Table 7.

Dosing and administration schedules considered during simulations for prophylactic treatment with rIX-FP, rFIX, rFIXFc and N9-GP.

	Administration frequency (Days)	Minimum dose (IU/kg per administration)	Maximum dose (IU/kg per administration)
rIX-FPa	Infants and children (< 12 years of age)
	7	35	50
	Adolescents and adults (≥ 12 years of age)
	7	35	50
	10 and 14b	50c	75
	Adults (≥ 18 years)
	21b,d	100e,c	100e,c
rFIXf	Infants (< 6 years of age)
	3, 3.5, 4, 5, 6, 7g	25h	102h
	Children, adolescents and adults (≥ 6 years of age)
	3, 3.5, 4g	13	78
rFIXFci	Infants and children (< 12 years of age)
	7	50j	100
	Adolescents and adults (≥ 12 years of age) – Weekly prophylaxis
	7	17j	88j
	Adolescents and adults (≥ 12 years of age) – Individualized interval prophylaxis
	8 to 21j,k	100	100
N9-GPl	Adolescents and adults (≥ 12 years of age)m
	7n	10n	169n

^aSection 4.2 of EMA-approved SmPC²²; ^b10, 14 and 21-day interval allowed only for well-controlled patients; ^cMancuso 2020²³; ^d21-day interval allowed for patients ≥ 18 years; ^eSection 5.1 of EMA-approved SmPC²²; ^fSection 4.2 of EMA-approved SmPC²⁴; ^gIncrements between minimum and maximum administration schedule are an assumption; ^hMean ± 2SD with mean 63.7 and SD 19.1²⁴; ⁱSection 4.2 of EMA-approved SmPC²⁵; ^jEPAR²⁶; ^kOne-day increments (assumption); ^lSection 4.2 of EMA-approved SmPC¹⁹; ^mN9-GP was not approved for use in patients less than 12 years old during the time of the study; ⁿEPAR¹⁸.