KYGEVVI is a powder for solution taken orally or via feeding tube 3 times each day.1
KYGEVVI dosing1
Obtain baseline liver transaminase (ALT and AST) and total bilirubin levels prior to treatment initiation.
Dosage is based on weight. Monitor patient weight to assess potential impact on dosing.
A minimum of 2 weeks at the current dosage level is recommended before titrating to the next dosage level based on tolerability.
Maintenance dose: 800 mg/kg/day split into 3 equal doses.
Example for 30 lb (13.6 kg) patient: Three packets (4 g per packet) in 120 mL (4.1 oz) of water split into 3 doses of 35 mL per day administered approximately 6 hours apart (plus or minus 2 hours) with food.
Recommended starting, intermediate, and maintenance dosage of KYGEVVI1
KYGEVVI Dosage Level | Dosage (mg/kg/day) |
|---|---|
Starting | 260 mg/kg/day |
Intermediate | 520 mg/kg/day |
Maintenance | 800 mg/kg/day |
Increase in Liver Transaminases
Elevated liver transaminase [alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)] levels were reported in patients treated with KYGEVVI. Obtain baseline liver transaminase (ALT, AST) and total bilirubin levels in patients prior to treatment initiation with KYGEVVI. If signs or symptoms consistent with liver injury are observed, interrupt treatment with KYGEVVI until liver transaminase (ALT, AST) and total bilirubin levels have either returned to baseline or stabilized at a new baseline value. Consider permanently discontinuing KYGEVVI if signs or symptoms consistent with liver injury persist or worsen. Monitor liver transaminases and total bilirubin levels yearly and as clinically indicated.
Gastrointestinal Adverse Reactions
Diarrhea and vomiting leading to hospitalization, dose reduction, and permanent discontinuation were reported in patients treated with KYGEVVI. Based on the severity of the diarrhea and/or vomiting, reduce the dosage of KYGEVVI or interrupt treatment until diarrhea and/or vomiting improves or returns to baseline. Consider restarting KYGEVVI at the last tolerated dose, and increase the dose as tolerated. For persistent or recurring diarrhea and/or vomiting, consider discontinuing KYGEVVI permanently and provide supportive care with electrolyte repletion as clinically indicated.
KYGEVVI administration1
Each morning, adult patients or caregivers should prepare a one-day supply of KYGEVVI. Each single-use packet contains 4 g of KYGEVVI. Use 40 mL of room temperature water per packet to prepare the oral solution.1
The solution should be administered orally or via feeding tube in 3 equal doses throughout the day.
Discard any remaining KYGEVVI solution 16 hours after reconstitution or after taking or giving the 3 doses, whichever comes first.
Reconstituted oral solution may be stored at room temperature between 20°C to 25°C (68°F to 77°F) or refrigerated between 2°C to 8°C (36°F to 46°F) in between taking the doses.
KYGEVVI should be taken with food.
Detailed preparation and administration information can be found in the Instructions for Use.
Reference
- KYGEVVI (doxecitine and doxribtimine) U.S. Prescribing Information. Smyrna, GA: UCB, Inc.
