the only cold sore medication that combines anti-viral ... brochure.pdf · of cold sores (herpes...

The only cold sore medication that combines an anti-viral with an anti-inflammatory.

Please see Important Safety Information on page 6and enclosed full Product Information.

Ask your healthcare provider about

XERESE® (acyclovir and hydrocortisone) Cream 5%/1% is a prescription medicine used in patients ages 6 and older to lessen the healing time of cold sores (herpes labialis) and lessen the chance of a cold sore becoming worse (ulcerating). It should be used early, at the first sign of a cold sore.

A cold sore is a type of infection that appears around the mouth as a small, fluid-filled blister. Cold sores affect each person differently but they are often itchy, tingly, painful, and unsightly.1

What is a cold sore?

How did I get a cold sore? Cold sores, which are sometimes called “fever blisters”, are caused by a virus called herpes simplex 1 or HSV-1.1 This is not the same virus that causes genital herpes (HSV-2), chicken pox, or shingles (both HSV-3), but it is from the same family.

How common are cold sores? Cold sores are very common, affecting about 6 out of every 10 Americans.1,2 HSV-1 infection usually happens during childhood, but it can be years before the first cold sore appears.1,2

Does a change of seasons trigger cold sores? You may notice you get cold sores in a particular season. That’s because overexposure to sunlight, cold weather or wind are common cold sore triggers, along with:1,3-5

2

Fever, flu & common cold

Fatigue

Dental surgery

Stress


Triggers may vary from person to person. It is important to recognize your triggers so that you can try to avoid them in the future.

You are not alone

Summer

Fall

Winter

Spring

Sunlight

Cold windCold or Flu season

Cold weather or wind Sunlight reflected off snow

Sunlight Cool wind

3

Nearly 6 out of 10 people have the virus that causes cold sores.1,2

Possible seasonal triggers

Are cold sores contagious?

Cold sores are contagious. Your chance of passing along the HSV-1 virus increases when you have an active outbreak in the “weeping” stage, but cold sores are contagious at every stage.1,3

Is there a cure for cold sores?

Cold sores eventually heal, but there is no cure for the virus that causes them. Once you have the HSV-1 virus inside your body, it is with you for life. Luckily the virus lays dormant much of the time; however, once exposed to a trigger, it can become active again leading to an outbreak.1

How does a cold sore happen?

Two main activities take place in the body when a cold sore develops:6

4

How the virus spreads& behaves in the body


The HSV-1 virus destroys cells, and

The immune system �ghts cell destruction. This leads to an in�ammatory response, which manifests itself as painfulness, tenderness and the development of a lesion in the affected area.

Please see Important Safety Information on page 6Please see Important Safety Information on page 6Please see Important Safety Information on page 6

The immune system �ghts cell destruction. This leads to an in�ammatory response, which manifests itself as painfulness, tenderness

The immune system �ghts cell destruction. This leads to an in�ammatory response, which manifests itself as

Tingling/Redness: 1-2 days Often, the first sign of a cold sore is tingling, inflammation, or soreness around the mouth in the area where a blister is about to appear. It is important to recognize these early symptoms, which are signs that the body’s inflammatory response is taking action. It is important to start treatment with Xerese at the first sign of cold sore development.6

Blister: Approximately 2 daysBlisters filled with clear yellow fluid are visible on the outbreak area. If you continue to take XERESE at this stage, it may be less likely to progress further.

Weeping: Approximately 1 dayBlisters break open and fluid drains from the cold sore. (NOTE: the virus is most contagious at this stage, so careful hygiene is important.)

Crusting: 2-3 daysYellowish crust forms as the cold sore begins to heal. Bleeding from the crust is common.

Healing: Several daysThe crust gradually shrinks and falls off, revealing lightened skin that eventually returns to normal.

1

2

3

4

5

5

Five stages of a cold sore& when to use Xerese?

Xerese is not a cure for cold sores. Talk to your healthcare provider if your cold sore is not better in 2 weeks.

Five stages of a cold sore outbreak1,4,6

6

Discover XERESE

Important Safety Information

XERESE is for cold sores on lips and around the mouth only and should not be used in eyes, mouth, nose or on genitals. Use exactly as directed by your healthcare provider.

XERESE is not a cure for cold sores.

It is not known if XERESE is safe or works in children younger than 6 years old.

The safety of XERESE is unknown in women who are pregnant or breast-feeding, or in patients with a weak immune system (become sick very easily). Tell your healthcare provider about these or any other medical conditions you have before using XERESE.

Talk to your healthcare provider if your cold sore is not better in 2 weeks.

