For the treatment of patients with external genital and perianal warts (EGW)...
VEREGEN® is the first botanical drug approved for prescription use in the United States1
In clinical studies:
- 53.6% of VEREGEN® patients demonstrated complete clearance of EGW vs 35.3% for vehicle2
- 93.2% of VEREGEN® patients with complete clearance of EGW experienced sustained clearance at 12 weeks posttreatment vs 94.2% for vehicle2
In two phase 3, randomized, double-blind, vehicle-controlled studies (United States and international) of immunocompetent male and female patients (N=604) aged 18 years and older who had EGW, VEREGEN® or vehicle was applied 3 times daily until complete clinical (visual) clearance of all external genital or perianal warts (baseline and new) or up to 16 weeks. Those patients who experienced complete clearance of all warts were followed for a 12-week treatment-free period to assess sustained clearance.2
The most common adverse reactions were local skin and application site reactions including redness, itching, burning, pain, sores, swelling, hard spots, and rash with blisters.
- The majority of adverse events were mild or moderate local application site reactions1-4
- Only 2.3% of VEREGEN® patients discontinued treatment due to local adverse events1
VEREGEN® (sinecatechins) Ointment, 15% is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.
Do not use VEREGEN® Ointment, 15% if you are allergic to any ingredient in this product. Do not use VEREGEN® Ointment, 15% for warts in the vagina, cervix, or inside the anus. Avoid contact with your eyes, nostrils and mouth while ointment is on your finger(s).
Avoid use of VEREGEN® on open wounds. Do not expose skin that has been treated with VEREGEN® to the sunlight, sunlamps or tanning beds. Tell your doctor if you are using any other type of skin product on the area to be treated. Avoid sexual contact (genital, anal or oral) when VEREGEN® Ointment, 15% is on your genital or perianal skin. If you do choose to have sexual contact, you must wash off the ointment carefully before having protected sexual contact as the ointment may weaken condoms and vaginal diaphragms.
Be sure to tell the doctor if you have a weak immune system, if you are pregnant or nursing a baby, or if you have used VEREGEN® before. Avoid using this product in patients younger than 18 years of age or for longer than 16 weeks. If your warts do not go away or come back after treatment contact your doctor.
The most common side effects with VEREGEN® Ointment, 15% are local skin and application site reactions including (incidence ≥ 20%): redness, itching, burning, pain, sores, swelling, hard spots, rash with blisters.
For more information, consult your healthcare professional.
Please see link to full Patient Information. VEREGEN® (sinecatechins) Ointment, 15% Patient Information
Please see link to full Prescribing Information. VEREGEN® (sinecatechins) Ointment, 15% Full Prescribing Information
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
The information on this website should not take the place of talking with your healthcare professional. If you need medical information, please talk to your healthcare professional.
- Data on file, Fougera.
- VEREGEN® Ointment, 15% [Prescribing Information, 2018]. Melville. NY: PharmaDerm, part of Fougera Pharmaceuticals Inc.
- Stockfleth E, Beti H, Orasan R, et al. Topical Polyphenon® E in the treatment of external genital and perianal warts: a randomized controlled trial. Br J Dermatol. 2008;158(6):1329-1338.
- Tatti S, Swinehart JM, Thielert C, Tawfik H, Mescheder A, Beutner KR. Sinecatechins, a defined green tea extract, in the treatment of external anogenital warts: a randomized controlled trial. Obstet Gynecol. 2008;111(6):1371-1379.