Xerese (Page 3 of 3)

13 NONCLINICAL TOXICOLOGY

13.1 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 STUDIES

14.1 Clinical Trial Experience in Adults

In a double-blind, clinical trial, 1,443 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 Subjects

An 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 HANDLING

XERESE is supplied in a plastic-laminated aluminum tube containing 5 g of XERESE. Each gram of XERESE contains 50 mg (equivalent to 5%, w/w) acyclovir and 10 mg (equivalent to 1%, w/w) hydrocortisone in an aqueous cream base.

NDC 0187-5104-01 5 g tubes

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

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

General

Patients 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 Use

Advise patients to apply XERESE topically 5 times per day for 5 days. Instruct patients to topically apply a quantity of XERESE sufficient to cover the affected area, including the outer margin. Advise patients to avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection.

Distributed by:

Bausch Health US, LLC

Bridgewater, NJ 08807 USA

Manufactured by:

Bausch Health Companies Inc.

Laval, Quebec H7L 4A8, Canada

Product under license from Meda Pharma S.A.R.L., Luxembourg by Bausch Health Ireland Limited, Dublin, Ireland

U.S. Patent Number: 7,223,387

XERESE is a trademark of Meda Pharma S.A.R.L. used under license.

Zovirax is a registered trademark of the GlaxoSmithKline group of companies.

© 2020 Bausch Health Companies Inc. or its affiliates

9587303

FDA-Approved Patient Labeling

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 your 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. Talk with your healthcare provider about the best way to feed your baby if you use XERESE.

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 healthcare professionals.

What are the ingredients in XERESE?

Active ingredients: acyclovir and hydrocortisone

Inactive ingredients: cetostearyl alcohol, citric acid monohydrate, isopropyl myristate, mineral oil, Poloxamer 188, propylene glycol, sodium lauryl sulfate, purified water, USP, sodium hydroxide, and white petrolatum. May also contain hydrochloric acid.

Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA

Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada

Product under license from Meda Pharma S.A.R.L., Luxembourg by Bausch Health Ireland Limited, Dublin, Ireland

U.S. Patent Number: 7,223,387

XERESE is a trademark of Meda Pharma S.A.R.L. used under license.

Zovirax is a registered trademark of the GlaxoSmithKline group of companies.

© 2020 Bausch Health Companies Inc. or its affiliates

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

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

Revised: 08/2020

9587303

carton
(click image for full-size original)

NDC 0187-5104-01

Rx only

XERESE®
(Acyclovir and Hydrocortisone)
Cream 5%/1%

For Topical Use Only

Net Wt. 5 g

Ortho Dermatologics

XERESE
acyclovir and hydrocortisone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-5104
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR (ACYCLOVIR) ACYCLOVIR 50 mg in 1 g
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
cetostearyl alcohol
mineral oil
Poloxamer 188
propylene glycol
isopropyl myristate
sodium lauryl sulfate
petrolatum
citric acid monohydrate
sodium hydroxide
water
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-5104-01 1 TUBE in 1 CARTON contains a TUBE
1 5 g in 1 TUBE This package is contained within the CARTON (0187-5104-01)
2 NDC:0187-5104-02 20 PACKET in 1 CARTON contains a PACKET
2 0.5 g in 1 PACKET This package is contained within the CARTON (0187-5104-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022436 07/31/2009
Labeler — Bausch Health US LLC (831922468)
Establishment
Name Address ID/FEI Operations
Contract Pharmaceuticals Limited Canada 248761249 MANUFACTURE (0187-5104)
Establishment
Name Address ID/FEI Operations
Bausch Health Companies Inc. 245141858 MANUFACTURE (0187-5104)

Revised: 08/2020 Bausch Health US LLC

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