subcutaneous administration. Summary of infusions of intravenous administration compared

to HYQVIA administration is presented in Table 9.

Table 9 Summary of Infusions  Parameter
 Intravenous
 HYQVIA
 
Median monthly number of infusion

sites
 1.34

(1.2 to 1.7)
 1.09

(1.0 to 3.5)
 
Mean volume per site (mL)
 339

(75 to 800)
 292

(91 to 648)
 
Dose per site (g)
 33.9

(7.5 to 80.0)
 29.2

(9.1 to 64.8)
 
Median duration of individual

infusions (hr)
 2.33

(0.92 to 6.33)
 2.08

(0.83 to 4.68)
 
Monthly median infusion time

(hr/month)
 3.2
 2.64
 
Median maximum infusion rate

(mL/hr)
 246

(60 to 668)
 300

(10 to 300)
 
Percent (%) of infusion completed

Without change in rate, interruption

and discontinuation
 95.9
 97.7
 
Sixteen of 83 subjects (19.3%) were infused every 3 weeks and 67 (80.7%) were infused

every 4 weeks. Seventy-eight of 83 (94%) of subjects attained the same 3- or 4-week dosing

as their previous IV treatment. One decreased from 4 to 3 weeks, one from 4 to 2 weeks and

one from 3 to 2 weeks. The primary reason for decreasing the interval was discomfort due to

swelling.

In a separate study eva luating subcutaneous treatment with Immune Globulin Infusion 10%

(Human), a median of 21.43 sites were required each month with a median monthly infusion

time of 5.35 hours.

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