Products

Presentation

Zervira™ 200 Tablet: Each film coated tablet contains Amenamevir INN 200 mg

Description

Amenamevir is a first-in-class helicase–primase inhibitor (HPI) with a novel antiviral mechanism against herpesviruses. Unlike nucleoside analogs that require viral thymidine kinase activation and act by chain termination, amenamevir directly targets the helicase–primase complex, thereby blocking DNA strand separation and primer synthesis, essential for viral DNA replication. This mechanism provides strong efficacy against varicella-zoster virus (VZV) and herpes simplex viruses (HSV-1, HSV-2), including strains resistant to acyclovir. Following oral administration, amenamevir is well absorbed (enhanced with food), widely distributed to skin and ganglia, and primarily eliminated via feces (~70%), minimizing renal dependence and allowing use without dose adjustment in renal impairment.

Indications

• Herpes Zoster (Shingles)
• Recurrent Herpes Simplex (oral/genital)

Dosage & Administration

Adult:

Indication	Dose	Frequency
Herpes Zoster	400 mg (2 tablets at a time) once daily after a meal	7 days
Recurrent Herpes Simplex (oral/genital)	1200 mg (6 tablets) within 6 hours of symptom onset, after a meal	Single dose, can be used as patient initiated therapy.

Elderly: Same dose as adult.
Children: Safety and efficacy not established.

*No dose adjustment required for renal impaired patients.

Side Effects

Generally well tolerated. Possible adverse reactions include:

• Gastrointestinal: diarrhea, abdominal pain / discomfort, nausea, vomiting, dyspepsia (indigestion), decreased appetite (rare)
• Hematologic: thrombocytopenia (rare), abnormal liver enzymes (AST, ALT elevations) (infrequent, usually mild and reversible), increased blood urea nitrogen (BUN) or creatinine (occasional)
• Cardiovascular: palpitations (rare)
• Dermatologic: rash, urticaria, pruritus (itching), serious (rare but clinically important) such as erythema multiforme, stevens-johnson syndrome, toxic epidermal necrolysis.

Precautions

Skin reactions should be monitored. Discontinue if severe rash develops. Limited data available for hepatic impairment. Caution should be exercised.

Use in Pregnancy & Lactation

Pregnancy: There are no adequate and well-controlled studies in pregnant women. In animal studies, no evidence of impaired fertility or harm to the fetus due to Amenamevir has been reported. Use only if potential benefit justifies risk.

Lactation: Excretion in human milk is unknown. Avoid or discontinue breastfeeding if treatment is necessary

Drug Interaction

Amenamevir metabolism may involve CYP pathways. Caution is required when used with strong enzyme inducers or inhibitors (e.g. rifampin, ketoconazole).

Commercial Pack

Zervira™ 200 Tablet: Each box contains 1 alu-alu blister strip of 10 tablets.