NO boxed warning3
NO trend toward increased AE incidence rates of IBD, Candida infections, MACE, or malignancy through Year 54
NO required routine lab monitoring during treatment3
- Evaluate patients for TB prior to initiating treatment
<1% of patients had immunogenicity over 5 years5
IBD prevalence6,7
General population=1.3% | Patients with HS=3.3%
In the SUNNY clinical program (N=1084), <0.3% of new-onset IBD cases at Year 1 in COSENTYX1¶
SUNSHINE=0 | SUNRISE=3
The FIRST and ONLY FDA-approved IL-17A antagonist for your adult patients with moderate to severe HS3
COSENTYX is covered as a 1st- or 2nd-line biologic in HS across Private insurance, Medicaid, and Medicare8#**
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 have been reported during treatment with COSENTYX...
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 have been reported during treatment with COSENTYX.
WARNINGS AND PRECAUTIONS
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 incidence of some types of infections, including fungal infections, appeared to be dose-dependent in clinical trials.
In the postmarketing setting, serious and some fatal infections have been reported in patients treated with COSENTYX.
Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, monitor the patient closely and discontinue COSENTYX until the infection resolves.
Pre-treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Avoid administration of COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX. Consider anti-TB therapy prior to initiation of COSENTYX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients closely for signs and symptoms of active TB during and after treatment.
Inflammatory Bowel Disease
Inflammatory Bowel Disease (IBD) exacerbations, in some cases serious and/or leading to discontinuation of COSENTYX, occurred in COSENTYX treated subjects during clinical trials in PsO, PsA, AS, nr-axSpA, and HS. In adult subjects with HS, the incidence of IBD was higher in subjects who received COSENTYX 300 mg every 2 weeks (Ulcerative Colitis [UC] 1 case, EAIR 0.2/100 subject-years; Crohn’s Disease [CD] 1 case, EAIR 0.2/100 subject-years) compared to subjects who received COSENTYX 300 mg every 4 weeks (IBD 1 case, EAIR 0.2/100 subject-years). In addition, new onset IBD cases occurred in subjects treated with COSENTYX in clinical trials. In an exploratory trial in 59 subjects with active Crohn’s disease [COSENTYX is not approved for the treatment of Crohn’s disease], there were trends toward greater disease activity and increased adverse reactions in subjects treated with COSENTYX as compared to placebo-treated subjects.
Exercise caution when prescribing COSENTYX to patients with IBD. Patients treated with COSENTYX should be monitored for signs and symptoms of IBD.
Eczematous Eruptions
In postmarketing reports, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma, were reported in patients receiving COSENTYX; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of COSENTYX.
Treatment may need to be discontinued to resolve the eczematous eruption. Some patients were successfully treated for eczematous eruptions while continuing COSENTYX.
Hypersensitivity Reactions
Anaphylaxis and cases of urticaria occurred in COSENTYX treated subjects in clinical trials. If an anaphylactic or other serious allergic reaction occurs, administration of COSENTYX should be discontinued immediately and appropriate therapy initiated.
The removable caps of the COSENTYX 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. The safe use of the COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied.
Immunizations
Prior to initiating therapy with COSENTYX, consider completion of all age-appropriate immunizations according to current immunization guidelines. COSENTYX may alter a patient’s immune response to live vaccines. Avoid use of live vaccines in patients treated with COSENTYX.
MOST COMMON ADVERSE REACTIONS
Most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.
Please see Full Prescribing Information, including Medication Guide.
10/23 310615
COSENTYX® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in patients 6 years and older who are candidates for systemic therapy or phototherapy.
COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older...
COSENTYX® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in patients 6 years and older who are candidates for systemic therapy or phototherapy.
COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older.
COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis (AS).
COSENTYX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older.
COSENTYX is indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa (HS).
*Limitations apply. Enrolled patients awaiting coverage for COSENTYX after 2 years may be eligible for a limited Program extension. Valid only for those with private insurance. Program provides up to $16,000 annually for the cost of COSENTYX and up to $150 per infusion (up to $1,950 annually) for the cost of administration. Co-pay support for infusion administration cost not available in Rhode Island or Massachusetts. Offer not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this program without notice. See complete Terms & Conditions for details.
Definitions
AE, adverse event; FDA, US Food and Drug Administration; HS, hidradenitis suppurativa; IBD, inflammatory bowel disease; IL, interleukin; MACE, major adverse cardiovascular event; PBO, placebo; Q2W, every 2 weeks; Q4W, every 4 weeks; QW, every week; TB, tuberculosis; URTI, upper respiratory tract infection.
References
1. Kimball AB, Jemec GBE, Alavi A, et al. Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised,
placebo-controlled, double-blind phase 3 trials. Lancet. 2023;401(10378):747-761 and Supplementary Appendices. doi:10.1016/S0140-6736(23)00022-3
2. Data on file. Clinicaltrials.gov. Novartis Pharmaceuticals Corp; August 2023.
3. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
4. Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32(9):1507-1514.
5. Reich K, Blauvelt A, Armstrong A, et al. Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibits low immunogenicity in psoriasis patients treated up to 5 years. J Eur Acad Dermatol Venereol. 2019;33(9):1733-1741.
6. Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of inflammatory bowel disease among adults aged ≥18 years—United States, 2015. Morb Mortal Wkly Rep. 2016;65(42):1166-1169. doi:10.15585/mmwr.mm6542a3
7. Deckers IE, Benhadou F, Koldijk MJ, et al. Inflammatory bowel disease is associated with hidradenitis suppurativa: results from a multicenter cross-sectional study. J Am Acad Dermatol. 2017;76(1):49-53. doi:10.1016/j.jaad.2016.08.031
8. Data on file. Novartis Pharmaceuticals Corp; July 2023.