Acyclovir (Page 3 of 4)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Systemic exposure following topical administration of acyclovir is minimal. Dermal carcinogenicity studies were not conducted. Results from the studies of carcinogenesis, mutagenesis and fertility are not included in the full prescribing information for acyclovir cream due to the minimal exposures of acyclovir that result from dermal application. Information on these studies is available in the full prescribing information for acyclovir capsules, tablets, and suspension and acyclovir for injection.

14 CLINICAL STUDIES

14.1 Adult Subjects

Acyclovir cream was evaluated in two double-blind, randomized, placebo (vehicle)-controlled trials for the treatment of recurrent herpes labialis. The average patient had five episodes of herpes labialis in the previous 12 months. In the first trial, the median age of subjects was 37 years (range 18 to 81 years), 74% were female, and 94% were Caucasian. In the second trial, median age of subjects was 38 years (range 18 to 87 years), 73% were female, and 94% were Caucasian. Subjects were instructed to initiate treatment within 1 hour of noticing signs or symptoms and continue treatment for 4 days, with application of study medication 5 times per day. In both studies, the mean duration of the recurrent herpes labialis episode was approximately one-half day shorter in the subjects treated with acyclovir cream (n = 682) compared with subjects treated with placebo (n = 703) for approximately 4.5 days versus 5 days, respectively. No significant difference was observed between subjects receiving acyclovir cream or placebo in the prevention of progression of cold sore lesions.

14.2 Pediatric Subjects

An open-label, uncontrolled trial with acyclovir cream was conducted in 113 patients aged 12 to 17 years with recurrent herpes labialis. In this trial, therapy was applied using the same dosing regimen as in adults and subjects were followed for adverse events. The safety profile was similar to that observed in adults.

16 HOW SUPPLIED/STORAGE AND HANDLING

Acyclovir cream, 5% is white to off white homogenous cream which contains 50 mg (equivalent to 5% w/w) acyclovir in an aqueous cream base. Acyclovir cream is supplied as follows:

2-g tubes (NDC 72578-101-04).

5-g tubes (NDC 72578-101-05).

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

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

G eneral

Patients should be informed that acyclovir cream is a prescription topical cream for the treatment of cold sores (recurrent herpes labialis) that occur on the face and lips. Acyclovir cream is not a cure for cold sores. Patients should be instructed that acyclovir cream is intended for cutaneous use only for herpes labialis of the lips and around the mouth. Patients should be advised that acyclovir cream should not be used in the eye, inside the mouth or nose, or on the genitals. Patients should be instructed to avoid applying other topical products to the affected area while using acyclovir cream.

Do not use if you are allergic to acyclovir cream or any of the ingredients in acyclovir cream. Before you use acyclovir cream, tell your doctor if you are pregnant, planning to become pregnant, or are breast-feeding.

I nstructions for Use

Treatment should be initiated at the earliest sign or symptom of recurrence. Instruct patients to wash hands prior to application and ensure the face and/or lips are clean and dry. Advise patients to apply acyclovir cream topically 5 times per day for 4 days. Instruct patients to topically apply a quantity of acyclovir cream 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. Instruct patients to wash their hands with soap and water after using acyclovir cream. Keep out of reach of children.

Po ss ible Side Effects

Common skin-related side effects that occurred when acyclovir cream was applied include application site reactions. Acyclovir cream has the potential for irritation and contact sensitization.

Manufactured by:

Cadila Healthcare Ltd.

Changodar, Ahmedabad, India

Distributed by:

Viona Pharmaceuticals Inc.

Cranford, NJ 07016

Rev.: 03/22

PATIENT INFORMATION Acyclovir ( ay sye’ kloe vir) Cream

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

What is acyclovir cream? Acyclovir cream is a prescription medicine used to treat cold sores (herpes labialis) that are recurring in adults and children 12 years of age and older, and who have normal immune systems. Acyclovir cream is not a cure for cold sores. It is not known if acyclovir cream is safe and effective in children less than 12 years of age.

Do not use acyclovir cream if you are allergic to acyclovir, valacyclovir, or any of the ingredients in acyclovir cream. See the end of this leaflet for a complete list of ingredients in acyclovir cream.

What should I tell my healthcare provider before using acyclovir cream? Before using acyclovir cream, 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 acyclovir cream will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if acyclovir passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use acyclovir cream. 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 acyclovir cream? Use acyclovir cream exactly as your healthcare provider tells you to use it. Use acyclovir cream as soon as you have the first symptoms of a cold sore such as itching, redness, burning or tingling, or when the cold sore appears. Wash your hands with soap and water before and after applying acyclovir cream. The affected area should be clean and dry before applying acyclovir cream. Apply acyclovir cream to the affected area 5 times each day for 4 days, including the outer edge. You should not apply other skin products to the affected area during treatment with acyclovir cream. Avoid unnecessary rubbing of the cold sore because this may cause the cold sore to spread to other areas around your mouth or make your cold sore worse.

What are the possible side effects of acyclovir cream? The most common side effects of acyclovir cream are skin reactions at the treatment site and may include: dry or cracked lips, peeling, flaking or dryness of the skin, a burning or stinging feeling, and itching. These are not all the possible side effects of acyclovir cream. 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 acyclovir cream? Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F) [see USP Controlled Room Temperature]. Keep acyclovir cream and all medicines out of reach of children.

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

What are the ingredients in acyclovir cream? Active ingredient: acyclovir, USP Inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water, and white petrolatum.

Manufactured by: Cadila Healthcare Limited Changodar, Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016

For more information, call 1-888-304-5011.

Rev.:03/22

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