The most common side effects of XERESE are: drying or �aking of the skin, tingling or burning after applying it, redness of the skin, swelling or changes in skin color where the cream is applied, and a bitter taste after applying XERESE. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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.

XERESE (acyclovir and hydrocortisone) Cream 5%/1% is a prescription medicine used in patients ages 6 and older to lessen the healing time of cold sores (herpes labialis) and lessen the chance of a cold sore becoming worse (ulcerating). It should be used early, at the �rst sign of a cold sore.


7

How does XERESE work?

XERESE (acyclovir and hydrocortisone cream 5%/1%) is a prescription cream made up of two medicinal ingredients: an anti-viral medication called acyclovir, and an anti-inflammatory medication called hydrocortisone. This means that XERESE can fight the virus that causes the cold sore AND treat the symptoms such as inflammation, tingling, pain, and blistering.6

XERESE may shorten healing time and help reduce symptoms and reduce the likelihood of ulcerative cold sores (meaning you can stop them from getting worse) when used at the first sign of an outbreak.6

XERESE Cream is intended for use in the early treatment of cold sores in people 6 and over. It should be used on the lips and around the mouth only. XERESE Cream should not be used in the eye, inside the mouth or nose, or on the genitals.6

How XERESE works

Only XERESE has DUAL-action, combiningan anti-viral with an anti-inflammatory

8

Caring for cold sores

How do I care for my cold sore?During an outbreak, follow these steps to care for your cold sore1,3:

Keep your face and the cold sore area clean. Wash your cold sore gently with soap and water, using the face cloth only once. Launder the cloth immediately afterward to help prevent spreading the virus.

Avoid touching your cold sore directly.

An ice pack can help reduce pain; do not apply ice directly to the affected area, however.


9

Caring for cold sores

1.

2.

3.

4.

5.

6.

How can I stop a cold sore from spreading?The following tips can help reduce your risk of spreading the virus to others:1,3-5

Seasonal triggers, such as overexposure to sunlight, cold weather or wind

Illness

Injury to the mouth

Stress

Menstruation

Recognize the common triggers of cold sore outbreaks and try to avoid or manage them. These include:

During outbreaks, avoid sharing anything that touches your mouth, including drinking glasses, coffee mugs, washcloths, towels, eating utensils, lipstick, and lip balm.

Avoid kissing during outbreaks.

Thoroughly wash any object that comes into contact with your cold sore. Use boiling water when possible.

Wash your hands frequently during an outbreak, especially immediately after touching the cold sore.

Do not use skincare products such as makeup, sunscreen or lip balm on the cold sore or surrounding area.

Remember that cold sores are contagious at all stages, especially the weeping stage.

For more information visit XERESE.com

References: 1. Pray WS. Preventing and treating cold sores. US Pharm. 2007;32: 16-23. 2. Xu F, Sternberg MR, Kottiri BJ, et al. Trends in herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. 3. US National Library of Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. 4. Arduino PG, Porter SR. J Oral Pathol Med. 2008;37(2):107-121. 5. Multi-sponsor Surveys, Inc. The 2011 Gallup Study of the Market for Cold Sore Treatment Products. Published April 2012. 6. XERESE [package insert]. Bridgewater, NJ; Valeant Pharmaceuticals North America LLC; 2012.

Xerese is a registered trademark of Meda Pharma S.A.R.L. used under license by Valeant. Except as otherwise indicated, all other product names, slogans and other marks are trademarks of the Valeant family of companies. © 2014 Valeant Pharmaceuticals North America LLC. DM/XRS/13/0003

XERESEXERESEXERESEXERESE.com.com

SCAN THIS CODE TO SEE ADOCTOR EXPLAIN THEXERESE 2-IN-1 EFFECT.

Learn more at: XERESE.com

The safety of XERESE is unknown in women who are pregnant or breast-feeding, or in patients with a weak immune system (become sick very easily). Tell your healthcare provider about these or any other medical conditions you have before using XERESE.

Help you and your doctor find the right treatment for you by answering the questions below. Share your answers with your doctor during today’s visit.

What concerns you most about cold sore outbreaks?

Less than once a year

3 or 4 times a year

Once or twice a year

5 or more times a year

How long they last

Pain and sensitivity

Unattractiveness

Other (please specify):

How often do you get cold sores?

What’s the best treatment for me?

For more information visit XERESE.com

XERESE (acyclovir and hydrocortisone Cream 5%/1%) is used for the early treatment of recurrent cold sores in people 12 years of age or older. XERESE Cream may help keep cold sores from becoming ulcers. It may also help cold sores heal faster.

