FAMCICLOVIR

Posology Herpes zoster in immunocompetent adults 500 mg three times daily for seven days. Treatment should be initiated as soon as possible after a diagnosis of herpes zoster. Herpes zoster in immunocompromised adults 500 mg three times daily for ten days.

Treatment should be initiated as soon as possible after a diagnosis of herpes zoster. Genital herpes in immunocompetent adults First episode of genital herpes: 250 mg three times daily for five days. Initiation of treatment is recommended as soon as possible after a diagnosis of first episode of genital herpes.

Episodic treatment of recurrent genital herpes: 125 mg twice daily for five days. g. tingling, itching, burning, pain) or lesions. Recurrent genital herpes in immunocompromised adults Episodic treatment of recurrent genital herpes: 500 mg twice daily for seven days.

g. tingling, itching, burning, pain) or lesions. Suppression of recurrent genital herpes in immunocompetent adults 250 mg twice daily. Suppressive therapy should be discontinued after a maximum of 12 months of continuous antiviral therapy to reassess recurrence frequency and severity.

The minimum period of reassessment should include two recurrences. Patients who continue to have significant disease may restart suppressive therapy. Suppression of recurrent genital herpes in immunocompromised adults 500 mg twice daily.

Patients with renal impairment Because reduced clearance of penciclovir is related to reduced renal function, as measured by creatinine clearance, special attention should be given to doses in patients with impaired renal function.

Dose recommendations for adult patients with renal impairment are provided in Table 1. Table 1 Dose recommendations for adult patients with renal impairment Indication and nominal dose regimen Creatinine clearance [ml/min] Adjusted dose regimen Herpes zoster in immunocompetent adults 500 mg three times daily for 7 days ≥ 60 40 to 59 20 to 39 < 20 Haemodialysis patients 500 mg three times daily for 7 days 500 mg twice daily for 7 days 500 mg once daily for 7 days 250 mg once daily for 7 days 250 mg following each dialysis during 7 days Herpes zoster in immunocompromised adults 500 mg three times daily for 10 days ≥ 60 40 to 59 20 to 39 < 20 Haemodialysis patients 500 mg three times daily for 10 days 500 mg twice daily for 10 days 500 mg once daily for 10 days 250 mg once daily for 10 days 250 mg following each dialysis during 10 days Genital herpes in immunocompetent adults – first episode of genital herpes 250 mg three times daily for 5 days ≥ 40 20 to 39 < 20 Haemodialysis patients 250 mg three times daily for 5 days 250 mg twice daily for 5 days 250 mg once daily for 5 days 250 mg following each dialysis during 5 days Genital herpes in immunocompetent adults – episodic treatment of recurrent genital herpes 125 mg twice daily for 5 days ≥ 20 < 20 Haemodialysis patients 125 mg twice daily for 5 days 125 mg once daily for 5 days 125 mg following each dialysis during 5 days Genital herpes in immunocompromised adults- episodic treatment of recurrent genital herpes 500 mg twice daily for 7 days ≥40 20 to 39 < 20 Haemodialysis patients 500 mg twice daily for 7 days 500 mg once daily for 7 days 250 mg once daily for 7 days 250 mg following each dialysis during 7 days Suppression of recurrent genital herpes in immunocompetent adults 250 mg twice daily ≥40 250 mg twice daily 20 to 39 < 20 Haemodialysis patients 125 mg twice daily 125 mg once daily 125 mg following each dialysis Suppression of recurrent genital herpes in immunocompromised adults 500 mg twice daily ≥40 20 to 39 < 20 Haemodialysis patients 500 mg twice daily 500 mg once daily 250 mg once daily 250 mg following each dialysis Patients with renal impairment on haemodialysis Since 4 h haemodialysis resulted in up to 75% reduction in plasma penciclovir concentrations, famciclovir should be administered immediately following dialysis.

