Is COSENTYX safe to use while breastfeeding?

It is not known whether secukinumab is excreted in human milk or absorbed systemically after ingestion. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for COSENTYX and any potential adverse effects on the breastfed child from COSENTYX or from the underlying maternal condition.

What is the maximum recommended human dose of COSENTYX?

The maximum recommended human dose (MRHD) of COSENTYX is not specified in the information provided. However, 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 MRHD.

Cosentyx Prescribing & Dosing Schedule

Q: What is the risk of taking COSENTYX during pregnancy?

Limited human data are available on the use of COSENTYX during pregnancy. The available data from an embryo-fetal development study in monkeys showed no adverse developmental effects in infants born to pregnant monkeys after subcutaneous administration of secukinumab during organogenesis at doses up to 30 times the maximum recommended human dose. However, the background risk of major birth defects and miscarriage in the indicated population is unknown.

Q: Can COSENTYX be used in pediatric patients?

The safety and effectiveness of COSENTYX have been established in pediatric subjects aged 6 years and older with moderate to severe plaque psoriasis, as well as in patients weighing 15 kg or more with juvenile psoriatic arthritis (JPsA) aged 2 years and older and enthesitis-related arthritis (ERA) aged 4 years and older. However, the safety and effectiveness of COSENTYX in pediatric patients below the age of 6 years or with body weight less than 15 kg have not been established.

Q: Is there any information on the use of COSENTYX in geriatric patients?

Although no differences in safety or efficacy were observed between older and younger subjects in clinical trials, the number of subjects aged 65 years and older was not sufficient to determine whether they responded differently from younger subjects. Of the 3430 plaque psoriasis subjects exposed to COSENTYX in clinical trials, a total of 230 were 65 years or older, and 32 subjects were 75 years or older.

Dosage & Administration

* Prior to COSENTYX initiation, complete all age-appropriate vaccinations, evaluate patients for tuberculosis (TB). . See Full Prescribing Information for instructions on preparation and administration of COSENTYX.
* 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.
* Plaque Psoriasis:
* Subcutaneous Dosage in Adults: Recommended dosage is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. For some patients, a dose of 150 mg may be acceptable.
* 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 (at the time of dosing), the dose is 75 mg.
* For patients ≥ 50 kg (at the time of dosing), the dose is 150 mg.

* Psoriatic Arthritis:
Adult Patients
Subcutaneous Dosage:
* For PsA patients with coexistent moderate to severe PsO, use the dosage and administration for PsO.
* 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.

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. maintenance dose 300 mg per infusion).
* Without a loading dosage: 1.75 mg/kg every 4 weeks (max. maintenance dose 300 mg per infusion).

Pediatric Patients 2 Years and Older
Subcutaneous Dosages: Administer by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter:

* For patients ≥ 15 kg and < 50 kg the dose is 75 mg.
* For patients ≥ 50 kg the dose is 150 mg.

* Ankylosing Spondylitis:
Subcutaneous Dosage:
Administer with or without a loading dosage.
The recommended dosages are:
* 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 ankylosing spondylitis, consider a dosage of 300 mg every 4 weeks.

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. maintenance dose 300 mg per infusion).
* Without a loading dosage: 1.75 mg/kg every 4 weeks (max. maintenance dose 300 mg per infusion).

* Non-Radiographic Axial Spondyloarthritis:
Subcutaneous Dosage:
Administer with or without a loading dosage. The recommended dosage is:
* 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.

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. maintenance dose 300 mg per infusion).
* Without a loading dosage: 1.75 mg/kg every 4 weeks (max. maintenance dose 300 mg per infusion).

* Enthesitis-Related Arthritis: Recommended weight-based dosage is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
* For patients ≥ 15 kg and < 50 kg the dose is 75 mg.
* For patients ≥ 50 kg the dose is 150 mg.

* Hidradenitis Suppurativa: Recommended dosage is 300 mg administered by subcutaneous injection at Weeks 0, 1, 2, 3 and 4 and every 4 weeks thereafter. If a patient does not adequately respond, consider increasing the dosage to 300 mg every 2 weeks.

Get Your Patient on Cosentyx

See your patient's specific prior authorization requirements including coverage restrictions and step therapies

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Cosentyx Prescribing Information

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Cosentyx Prior Authorization Resources

