For free samples, call 1-866-318-6977

For free samples, call 1-866-318-6977

FREQUENTLY ASKED QUESTIONS
ABOUT ACCESS AND TREATMENT

COSENTYX® CONNECT

What is COSENTYX® Connect?

COSENTYX® Connect is a support program designed to help patients start and stay on COSENTYX®. With a full range of personalized services like a dedicated Personal Support Specialist, a $0 co-pay,* and injection help, COSENTYX® Connect is here throughout the treatment journey.

The COSENTYX® Connect Personal Support Program can help set patients up for success with a number of helpful features:

Personal Support Specialist

A Personal Support Specialist (PSS) from the start

Injection Support

Supplemental injection training support

$0 Co-pay card

Financial support so eligible patients can pay $0* or get started quickly for FREE if a prior authorization (PA) is denied while coverage is pursued

Welcome Kit

Comprehensive educational resources to support their journey

The COSENTYX® Connect Personal Support Program helps patients get coverage for and access to COSENTYX:

  • Investigate prescription coverage restrictions (eg, PAs) and provide information for initiating a PA request and/or up to 2 levels of appeal. Fax communications keep your office informed every step of the way

  • Financial support: $0 Co-pay* Program for eligible commercially insured patients. The Covered Until You’re Covered Program offers up to 2 years of COSENTYX for FREE while coverage is pursued for eligible commercially insured patients whose prescription coverage isn’t initially approved

  • Following Rx approval, transfer the Rx to the office’s preferred or payer-mandated Specialty Pharmacy for processing and delivery. Work closely with the patient and pharmacy to ensure a timely delivery

  • A multilingual PSS that helps patients get started and supports them through their first year of treatment

  • Automatic enrollment into the COSENTYX® Connect Personal Support Program provides patients with personalized support for up to 12 months after Rx transfer

  • A Field Reimbursement Manager (FRM) is only a phone call away to answer any questions you may have

*Limitations apply. Up to a $16,000 annual limit. 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. Limitations may apply in MA and CA. For complete Terms & Conditions details, call 1-844-267-3689.

Certain payers have carve-outs that restrict utilization of manufacturer support programs.

Covered Until You’re Covered Program: Eligible patients must have commercial insurance, a valid prescription for COSENTYX, and a denial of insurance coverage based on a prior authorization request. Program requires the submission of an appeal of the coverage denial within the first 90 days of enrollment in order to remain eligible. Program provides initial 5 weekly doses (if prescribed) and monthly doses for free to patients for up to two years or until they receive insurance coverage approval, whichever occurs earlier. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. Patients may be asked to reverify insurance coverage status during the course of the program. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Limitations may apply. Enrolled patients awaiting coverage for COSENTYX after two years may be eligible for a limited Program extension. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this Program without notice.

Rx=prescription.

What is a Start Form?

Also known as the Service Request Form (SRF), the Start Form serves as an enrollment channel for the patient into the COSENTYX® Connect Personal Support Program and the Covered Until You’re Covered Program.* The Start Form requires important information that must be filled out by both the HCP and the patient, which includes the patient’s prescription, patient insurance, and patient and HCP signatures.

An electronic Start Form is available through
CoverMyMeds.

If you have questions about the Start Form, please contact your FRM or call 1-844-COSENTYX (1-844-267-3689).

Start Form

*Covered Until You’re Covered Program: Eligible patients must have commercial insurance, a valid prescription for COSENTYX, and a denial of insurance coverage based on a prior authorization request. Program requires the submission of an appeal of the coverage denial within the first 90 days of enrollment in order to remain eligible. Program provides initial 5 weekly doses (if prescribed) and monthly doses for free to patients for up to two years or until they receive insurance coverage approval, whichever occurs earlier. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. Patients may be asked to reverify insurance coverage status during the course of the program. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Limitations may apply. Enrolled patients awaiting coverage for COSENTYX after two years may be eligible for a limited Program extension. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this Program without notice.

What is CoverMyMeds?

covermymed

CoverMyMeds is a free healthcare service that provides prescription decision support, electronic prior authorization (ePA), and specialty support services.

COSENTYX has partnered with CoverMyMeds to create a convenient way to get patients started on COSENTYX. Log in to covermymeds.com to submit and follow up on an ePA; decisions are typically made within 3 days. If the payer denies the PA, you can send an electronic Start Form through CoverMyMeds to enroll eligible* commercially insured patients in our Covered Until You’re Covered Program.

To learn more, click the CoverMyMeds bar on the
Getting Started page.

If you’d like an account, it’s easy to open one
online
.

Onboarding brochure

CoverMyMeds is a registered trademark of CoverMyMeds LLC. All rights reserved.

*Certain payers have carve-outs that restrict utilization of manufacturer support programs.

