The WINLEVI^® Way

First-in-Class

A novel way to target androgen receptors in acne vulgaris^1,2*

*The exact mechanism of WINLEVI in acne vulgaris is unknown.¹

Access and Reimbursement Support

For your convenience, please download the Authorization and Appeals Kit, as well as individual sample letters you may need for patient access to WINLEVI.

Formulary Exception Request Letter

Letter of Appeal

Prior Authorization Request Letter

Letter of Medical Necessity

Discover Savings for eligible commercially insured patients prescribed WINLEVI

Pass savings along to your patients with the WINLEVI Co-Pay Program

Commercially insured patients may pay as little as $20 when WINLEVI is covered or a prior authorization (PA) is approved
Commercially insured patients may pay as little as $90 when WINLEVI is not covered or a PA is denied
The WINLEVI Co-Pay Program can be used at any participating pharmacy

Discover the program

Enrollment is subject to applicable program maximum restrictions, terms and conditions, and eligibility criteria.

Sign up for updates

For future updates and helpful information regarding prescribing WINLEVI, sign up to receive email communications.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream.

Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with WINLEVI. In the PK trial, HPA axis suppression was observed in 5% of adult subjects and 9% of adolescent subjects at Day 14. All subjects returned to normal HPA axis function at follow-up 4 weeks after stopping treatment. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and the use of occlusive dressings. Attempt to withdraw use if HPA axis suppression develops.

Pediatric patients may be more susceptible to systemic toxicity.

Hyperkalemia: Elevated potassium levels were observed in some subjects during the clinical trials. Shifts from normal to elevated potassium levels were observed in 5% of WINLEVI-treated subjects and 4% of vehicle-treated subjects.

ADVERSE REACTIONS

Most common adverse reactions occurring in 7% to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle.

To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

The WINLEVI® Way

Access and Reimbursement Support

Discover Savings for eligible commercially insured patients prescribed WINLEVI

Sign up for updates

INDICATION

IMPORTANT SAFETY INFORMATION

The WINLEVI^® Way