About Denavir


Having Denavir® (penciclovir cream, 1%) on hand means you can be ready to start treating when you first feel a cold sore coming on.


Denavir is a steroid-free topicalTopical: application to a localized area of the skin. cream that you apply directly to the cold sore for soothing relief.4,54. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.

5. Boon R, Goodman JJ, Martinez J, et al, for the Penciclovir Cream Herpes Labialis Study Group. Penciclovir cream for the treatment of sunlight-induced herpes simplex labialis: a randomized, double-blind, placebo-controlled trial. Clin Ther. 2000;22:76-90.
 It’s non-greasy, dries clear, and penetrates to target the virus that causes cold sores.4,64. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.

6. Earnshaw DL, Bacon TH, Darlison SJ, et al. Mode of antiviral action of penciclovir in MRC-5 cells infected with herpes simplex virus type 1 (HSV-1), HSV-2, and varicella-zoster virus. Antimicrob Agents Chemother. 1992;36:2747-2757.



 Denavir selectively targets cells infected with HSV-1 and prevents the virus from reproducing.


How Denavir Works

Denavir (penciclovir cream, 1%) contains an antiviral medicine (that’s the penciclovir part). It targets the virus that causes cold sores. 4,64. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.

6. Earnshaw DL, Bacon TH, Darlison SJ, et al. Mode of antiviral action of penciclovir in MRC-5 cells infected with herpes simplex virus type 1 (HSV-1), HSV-2, and varicella-zoster virus. Antimicrob Agents Chemother. 1992;36:2747-2757.


 


Denavir penetrates the cold sore

 

…and helps make it disappear.


Here’s how it works: when you apply Denavir, it penetrates the skin to deliver penciclovir directly to the site of infection. It targets cells that are infected with HSV-1Herpes simplex virus type 1 (HSV-1): virus that causes cold sores and stays in the body for life; it does not cause symptoms when in an inactive, or latent, state, but may cause cold sores when reactivated. 4,64. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.

6. Earnshaw DL, Bacon TH, Darlison SJ, et al. Mode of antiviral action of penciclovir in MRC-5 cells infected with herpes simplex virus type 1 (HSV-1), HSV-2, and varicella-zoster virus. Antimicrob Agents Chemother. 1992;36:2747-2757.
 That way, the healing process can begin.4,5,74. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.

5. Boon R, Goodman JJ, Martinez J, et al, for the Penciclovir Cream Herpes Labialis Study Group. Penciclovir cream for the treatment of sunlight-induced herpes simplex labialis: a randomized, double-blind, placebo-controlled trial. Clin Ther. 2000;22:76-90.

7. Raborn GW, Martel AY, Lassonde M, et al; on behalf of the Worldwide Topical Penciclovir Collaborative Study Group. Effective treatment of herpes simplex labialis with penciclovir cream: combined results of two trials. J Am Dent Assoc. 2002;133:303-309.


Feel the tingling or burning of an oncoming cold sore? As soon as you feel it, you can treat it.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010. But not everyone gets symptoms before a cold sore.2,32. Arduino PG, Porter SR. Herpes simplex virus type I infection: overview on relevant clinic-pathological features. J Oral Pathol Med. 2008;37:107-121.

3. Fatahzadeh M, Schwartz RA. Herpes simplex virus infections: epidemiology, pathogenesis, symptomatology, diagnosis, and management. J Am Acad Dermatol. 2007;57:737-763.
 No worries. Unlike some other cold sore medicines, you can start Denavir when the blister forms, too.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010. 


 Denavir selectively targets cells infected with HSV-1 and prevents the virus from reproducing.


Side Effects

Denavir was well tolerated in clinical studies.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.


The most common side effect with Denavir was headache, which occurred in 5.3% of patients treated with Denavir and 5.8% of those who received a cream that contained no medication (placebo).44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.


Other side effects with Denavir reported in less than 2% of patients included: application site reactions, decreased sensitivity to touch, local numbness, taste perversion and rash.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.


Precautions

Denavir should only be used on the lips and face. Application inside the nose or mouth is not recommended. Sores that do not improve or that worsen while on therapy should be evaluated by your healthcare provider.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.


Denavir is approved for the treatment of recurrent cold sores in adults and children 12 years of age and older. Denavir is not a cure for cold sores, and not all patients respond to it. Do not use if you are allergic to Denavir (penciclovir) or any of its ingredients. Before you use Denavir, tell your healthcare provider if you are pregnant, planning to become pregnant, or are breast-feeding.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.


How to Use Denavir

Denavir combines the power of an antiviralAntiviral: medication that reduces the activity of viruses in the body. medication and the soothing relief of a cream.4,54. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.

5. Boon R, Goodman JJ, Martinez J, et al, for the Penciclovir Cream Herpes Labialis Study Group. Penciclovir cream for the treatment of sunlight-induced herpes simplex labialis: a randomized, double-blind, placebo-controlled trial. Clin Ther. 2000;22:76-90.


When to Use Denavir44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.

  • Apply Denavir every 2 hours during waking hours for a period of 4 days.
  • When possible, start applying Denavir at the first sign or symptom of a cold sore. But know that, unlike some other prescription and over-the-counter cold sore medicines, Denavir can be started even when the blister has formed.

How to Apply Denavir44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.

  • Wash your hands. Your face should be clean and dry. Apply a layer of Denavir to cover only the cold sore area or the area of tingling (or other symptoms) before the cold sore appears. Rub in the cream until it disappears.
  • Apply Denavir with your finger or a cotton swab. Wash your hands with soap and water after using Denavir. Particular care should be taken to avoid application in or near the eyes since it may cause irritation.

Be Ready for Your Next Cold Sore

Denavir comes in a 5-gram tube, which often provides enough medicine for several cold sore outbreaks. Keep your unused Denavir on hand until the tube expiration date. You’ll be ready when you feel the symptoms of your next cold sore.




Important Safety Information

Denavir should only be used on herpes labialis on the lips or face. Application to mucous membranes is not recommended. Denavir should not be used in patients with known hypersensitivity to the product or any of its ingredients.

 

There are no adequate and well-controlled Denavir studies in pregnant women; therefore, Denavir should be used during pregnancy only if clearly needed. There is no information on whether Denavir is excreted in human milk after topical administration; a decision whether to discontinue Denavir should take into account the importance of the drug to the mother. The effect of Denavir has not been established in immunocompromised patients. Denavir does not cure cold sores.

 

In clinical studies, the most common adverse reaction with Denavir was headache, which occurred in 5.3% of patients who received Denavir and 5.8% of patients who received placebo. Other adverse reactions with Denavir occurred in less than 2% of patients and included application site reaction, decreased sensitivity to touch/local anesthesia, taste perversion, and rash.

 

Other reported adverse reactions have included swelling of the mouth or throat, pain, alterations in sense of smell, abnormal touch sensation, itching, skin discoloration, and hives.

 

Denavir is available by prescription only. Please see the Full Prescribing Information.

 

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

 


DENAVIR Featured on The Balancing Act













Denavir® (penciclovir cream, 1%) is indicated
for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of
age and older.