Covered Until You’re Covered Program: Eligible patients must have commercial insurance, a valid prescription for COSENTYX, and a denial of insurance coverage based on a prior authorization request. Program requires the submission of an appeal of the coverage denial within the first 90 days of enrollment in order to remain eligible. Program provides initial 5 weekly doses (if prescribed) and monthly doses for free to patients for up to two years or until they receive insurance coverage approval, whichever occurs earlier. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. Patients may be asked to reverify insurance coverage status during the course of the program. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Limitations may apply. Enrolled patients awaiting coverage for COSENTYX after two years may be eligible for a limited Program extension. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this Program without notice.

What is a Field Reimbursement Manager (FRM) and how can they help me?

Phone

COSENTYX FRMs are expert insurance professionals available to offer support and resources to help ensure patients can access COSENTYX.

FRMs can support your office by:

  • Addressing local and regional insurance landscape and coverage obstacles

  • Serving as a liaison between the customer and COSENTYX® Connect throughout the reimbursement journey

  • Educating customers about COSENTYX® Connect and product access process

What is a Personal Support Specialist?

Personal Support Specialist

COSENTYX® Connect Personal Support Specialists are trained experts who offer patients dedicated support in the following ways:

  • Supplemental virtual injection training

  • Multilingual support

  • Available to answer patient questions

  • Help navigate insurance coverage and saving options

  • Check-ins throughout the patient’s treatment via phone, email, or text

FINANCIAL SUPPORT

How can patients sign up for $0 co-pay*?

$0 Co-pay

Eligible patients may pay nothing for their monthly COSENTYX prescriptions through the $0 Co-pay Program* if they have commercial prescription insurance. Patients may start saving today when they sign up for COSENTYX® Connect. Have them visit the link below to register for the $0 co-pay or call 1-844-COSENTYX (1-844-267-3689) and press option 1.

$0 co-pay sign-up

*Limitations apply. Up to a $16,000 annual limit. 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. Limitations may apply in MA and CA. For complete Terms & Conditions details, call 1-844-267-3689.

Certain payers have carve-outs that restrict utilization of manufacturer support programs.

Are there options for patients who are
not initially covered for COSENTYX
through their commercial or private
insurance?

Covered Until You're Covered

If patients have commercial insurance and their prescription coverage isn’t initially approved, eligible* patients may get up to 2 years of COSENTYX for FREE through the Covered Until You’re Covered Program while we work with you and their healthcare provider to try to secure coverage for COSENTYX.

*Certain payers have carve-outs that restrict utilization of manufacturer support programs.

Covered Until You’re Covered Program: Eligible patients must have commercial insurance, a valid prescription for COSENTYX, and a denial of insurance coverage based on a prior authorization request. Program requires the submission of an appeal of the coverage denial within the first 90 days of enrollment in order to remain eligible. Program provides initial 5 weekly doses (if prescribed) and monthly doses for free to patients for up to two years or until they receive insurance coverage approval, whichever occurs earlier. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. Patients may be asked to reverify insurance coverage status during the course of the program. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Limitations may apply. Enrolled patients awaiting coverage for COSENTYX after two years may be eligible for a limited Program extension. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this Program without notice.

What is the Covered Until You’re
Covered Program*?

Covered Until You're Covered

If coverage is denied, FREE COSENTYX is available for up to 2 years with the Covered Until You’re Covered Program* for eligible commercially insured patients while coverage is pursued.

Please fill out a Start Form and fax it to COSENTYX® Connect. Contact your FRM or 1-844-COSENTYX (1-844-267-3689) if you have questions.

Start Form

*Covered Until You’re Covered Program: Eligible patients must have commercial insurance, a valid prescription for COSENTYX, and a denial of insurance coverage based on a prior authorization request. Program requires the submission of an appeal of the coverage denial within the first 90 days of enrollment in order to remain eligible. Program provides initial 5 weekly doses (if prescribed) and monthly doses for free to patients for up to two years or until they receive insurance coverage approval, whichever occurs earlier. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. Patients may be asked to reverify insurance coverage status during the course of the program. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Limitations may apply. Enrolled patients awaiting coverage for COSENTYX after two years may be eligible for a limited Program extension. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this Program without notice.

Certain payers have carve-outs that restrict utilization of manufacturer support programs.

INSURANCE COVERAGE

Does my patient’s health plan
cover COSENTYX?

The majority of commercial health plan formularies cover COSENTYX.* Check the health plan’s coverage details by calling or visiting them online. If you have questions about specific plans and coverage tiers, your COSENTYX Field Reimbursement Manager or Sales Representative can help. Get in touch here.

*COSENTYX is present on formularies as either a first-, second-, third-, or fourth-line biologic.

How can I help patients get started
on COSENTYX?

