Veregen(R) (sinecatechins) Ointment, 15%

VEREGEN®:

Rx Only

  • Proven effective in clearing both existing AND newly emerging external genital and perianal warts
  • Veregen demonstrated complete clearance in 53.6% of all patients studied in two Phase III randomized, double-blind, placebo-controlled trials1
    • At 12 weeks post treatment, 93.2% of Veregen patients who experienced complete clearance remained clear
  • The majority of local application site reactions in one Phase III randomized, double-blind, placebo-controlled trial, were identified as local skin and application site reactions and peaked at week 2 of treatment2

For more information, visit Veregen.com

Important Selected Product Safety Information

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 or if you are pregnant or nursing a baby. Avoid using this product in patients younger than 18 years of age, or for longer than 16 weeks, or for multiple treatment courses. If your warts do not go away or come back after treatment contact your doctor.

The most common adverse reactions that occurred in more than 20% of patients in studies with VEREGEN® were reactions of the skin and application site. These included reddening of the skin, itching, burning, pain or discomfort, skin ulcers, wearing down of the skin, swelling, hard spots, and rash with blisters.

For more information, consult your healthcare professional. Please see link to Full Patient Information below.

VEREGEN® (sinecatechins) Ointment 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

References:
  1. Veregen Ointment, 15% [Prescribing Information]. Melville, NY: PharmaDerm, a division of Fougera Pharmaceuticals Inc., Inc.
  2. 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.