(BPT) - Please see IMPORTANT SAFETY INFORMATION ABOUT VEREGEN® (sinecatechins) Ointment, 15% below.
There are approximately 20 million new cases of sexually transmitted infections (STIs) in the United States every year, and America's youth between the ages of 15 and 24 account for about half of these infections.[i] While STIs are traditionally associated with this younger population, the reality is that the prevalence of STIs in older generations is just as important.
Every year, more than half of the estimated cases of human papillomavirus (HPV) infection occur in adults over the age of 25.[i]
HPV is one of the most common STIs in the United States, and there are two strains of HPV - strains 6 and 11 - that most commonly cause genital warts.[ii],[iii] Genital warts can appear as small, flesh-colored bumps or groups of bumps on the outside of the genitals or around the outside of the anus and may be flat, raised, or cauliflower-shaped.[iii]
Think you're too old to contract an STI like genital warts? Consider the following points from a 2013 study of participants in private health plans from 2003-2010:
- For women in their 30s, rates of genital warts rose from 2003 to 2009. Specifically, for women between the ages of 30 to 34, the rate increased from 1.6 to 2.5 per 1,000 women. For those between the ages of 35 to 39 years old, the rate rose from 1.3 to 1.7 per 1,000 women.[iv]
- The same is true for men in their 30s. Specifically, for men between the ages of 30 to 34, the rate rose from 2.5 to 4.1 per 1,000 men. For men between the ages of 35 to 39, the rate increased from 1.4 to 2.4 per 1,000 men.[iv]
- In 2010, the prevalence of genital warts was nearly equal among women ages 15 to 19 and 35 to 39 years old (nearly 2 per 1,000 women).[iv]
The good news is that whether you're a college student rushing to class, a young professional between meetings, or an on-the-go parent, there are treatment options for external genital and perianal warts that can easily be incorporated into your daily routine. Options include provider-administered treatments, like laser therapy or cryotherapy, and patient-applied treatment therapies like creams and ointments that can be applied at your convenience in the privacy of your own home.[v]
One patient-applied prescription treatment recommended by the U.S. Centers for Disease Control and Prevention for appropriate patients with external genital and perianal warts is VEREGEN® (sinecatechins) Ointment, 15%.[v] In two clinical studies, VEREGEN® was proven to provide complete clearance of external genital and perianal warts in the majority of patients compared against a 'vehicle' (placebo) (53.6 percent VEREGEN® vs. 35.3 percent vehicle) when applied 3 times daily for up to 16 weeks or until complete clearance of all warts (baseline and new warts occurring during treatment).[vi]
If you have external genital or perianal warts or think you may have external genital or perianal warts, talk to your doctor about whether VEREGEN® may be right for you. And, visit www.VEREGEN.com for additional information and resources, and to learn more about whether you are eligible to receive the VEREGEN® Instant Savings Card.
IMPORTANT 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, 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: redness, itching, burning, pain, sores, swelling, hard spots, and rash with blisters. For more information, consult your healthcare professional.
VEREGEN® (sinecatechins) is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.
Please see the SUMMARY OF INFORMATION ABOUT VEREGEN® (sinecatechins) Ointment, 15% below.
SUMMARY OF INFORMATION ABOUT
VEREGEN® (sinecatechins) Ointment, 15%
The Risk information presented here is not comprehensive. To learn more, talk to your healthcare provider or pharmacist about VEREGEN®.
The FDA-approved product labeling can be found at www.VEREGEN.com.
What is VEREGEN® Ointment?
VEREGEN® Ointment is a medicine for skin use only (topical) for the treatment of warts on the outside of the genitals and around the outside of the anus. It is not a treatment for warts in the vagina, cervix, or inside the anus. Your doctor may recommend examination and screening tests (such as a Pap smear) to evaluate these areas.
Who should not use VEREGEN® Ointment?
Do not use VEREGEN® Ointment if you are allergic to an ingredient in VEREGEN® Ointment. The list of ingredients is at the end of this leaflet.
What should I tell my doctor before using VEREGEN® Ointment?
Tell your doctor about all your health conditions and all the medicines you take including prescription, over-the-counter medicine, vitamins, supplements, and herbals. Be sure to tell your doctor if you are:
- pregnant or planning to become pregnant, as it is not known if VEREGEN® Ointment can harm your unborn baby. Your doctor will determine whether the benefit outweighs the risk.
- breastfeeding, as it is not known if VEREGEN® Ointment can pass into your milk and if it can harm your baby.
- using any other type of skin product or have open wounds on the area to be treated. VEREGEN® Ointment should not be used until your skin has healed from other treatments applied to the same area.
- immunocompromised. This means that your immune system cannot fight infections as well as it should.
How should I use VEREGEN® Ointment?
