its primary uses include:
- Moderate to severe plaque psoriasis: Cosentyx offers significant skin clearance for systemic or phototherapy candidates, reducing redness, scaling, and itching.
- Active psoriatic arthritis (PsA): Cosentyx treats psoriatic arthritis by reducing joint pain, stiffness, and swelling, improving function, and preventing joint damage, alongside treating skin psoriasis.
- Active ankylosing spondylitis (AS): Cosentyx treats inflammatory arthritis of the spine, easing pain and stiffness, and improving mobility.
- Active non-radiographic axial spondyloarthritis (nr-axSpA): A condition similar to AS but without visible joint damage on X-rays.
Clinical trials have demonstrated the effectiveness of Cosentyx. For many patients with plaque psoriasis, studies have shown that a significant number achieved 75% to 90% clearer skin within the first few months of treatment, with results often lasting with continued therapy (Novartis Pharmaceuticals Corporation, 2023). This level of improvement can be life-changing for those who have struggled with persistent symptoms.
How does Cosentyx work?
In a healthy individual, the immune system produces proteins to fight off infections. In autoimmune conditions, this system becomes overactive and mistakenly attacks the body’s own tissues. A key protein involved in this process is called interleukin-17A (IL-17A).
Think of IL-17A as a messenger that sends out constant signals to increase inflammation. In conditions like psoriasis and psoriatic arthritis, the body produces too much IL-17A, which leads to the rapid growth of skin cells (plaques) and inflammation in the joints.
Cosentyx works by specifically targeting and blocking the action of IL-17A. It acts like a precision tool that intercepts and neutralizes this specific inflammatory messenger. By stopping the IL-17A signal, Cosentyx helps to quiet the overactive immune response. This targeted mechanism is important because it calms the specific pathway driving the disease without broadly suppressing the entire immune system, helping to restore balance and reduce symptoms at their source.
Cosentyx side effects
As with any medication, Cosentyx has potential side effects. Your healthcare provider will review these with you and monitor your health to ensure the treatment is safe for you.
The most common side effects are generally mild and may include:
- Cold symptoms (runny nose, sore throat)
- Diarrhea
- Upper respiratory infections
Cosentyx can raise infection risk. Your doctor will screen for TB pre-treatment and advise watching for infection signs like fever, persistent cough, or skin sores.
Serious side effects are less common but require attention. Cosentyx may cause new or worsening inflammatory bowel disease (Crohn’s disease or ulcerative colitis). You should tell your doctor immediately if you experience persistent diarrhea, abdominal pain, or blood in your stool. In rare cases, a serious allergic reaction can occur. Seek emergency medical help if you develop hives, trouble breathing, or swelling of your face, tongue, or throat (Mayo Clinic, 2024).
Cosentyx dosage
Cosentyx is given as an injection under the skin (subcutaneous injection). It is typically administered using a prefilled syringe, a Sensoready® Pen, or an UnoReady® Pen.
Treatment starts with weekly injections for five weeks (“loading dose”), then switches to a monthly “maintenance dose.” You’ll be taught to self-inject at home.
Before Cosentyx, doctors check for infections like TB. Routine bloodwork isn’t always needed, but regular follow-ups are vital to monitor effectiveness, side effects, and ensure continued suitability.
Does Cosentyx have a generic version?
Currently, there is no generic or biosimilar version of Cosentyx (secukinumab) available in the United States. However, international versions may exist in other markets. Cosentyx is a complex biologic medication, and creating an exact copy (a generic) is not possible.
Instead of generics, biologics have alternatives called “biosimilars.” A biosimilar is a biologic drug that has been shown to be highly similar to an already FDA-approved biologic and has no clinically meaningful differences in terms of safety and effectiveness (FDA, 2023). While biosimilars exist for other biologic drugs, an FDA-approved biosimilar for Cosentyx has not yet been brought to market.
Conclusion
For those living with the challenges of moderate to severe psoriasis, psoriatic arthritis, or other related inflammatory conditions, Cosentyx offers a highly targeted and effective treatment option. By precisely blocking the IL-17A protein, it helps to control the underlying inflammation that drives these diseases, leading to clearer skin, reduced joint pain, and an improved quality of life.