There are 3 fast and convenient ways to get patients started on COSENTYX:

  • Through your CoverMyMeds account—with an integrated electronic Start Form

  • Directly with a Specialty Pharmacy—office preferred or health plan required

  • Through COSENTYX® Connect—with comprehensive dedicated support that transmits the prescription, connects you to PA resources, and enrolls the patient in support programs, if eligible

Choose the channel that’s right for your office. Most prescriptions receive prior authorization (PA) approval the first time around.

There are 2 options through COSENTYX® Connect that guarantee your eligible commercially insured patient access to treatment.

  • The Covered Until You’re Covered Program* provides eligible patients with up to 2 years of FREE COSENTYX while their PA denial is being appealed

  • The $0 Co-pay Program keeps COSENTYX affordable throughout the course of therapy

ICD-10 Coding

*Covered Until You’re Covered Program: Eligible patients must have commercial insurance, a valid prescription for COSENTYX, and a denial of insurance coverage based on a prior authorization request. Program requires the submission of an appeal of the coverage denial within the first 90 days of enrollment in order to remain eligible. Program provides initial 5 weekly doses (if prescribed) and monthly doses for free to patients for up to two years or until they receive insurance coverage approval, whichever occurs earlier. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. Patients may be asked to reverify insurance coverage status during the course of the program. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Limitations may apply. Enrolled patients awaiting coverage for COSENTYX after two years may be eligible for a limited Program extension. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this Program without notice.

Certain payers have carve-outs that restrict utilization of manufacturer support programs.

Limitations apply. Up to a $16,000 annual limit. 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. Limitations may apply in MA and CA. For complete Terms & Conditions details, call 1-844-267-3689.

How is COSENTYX committed to making sure your qualified commercially insured patients can start and stay on COSENTYX?

Through formulary coverage and COSENTYX programs, your qualified commercially insured patients can start and stay on their treatment.

  • COSENTYX is included on most formularies for commercially insured patients1* AND with the COSENTYX $0 co-pay program, 98% of enrollees paid nothing out of pocket2

  • Up to 2 years of FREE COSENTYX is available with Covered Until You're Covered for qualified‡§ commercially insured patients if a PA is denied while coverage is pursued

ICD-10 Coding

*COSENTYX is present on formularies as either first-, second-, third-, or fourth-line biologic. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. Coverage information is subject to change by the relevant payer.

Limitations apply. Up to a $16,000 annual limit. 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. Limitations may apply in MA and CA. For complete Terms & Conditions details, call 1-844-267-3689.

Certain payers have carve-outs that restrict utilization of manufacturer support programs.

§Covered Until You’re Covered Program: Eligible patients must have commercial insurance, a valid prescription for COSENTYX, and a denial of insurance coverage based on a prior authorization request. Program requires the submission of an appeal of the coverage denial within the first 90 days of enrollment in order to remain eligible. Program provides initial 5 weekly doses (if prescribed) and monthly doses for free to patients for up to two years or until they receive insurance coverage approval, whichever occurs earlier. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. Patients may be asked to reverify insurance coverage status during the course of the program. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Limitations may apply. Enrolled patients awaiting coverage for COSENTYX after two years may be eligible for a limited Program extension. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this Program without notice.

References: 1. Data on file. Cosentyx Access. Novartis Pharmaceuticals Corp; January 2022. 2. Data on file. Cosentyx PSS Co-pay Data. Novartis Pharmaceuticals Corp; August 2020.

How do I appeal a prior authorization
(PA) denial?

If a PA has been denied, the insurance company will provide a written explanation as to why it was denied and include information about how to request an appeal.

An appeal is a request to the patient’s insurance company to reconsider their decision to deny coverage of COSENTYX. Appropriate documentation, such as an appeal letter, letter of medical necessity, and relevant medical records can/should be submitted.

If you have questions, please contact your FRM or call 1-844-COSENTYX (1-844-267-3689).

PA & Appeals Kits

What should I do if an insurance plan
no longer covers COSENTYX?

Most insurance plans have a list of preferred and covered medications called a formulary. This list may be re-evaluated every year based on a number of factors, including cost, safety, and effectiveness of the medication. An insurance plan may decide to remove COSENTYX from their formulary and exclude it from coverage, which causes patients to experience a nonmedical switch to another medication. Nonmedical switching involves a change in medication in a patient who is stable on their prescribed medication for insurer cost-saving reasons, rather than for reasons related to effectiveness or safety.1

If a patient and the prescriber wish to continue with COSENTYX, follow these next steps and request a medical exception from the insurance company.

  • Call the insurance company and tell them that the patient and doctor want to stay with COSENTYX. Ask for information that can help get a medical exception so COSENTYX coverage doesn’t end. A medical exception can be based on:

    • Prior medications the patient has taken for their condition

    • How long they have been on COSENTYX

    • Satisfaction with the results

    • Concerns about unnecessary doctor visits during the COVID-19 pandemic

If the exception request is denied, the insurance company will provide a written explanation as to why it was denied and include information about how to request an appeal. Your office may file an appeal on the patient’s behalf.