- Use VEREGEN® Ointment only on the area affected exactly as prescribed by your doctor.
- Wash your hands before and after application of VEREGEN® Ointment. A small amount of the ointment should be applied to all warts using your finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts as directed by your doctor.
- Apply VEREGEN® Ointment three times per day-in the morning, at noontime and in the evening.
- Do not wash off the ointment from the treated area before the next application. When you wash the treatment area or bathe, apply the ointment afterwards.
- Treatment with VEREGEN® Ointment should be continued until complete clearance of all warts, but no longer than 16 weeks. If your warts do not go away, or if they come back after treatment call your doctor.
- VEREGEN® Ointment is not a certain cure for warts on your genitals or around your anus. New warts may develop during or after the use of VEREGEN® Ointment, and may need treatment.
What should I avoid while using VEREGEN® Ointment?
- Do not apply VEREGEN® Ointment on open wounds or into the vagina or into the anus.
- Genital warts are a sexually transmitted disease, and you may infect your partner.
- Avoid sexual contact (genital, anal or oral) when VEREGEN® Ointment 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. Talk to your doctor about safe sex practices.
- Avoid contact with your eyes, nostrils and mouth while ointment is on your finger(s).
- Women using tampons: insert the tampon before applying the ointment. If you need to change your tampon while the ointment is on your skin, avoid getting the ointment into the vagina.
- Uncircumcised men treating warts under the foreskin should retract the foreskin and clean the area daily.
- Do not expose the genital area treated with VEREGEN® Ointment to sunlight, sunlamps or tanning beds.
- Do not cover the treated area. Loose-fitting undergarments can be worn after applying VEREGEN® Ointment.
- VEREGEN® Ointment may stain your light colored clothes and bedding.
What are the possible side effects of VEREGEN® Ointment?
The most common side effects with VEREGEN® Ointment are local skin and application site reactions including:
- hard spots
- rash with blisters
Many patients experience itching, reddening or swelling on or around the application site during the course of treatment. Some of these side effects could be a sign of an allergic reaction. If you experience open sores or other severe reactions at the locations you applied VEREGEN® Ointment, stop treatment and call your doctor right away. You may experience other side effects of VEREGEN® Ointment that are not mentioned here. Ask your doctor or pharmacist for more information. Patients should be aware that new warts may develop during treatment as VEREGEN® Ointment is not a cure.
How should I store VEREGEN® Ointment?
- Store VEREGEN® Ointment refrigerated or up to 77°F (25°C).
- Do not freeze.
- Make sure the cap on the tube is tightly closed.
- Safely throw away VEREGEN® Ointment tubes that are out of date or are empty.
Keep VEREGEN® Ointment and all medicines out of the reach of children.
General advice about prescription medicines
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use VEREGEN® Ointment for a condition for which it was not prescribed. Do not give VEREGEN® Ointment to other people, even if they have the same symptoms you have. It may harm them. Do not use VEREGEN® Ointment after the expiration date on the tube. This is a summary of the most important information about VEREGEN® Ointment. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about VEREGEN® Ointment that is written for the doctor.
What are the ingredients in VEREGEN® Ointment?
A defined green tea extract named sinecatechins.
Isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol.
You are encouraged to report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Please visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you have a product complaint about VEREGEN®, please call PharmaDerm customer service at 1-800-525-8747.
This article is sponsored by PharmaDerm.© 2017 PharmaDerm. All rights reserved.
Veregen® is a registered trademark of Medigene AG, D-82152 Planegg/Martinsried, Germany.
[i] CDC. CDC Fact Sheet: Incidence, Prevalence, and Cost of Sexually Transmitted Infections in the United States. https://www.cdc.gov/std/stats/sti-estimates-fact-sheet-feb-2013.pdf. Accessed March 14, 2017.
[ii] Diseases and Conditions: Genital Warts. Mayo Clinic. http://www.mayoclinic.org/diseases-conditions/genital-warts/basics/definition/con-20019380. Accessed March 14, 2017.
[iii] Genital Warts. U.S. National Library of Medicine MedlinePlus Medical Encyclopedia. https://medlineplus.gov/ency/article/000886.htm. Accessed March 14, 2017.
[iv] Flagg, Elaine W., Ph.D., Schwartz, Robert, BS, Weinstock, Hillard, MD, MPH. Prevalence of Anogenital Warts Among Participants in Private Health Plans in the United States, 2003-2010: Potential Impact of Human Papillomavirus Vaccination. American Journal of Public Health. 2013; 103(8):1428-1435.
[v] CDC. 2015 Sexually Transmitted Diseases Treatment Guidelines. https://www.cdc.gov/std/tg2015/. Accessed March 14, 2017.
[vi] Veregen (sinecatechins) [prescribing information], Melville, NY: PharmaDerm a division of Fougera; Revised 2012.