While patient experiences can vary, Cosentyx is a well-established therapy with a clear safety profile. When prescribed and monitored by a qualified healthcare provider, it can be a powerful tool in managing your condition. Working in partnership with your doctor will help you make informed decisions and find the treatment plan that best supports your long-term health and well-being.
References
- Food and Drug Administration (FDA). (2023). Biosimilar and Interchangeable Biologics: More Treatment Choices.
- https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices
- Mayo Clinic. (2024). Secukinumab (Subcutaneous Route). https://www.mayoclinic.org/drugs-supplements/secukinumab-subcutaneous-route/side-effects/drg-20150388
- Novartis Pharmaceuticals Corporation. (2023). COSENTYX® (secukinumab) Prescribing Information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s274lbl.pdf
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Brand Information
COSENTYX (secukinumab)
1DOSAGE FORMS AND STRENGTHS
Injection for subcutaneous use:
- 300 mg/2 mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose UnoReady pen
- 300 mg/2 mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose prefilled syringe
- 150 mg/mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose Sensoready pen
- 150 mg/mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose prefilled syringe
- 75 mg/0.5 mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose prefilled syringe (for pediatric patients less than 50 kg)
Injection for intravenous use:
- 125 mg/5 mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose vial for dilution prior to intravenous infusion (for healthcare professional use only).
2CONTRAINDICATIONS
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)].
3ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail elsewhere in the labeling:
- Infections
- Hypersensitivity Reactions
- Inflammatory Bowel Disease
- Eczematous Eruptions
3.1Clinical 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). Subjects randomized to COSENTYX received 300 mg or 150 mg doses subcutaneously at Weeks 0, 1, 2, 3, and 4 followed by the same dose every 4 weeks
Table 2 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the COSENTYX groups than the placebo group during the 12-week placebo-controlled period of these trials.
Adverse reactions that occurred in subjects treated with COSENTYX at rates less than 1% in the placebo-controlled period of Trials PsO1, PsO2, PsO3, and PsO4 through Week 12 included: sinusitis, tinea pedis, conjunctivitis, tonsillitis, oral candidiasis, impetigo, otitis media, otitis externa, IBD, increased liver transaminases, and neutropenia.
Infections
In the placebo-controlled period of the clinical trials in PsO (a total of 1,382 subjects treated with COSENTYX and 694 subjects treated with placebo up to 12 weeks), infections were reported in 28.7% of subjects treated with COSENTYX compared with 18.9% of subjects treated with placebo.
Over the entire treatment period (a total of 3,430 PsO subjects treated with COSENTYX for up to 52 weeks for the majority of subjects), infections were reported in 47.5% of subjects treated with COSENTYX (0.9 per subject-year of follow-up) and serious infections were reported in 1.2% of subjects treated with COSENTYX (0.015 per subject-year of follow-up).
Phase 3 data showed an increasing trend for some types of infection with increasing serum secukinumab concentrations. Candida infections, herpes viral infections, staphylococcal skin infections, and infections requiring treatment increased as serum secukinumab concentration increased.
In the PsO open-label extension of Trials PsO1 and PsO2 (median follow-up of 3.9 years), representing 3,582 subject-years of exposure, 74% of COSENTYX treated subjects reported infections (55 per 100 subject-years) and serious infections were reported in 4.5% of COSENTYX treated subjects (1.4 per 100 subject-years). Sepsis was reported in 5 COSENTYX treated subjects (0.2 per 100 subject-years).
Neutropenia was observed in controlled portion of clinical trials. Most cases of COSENTYX associated neutropenia were transient and reversible. No serious infections were associated with cases of neutropenia.
In the open-label extension of Trials PsO1 and PsO2, neutropenia (ANC < 1 x 10
Inflammatory Bowel Disease
Cases of IBD, in some cases serious, were observed in subjects treated with COSENTYX in clinical trials. In the PsO program, with 3,430 subjects exposed to COSENTYX over the entire treatment period for up to 52 weeks (2,725 subject-years), there were 3 cases (0.11 per 100 subject-years) of exacerbation of CD, 2 cases (0.08 per 100 subject-years) of exacerbation of UC, and 2 cases (0.08 per 100 subject-years) of new onset UC. There were no IBD cases in placebo-treated subjects (N = 793; 176 subject-years) during the 12-week placebo-controlled period.