XERESE Cream is intended for use on the lips and around the mouth. Do not use XERESE Cream in the eye, inside the mouth or nose, or on the genitals. Consult a doctor if a cold sore fails to heal within 2 weeks. XERESE Cream may not be prescribed for people who have certain medical conditions, such as a weakened immune system. Some people may experience irritation or be sensitive to some of the ingredients in XERESE Cream. The most common side effects of XERESE Cream included drying or �aking of the skin, burning or tingling after application, redness, swelling, and changes in skin color.

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.

Please see your healthcare provider for full Prescribing Information. - DM/XRS/13/0003

References: 1. Pray WS. Preventing and treating cold sores. US Pharm. 2007;32: 16-23. 2. Xu F, Sternberg MR, Kottiri BJ, et al. Trends in herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. 3. US National Library of Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. 4. Arduino PG, Porter SR. J Oral Pathol Med. 2008;37(2):107-121. 5. Multi-sponsor Surveys, Inc. The 2011 Gallup Study of the Market for Cold Sore Treatment Products. Published April 2012. 6. XERESE [package insert]. Bridgewater, NJ; Valeant Pharmaceuticals North America LLC; 2012.

© 2013 Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC.XERESE is a registered trademark of the GlaxoSmithKline group of companies. XRS-XXX

SCAN THIS CODE TO SEE A DOCTOR EXPLAIN THE XERESE 2-IN-1 EFFECT.


treatment of recurrent cold sores in people 12 years of age or older. XERESE Cream may help keep cold sores from becoming ulcers. It may also help cold

XERESE Cream is intended for use on the lips and around the mouth. Do not use XERESE Cream in the eye, inside the mouth or nose, or on the genitals.

may not be prescribed for people who have certain medical conditions, such as a weakened immune system. Some people may experience irritation or be sensitive to some of the ingredients in XERESE Cream. The most common side effects of XERESE Cream included drying or �aking of the skin, burning

Please see your healthcare provider for full Prescribing Information.

Xu F, Sternberg MR, Kottiri BJ, et al. Trends in Xu F, Sternberg MR, Kottiri BJ, et al. Trends in Xu F, Sternberg MR, Kottiri BJ, et al. Trends in US National Library of US National Library of US National Library of

Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Multi-sponsor Surveys, Inc. The 2011 Gallup Study of Multi-sponsor Surveys, Inc. The 2011 Gallup Study of

XERESE [package insert]. Bridgewater, NJ; Valeant XERESE [package insert]. Bridgewater, NJ; Valeant XERESE [package insert]. Bridgewater, NJ; Valeant

For more information visitXERESE.com

XERESE (acyclovir and hydrocortisone Cream 5%/1%) is used for the early XERESE (acyclovir and hydrocortisone Cream 5%/1%) is used for the early treatment of recurrent cold sores in people 12 years of age or older. XERESE treatment of recurrent cold sores in people 12 years of age or older. XERESE Cream may help keep cold sores from becoming ulcers. It may also help cold Cream may help keep cold sores from becoming ulcers. It may also help cold sores heal faster.

XERESE Cream is intended for use on the lips and around the mouth. Do not XERESE Cream is intended for use on the lips and around the mouth. Do not use XERESE Cream in the eye, inside the mouth or nose, or on the genitals. use XERESE Cream in the eye, inside the mouth or nose, or on the genitals. Consult a doctor if a cold sore fails to heal within 2 weeks. XERESE Cream Consult a doctor if a cold sore fails to heal within 2 weeks. XERESE Cream may not be prescribed for people who have certain medical conditions, such may not be prescribed for people who have certain medical conditions, such as a weakened immune system. Some people may experience irritation or be as a weakened immune system. Some people may experience irritation or be sensitive to some of the ingredients in XERESE Cream. The most common sensitive to some of the ingredients in XERESE Cream. The most common side effects of XERESE Cream included drying or �aking of the skin, burning side effects of XERESE Cream included drying or �aking of the skin, burning or tingling after application, redness, swelling, and changes in skin color.or tingling after application, redness, swelling, and changes in skin color.

You are encouraged to report negative side effects of prescription drugs to 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 FDA. Visit www.fda.gov /medwatch, or call 1-800-FDA-1088.

