Safety and efficacy of chronic use of recombinant human hyaluronidase in HYQVIA have not been established in conditions other than PI.
2 DOSAGE AND ADMINISTRATION

For subcutaneous use only.

2.1 DosageInitiation of Treatment with HYQVIA

•
For patients previously on another IgG treatment, administer the first dose approximately one week after the last infusion of their previous treatment. 
•
Increase the dose and frequency from a 1-week dose to a 3- or 4-week dose (see ramp-up schedule in Table 1). 
•
Initiating treatment at a full monthly dose was not eva luated in the clinical trial. 
Table 1 Initial Treatment Interval/Dosage Ramp-Up Schedule  Week
 Infusion Number
 Dose Interval
 Example for 30 grams per 4 weeks
 
1
 1st infusion
 1-week-dose
 7.5 grams
 
2
 2nd infusion
 2-week-dose
 15 grams
 
3
 No infusion
 
4
 3rd infusion
 3-week-dose
 22.5 grams
 
5
 No infusion
 
6
 No infusion
 
7
 4th infusion (if required)
 4-week-dose
 30 grams
 
For patients switching from Immune Globulin Intravenous (Human) [IGIV] treatment:

Administer HYQVIA at the same dose and frequency as the previous intravenous treatment, after the initial dose ramp-up.

For patients naïve to IgG treatment or switching from Immune Globulin Subcutaneous (Human) [IGSC]:

Administer HYQVIA at 300 to 600 mg/kg at 3 to 4 week intervals, after initial ramp-up.
Individualization of Dose

If HYQVIA is administered at the same dose and frequency, the serum IgG levels from HYQVIA should be comparable to serum IgG levels from intravenous treatment.
For dose adjustment:
•
Calculate the difference between the patient's serum IgG trough level during HYQVIA treatment and the IgG trough level during the previous intravenous treatment.
•
Find this difference (in mg/dL) in the columns of Table 2 and the corresponding amount (in mL) by which to increase or decrease the dose based on the patient's body weight and desired change in IgG trough level.
Table 2 Individualization in Volume Administered per Dosing Interval for Intended Change in IgG Trough Levela   Difference in IgG Trough Levels
Body Weight 100 mg/dL 200 mg/dL 300 mg/dL 400 mg/dL
10 kg
 3 mL
 6 mL
 9 mL
 12 mL
 
20 kg
 6 mL
 12 mL
 18 mL
 24 mL
 
30 kg
 9 mL
 18 mL
 27 mL
 36 mL
 
40 kg
 12 mL
 24 mL
 36 mL
 48 mL
 
50 kg
 15 mL
 30 mL
 45 mL
 61 mL
 
60 kg
 18 mL
 36 mL
 55 mL
 73 mL
 
70 kg
 21 mL
 42 mL
 64 mL
 85 mL
 
80 kg
 24 mL
 48 mL
 73 mL
 97 mL
 
90 kg
 27 mL
 55 mL
 82 mL
 109 mL
 
100 kg
 30 mL
 61 mL
 91 mL
 121 mL
 
110 kg
 33 mL
 67 mL
 100 mL
 133 mL
 
120 kg
 36 mL
 73 mL
 109 mL
 145 mL
&