One case of exacerbation of Crohn’s disease in a subject treated with COSENTYX subject was reported in open-label portions of clinical trials in PsO.
Adverse Reactions from Clinical Trials in Pediatric Subjects with PsO
The safety of COSENTYX was assessed in two Phase 3 trials in pediatric subjects with PsO.
- The first was a randomized, double-blind, placebo and active-controlled, 236-week trial (Trial PsO8) that enrolled 162 pediatric subjects 6 years of age and older, with severe PsO (defined by PASI score ≥ 20, an IGA modified 2011 score of 4, and involving ≥ 10% of the body surface area [BSA]) who were candidates for systemic therapy. The 162 subjects were randomized to receive placebo, a biologic active control, or COSENTYX. In the COSENTYX groups, subjects with body weight (BW) less than 25 kg received 75 mg, subjects with BW 25 to less than 50 kg received either 75 mg or 150 mg (2 times the recommended dose), and subjects with BW of at least 50 kg received either 150 mg or 300 mg (2 times the recommended dose). Subjects were dosed at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
- The second trial was a randomized, open-label, 208-week trial (Trial PsO9; NCT03668613) of 84 pediatric subjects 6 years of age and older with moderate to severe PsO (defined by a PASI score ≥ 12, IGA mod 2011 score of ≥ 3, and BSA involvement of ≥ 10% at randomization) who were randomized into two COSENTYX arms [Arm 1: 75 mg for BW < 50 kg or 150 mg for ≥ 50 kg; and Arm 2: 75 mg for BW < 25 kg, 150 mg for BW ≥ 25 kg and < 50 kg, or 300 mg for BW ≥ 50 kg]. Subjects were dosed at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
The safety profile of COSENTYX reported in these trials was consistent with the safety profile reported in adult PsO trials.
Infections
One case of methicillin-resistant Staphylococcus aureus (MRSA) toxic shock syndrome (TSS) was reported in a COSENTYX treated pediatric subject during the placebo-controlled period.
In the pediatric safety pool, which includes all subjects who took at least one dose of COSENTYX during the treatment periods [198 subjects (287 subject-years)], 22 (11%) subjects reported ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 neutropenia (≥ 1,000 to < 1,500 cells/mm
Adverse Reactions from Clinical Trials in Adults with PsA
COSENTYX was studied in two placebo-controlled PsA trials with 1,003 adult patients (703 patients on COSENTYX and 300 patients on placebo). Of the 703 patients who received COSENTYX, 299 patients received a subcutaneous loading dose of COSENTYX (PsA1) and 404 patients received an intravenous loading dose of secukinumab (PsA2) followed by COSENTYX administered by subcutaneous injection every four weeks. During the 16-week placebo-controlled period of the trials in patients with PsA, the overall proportion of patients with adverse events was similar in the secukinumab and placebo-treatment groups (59% and 58%, respectively). The adverse events that occurred at a proportion of at least 2% and at a higher proportion in the COSENTYX groups than the placebo groups during the 16-week placebo-controlled period were nasopharyngitis, upper respiratory tract infection, headache, nausea, and hypercholesterolemia. The safety profile observed in adult patients with PsA treated with COSENTYX is consistent with the safety profile in the PsO trials in adults.
Similar to the clinical trials in patients with PsO, there was an increased proportion of patients with infections in the COSENTYX groups (29%) compared to placebo group (26%).
There were cases of CD and UC in the secukinumab group that included patients who experienced either exacerbations or the development of new disease. There were three cases of IBD, of which two patients received secukinumab and one received placebo.