Please see your healthcare provider for full Prescribing Information. Please see your healthcare provider for full Prescribing Information. - DM/XRS/13/0003

References: References: References: 1. 1. Pray WS. Preventing and treating cold sores. US Pharm. 2007;32: 16-23. Pray WS. Preventing and treating cold sores. US Pharm. 2007;32: 16-23. Pray WS. Preventing and treating cold sores. US Pharm. 2007;32: 16-23. Pray WS. Preventing and treating cold sores. US Pharm. 2007;32: 16-23. Pray WS. Preventing and treating cold sores. US Pharm. 2007;32: 16-23. Pray WS. Preventing and treating cold sores. US Pharm. 2007;32: 16-23. Pray WS. Preventing and treating cold sores. US Pharm. 2007;32: 16-23. Pray WS. Preventing and treating cold sores. US Pharm. 2007;32: 16-23. Pray WS. Preventing and treating cold sores. US Pharm. 2007;32: 16-23. Pray WS. Preventing and treating cold sores. US Pharm. 2007;32: 16-23. 2. 2. Xu F, Sternberg MR, Kottiri BJ, et al. Trends in Xu F, Sternberg MR, Kottiri BJ, et al. Trends in Xu F, Sternberg MR, Kottiri BJ, et al. Trends in herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. 4.4. Arduino PG, Porter SR. J Oral Pathol Med. 2008;37(2):107-121. Arduino PG, Porter SR. J Oral Pathol Med. 2008;37(2):107-121. Arduino PG, Porter SR. J Oral Pathol Med. 2008;37(2):107-121. Arduino PG, Porter SR. J Oral Pathol Med. 2008;37(2):107-121. Arduino PG, Porter SR. J Oral Pathol Med. 2008;37(2):107-121. Arduino PG, Porter SR. J Oral Pathol Med. 2008;37(2):107-121. Arduino PG, Porter SR. J Oral Pathol Med. 2008;37(2):107-121. Arduino PG, Porter SR. J Oral Pathol Med. 2008;37(2):107-121. Arduino PG, Porter SR. J Oral Pathol Med. 2008;37(2):107-121. 5. 5. Multi-sponsor Surveys, Inc. The 2011 Gallup Study of Multi-sponsor Surveys, Inc. The 2011 Gallup Study of Multi-sponsor Surveys, Inc. The 2011 Gallup Study of the Market for Cold Sore Treatment Products. Published April 2012. the Market for Cold Sore Treatment Products. Published April 2012. the Market for Cold Sore Treatment Products. Published April 2012. the Market for Cold Sore Treatment Products. Published April 2012. the Market for Cold Sore Treatment Products. Published April 2012. the Market for Cold Sore Treatment Products. Published April 2012. the Market for Cold Sore Treatment Products. Published April 2012. the Market for Cold Sore Treatment Products. Published April 2012. the Market for Cold Sore Treatment Products. Published April 2012. the Market for Cold Sore Treatment Products. Published April 2012. 6.6. XERESE [package insert]. Bridgewater, NJ; Valeant XERESE [package insert]. Bridgewater, NJ; Valeant XERESE [package insert]. Bridgewater, NJ; Valeant Pharmaceuticals North America LLC; 2012.Pharmaceuticals North America LLC; 2012.Pharmaceuticals North America LLC; 2012.Pharmaceuticals North America LLC; 2012.Pharmaceuticals North America LLC; 2012.Pharmaceuticals North America LLC; 2012.Pharmaceuticals North America LLC; 2012.

© 2013 Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC.© 2013 Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC.© 2013 Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC.© 2013 Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC.© 2013 Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC.© 2013 Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC.© 2013 Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC.© 2013 Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC.© 2013 Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC.© 2013 Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC.© 2013 Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC.XERESE is a registered trademark of the GlaxoSmithKline group of companies. XERESE is a registered trademark of the GlaxoSmithKline group of companies. XERESE is a registered trademark of the GlaxoSmithKline group of companies. XERESE is a registered trademark of the GlaxoSmithKline group of companies. XERESE is a registered trademark of the GlaxoSmithKline group of companies. XERESE is a registered trademark of the GlaxoSmithKline group of companies. XERESE is a registered trademark of the GlaxoSmithKline group of companies. XERESE is a registered trademark of the GlaxoSmithKline group of companies. XERESE is a registered trademark of the GlaxoSmithKline group of companies. XRS-XXXXRS-XXXXRS-XXX



For more information visit

XERESE (acyclovir and hydrocortisone Cream 5%/1%) is used for the early treatment of recurrent cold sores in people 12 years of age or older. XERESE Cream may help keep cold sores from becoming ulcers. It may also help cold

XERESE Cream is intended for use on the lips and around the mouth. Do not use XERESE Cream in the eye, inside the mouth or nose, or on the genitals. Consult a doctor if a cold sore fails to heal within 2 weeks. XERESE Cream may not be prescribed for people who have certain medical conditions, such as a weakened immune system. Some people may experience irritation or be sensitive to some of the ingredients in XERESE Cream. The most common side effects of XERESE Cream included drying or �aking of the skin, burning or tingling after application, redness, swelling, and changes in skin color.

