For the treatment of external genital and perianal warts (EGW) What you need to know about EGW Indication VEREGEN is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. Important Safety Information Do not use VEREGEN Ointment, 15% if you are allergic to any ingredient in this product. Please see additional Important Safety Information throughout this booklet. Please see Brief Summary of full Prescribing Information in pocket.
Questions & answers What are external genital and perianal warts? External genital and perianal warts, or EGW, is a sexually transmitted disease (STD). The warts are small growths that appear on the genitals or near the anus. Those around the anus are called perianal warts. The warts may be raised or flat, single or multiple, small or large. What causes EGW? EGW is caused by a virus called human papillomavirus (HPV). HPV is estimated to be the most common sexually transmitted infection. You can get EGW by having sexual contact with someone who has HPV. You can catch it from vaginal, anal, and oral sex. Where does EGW appear on the body? In women: on the vulva and the skin around the vaginal area In men: on the penis, especially under the foreskin in uncircumcised men In both women and men: perianal warts appear in the area around the anus How does someone get EGW? EGW may appear within several weeks after sexual contact (genital, anal, oral) with someone who has HPV. The warts may not be seen for months, or not appear at all. This makes it hard to know exactly when or from whom a person contracts EGW. 2
Can I have an HPV infection even if I don t see any warts? Yes. EGW doesn t have to be seen to be there. Sometimes you can t see anything on your partner. But he or she may still have an HPV infection and infect you. How can I protect myself? Because EGW is sexually transmitted, the only way to completely prevent it is to not have sex. If you choose to be sexually active, limit the number of partners you have to lower your risk of getting HPV. Using a condom every time you have sex may help reduce the risk of getting HPV. But a condom doesn t always cover all of the affected skin so it cannot fully protect you or your partner. An HPV vaccine is available. Ask your doctor if this method of prevention is right for you. Important! EGW is sexually transmitted. You could infect your partner. Be sure to talk to your doctor about safe sex practices to reduce this risk. 3
Questions & answers (cont'd) Who is most likely to get EGW? Any sexually active person can get it, regardless of age, race, social class, or sexual preference. You are more likely to get it if you: Have unprotected sex Have more than 1 sex partner Have sex with someone who has had other sex partners Have or have had another STD What does EGW look like? You may notice: Small, flesh-colored spots or growths that are raised or flat in your genital and/or anal area Several warts close together that have a cauliflower-like shape Itching or discomfort in your genital and/or anal area Bleeding when you have sexual intercourse 4
How can a doctor tell if I have EGW? If you think you have EGW or have been exposed to HPV, see your doctor. You can check yourself and your partner(s), but sometimes the warts can be small and hard to see. Your doctor will check very closely and may use a magnifying lens to find small ones. Only your doctor can tell you for sure. Why is treatment important? Left untreated, the warts could: Stay the same size Increase in number and size Go away on their own Protect yourself and your partner HPV spreads through sexual contact. If you have EGW, avoid sexual contact until you have been treated. Ask your healthcare professional when you may resume sexual contact. Be sure to tell your partner so he or she can be checked by a healthcare professional. 5
How treatment with VEREGEN What is VEREGEN? VEREGEN is a medicine to be used only on the skin (topical) and for the treatment of warts only on the outside of the genitals and around the outside of the anus. VEREGEN is the first prescription botanical treatment approved for use in the United States. It s made from an extract of natural green tea leaves. It should be used by people 18 years and older who are able to develop a normal immune response. How has VEREGEN been shown to help? In 2 clinical studies, VEREGEN was applied 3 times a day for up to 16 weeks. It was shown to: Provide complete clearance of EGW (53.6% vs 35.3% for vehicle) 93.2% of VEREGEN patients with complete clearance of EGW experienced sustained clearance at 12 weeks posttreatment (vs 94.2% for vehicle) VEREGEN is not a certain cure for EGW. New warts may develop during or after the use of VEREGEN, which may need treatment. Talk to your doctor if you have more questions about VEREGEN. 6