Novartis is here to help: it is our goal to help make the medical exception request process as seamless as possible. Get help through COSENTYX® Connect or CoverMyMeds.

For help submitting a medical exception request, please see the Formulary Change Navigation Flashcard and the Medical Exception Request Letter.

Reference: 1. Costa OS, Salam T, Duhig A, et al. Specialist physician perspectives on non-medical switching of prescription medications. J Mark Access Health Policy. 2020;8(1):1738637.

What is a medical exception?

A medical exception request is a way to ask an insurance company to reconsider a formulary decision with respect to an individual patient for medical reasons. The prescriber must submit a statement of medical necessity with supporting information describing why COSENTYX is preferred over the insurance-mandated treatment option.

Novartis is here to help: it is our goal to help make the medical exception request process as seamless as possible. Get help through COSENTYX® Connect or CoverMyMeds, or contact your Field Reimbursement Manager (FRM).

For help submitting a medical exception request, please see the Medical Exception Request Letter and the Formulary Change Navigation Flashcard.

Formulary Change Navigation Flashcard

What happens if the insurance company
denies a medical exception or prior authorization (PA)?

If an exception request or PA is denied, the insurance company will provide a written explanation as to why it was denied and include information about how to request an appeal. Your office may file an appeal on the patient’s behalf.

Novartis is here to help: it is our goal to help make the medical exception request process as seamless as possible. Get help through COSENTYX® Connect or CoverMyMeds.

For additional information and sample letters, download the appropriate PA & Appeals Kit that corresponds to the patient’s disease.

COSENTYX has a program for eligible* commercially insured patients called Covered Until You’re Covered. If coverage is denied, this program provides up to 2 years of COSENTYX for FREE while coverage is being pursued. To enroll, submit a Start Form to COSENTYX® Connect.

If you have questions, please contact your FRM or call 1-844-COSENTYX (1-844-267-3689).

PA & Appeals Kits

*Certain payers have carve-outs that restrict utilization of manufacturer support programs.

Covered Until You’re Covered Program: Eligible patients must have commercial insurance, a valid prescription for COSENTYX, and a denial of insurance coverage based on a prior authorization request. Program requires the submission of an appeal of the coverage denial within the first 90 days of enrollment in order to remain eligible. Program provides initial 5 weekly doses (if prescribed) and monthly doses for free to patients for up to two years or until they receive insurance coverage approval, whichever occurs earlier. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. Patients may be asked to reverify insurance coverage status during the course of the program. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Limitations may apply. Enrolled patients awaiting coverage for COSENTYX after two years may be eligible for a limited Program extension. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this Program without notice.

How can I help if a patient is having
trouble refilling their prescription?

If a patient is having issues refilling their COSENTYX prescription, they may be out of refills or the prior authorization (PA) from their insurance company may have expired. Ask the patient to check with their pharmacy for more information and let you know what they learn. You may need to provide a new prescription and/or process another PA. Remind the patient to make a note of their PA approval and number of refills for future reference.

STARTING COSENTYX

How can I provide patients with more
information about their disease?

Patients can use one of the COSENTYX patient brochures to learn more about their disease and how COSENTYX can help them take control of their disease.

How can I provide patients with more
information about COSENTYX?

Patients can use one of the COSENTYX patient brochures to learn more about how COSENTYX can help them take control of their disease. For additional information about COSENTYX, patients can also visit www.COSENTYX.com.

COSENTYX.com

How can I find dosing information
for COSENTYX?

COSENTYX Getting Started

Please review the ICD-10 Coding information for full details of dosing information and suggested prescribing approaches for each indication.

Patients can also call their Personal Support Specialist.

ICD-10 Coding

Are there resources that can help
patients learn how to self-inject?

Patients can either watch the helpful injection videos for step-by-step instructions on how to safely self-inject COSENTYX or use the supplemental Quick Tips for Using the Sensoready® Pen brochure.

Patients enrolled in COSENTYX® Connect with a Personal Support Specialist may also request a live or virtual supplemental injection training.

Where can I learn more about the
results of COSENTYX treatment in
clinical trials?

Please visit CosentyxHCP.com to learn more about how COSENTYX performed in clinical trials.

CosentyxHCP.com

What testing do patients need to
complete before starting COSENTYX?

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Please see the full Prescribing Information for more information about pre-treatment evaluation for tuberculosis.

Prescribing Information

For additional resources, please visit the
Our Partners page or contact your FRM.

5/22 202556

Expand ISI

INDICATIONS

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

COSENTYX® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

WARNINGS AND PRECAUTIONS

Infections

Collapse ISI

INDICATIONS

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).

IMPORTANT SAFETY INFORMATION

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.