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.

Please see your healthcare provider for full Prescribing Information.

Xu F, Sternberg MR, Kottiri BJ, et al. Trends in Xu F, Sternberg MR, Kottiri BJ, et al. Trends in Xu F, Sternberg MR, Kottiri BJ, et al. Trends in Xu F, Sternberg MR, Kottiri BJ, et al. Trends in Xu F, Sternberg MR, Kottiri BJ, et al. Trends in herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. herpes simplex virus type 1 and 2 seroprevalence in the United States. JAMA. 2006;296:964-973. 3.3. US National Library of US National Library of US National Library of US National Library of Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012. Medicine. Herpes—oral. MedlinePlus. http://www.nlm.nih.gov /medlineplus/ency/article/000606.htm. Accessed July 5, 2012.

Multi-sponsor Surveys, Inc. The 2011 Gallup Study of Multi-sponsor Surveys, Inc. The 2011 Gallup Study of Multi-sponsor Surveys, Inc. The 2011 Gallup Study of Multi-sponsor Surveys, Inc. The 2011 Gallup Study of Multi-sponsor Surveys, Inc. The 2011 Gallup Study of XERESE [package insert]. Bridgewater, NJ; Valeant XERESE [package insert]. Bridgewater, NJ; Valeant XERESE [package insert]. Bridgewater, NJ; Valeant XERESE [package insert]. Bridgewater, NJ; Valeant XERESE [package insert]. Bridgewater, NJ; Valeant XERESE [package insert]. Bridgewater, NJ; Valeant

XRS-XXXXRS-XXX



What treatments do you usually use to treat your cold sores or cold sore pain? (Check all that apply)

XERESE (acyclovir and hydrocortisone) Cream 5%/1%

Nonprescription treatment

Home remedy

I don’t use any kind of treatment

Other (please specify):

Please see Indication and Important Safety Information on page 6. Please see full Product Information.

Are you satis�ed with your cold sore treatment?

Always

Usually

Sometimes

Never

Would you like to know more about a prescription cream that may help shorten your cold sore outbreaks?

Yes No

For more information visitFor more information visitQuestionnaire

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use XERESE safely and effectively. See full prescribing information for XERESE.

XERESE® (acyclovir and hydrocortisone) cream for topical use

Initial U.S. Approval: 2009

------------------------------ RECENT MAJOR CHANGES -----------------------------

Indications and Usage (1) 01/2014 Dosage and Administration (2) 01/2014

-------------------------------INDICATIONS AND USAGE ------------------------------

XERESE, a combination of acyclovir, a herpes simplex virus nucleoside analog DNA polymerase inhibitor, and hydrocortisone, a corticosteroid, is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older). (1)

--------------------------- DOSAGE AND ADMINISTRATION --------------------------

Topically apply XERESE 5 times per day for 5 days. Therapy should be initiated as early as possible after the first signs and symptoms (i.e., during the prodrome or when lesions appear). (2)

-------------------------- DOSAGE FORMS AND STRENGTHS -------------------------

Topical cream containing 5% acyclovir and 1% hydrocortisone. (3)

--------------------------------- CONTRAINDICATIONS --------------------------------

None. (4)

----------------------------WARNINGS AND PRECAUTIONS ---------------------------

• Only for topical use for recurrent herpes labialis on the lips and around the mouth. (5)

---------------------------------ADVERSE REACTIONS--------------------------------

The following most common adverse reactions (<1%) were local skin reactions:

• Drying or flaking of the skin; burning or tingling, erythema; pigmentation changes; application site reactions including signs and symptoms of inflammation. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

--------------------------------- DRUG INTERACTIONS --------------------------------

No drug interaction studies have been performed with XERESE. (7)

----------------------------USE IN SPECIFIC POPULATIONS---------------------------

• Immunocompromised Patients: Benefit has not been adequately assessed. (8.6)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 01/2014

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS

5.1 General6 ADVERSE REACTIONS

6.1 Adverse Reactions in Clinical Trials7 DRUG INTERACTIONS8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Immunocompromised Subjects

10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action 12.3 Pharmacokinetics 12.4 Microbiology

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES 14.1 Clinical Trial Experience in Adults 14.2 Clinical Trial Experience in Pediatric Subjects

16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION* Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGEXERESE, a combination of acyclovir, a herpes simplex virus nucleoside analog DNA polymerase inhibitor, and hydrocortisone, a corticosteroid, is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older).

