recombinant human enzyme for enhanced interstitial transport of therapeutics. J of Controlled Release 2006; 114:230-241.
9.
Wasserman RL, Melamed I, Kobrynski L, Strausbaugh SD, Stein MR, Sharkhawy M, Engl W, Leibl H, Sobolevsky L, Gelmont D, Schiff RI, Grossman WJ. Efficacy, Safety, and Pharmacokinetics of a 10% Liquid Immune Globulin Preparation (GAMMAGARD LIQUID, 10%) Administered Subcutaneously in Subjects with Primary Immunodeficiency Disease. J Clin Immunol. 2011 Mar 22. [Epub ahead of print]
10.
Golding B. IGIV Clinical Endpoints. Presented at: Blood Products Advisory Committee, 65th Meeting. 17 March 2000. Silver Spring, MD.
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
HYQVIA is supplied in a dual vial unit of two single use vials containing the labeled amount of functionally active Immune Globulin Infusion 10% (Human) and Recombinant Human Hyaluronidase. The packaging of this product is not made with natural rubber latex.
The following presentations of HYQVIA are available:
Immune Globulin Infusion 10% (Human)
Recombinant Human Hyaluronidase
NDC Number
Volume
Grams Protein
Volume
Units
0944-2510-02
25 mL
2.5
1.25 mL
200
0944-2511-02
50 mL
5.0
2.5 mL
400
0944-2512-02
100 mL
10.0
5.0 mL
800
0944-2513-02
200 mL
20.0
10.0 mL
1600
0944-2514-02
300 mL
30.0
15.0 mL
2400
Storage and Handling
Do not freeze.
Keep the vials in the carton in order to protect from light.
Refrigeration: 2° to 8°C [36° to 46°F] for up to 36 months.
Room Temperature: up to 25°C [77°F] for up to 3 months during the first 24 months from the date of manufacturing (Mfg date) printed on the carton.
•
HYQVIA must be used within 3 months after removal to room temperature but within the expiration date on the carton and vial label.
•
Do not return HYQVIA to the refrigerator after it has been stored at room temperature.
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Information for Patients).
Inform patients to immediately report the following signs and symptoms to their healthcare professional:
•
Acute respiratory distress, wheezing, swelling of the airway or severe hives or itching. [see Warnings and Precautions (5.1)]
•
Instruct patients to immediately report symptoms of thrombosis. These symptoms may include pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body. [see Warnings and Precautions (5.2)]
•
Advise patients that PH20 antibodies can develop. The potential exists for such antibodies to cross-react with endogenous PH20, which is known to be expressed in the adult male reproductive tract. The clinical significance of these antibodies is unknown. [see Warning and Precautions (5.3)]
•
Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting. [see Warnings and Preca