Adverse Reactions from Clinical Trials in Adults with AS
COSENTYX was studied in two placebo-controlled AS trials with 590 adult patients (394 patients on COSENTYX and 196 patients on placebo). Of the 394 patients who received COSENTYX, 145 patients received a subcutaneous load of COSENTYX (study AS1), and 249 received an intravenous loading dose of secukinumab (study AS2) followed by COSENTYX administered by subcutaneous injection every four weeks. During the 16-week placebo-controlled period of the trials in patients with AS, the overall proportion of patients with adverse events was higher in the secukinumab groups than the placebo-treatment groups (66% and 59%, respectively). The adverse events that occurred at a proportion of at least 2% and at a higher proportion in the COSENTYX groups than the placebo groups during the 16-week placebo-controlled period were nasopharyngitis, nausea, and upper respiratory tract infection. The safety profile observed in patients with AS treated with COSENTYX is consistent with the safety profile in PsO clinical trials. In a third controlled trial of AS (study AS3), the safety profile of the 300 mg dose of COSENTYX was consistent with the safety profile of the 150 mg dose of COSENTYX.
Similar to clinical trials in patients with PsO, there was an increased proportion of patients with infections in the COSENTYX groups (31%) compared to the placebo group (18%).
In the original AS program, with 571 patients exposed to COSENTYX, there were 8 cases of IBD during the entire treatment period [5 cases of Crohn’s (0.7 per 100 patient-years) and 3 cases of UC (0.4 per 100 patient-years)]. During the placebo-controlled 16-week period, there were 2 Crohn’s disease exacerbations and 1 new onset UC case that was a serious adverse event in patients treated with COSENTYX compared to none of the patients treated with placebo. During the remainder of the trial when all patients received COSENTYX, 1 patient developed Crohn’s disease, 2 patients had Crohn’s exacerbations, 1 patient developed UC, and 1 patient had an UC exacerbation.
Adverse Reactions from Clinical Trials in Adults with nr-axSpA
COSENTYX was studied in one randomized, double-blind, placebo-controlled nr-axSpA trial with 555 adult patients (185 patients received a loading COSENTYX dose, 184 patients did not receive a loading COSENTYX dose, and 186 patients received placebo). The safety profile for patients with nr-axSpA treated with COSENTYX was overall similar to the safety profile seen in patients with AS and other previous experience with COSENTYX. Patients in nr-axSpA1 trial who received the loading dosing regimen compared to those without the loading regimen, had higher incidence of infections and infestations (92 per 100 patient-years versus 72 per 100 patient-years), including nasopharyngitis, upper respiratory tract infection and urinary tract infection, and gastrointestinal disorders (27 per 100 patient-years versus 22 per 100 patient-years), including gastritis, lower abdominal pain, colitis, diarrhea, and hematochezia.
Adverse Reactions from Clinical Trials in Pediatric Patients with Juvenile Psoriatic Arthritis (JPsA) and ERA
COSENTYX was studied in one double-blind, placebo-controlled, event-driven, randomized trial in 86 pediatric patients aged 2 to less than 18 years old with JPsA and ERA. The safety profile reported in this trial was consistent with the safety profile of secukinumab.
Adverse Reactions from Clinical Trials in Adults with HS
COSENTYX was studied in two 52-week, randomized, double-blind, placebo-controlled HS trials with 1,084 adult subjects (361 subjects received COSENTYX 300 mg every 2 weeks, 360 subjects received COSENTYX 300 mg every 4 weeks, and 363 subjects received placebo) with a total of 901 subject-years of COSENTYX exposure (the median duration of exposure for subjects treated with COSENTYX was 360 days). The safety profile of COSENTYX observed in these HS trials was consistent with the known safety profile of COSENTYX observed in the PsO trials.
Infections
During the 16-week placebo-controlled period, subjects who received COSENTYX 300 mg every 2 weeks had the highest incidence of fungal infections (5.3%), compared to subjects who received COSENTYX 300 mg every 4 weeks (4.2%) and subjects who received placebo (2.8%). With longer exposure, the rate of fungal infections remained higher for subjects who received COSENTYX 300 mg every 2 weeks (14.7/100 subject-years) compared to subjects who received COSENTYX 300 mg every 4 weeks (10.1/100 subject-years). The majority of the cases were reported as non-serious, non-severe, and resolved with anti-fungal treatment.
Inflammatory Bowel Disease
In the open-labeled portion of HS clinical trials, five (0.7%) IBD adverse reactions were reported, all of which were serious and led to withdrawal of trial drug, and occurred only in subjects treated with COSENTYX 300 mg every 2 weeks. There were no IBD cases in subjects treated with COSENTYX 300 mg every 4 weeks.