2 DOSAGE AND ADMINISTRATIONTopically apply XERESE 5 times per day for 5 days. Therapy should be initiated as early as possible after the first signs and symptoms (i.e., during the prodrome or when lesions appear).

For each dose, topically apply a quantity of XERESE sufficient to cover the affected area, including the outer margin. Avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. For children 6 years of age and older, the dosage is the same as in adults.

3 DOSAGE FORMS AND STRENGTHSEach gram of XERESE contains 5% (w/w) acyclovir and 1% (w/w) hydrocortisone in an aqueous cream base.

4 CONTRAINDICATIONSNone.

5 WARNINGS AND PRECAUTIONS5.1 General

XERESE is intended for cutaneous use only for herpes labialis of the lips and around the mouth. XERESE should not be used in the eye, inside the mouth or nose, or on the genitals.

There are other orofacial lesions, including bacterial and fungal infections, which may be difficult to distinguish from a cold sore. Patients should be encouraged to seek medical advice when a cold sore fails to heal within 2 weeks.

XERESE has a potential for irritation and contact sensitization [see Adverse Reactions (6.1)].

6 ADVERSE REACTIONS6.1 Adverse Reactions in Clinical Trials

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.

The safety data derived from XERESE clinical trials reflect exposure to XERESE in 1056 subjects with recurrent herpes labialis treated 5 times daily for 5 days.

The most common adverse reactions (<1%) were local skin reactions, and occurred in the area of the application site, including:

– Drying or flaking of the skin; burning or tingling following application; erythema; pigmentation changes; application site reaction including signs and symptoms of inflammation.

Contact dermatitis following application has been observed when applied under occlusion in dermal safety trials. Where contact sensitivity tests have been conducted, the reactive substances were hydrocortisone or a component of the cream base.

A trial enrolling 225 healthy adults was conducted to evaluate the contact sensitization potential of XERESE using repeat insult patch testing methodology. Of 205 evaluable subjects, one confirmed case (0.5%) of sensitization to hydrocortisone and 2 additional cases (1.0%) of possible sensitization to the XERESE base were identified. Additionally, one subject developed a contact allergy in the photosafety study to propylene glycol, one of the inactive ingredients of the cream base.

Dermal tolerance was assessed in a 21-day cumulative irritation trial in 36 healthy subjects. XERESE, its cream base and Zovirax® (acyclovir) Cream 5% all showed a high and cumulative irritation potential under occlusive and semiocclusive conditions.

Photoallergic potential and phototoxicity were assessed in two trials in 50 and 30 healthy volunteers, respectively. No photoallergic or phototoxicity potential was identified for XERESE.

7 DRUG INTERACTIONSNo drug interaction studies have been performed with XERESE.

8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy

Teratogenic Effects Pregnancy Category B. Acyclovir was not teratogenic in the mouse, rabbit or rat at exposures greatly in excess of human exposure. There are no adequate and well-controlled trials of systemic acyclovir in pregnant women. A prospective epidemiologic registry of acyclovir use during pregnancy between 1984 and 1999 followed 749 pregnancies in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximated that found in the general population. However, the size of the registry was insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses.

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Animal reproduction studies have not been conducted with XERESE. No trials have been performed in pregnant women. Systemic exposure of acyclovir and hydrocortisone following topical administration of XERESE is minimal.

8.3 Nursing MothersIt is not known whether topically applied acyclovir or hydrocortisone is excreted in breast milk. Systemic exposure following topical administration of either drug is expected to be below detection limits. Because many drugs are excreted in human milk, caution should be exercised when XERESE is administered to a nursing woman.

8.4 Pediatric UseSafety and effectiveness in pediatric subjects less than 6 years of age have not been established.

8.5 Geriatric UseIn clinical studies, there were insufficient subjects above 65 years of age to reach a firm conclusion regarding safety and efficacy of XERESE in this group, although the available results were similar to lower age subjects.

8.6 Immunocompromised SubjectsEven though the safety of XERESE has been studied in immunocompromised subjects, data are insufficient to support use in this population. Immunocompromised subjects should be encouraged to consult a physician concerning the treatment of any infection.

Benefit has not been adequately assessed in immunocompromised patients. A randomized, double-blind trial was conducted in 107 immunocompromised subjects with stable HIV infection and recurrent herpes labialis. Subjects had on average 3.7 episodes of herpes labialis in the previous 12 months. The median age was 30 years (range 19 to 64 years), 46% were female, and all Caucasian. Median CD4+ T-cell count at screening was 344/mm3 (range 100-500/mm3). Subjects were treated with XERESE or 5% acyclovir in XERESE vehicle. The primary objective was to exclude a doubling of the healing time in either treatment arm. The mean healing time for cold sores was similar between the two treatment groups: 6.6 days for XERESE and 6.9 days for 5% acyclovir in XERESE vehicle.