(sinecatechins) may help How should I use VEREGEN? Use VEREGEN only on the affected area, exactly as prescribed by your doctor. Wash your hands before and after applying VEREGEN Put VEREGEN on each wart, using your finger(s). Dab it on to make sure all of the warts are covered, and leave a thin layer of VEREGEN on the warts Apply VEREGEN 3 times a day for example, in the morning, evening, and before bedtime Do not wash off the ointment from the treated area before the next application. When you wash the treatment area or bathe, apply VEREGEN afterward Use VEREGEN until all warts have completely cleared, but no longer than 16 weeks It is important to stick with your VEREGEN treatment exactly as prescribed by your doctor. Proper treatment may help clear visible warts. Important Safety Information 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). Please see additional Important Safety Information throughout this booklet. Please see Brief Summary of full Prescribing Information in pocket. 7
How treatment with VEREGEN (cont'd) Can I be sexually active while being treated with VEREGEN? VEREGEN does not prevent the transfer of HPV. It is possible to have protected sex using a condom for vaginal, anal, and oral sex; however, you need to be careful as VEREGEN may weaken condoms and vaginal diaphragms. Be sure to wash off all the VEREGEN ointment with soap and warm water beforehand. Avoid sexual contact (genital, anal, oral) when VEREGEN is on your skin. After sex, wash your hands and the treatment area, then reapply VEREGEN. Will EGW come back? During clinical trials, people who had complete clearance of EGW using VEREGEN were observed for another 12 weeks after their treatment ended. Of those people, more than 90% who used VEREGEN and more than 90% who used vehicle had no recurrence of EGW at that time. (Remember: HPV can stay in the body without symptoms, so EGW can come back in the future.) If your EGW do not go away, or if they come back after treatment, talk to your doctor. 8
(sinecatechins) may help Will I have side effects? People may experience redness, sores, swelling, and hard spots while using VEREGEN. In clinical trials, some of the most common side effects (such as redness, sores, swelling, and hard spots) were most intense by Week 2 of treatment. Very few people in the clinical studies stopped using VEREGEN because of the side effects. If you experience more severe side effects with VEREGEN, stop treatment and call your doctor right away. 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. Important Safety Information Avoid use of VEREGEN on open wounds. Do not expose skin that has been treated with VEREGEN to 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. Please see additional Important Safety Information throughout this booklet. Please see Brief Summary of full Prescribing Information in pocket. 9
Learn more Helpful resources You re not alone! Below is a list of helpful organizations that can provide you with more information on EGW and treatment options. American Sexual Health Association www.ashastd.org Centers for Disease Control and Prevention www.cdc.gov Planned Parenthood www.plannedparenthood.org Remember, your doctor is your best resource for information on treating EGW. 10
Find more information and an offer for prescription savings at VEREGEN.com Important Safety Information 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. Please see additional Important Safety Information throughout this booklet. Please see Brief Summary of full Prescribing Information in pocket. 11
The FIRST BOTANICAL DRUG approved for prescription use in the United States Important Safety Information 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, and rash with blisters. For more information, consult your healthcare professional. If you have a product complaint about VEREGEN, please call PharmaDerm customer service at 1-800-525-8747. Please see additional Important Safety Information throughout this booklet. Please see Brief Summary of full Prescribing Information in pocket. 100 College Road West, Princeton, NJ 08540. VEREGEN is a registered trademark of Medigene AG, D-82152 Planegg/Martinsried, Germany. 2017 Fougera Pharmaceuticals Inc. All rights reserved. P-VRG-1349626 09/2017
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: redness itching burning pain sores swelling 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? Active ingredient: A defined green tea extract named sinecatechins. Inactive ingredients: Isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol. Manufactured for: PharmaDerm, a division of Fougera Pharmaceuticals Inc. Melville, New York 11747 Manufactured by: C.P.M. Contract Pharma GmbH & Co. KG Frühlingstrasse 7 D-83620 Feldkirchen-Westerham, Germany For more information, go to www.pharmaderm.com or call 1-800-645-9833. VEREGEN is a registered trademark of Medigene AG, D-82152 Planegg/Martinsried, Germany. 2016 Fougera Pharmaceuticals Inc. All rights reserved. U.S. Patent Nos. 5795911 and 5968973 P-VRG-1332633 06/2016