HOVILPR Ref.[117015] Active ingredients:

2.1 Recommended Dosage

Initiate treatment with a loading dose of 400 mg (four 100 mg tablets) on day 1, followed by a maintenance dose of 100 mg (one tablet) daily by mouth with or without food, until HSV lesions have healed [see Clinical Pharmacology (12.3), Clinical Studies (14.1)].

2.2 Co-administration with Acid-Reducing Agents

While taking HOVILPRI, avoid concomitant use of the following proton pump inhibitors [see Warnings and Precautions (5.1), Drug Interactions (7.2), Clinical Pharmacology (12.3)]:

• Esomeprazole or rabeprazole
• Omeprazole or lansoprazole at daily doses above 20 mg
• Pantoprazole at daily doses above 40 mg

Take HOVILPRI 2 hours before or 12 hours after taking a H2-receptor antagonist [see Warnings and Precautions (5.1), Drug Interactions (7.2), Clinical Pharmacology (12.3)].

Separate any dosing of antacids from HOVILPRI dosing by 2 hours [see Warnings and Precautions (5.1), Drug Interactions (7.2)].

2.3 Missed Dosage

If a dose of HOVILPRI is missed, take it as soon as it is remembered. If it is not taken until the scheduled dosing time on the next day, take two tablets at that time.

There is no known specific antidote for HOVILPRI. In the event of an overdose, patients should be monitored for adverse reactions and managed with supportive care, as appropriate.

Due to the high plasma protein binding of pritelivir, hemoperfusion or dialysis is unlikely to significantly reduce systemic exposure of pritelivir. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].