KYGEVVI is intended for use with the instructions and supervision of specialist healthcare professionals experienced in the management of patients with mitochondrial disorders. Posology Dosing for KYGEVVI is based on weight of the patient; reassessment of weight should be performed by the prescribing physician.
KYGEVVI is titrated and dosed based on individual patient tolerability, up to a maximum recommended maintenance dose of 400 mg/kg/day of doxecitine and 400 mg/kg/day of doxribtimine. KYGEVVI should be administered every day in 3 equal doses with food.
Table 1:
KYGEVVI recommended dosing schedule1: Initial dosage 130 mg/kg/day of doxecitine and 130 mg/kg/day of doxribtimine Day 14 Intermediate Dosage 260 mg/kg/day of doxecitine and 260 mg/kg/day of doxribtimine Day 28 Maintenance Dosage 400 mg/kg/day of doxecitine and 400 mg/kg/day of doxribtimine 1For patients with moderate or severe renal impairment a slower titration (at least 4 weeks between each dose increase) should be used.
Tables 2, 3, 4 and 5 show the appropriate number of KYGEVVI powder sachets and required dilution volume by body weight for the recommended dosage levels. 3 Delayed or missed dose If a dose is missed, the dose should be taken as soon as possible.
However, if it is within 2 hours to the next dose, the dose should not be taken. The patient should take the next dose at the usual time. A double or extra dose should not be taken to make up for the missed dose. If a dose is spit out or if it is uncertain that all of the medicine was taken, another dose should not be taken.
Wait until the next scheduled dose. Special populations Elderly Specific pharmacokinetic evaluations in the elderly have not been performed. No dosage adjustment is recommended in elderly patients based on limited data in patients aged 65 years and older.
Renal impairment There is no experience with the use of doxecitine and doxribtimine in patients with TK2d with renal impairment. 73 m2) renal impairment. 2). 2) a slower titration (at least 4 weeks between each dose increase) should be used to allow for an assessment of the dose tolerability and to mitigate potential safety consequences of this high exposure to KYGEVVI.
Hepatic impairment There is limited experience with the use of doxecitine and doxribtimine in patients with hepatic impairment. 4). Insufficient data are available to provide a dose adjustment recommendation in patients with moderate or severe hepatic impairment.
Method of administration KYGEVVI is for oral use. The reconstituted oral solution should be taken with food 3 times a day in equally divided doses, approximately 6 hours ± 2 hours apart. 0 8 320 100 aVolume of water to reconstitute the powder for the preparation of one day's supply of reconstituted oral solution.
bThe number indicates the number of sachets needed for one day supply preparation of reconstituted oral solution. cThe volume of each individual dose, when multiplied by three, may not match the indicated total daily water volume, this is not an error.
Final volume of the reconstituted oral solution will increase after the powder of the prescribed number of sachets is added to the water volume. 0 15 600 200 aVolume of water to reconstitute the powder for the preparation of one day's supply of reconstituted oral solution.
bThe number indicates the number of sachets needed for one day supply preparation of reconstituted oral solution. cThe volume of each individual dose, when multiplied by three, may not match the indicated total daily water volume, this is not an error.
Final volume of the reconstituted oral solution will increase after the powder of the prescribed number of sachets is added to the water volume.
Table 4:
Recommended day 28 maintenance dosage 400 mg/kg/day of doxecitine and 400 […]