10 OVERDOSAGEOverdosage by topical application of XERESE is unlikely because of minimal systemic exposure [see Clinical Pharmacology (12.3)].

11 DESCRIPTIONXERESE contains acyclovir, a synthetic nucleoside analogue active against herpes viruses, and hydrocortisone, an anti-inflammatory corticosteroid, combined in a cream for topical administration. Each gram of XERESE contains 5% (w/w) of acyclovir, 1% (w/w) of hydrocortisone and the following inactive ingredients: cetostearyl alcohol, mineral oil, Poloxamer 188, propylene glycol, isopropyl myristate, sodium lauryl sulfate, white petrolatum, citric acid, sodium hydroxide and water. Sodium hydroxide or hydrochloric acid may have been added to adjust the pH to approximately pH 5.

Acyclovir, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one, is a synthetic nucleoside analogue active against herpes viruses. The maximum solubility of acyclovir in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25. Its empirical formula is C8H11N5O3. The structural formula is provided in Figure 1:

Figure 1: Structural Formula of Acyclovir

Hydrocortisone, pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-(11(beta))-, is an anti-inflammatory corticosteroid. Its empirical formula is C21H30O5. The structural formula is provided in Figure 2:

Figure 2: Structural Formula of Hydrocortisone

12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action

Acyclovir is an antiviral drug and hydrocortisone an anti-inflammatory drug [see Microbiology (12.4)].

12.3 PharmacokineticsThe plasma concentrations of acyclovir and hydrocortisone were not measured following topical administration of XERESE on cold sores.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin and can have systemic side effects depending on both the potency of the corticosteroid and the surface area of application. Inflammation and/or other disease processes in the skin that disrupt the skin barrier can increase percutaneous absorption.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. They are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

12.4 MicrobiologyMechanism of Action Acyclovir is a synthetic purine nucleoside analogue with inhibitory activity against herpes simplex viruses type 1 (HSV-1) and type 2 (HSV-2) in cell culture and in vivo.

The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In cell culture, acyclovir triphosphate stops replication of herpes viral DNA. This inhibition is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase.

Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. It is used topically for its anti-inflammatory effects which suppress the clinical manifestations of the disease in a wide range of disorders where inflammation is a prominent feature.

Antiviral Activity The quantitative relationship between the cell culture susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (EC50), vary greatly depending upon a number of factors. Using plaque-reduction assays on Vero cells, the median EC50 value of acyclovir against clinical herpes virus isolates (subjects receiving placebo) was 1.3 μM (range: <0.56 to 3.3 μM).

Resistance Resistance of HSV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV with reduced susceptibility to acyclovir have been recovered from immunocompromised subjects, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated from immunocompromised subjects thus far have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults.

The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.

PATIENT INFORMATION

XERESE® (sûr-eeze) (acyclovir and hydrocortisone) Cream 5%/1%

Important information: XERESE is for use on cold sores on the lips and around the mouth only. XERESE should not be used in eyes, mouth, nose or on your genitals.

What is XERESE?• XERESE is a prescription medicine used in people 6 years of age and older to shorten

the healing time of cold sores (herpes labialis) and lower the chance of a cold sore becoming worse (ulcerating).

• XERESE is not a cure for cold sores.• It is not known if XERESE is safe and effective in children less than 6 years of age.

What should I tell my healthcare provider before using XERESE?Before using XERESE, tell your healthcare provider about all of your medical conditions, including if you:• become sick very easily (have a weak immune system)• are pregnant or plan to become pregnant. It is not known if XERESE will harm your

unborn baby.• are breastfeeding or plan to breastfeed. It is not known if XERESE passes into your

breast milk.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use XERESE?• Use XERESE exactly as your healthcare provider tells you to use it.• Use XERESE as soon as you have the first symptom of a cold sore such as itching,

redness, burning or tingling or when the cold sore appears.• Apply XERESE over the affected area, including the outer edge of the cold sore.• Do not rub the cold sore because this may cause the cold sore to spread to other areas

around your mouth, or make your cold sore worse.• Do not cover the cold sore or the area around the cold sore with a bandage.• Do not use other skin products (such as make-up, sun screen or lip balm) or other skin

medicine on the cold sore or the area around the cold sore.• Tell your healthcare provider if your cold sore is not better in 2 weeks.

