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August 16, 2017 STIs and Relationships: What a Diagnosis Really Means
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ARTICLE DESCRIPTION:

(BPT) - Please see IMPORTANT SAFETY INFORMATION ABOUT VEREGEN® (sinecatechins) Ointment, 15% below.

Embarrassment. Panic. Regret. These are just some of the reactions the phrase “sexually transmitted infection” (STI) can conjure. If you’re diagnosed with an STI while in a relationship, you may also wonder “Is my partner infected?,” “Can I infect my partner?” and “How do I keep us both safe?”

Initiating a conversation with your partner as soon as possible is vital to protecting the health of both individuals. When approaching this important discussion, consider the following:

Know the facts and realities. There are approximately 20 million new cases of STIs in the U.S. every year.[i] In fact, the most common STI in the country, human papillomavirus – or HPV – is so common that nearly all sexually active people get it at some point in their lives.[ii]Discussion tip: Reinforce the fact that STIs are common, and many are curable and all are treatable.[iii]Avoid placing blame. A diagnosis while in a relationship doesn’t necessarily mean infidelity. Consider the possibility that infection could have occurred prior to the start of your relationship. There are many STIs – like those caused by HPV, including genital warts – that may not cause physical symptoms for weeks, and in some cases even months, or years after infection.[iv]Discussion tip: Don’t dwell on what might have happened in the past. Keep the conversation focused on what comes next.Have a plan. Remember how shocking it can be to be faced with an STI diagnosis. Take the conversation a step further by not just sharing your diagnosis, but by coming prepared with information on diagnosis and treatment that can help inform a plan of action.Discussion tip: Suggest visiting a dermatologist, gynecologist, or primary care doctor for testing, and to receive treatment, if needed. It can be valuable to work as a team, so suggest taking on the next steps together.

After being diagnosed with an STI, you should talk to your doctor about treatment. If you and your partner have external genital or perianal warts, for example, there are provider-administered and patient-applied prescription therapies you can consider with your doctor.[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 or your partner 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.

Remember that contracting an STI doesn’t have to be a relationship deal-breaker. By arming yourselves with the facts, coming up with a realistic plan of action, and supporting each other, you and your partner can end up with a relationship stronger than ever before.

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.

INDICATION

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:

rednessitchingburningpainsoresswellinghard spotsrash 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.

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 May 9, 2017.[ii] CDC. Genital HPV infection - Fact Sheet. Centers for Disease Control and Prevention. http://www.cdc.gov/std/hpv/stdfact-hpv.htm. Accessed May 9, 2016.[iii] CDC. CDC Infographic: The Lowdown on How to Prevent Sexually Transmitted Diseases. https://www.cdc.gov/std/prevention/lowdown/the_lowdown_infographic_poster_30x20.pdf. Accessed May 9, 2017.[iv] White C. Genital warts: MedlinePlus Medical Encyclopedia. Nlmnihgov. 2015. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000886.htm. Accessed May 9, 2017.[v] CDC. 2015 Sexually Transmitted Diseases Treatment Guidelines. https://www.cdc.gov/std/tg2015/. Accessed May 9, 2017.[vi] Veregen (sinecatechins) [prescribing information], Melville, NY: PharmaDerm a division of Fougera; Revised 2012.

Please see IMPORTANT SAFETY INFORMATION ABOUT VEREGEN® (sinecatechins) Ointment, 15% below.Embarrassment. Panic. Regret. These are just some of the reactions the phrase “sexually transmitted infection” (STI) can conjure. If you’re diagnosed with an STI while in a relationship, you may also wonder “Is my partner infected?,” “Can I infect my partner?” and “How do I keep us both safe?”Initiating a conversation with your partner as soon as possible is vital to protecting the health of both individuals. When approaching this important discussion, consider the following:? Know the facts and realities. There are approximately 20 million new cases of STIs in the U.S. every year.i In fact, the most common STI in the country, human papillomavirus – or HPV – is so common that nearly all sexually active people get it at some point in their lives.iio Discussion tip: Reinforce the fact that STIs are common, many are curable, and all are treatable.iii? Avoid placing blame. A diagnosis while in a relationship doesn’t necessarily mean infidelity. Consider the possibility that infection could have occurred prior to the start of your relationship. There are many STIs – like those caused by HPV, including genital warts – that may not cause physical symptoms for weeks, and in some cases even months or years after infection.ivo Discussion tip: Don’t dwell on what might have happened in the past. Keep the conversation focused on what comes next.? Have a plan. Remember how shocking it can be to be faced with an STI diagnosis. Take the conversation a step further by not just sharing your diagnosis, but by coming prepared with information on diagnosis and treatment that can help inform a plan of action.o Discussion tip: Suggest visiting a dermatologist, gynecologist, or primary care doctor for testing, and to receive treatment, if needed. It can be valuable to work as a team, so suggest taking on the next steps together.After being diagnosed with an STI, you should talk to your doctor about treatment. If you and your partner have external genital or perianal warts, for example, there are provider-administered and patient-applied prescription therapies you can consider with your doctor. vOne 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).viIf you or your partner 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.P-VRG-1346266 6/2017 Page 2 of 5Remember that contracting an STI doesn’t have to be a relationship deal-breaker. By arming yourselves with the facts, coming up with a realistic plan of action, and supporting each other, you and your partner can end up with a relationship stronger than ever before.IMPORTANT SAFETY INFORMATIONDo 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.INDICATIONVEREGEN® (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 ABOUTVEREGEN® (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.P-VRG-1346266 6/2017 Page 3 of 5Who 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:o 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.o breastfeeding, as it is not known if VEREGEN® Ointment can pass into your milk and if it can harm your baby.o 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.o 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 changeP-VRG-1346266 6/2017 Page 4 of 5your 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:o rednesso itchingo burningo paino soreso swellingo hard spotso rash with blistersMany 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 medicinesMedicines 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.P-VRG-1346266 6/2017 Page 5 of 5What 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.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 May 9, 2017.ii CDC. Genital HPV infection - Fact Sheet. Centers for Disease Control and Prevention. http://www.cdc.gov/std/hpv/stdfact-hpv.htm. Accessed May 9, 2016.iii CDC. CDC Infographic: The Lowdown on How to Prevent Sexually Transmitted Diseases. https://www.cdc.gov/std/prevention/lowdown/the_lowdown_infographic_poster_30x20.pdf. Accessed May 9, 2017.iv White C. Genital warts: MedlinePlus Medical Encyclopedia. Nlmnihgov. 2015. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000886.htm. Accessed May 9, 2017.v CDC. 2015 Sexually Transmitted Diseases Treatment Guidelines. https://www.cdc.gov/std/tg2015/. Accessed May 9, 2017.vi Veregen (sinecatechins) [prescribing information], Melville, NY: PharmaDerm a division of Fougera; Revised 2012.

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