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Famvir for Genital Herpes and shingles

FAMVIR® (famciclovir) is an oral antiviral prescription medication that is prescribed for:

• Treatment of recurrent genital herpes in otherwise healthy patients
• Suppression of recurrent genital herpes in otherwise healthy patients
• The only antiviral indicated to treat genital and/or orolabial HSV in HIV+ patients
• Treatment of herpes zoster (shingles)

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What is FAMVIR?

FAMVIR® (famciclovir) is an oral antiviral prescription medication that is prescribed for:

• Treatment of recurrent genital herpes in otherwise healthy patients
• Suppression of recurrent genital herpes in otherwise healthy patients
• The only antiviral indicated to treat genital and/or orolabial HSV in HIV+ patients
• Treatment of herpes zoster (shingles)

How is FAMVIR prescribed for genital herpes?

FAMVIR can be prescribed in one of three ways:

Episodic treatment—The dose of FAMVIR is one 125-mg tablet, twice a day, for 5 days.†

Suppressive treatment—For patients with frequent or severe outbreaks, the dose of FAMVIR is one 250-mg tablet, twice a day, for up to 1 year.† ‡

Patients with HIV—FAMVIR is the only prescription oral antiviral therapy indicated for treating genital or orolabial herpes in people infected with HIV. In patients with herpes simplex and HIV, the dose of FAMVIR is one 500 mg tablet, twice a day, for 7 days.†

† Dose reduction recommended for patients with renal impairment.
‡ The safety and efficacy of FAMVIR therapy beyond 1 year of treatment have not been established.

How is FAMVIR prescribed for herpes zoster?

The dose of FAMVIR for the treatment of herpes zoster is one 500 mg tablet, three times a day, for 7 days.* ,†
* Dose reduction recommended in patients with renal impairment.
† Therapy should be initiated promptly as soon as herpes zoster is diagnosed. The efficacy of treatment started more than 3 days (72 hours) after rash onset has not been established.

Why use FAMVIR for genital herpes?

One clinical study showed that episodic treatment with prescription oral FAMVIR significantly relieved all of the symptoms of a genital herpes outbreak compared to placebo. In a clinical trial compared to placebo episodic treatment with prescription oral FAMVIR® (famciclovir) shortened the duration of pain, burning, and itching during an outbreak, and reduced viral shedding (clinical significance unknown).

Many patients on suppressive therapy with FAMVIR go nearly a year to first recurrence.

• The efficacy of FAMVIR has not been established for the treatment of an initial outbreak of genital herpes infection.
• The safety and efficacy of FAMVIR for suppressive therapy beyond 1 year of treatment have not been established.
• No medication has been proven to prevent the spread of genital herpes to other people. There is no cure for genital herpes.

Why use FAMVIR for herpes zoster?

Postherpetic neuralgia (PHN) is severe, chronic pain, which can persist for a month, a year, or even a lifetime following the herpes zoster rash. FAMVIR has been proven to shorten the duration of PHN. One clinical study showed that the median time to resolution of PHN in patients age 50 or older was 63 days with FAMVIR vs 163 days with placebo. FAMVIR should be started within 72 hours of the first sign of the herpes zoster rash. The efficacy of treatment started more than 72 hours after rash onset has not been established. The efficacy of FAMVIR has not been established for the treatment of ophthalmic zoster, disseminated zoster, or in immunocompromised patients with herpes zoster.

What are the most common adverse events?

In clinical trials, the most commonly reported adverse events were headache (zoster: 22.7%; episodic: 23.6%; suppression: 39.3%), nausea (zoster: 12.5%; episodic: 10%); and diarrhea (suppression: 9%).
No clinically important abnormalities were seen in hematology, clinical chemistry, or urinalysis parameters.
No clinically significant interactions with cimetidine, allopurinol, theophylline, digoxin, and zidovudine (AZT).

Should FAMVIR be taken with or without food?

FAMVIR can be taken without regard to meals.

Who cannot take FAMVIR?

FAMVIR should not be taken by patients with known hypersensitivity to the product, its components, and DENAVIR® (penciclovir cream).

FAMVIR (Pregnancy Category B) should be used during pregnancy only if the benefit to the patient clearly exceeds the risk to the foetus.

Important Famvir Information

• In clinical trials the most commonly reported adverse events were headache (episodic: 23.6%; suppression: 39.3%), nausea (episodic: 10%); and diarrhea (suppression: 9%).
• No clinically important abnormalities were seen in haematology, clinical chemistry, or urinalysis parameters.
• No clinically significant interactions with cimetidine, allopurinol, theophylline, digoxin, and zidovudine (AZT).
• FAMVIR (Pregnancy Category B)
• FAMVIR is contraindicated in patients with known hypersensitivity to the product, its components, and DENAVIR® (penciclovir cream).
• The efficacy of FAMVIR has not been established for the treatment of an initial outbreak of genital herpes infection, ophthalmic zoster, disseminated zoster, or in immunocompromised patients with herpes zoster.
• The safety and efficacy of FAMVIR for suppressive therapy beyond 1 year of treatment have not been established.
• There is no cure for genital herpes.
• Dose reduction recommended in patients with renal impairment.
• No treatment can prevent the spread of genital herpes.