What are the possible side effects of XERESE?The most common side effects of XERESE are skin reactions at the treatment site and may include:• drying or flaking, tingling or burning after you apply XERESE, redness, changes in skin

color where the cream is applied, and swelling.These are not all the possible side effects of XERESE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store XERESE?• Store XERESE at room temperature between 68° to 77°F (20° to 25°C). Do not

freeze XERESE.Keep XERESE and all medicines out of the reach of children.

General information about the safe and effective use of XERESE Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use XERESE for a condition for which it was not prescribed. Do not give XERESE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about XERESE that is written for health professionals.

What are the ingredients in XERESE? Active ingredients: acyclovir and hydrocortisone Inactive ingredients: cetostearyl alcohol, mineral oil, Poloxamer 188, propylene glycol, isopropyl myristate, sodium lauryl sulfate, white petrolatum, citric acid, sodium hydroxide and water. May also contain hydrochloric acid.

Manufactured for: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807

Manufactured by: Contract Pharmaceuticals Limited (CPL) 7600 Danbro Crescent Mississauga, Ontario Canada L5N 6L6

Produced under license: MEDA Pharma SARL, Luxembourg, by Valeant International Bermuda

For more information call 1-800-321-4576.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Rev. 02/2014

2006785 9379300

13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Systemic exposure following topical administration of acyclovir is minimal. Results from previous studies of carcinogenesis, mutagenesis and fertility for acyclovir and hydrocortisone are not included in the full prescribing information for XERESE due to the minimal exposures that result from dermal application. Information on these studies following systemic exposure is available in the full prescribing information for acyclovir and hydrocortisone products approved for oral or parenteral administration. Dermal carcinogenicity studies have not been conducted.

14 CLINICAL STUDIES14.1 Clinical Trial Experience in Adults

In a double-blind, clinical trial, 1443 subjects with recurrent labial herpes were randomized to receive XERESE, 5% acyclovir in XERESE vehicle or vehicle alone. Subjects had, on average, 5.6 episodes of herpes labialis in the previous 12 months. The median age was 44 years (range 18 to 80 years), 72% were female, and 91% were Caucasian. Subjects were instructed to initiate treatment within 1 hour of noticing signs or symptoms and continue treatment for 5 days, with application of study medication 5 times per day. Ulcerative cold sores occurred in 58% of the subjects treated with XERESE compared to 74% in subjects treated with vehicle and 65% in subjects treated with 5% acyclovir in XERESE vehicle. The mean time to skin normalization was approximately 1.6 days shorter in the subjects treated with XERESE compared to vehicle. Clinical signs in terms of size of the cold sore and symptoms such as tenderness were reduced with XERESE as compared to vehicle.

14.2 Clinical Trial Experience in Pediatric SubjectsAn open label safety trial in adolescents with recurrent herpes labialis was conducted in 134 subjects. Subjects had, on average, 4 episodes of herpes labialis in the previous 12 months. The median age was 14 years (range 12 to 17 years); 50% were female and all were Caucasian. XERESE was applied using the same dosing regimen as in adults and subjects were monitored for adverse events and selected efficacy parameters. The safety profile of XERESE appeared similar to that observed in adults.

An open label safety trial in children with recurrent herpes labialis was conducted in 54 subjects, who averaged an episode of herpes labialis 2 months prior to trial entry. The mean age was 9 years (range 6 to 11 years); 57% were female and 90% were Caucasian. XERESE was applied using the same dosing regimen as in adolescents and adults and subjects were monitored for adverse events and select efficacy parameters. The safety profile of XERESE appeared similar to that observed in adults.

16 HOW SUPPLIED/STORAGE AND HANDLINGXERESE is supplied in a plastic-laminated aluminum tube containing 5 gm of XERESE. Each gram of XERESE contains 5% (w/w) acyclovir and 1% (w/w) hydrocortisone in an aqueous cream base.

NDC 0187-5104-01: 5 gm tubes

Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Do not freeze.

17 PATIENT COUNSELING INFORMATIONSee FDA-approved patient labeling (Patient Information)

GeneralPatients should be informed that XERESE is not a cure for cold sores. Patients should be instructed that XERESE is intended for cutaneous use only for herpes labialis of the lips and around the mouth. Patients should be advised that XERESE should not be used in the eye, inside the mouth or nose, or on the genitals.

Instructions for UsePatients should be advised to apply XERESE topically 5 times per day for 5 days. Patients should be instructed to topically apply a quantity of XERESE sufficient to cover the affected area, including the outer margin. Patients should be advised to avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection.

the only cold sore medication that combines anti-viral ... brochure.pdf · of cold sores (herpes...

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