Development and reproductive toxicology studies have been conducted with recombinant human hyaluronidase in mice and rabbits [see Animal Toxicology and/or Pharmacology (13.2)]. No adverse effects on pregnancy were associated with anti-rHuPH20 antibodies. In these studies, maternal antibodies to recombinant human hyaluronidase were transferred to offspring in utero. The effects of antibodies to the recombinant human hyaluronidase component of HYQVIA on the human embryo or on human fetal development are unknown. HYQVIA should be given to a pregnant woman only if clearly indicated.

Women who become pregnant during HYQVIA treatment are encouraged to enroll in the HYQVIA Pregnancy Registry by calling 1-866-424-6724.

8.3 Nursing Mothers In animal studies, maternal antibodies binding to recombinant human hyaluronidase were transferred to offspring during lactation. The effects of antibodies that bind to recombinant human hyaluronidase of HYQVIA transferred during human lactation are unknown. HYQVIA should be given to a nursing woman only if clearly indicated.

8.4 Pediatric Use Safety has not been established in children.

8.5 Geriatric Use HYQVIA was eva luated in 7 subjects over age 65 in the clinical trial. The available data are limited to draw safety conclusions.

11 DESCRIPTION

HYQVIA is a dual vial unit with one vial of Immune Globulin Infusion 10% (Human) and one vial of Recombinant Human Hyaluronidase.

The Immune Globulin Infusion 10% (Human) of HYQVIA is a ready-for-use sterile, liquid preparation of highly purified and concentrated IgG antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in the primary component. Pre-kallikrein activator activity is not detectable. The Immune Globulin Infusion 10% (Human) of HYQVIA contains 100 mg/mL protein. At least 98% of the protein is IgG, average immunoglobulin A (IgA) concentration is 37μg/mL, and immunoglobulin M (IgM) is present in trace amounts. The Immune Globulin Infusion 10% (Human) of HYQVIA contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent. There is no added sugar, sodium, or preservatives. The pH is 4.6 to 5.1. The osmolality is 240 to 300 mOsmol/kg.

The Immune Globulin Infusion 10% (Human) of HYQVIA is manufactured from large pools of human plasma. IgG preparations are purified from plasma pools using a modified Cohn‑Oncley cold ethanol fractionation process, as well as cation and anion exchange chromatography.

Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of the Immune Globulin Infusion 10% (Human) of HYQVIA is collected only at FDA approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordan