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130 kg
39 mL
79 mL
118 mL
158 mL
140 kg
42 mL
85 mL
127 mL
170 mL
aDerived using a slope of 3.3 kg/dL
Example 1: A patient with a body weight of 80 kg has a measured IgG trough level of 800 mg/dL and the reference trough level is 1000 mg/dL. The trough level difference is 200 mg/dL (1000 mg/dL minus 800 mg/dL). The dose of HYQVIA would be increased by 48 mL (4.8 grams) per dosing interval.
Example 2: A patient with a body weight of 60 kg has a measured IgG trough level of 1000 mg/dL and the reference trough level is 900 mg/dL. The trough level difference is -100 mg/dL (900 mg/dL minus 1000 mg/dL). The dose of HYQVIA would be decreased by 18 mL (1.8 grams) per dosing interval.
HYQVIA can be used to administer a full therapeutic dose in one site up to every four weeks. Adjust the frequency and number of infusion sites taking into consideration volume, total infusion time, and tolerability. Adjust the frequency as needed so that the patient receives the same weekly equivalent dose.
Example: When adjusting a dose of 30 grams administered every 3 weeks; administer 40 grams of HYQVIA every 4 weeks. If a higher trough level is required, relative to intravenous treatment at 3 or 4 week intervals, increase the dose or decrease the dosing interval. eva luate the use ofa second site or infusing at shorter intervals when the volume of HYQVIA is greater than 600 mL.
If a patient misses a dose, administer the missed dose as soon as possible and then resume scheduled treatments as applicable.
If HYQVIA is administered at a different interval than the previous treatment, either intravenously or subcutaneously, then Table 2 should not be used and the dose of HYQVIA should be adjusted, if necessary, based on clinical response.
2.2 AdministrationHYQVIA should be administered by a healthcare professional, caregiver or self-administered by the patient after appropriate training.
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Infusion requires an infusion pump capable of infusing a patient’s therapeutic dose at infusion rates up to 300 mL/hr/site. The pump must have the ability to titrate the flow rate up or down if required to improve tolerability. To ensure maximum flow rates, use a subcutaneous needle set that is 24 gauge and labeled for high flow rates.
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Infuse the two components of HYQVIA sequentially, beginning with the Recombinant Human Hyaluronidase.
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Initiate the infusion of the full dose of the Immune Globulin Infusion 10% (Human) through the same subcutaneous needle set within approximately 10 minutes of the Recombinant Human Hyaluronidase infusion.
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For each full or partial vial of Immune Globulin Infusion 10% (Human) used, administer the entire contents of the Recombinant Human Hyaluronidase vial.
Selection of Infusion Site(s)
The suggested site(s) for the infusion of HYQVIA are the abdomen and thighs. If two sites are used, the two infusion sites should be on opposite sides of the body. Avoid bony prominences, or areas that are scarred, inflamed or infected.
Volume per Site
Administer up to 600 mL per site for patients greater than or equal to 40 kg and up to 300 mL per site for patients less than 40 kg.
A second site can be used at the discretion of the physician and patient based on tolerability and total volume. If a second site is used, administer half of total volume of the Recombinant Human Hyaluronidase of HYQVIA in each site.
Rate of Infusion
Adm
