Route of administration and food

“HOVILPRI (pritelivir) tablets, for oral use” (opens the prescribing information at this quote)
“daily by mouth with or without food” (opens the prescribing information at this quote)
“Take HOVILPRI with or without food.” (opens the prescribing information at this quote)
“Each tablet contains 100 mg of pritelivir (equivalent to 123.9 mg of pritelivir mesylate) and is available as immediate release tablets for oral administration.” (opens the prescribing information at this quote)

Food effect with a high-fat meal

“AUC ratio fed/fasted: 1.16” (opens the prescribing information at this quote)
“Cmax ratio fed/fasted: 1.33” (opens the prescribing information at this quote)
“Food effect after high-fat meal: 150 calories from protein, 250 calories from carbohydrates, and 500-600 calories from fat; a total of 1000 calories with >50% calories from fat.” (opens the prescribing information at this quote)

“Following a fatty diet, pritelivir time to maximum concentration was 1.5 hour delayed and maximum plasma concentration and area under the plasma concentration-time curve from time 0 to the last quantifiable concentration were 33% and 16% higher, respectively.” (opens the source at this quote in a new tab)

Patient instructions for taking the tablets

“Take HOVILPRI exactly as your healthcare provider tells you to take it.” (opens the prescribing information at this quote)
“On Day 1 (first day of treatment): take 400 mg by mouth (four 100 mg tablets) at one time.” (opens the prescribing information at this quote)
“After Day 1: take 100 mg by mouth (one 100 mg tablet) 1 time a day.” (opens the prescribing information at this quote)
“Take HOVILPRI as prescribed by your healthcare provider until your HSV lesions have healed.” (opens the prescribing information at this quote)

Patient instructions for timing with H2-receptor blockers and antacids

“If you take an H2-receptor blocker (such as famotidine, ranitidine), take HOVILPRI at least 2 hours before or 12 hours after taking the H2-receptor blocker.” (opens the prescribing information at this quote)
“If you take an antacid (such as Tums, Mylanta, Maalox), take HOVILPRI 2 hours before or 2 hours after taking the antacid.” (opens the prescribing information at this quote)

Patient instructions for a missed dose and for an overdose

“If you miss a dose of HOVILPRI, take it as soon as you remember. If you don’t remember until the next day’s scheduled dose, take 2 tablets at that time.” (opens the prescribing information at this quote)
“If you take too much HOVILPRI, call your healthcare provider, or the Poison Help line (1-800-222-1222), or go to the nearest hospital emergency room right away.” (opens the prescribing information at this quote)

Counseling on adherence and missed doses

“Inform patients that it is important not to miss or skip doses and to take HOVILPRI for the duration that is recommended by the healthcare provider.” (opens the prescribing information at this quote)
“Instruct patients that if they miss a dose of HOVILPRI, they should take it as soon as they remember. If it is not taken until the scheduled dosing time on the next day, take two tablets at that time” (opens the prescribing information at this quote)

Packaging and storage

“HOVILPRI is available in cartons of 16 or 32 film-coated tablets.” (opens the prescribing information at this quote)
“Each carton contains two blister wallets. Each blister wallet contains 16 film-coated tablets, for a total of 32 film-coated tablets per carton.” (opens the prescribing information at this quote)
“Each carton contains one blister wallet containing 16 film-coated tablets.” (opens the prescribing information at this quote)
“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)” (opens the prescribing information at this quote)
“Keep HOVILPRI and all medicines out of the reach of children.” (opens the prescribing information at this quote)

Administration conditions in the phase 1 interaction trials

“Pritelivir was administered orally 1 hour before breakfast or 2 hours after breakfast with 240 mL of water.” (opens the source at this quote in a new tab)

Gastric route and oral suspension in the European paediatric investigation plan

“A paediatric investigation plan for pritelivir (mesylate monohydrate), film-coated tablet, oral use, gastric use, the details of which are set out in the opinion of the Paediatric Committee of the European Medicines Agency annexed hereto, together with its appendices, is hereby agreed.” (opens the source at this quote in a new tab)
“Development of an oral suspension prepared from the film-coated tablets.” (opens the source at this quote in a new tab)

Administration through a gastrostomy tube in a published case

“pritelivir was administered via PEG with excellent compliance and no adverse events.” (opens the source at this quote in a new tab)
“In our case, pritelivir was effective in treating a life-threatening mucocutaneous disease with severe gastrointestinal mucositis that impaired both oral drug intake and potentially gastrointestinal absorption.” (opens the source at this quote in a new tab)