The recommended dose regimens for haemodialysis patients are included in Table 1. Patients with hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment. 2). Elderly patients (≥65 years) Dose modification is not required unless renal function is impaired.

Paediatric population The safety and efficacy of famciclovir in children and adolescents aged less than 18 years have not been established. 2. Black patients A placebo-controlled study in immunocompetent black patients with recurrent genital herpes showed no difference in efficacy between patients receiving famciclovir 1000 mg twice daily for one day and placebo.

There were no unexpected or new safety finding in this trial in Black patients. This lack of efficacy in the one-day treatment regimen cannot be extrapolated to the five-day treatment regimen for recurrent genital herpes (125 mg twice daily for five days) or other indications in Black patients.

2).

Headache and nausea have been reported in clinical studies. These were generally mild or moderate in nature and occurred at a similar incidence in patients receiving placebo treatment. All other adverse reactions were added during postmarketing.

The pooled global placebo or active controlled clinical trials (n=2326 for Famciclovir arm) were retrospectively reviewed to obtain a frequency category for all adverse reactions mentioned below. The following table specifies the estimated frequency of adverse reactions based on all the spontaneous reports and literature cases that have been reported for Famciclovir since its introduction to the market.

Adverse reactions (Table 2) are ranked under headings of frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available data).

Table 2 Adverse reactions from clinical trials and post-marketing spontaneous reports Blood and lymphatic system disorders Rare: Thrombocytopenia.

Psychiatric disorders Uncommon:

Confusional state (predominantly in the elderly).

Rare:

Hallucinations.

Nervous system disorders Very common:

Headache.

Common:

Dizziness.

Uncommon:

Somnolence (predominantly in the elderly).

Not known:

Seizure*.

Cardiac disorders Rare:

Palpitations.

Gastrointestinal disorders Common:

Nausea, vomiting, abdominal pain, diarrhoea.

Hepatobiliary disorders Common:

Abnormal liver function tests.

Rare:

Cholestatic jaundice.

Immune system disorders Not known:

Anaphylactic shock*, anaphylactic reaction*.

Skin and subcutaneous tissue disorders Common:

Rash, pruritus. g. face oedema, eyelid oedema, periorbital oedema, pharyngeal oedema), urticaria. g. erythema multiforme, Stevens- Johnson Syndrome, Toxic Epidermal Necrolysis), Hypersensitivity vasculitis*. *Adverse drug reactions reported from post-marketing experience with Famciclovir via spontaneous case reports and literature cases which have not been reported in clinical trials.

Because these adverse drug reactions have been reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency. Frequency is therefore listed as “not known”. Overall, adverse reactions reported from clinical studies with immunocompromised patients were similar to those reported in the immunocompetent population.

Nausea, vomiting and abnormal liver function tests were reported more frequently, especially at higher doses. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

9). Use in patients with hepatic impairment Famciclovir has not been studied in patients with severe hepatic impairment. Conversion of famciclovir to its active metabolite penciclovir may be impaired in these patients resulting in lower penciclovir plasma concentrations, and thus a decrease of efficacy of famciclovir may occur.

Use for zoster treatment Clinical response should be closely monitored, particularly in immunocompromised patients. Consideration should be given to intravenous antiviral therapy when response to oral therapy is considered insufficient.

e. those with visceral involvement, disseminated zoster, motor neuropathies, encephalitis and cerebrovascular complications should be treated with intravenous antiviral therapy. Moreover, immunocompromised patients with ophthalmic zoster or those with a high risk for disease dissemination and visceral organ involvement should be treated with intravenous antiviral therapy.

Transmission of genital herpes Patients should be advised to avoid intercourse when symptoms are present even if treatment with an antiviral has been initiated. During suppressive treatment with antiviral agents, the frequency of viral shedding is significantly reduced.

However, transmission is still possible. Therefore, in addition to therapy with famciclovir, it is recommended that patients use safer sex practices.

1. • Hypersensitivity to penciclovir