Denavir: Package Insert and Label Information (Page 2 of 2)

Impairment of Fertility

Testicular toxicity was observed in multiple animal species (rats and dogs) following repeated intravenous administration of penciclovir (160 mg/kg/day and 100 mg/kg/day, respectively, approximately 1155 and 3255x the maximum theoretical human AUC). Testicular changes seen in both species included atrophy of the seminiferous tubules and reductions in epididymal sperm counts and/or an increased incidence of sperm with abnormal morphology or reduced motility. Adverse testicular effects were related to an increasing dose or duration of exposure to penciclovir. No adverse testicular or reproductive effects (fertility and reproductive function) were observed in rats after 10 to 13 weeks dosing at 80 mg/kg/day, or testicular effects in dogs after 13 weeks dosing at 30 mg/kg/day (575 and 845x the maximum theoretical human AUC, respectively). Intravenously administered penciclovir had no effect on fertility or reproductive performance in female rats at doses of up to 80 mg/kg/day (260x the maximum human dose [BSA]).

There was no evidence of any clinically significant effects on sperm count, motility or morphology in 2 placebo-controlled clinical trials of Famvir® (famciclovir [the oral prodrug of penciclovir], 250 mg twice daily; n=66) in immunocompetent men with recurrent genital herpes, when dosing and follow-up were maintained for 18 and 8 weeks, respectively (approximately 2 and 1 spermatogenic cycles in the human).

14 CLINICAL STUDIES

DENAVIR was studied in two double-blind, placebo (vehicle)-controlled trials for the treatment of recurrent herpes labialis in which otherwise healthy adults were randomized to either DENAVIR or placebo. Therapy was to be initiated by the subjects within 1 hour of noticing signs or symptoms and continued for 4 days, with application of study medication every 2 hours while awake. In both studies, the mean duration of lesions was approximately one-half-day shorter in the subjects treated with DENAVIR (N=1,516) as compared to subjects treated with placebo (N=1,541) (approximately 4.5 days versus 5 days, respectively). The mean duration of lesion pain was also approximately one half-day shorter in the DENAVIR group compared to the placebo group.

16 HOW SUPPLIED/STORAGE AND HANDLING

DENAVIR is supplied in a 5 gram tube containing 10 mg of penciclovir per gram in a cream base, which is equivalent to 1% (w/w). The white cream is available as follows:

NDC 0378-9720-55
carton containing one 5 gram tube

Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Administration Instructions

Advise the patient that treatment should be started at the earliest sign of a cold sore (i.e. tingling, redness, itching, or bump). Inform the patient to apply the cream every 2 hours during waking hours for 4 days and to wash their hands with soap and water after using DENAVIR.

Denavir is a registered trademark of Denco Asset, LLC, a Mylan Company.

The brands listed are trademarks of their respective owners.

©2018 Mylan Pharmaceuticals Inc.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Confab Laboratories Inc.
St-Hubert, Canada J3Y 3X3

Revised: 11/2018

301459-03
CON:PENCCR:R2

PRINCIPAL DISPLAY PANEL – 1%

NDC 0378-9720-55 Rx only

Denavir®
(penciclovir cream) 1%
For Topical Use Only

5 g (Net Wt.)

Each gram contains 10 mg penciclovir; inactive ingredients consist of cetomacrogol 1000
BP, cetostearyl alcohol, mineral oil, propylene glycol, purified water and white petrolatum.

Usual Dosage: See accompanying prescribing information.

To Open Tube: Unscrew cap, puncture aluminum seal with pointed end of cap.

Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Denavir® is a registered trademark of Denco Asset, LLC, a Mylan Company
© 2018 Mylan Pharmaceuticals Inc.

Comments or Questions? Call 1-877-446-3679 (1-877-4-INFO-RX)

Manufactured in Canada for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

CON:9720:55:1C:R1

Denavir Cream 1% Carton Label
(click image for full-size original)
DENAVIR
penciclovir cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-9720
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENCICLOVIR (PENCICLOVIR) PENCICLOVIR 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL
MINERAL OIL
POLYOXYL 20 CETOSTEARYL ETHER
PROPYLENE GLYCOL
WATER
PETROLATUM
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-9720-55 1 TUBE in 1 CARTON contains a TUBE
1 5 g in 1 TUBE This package is contained within the CARTON (0378-9720-55)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020629 09/24/2018
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 11/2018 Mylan Pharmaceuticals Inc.

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