Adverse Reactions of Intravenous COSENTYX
The safety of intravenous COSENTYX is based on the pharmacokinetic exposure and extrapolation of the established safety of subcutaneous COSENTYX in PsA, AS and nr-axSpA patients
3.2Postmarketing Experience
The following adverse reactions have been reported during post-approval use of COSENTYX. Because they are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune system disorders: anaphylaxis, angioedema, systemic vasculitis
Skin and subcutaneous tissue disorders: eczematous eruptions (atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma), cutaneous vasculitis, pyoderma gangrenosum
Infections: bacterial, viral, and fungal opportunistic infections, including esophageal candidiasis, tracheobronchial candidiasis, cutaneous aspergillosis, cytomegalovirus gastroenteritis/colitis, herpes simplex encephalitis, herpes simplex keratitis, Pneumocystis jiroveci pneumonia, Hepatitis B virus reactivation, histoplasmosis, toxoplasmosis
4DRUG 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
5OVERDOSAGE
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.
6DESCRIPTION
Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains.
COSENTYX Injection for Subcutaneous Use
COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose 300 mg/2 mL UnoReady pen with a 27-gauge fixed ½-inch needle, a single-dose 150 mg/mL Sensoready pen with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (300 mg/2 mL, 150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX 150 mg/mL Sensoready pen or 1 mL and 0.5 mL prefilled syringes contains natural rubber latex.
Each COSENTYX 300 mg/2 mL UnoReady pen or 300 mg/2 mL prefilled syringe contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8.
Each COSENTYX 150 mg/mL Sensoready pen or 150 mg/mL prefilled syringe contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8.
Each COSENTYX 75 mg/0.5 mL prefilled syringe contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8.
COSENTYX Injection for Intravenous Use
COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution.
Each COSENTYX vial contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.
7HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
COSENTYX (secukinumab) injection is a clear to opalescent, colorless to slightly yellowish solution available as follows:
COSENTYX injection for subcutaneous use
COSENTYX 300 mg/2 mL UnoReady pen
- NDC 0078-1070-68: Carton of one 300 mg/2 mL (300 mg dose) single-dose UnoReady pen (injection)
COSENTYX 300 mg/2 mL (150 mg/mL) prefilled syringe
- NDC 0078-1070-97: Carton of one 300 mg/2 mL (150 mg/mL) single-dose prefilled syringe (injection)
COSENTYX 150 mg/mL Sensoready pen
- NDC 0078-0639-41: Carton of two 150 mg/mL (300 mg dose) single-dose Sensoready pens (injection)
- NDC 0078-0639-68: Carton of one 150 mg/mL single-dose Sensoready pen (injection)
COSENTYX 150 mg/mL prefilled syringe
- NDC 0078-0639-98: Carton of two 150 mg/mL (300 mg dose) single-dose prefilled syringes (injection)
- NDC 0078-0639-97: Carton of one 150 mg/mL single-dose prefilled syringe (injection)
COSENTYX 75 mg/0.5 mL prefilled syringe (for pediatric patients less than 50 kg)
- NDC 0078-1056-97: Carton of one 75 mg/0.5 mL single-dose prefilled syringe (injection)
The removable cap of the COSENTYX 150 mg/mL Sensoready pen and prefilled syringe, and 75 mg/0.5 mL prefilled syringe contains natural rubber latex. Each 300 mg/2 mL UnoReady pen, 150 mg/mL Sensoready pen and 300 mg/2 mL, 150 mg/mL, and 75 mg/0.5 mL prefilled syringe is equipped with a needle safety guard.
COSENTYX injection for intravenous use
- NDC 0078-1168-61: Carton containing one 125 mg/5 mL (25 mg/mL) solution in a single-dose vial for dilution prior to intravenous infusion.
Storage and Handling
Refrigerate COSENTYX injection for subcutaneous use (300 mg/2 mL UnoReady Pen, 150 mg/mL Sensoready Pens, and 150 mg/mL and 75 mg/0.5 mL Prefilled Syringes), and COSENTYX injection for intravenous use at 2ºC to 8ºC (36ºF to 46ºF). Keep the products in the original carton to protect from light until the time of use. Do not freeze. To avoid foaming, do not shake. COSENTYX does not contain a preservative; discard any unused portion.
