Single Day Famvir - famciclovir tablets





  Novartis Pharma US

 
Healthcare Professionals

The FIRST AND ONLY single-day
episodic treatment for recurrent genital herpes in
immunocompetent patients

Stops or shortens an outbreak with a single day of treatment

75% of all patients healed * within 5.4 days1

75% of all patients had healing in 5.4 days with FAMVIR (ITT, n=163) vs 8.9 days (median) with placebo (ITT, n=166) [P<.001]1
50% of all patients had healing in 3.5 days with FAMVIR (ITT, n=163) vs 5 days with placebo (ITT, n=166) [P<.001]2
Among patients with non-aborted lesions, the median time to healing was 4.3 days with FAMVIR (mITT, n=125) vs 6.1 days with placebo (mITT, n=145) [P<.001]2,3

1 in 4 patients had their outbreak stopped2,3

23% of patients treated with FAMVIR (ITT, n=163) had no outbreak development beyond erythema vs 13% of those treated with placebo (ITT, n=166) [P=.003]2,3

Stops pain and burning in less than 24 hours (median time)

Stops pain in 22 hours
Stops burning in 17 hours
Relieves all symptoms in 3.3 days vs. 5.4 days (median) with placebo

In the clinical trial, treatment was initiated within 6 hours of either symptom onset or lesion appearance.

Delivers a full course of therapy early—as viral activity is increasing

“...the window of opportunity for treating recurrent genital herpes with an antiviral drug is as early as possible, when the virus titer is increasing.”2

The natural course of a recurrent genital herpes outbreak in untreated patients

Course of an Outbreak (Average Days After Prodrome Onset

Empower patients to stop or shorten an outbreak as soon as they feel it

Patients should initiate treatment as soon as possible

Instruct patients to take two 500-mg FAMVIR tablets at the first sign or symptom and another two tablets about 12 hours later3
–   In the clincial trail, treatment was initiated within 6 hours of either symptom onset or lesion appearance.
Prescribe a sufficient supply for current and future episodes
–   Patients should keep FAMVIR on hand for future episodes to avoid delays in initiating treatment.
–   It may be helpful to have medication available at multiple locations (eg, at home, at work, in gym bag)

Single-Day FAMVIR generally safe and well tolerated

Common side effects were mild to moderate in nature2,3
Pregnancy Category B3
Dosage adjustment is recommended when administering FAMVIR to patients with creatinine clearance values <60 mL/min. In patients with underlying renal disease who have received inappropriately high doses of FAMVIR for their level of renal function, acute renal failure has been reported3

Dosing Instructions

ITT = intent-to-treat population, which includes patients with aborted and non-aborted lesions; mITT = modified intent-to-treat population, which excludes patients with aborted lesions. *Loss of all crusts and reepithelialization of genital herpes. Healing time of aborted lesions = 0 days.

References:
1. Data on file, Novartis Pharmaceuticals Corporation.
2. Aoki FY, Tyring S, Diaz-Mitoma F, et al. Single-day, patient-initiated famciclovir therapy for recurrent genital herpes: a randomized, double-blind, placebo-controlled trial. Clin Infect Dis. 2006:42:8-13.
3. FAMVIR Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals Corp.; July 2006.
4. Brown ZA, Kern ER, Spruance SL, Overall JC. Clinical and virologic course of herpes simplex genitalis.West J Med. 1979;130:414-421.
5. Corey L, Adams HG, Brown ZA, Holmes KK. Genital herpes simplex virus infections: clinical manifestations, course, and complications. Ann Intern Med. 1983;98:958-972.
6. Sacks SL. Frequency and duration of patient observed recurrent genital herpes simplex virus infection: characterization of the nonlesional prodrome. J Infect Dis: 1984:150:873-877.




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