Most recent state uniform prior authorization forms

Verified: Sep 24, 2024Arizona - Uniform Prior Authorization Form

Verified: Sep 24, 2024Colorado - Uniform Prior Authorization Form

Verified: Sep 24, 2024Hawaii - Uniform Prior Authorization Form

Verified: Sep 24, 2024Illinois - Uniform Prior Authorization Form

Verified: Sep 24, 2024Indiana - Uniform Prior Authorization Form

Verified: Sep 24, 2024Louisiana - Uniform Prior Authorization Form

Verified: Sep 24, 2024Minnesota - Uniform Prior Authorization Form

Verified: Sep 24, 2024New Hampshire - Uniform Prior Authorization Form

Verified: Sep 24, 2024New Mexico - Uniform Prior Authorization Form

Verified: Sep 24, 2024Oregon - Uniform Prior Authorization Form

Verified: Sep 24, 2024Texas - Uniform Prior Authorization Form

Verified: Oct 05, 2024Washington - Uniform Prior Authorization Form

Verified: Oct 05, 2024Wisconsin - Uniform Prior Authorization Form

Consentyx Connect Start Form

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Reimbursement help (FRM)

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Copay savings program

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Overview

Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)

Patient benefit

A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max

Patient eligibility

Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
May never be used with government insurance

How to sign up

Cards may be downloadable digital cards or hard copies
Some pharmacos offer debit cards with pre-loaded copay benefit
Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form

Bridge program

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Overview

Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)

Patient benefit

100% free (outside of insurance)

Patient eligibility

HCP must enroll patient
May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries

How to sign up

Typically HCP assisted enrollment (via form)

Foundation programs

Consentyx Connect Start Form

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Cosentyx Patient Assistance Program Income Requirements

Novartis Patient Assistance Foundation Application - English

Novartis Patient Assitance Foundation Application - Spanish

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Overview

Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned

Patient benefit

Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and copays) until the grant is exhausted

Patient eligibility

Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.

How to sign up

Patients submit proof of out-of-pocket drug costs to charities for reimbursement

Cosentyx PubMed™ News

Cosentyx Patient Education

Getting started on Cosentyx

Instructions For Use (75mg Pre-filled Syringe): All Indications

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Instructions For Use (150 mg Pre-filled Syringe): All Indications

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Instructions For Use (150mg Sensoready Pen): All Indications

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Instructions For Use (Video - 150 mg Sensoready Pen): All Indications

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Patient toolkit

About Cosentyx: Plaque Psoriasis

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Patient Stories: Plaque Psoriasis

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View How to Take Cosentyx: Plaque Psoriasis

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Side Effects: Plaque Psoriasis

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About Cosentyx: Psoriatic Arthritis

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Patient Stories: Psoriatic Arthritis

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Patient Resources: Psoriatic Arthritis

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View How to Take Cosentyx: Psoriatic Arthritis

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About Cosentyx: Ankylosing Spondylitis

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Patient Stories: Ankylosing Spondylitis

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View How to Take Cosentyx: Ankylosing Spondylitis

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About Cosentyx: nr-axSpA

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View How to Take Cosentyx: nr-axSpA

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About Cosentyx: Pediatric Psoriasis

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About Cosentyx: ERA & JPsA

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Side Effects: Psoriatic Arthritis

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Patient Resources: Ankylosing Spondylitis

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Side Effects: Ankylosing Spondylitis

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Side Effects: nr-axSpa

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Other resources

Sharps Container

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Twill Care App: Plaque Psoriasis

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Cosentyx FAQs

Limited human data are available on the use of COSENTYX during pregnancy. The available data from an embryo-fetal development study in monkeys showed no adverse developmental effects in infants born to pregnant monkeys after subcutaneous administration of secukinumab during organogenesis at doses up to 30 times the maximum recommended human dose. However, the background risk of major birth defects and miscarriage in the indicated population is unknown.

The safety and effectiveness of COSENTYX have been established in pediatric subjects aged 6 years and older with moderate to severe plaque psoriasis, as well as in patients weighing 15 kg or more with juvenile psoriatic arthritis (JPsA) aged 2 years and older and enthesitis-related arthritis (ERA) aged 4 years and older. However, the safety and effectiveness of COSENTYX in pediatric patients below the age of 6 years or with body weight less than 15 kg have not been established.

Although no differences in safety or efficacy were observed between older and younger subjects in clinical trials, the number of subjects aged 65 years and older was not sufficient to determine whether they responded differently from younger subjects. Of the 3430 plaque psoriasis subjects exposed to COSENTYX in clinical trials, a total of 230 were 65 years or older, and 32 subjects were 75 years or older.

Dosage & Administration

Get Your Patient on Cosentyx

Cosentyx Prescribing Information

Request Cosentyx Samples

Is my patient eligible for Cosentyx samples?

How do I find out who my Cosentyx rep is?

Cosentyx Prior Authorization Resources

Most recent state uniform prior authorization forms

Benefits investigation

Reimbursement help (FRM)

Cosentyx Financial Assistance Options

Copay savings program

Overview

Patient benefit

Patient eligibility

How to sign up

Bridge program

Overview

Patient benefit

Patient eligibility

How to sign up

Foundation programs

Overview

Patient benefit

Patient eligibility

How to sign up

Cosentyx PubMed™ News

Cosentyx Patient Education

Getting started on Cosentyx

Patient toolkit

Other resources

Cosentyx FAQs