If removed from refrigeration, COSENTYX 150 mg/mL Sensoready Pens, and 150 mg/mL and 75 mg/0.5 mL Prefilled Syringes:
- May be stored for up to 4 days at room temperature not to exceed 30°C (86°F).
- Write the date COSENTYX is removed from and returned to the refrigerator in the space provided on the carton.
- Discard if stored outside of the refrigerator over 4 days.
- May be returned to the refrigerator only one time and must be stored at 2ºC to 8ºC (36ºF to 46ºF) until used or expired.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Infections
Inform patients that COSENTYX may lower the ability of their immune system to fight infections and that serious infections, including opportunistic infections, may occur with the use of COSENTYX. Instruct patients of the importance of communicating any history of infections to the doctor and contacting their doctor if they develop any symptoms of infection
Hypersensitivity
Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions
Eczematous Eruptions
Inform patients that skin reactions resembling eczema may occur with the use of COSENTYX. Instruct patients to seek medical advice if they develop signs or symptoms of eczema
Risk of Hypersensitivity in Latex-Sensitive Individuals
Advise latex-sensitive patients that the removal caps of the COSENTYX 150 mg/mL Sensoready pen and the COSENTYX 1 mL and 0.5 mL prefilled syringes contain natural rubber latex, which may cause an allergic reaction in latex-sensitive individuals
Immunization
Advise patients that vaccination with live vaccines is not recommended during COSENTYX treatment. Instruct patients to inform the healthcare practitioner that they are taking COSENTYX prior to a potential vaccination
Instructions on Subcutaneous Injection Technique
If a patient or caregiver is to subcutaneously administer COSENTYX using the UnoReady pen, Sensoready pen, or the prefilled syringe, instruct him/her in injection techniques and assess their ability to inject subcutaneously to ensure the proper administration of COSENTYX
For pediatric patients, inform patients and caregivers that pediatric patients should not self-administer COSENTYX.
Instruct patients or caregivers in the technique of proper syringe and needle disposal and advise them not to reuse these items. Instruct patients to inject the full amount of COSENTYX according to the directions provided in the Medication Guide and Instructions for Use.
Storage
Instruct patients to store COSENTYX in a refrigerator at 2°C to 8°C (36ºF to 46ºF) and to discard expired or unused COSENTYX.
Inform patients that if removed from refrigeration, COSENTYX 150 mg/mL Sensoready pens, 150 mg/mL and 75 mg/0.5 mL prefilled syringes may be stored for up to 4 days at room temperature not to exceed 86°F (30°C). Instruct patients to discard if kept outside of the refrigerator over 4 days
Manufactured by:
US License Number 1244
© Novartis
T2025-48
9PRINCIPAL DISPLAY PANEL
NDC 0078-0639-97
Rx only
Cosentyx
(secukinumab)
Injection
Single-dose Prefilled Syringe
150 mg/mL
1 Prefilled Syringe
ATTENTION: Dispense with enclosed Medication Guide.
For Subcutaneous Use Only
Sterile Solution - Contains No Preservative
Caution: Contains Natural Rubber Latex Which May Cause Allergic Reaction.
NOVARTIS
10PRINCIPAL DISPLAY PANEL
NDC 0078-1056-97
Rx only
Cosentyx
(secukinumab)
75 mg/0.5 mL
1 Single-dose Prefilled Syringe
For Subcutaneous Use Only
Caution: Contains Natural Rubber Latex
ATTENTION:
NOVARTIS
11PRINCIPAL DISPLAY PANEL
NDC 0078-1070-68
Rx only
Cosentyx
(secukinumab)
Single-dose prefilled UnoReady
300 mg/2 mL
For Subcutaneous Use Only
1 UnoReady
ATTENTION: Dispense with enclosed Medication Guide.
Carton contains: • 1 Single-dose prefilled UnoReady
NOVARTIS
12PRINCIPAL DISPLAY PANEL
NDC 0078-1168-61
Rx only
Cosentyx
(secukinumab)
125 mg/5 mL
For Intravenous Infusion After Dilution.
ATTENTION: Dispense with enclosed Medication Guide.
1 Single-Dose Vial.
Discard Unused Portion.
NOVARTIS
