By Cindi Berry, RN BSN
Primary Immunodeficiency (PI) diseases are comprised of over 250 chronic disorders that all share the same common, characteristic: a defect in the body's normal immune function. In most cases, once a diagnosis has been confirmed, a patient is started on life-long replacement therapy called Immune Globulin (IG) therapy. Patients generally have an option to receive IG therapy by IV infusions (usually once a month), or by subcutaneous administration (SCIG), which is usually administered on a weekly basis, as independent therapy. Up until late 2014, these were the only two options for PI patients when considering IG therapy.
In September 2014, Baxter BioScience released its new product called HYQVIA. This new therapy was approved in the U.S. market for IG administration for adult patients with a diagnosis of Primary Immunodeficiency.
HYQVIA is very different from other IG therapies. Consider it a "hybrid." It is not an IV infusion; instead it allows the volume of an IV infusion to take place in the subcutaneous space. Since large volumes of drug are administered subcutaneously, it is not your average subcutaneous infusion - but is always given subcutaneously. HYQVIA can be administered as a subcutaneous infusion up to 600 ml in one site. It is recommended to only use 1 or 2 sites for administration, using the upper thigh or upper- to mid-abdomen only.
It is also the only drug on the market that is intended for the use of a healthcare professional in a clinical setting or a homecare setting, or a patient or caregiver to learn in the homecare setting. Unlike other IG brands, it is only FDA approved for adult administration, defined as anyone over the age of 16.
HYQVIA is a dual-drug delivery system delivering two components:
- Hyaluronidase
- Immune Globulin 10%
Hyaluronidase: The hyaluronidase packaged for HYQVIA is a specific hyaluronidase which is not interchangeable with other hyaluronidase products. HYQVIA hyaluronidase is a completely humanized product, therefore the product does not contain any animal products like the other hyaluronidase products on the market. This specific hyaluronidase allows the patient to receive this drug without the concern of a reaction or allergy to the medication. Hyaluronidase itself has been around for over 50 years, but it is not widely used in general practice. You may recognize this as a drug used to treat extravasations or to help give hydration to a hospice patient who doesn't have IV access.
Hyaluronidase is a drug that allows a medication or fluid to absorb more quickly under the skin. It is administered in the subcutaneous space, binding with the hyaluronan matrix in the skin. This bond breaks down the hyaluronan, which helps increase the permeability of fluid distribution. The hyaluronidase when used in HYQVIA administration is considered the "spreading factor."
Immune Globulin 10%: The IG product in HYQVIA is a 10% solution, meaning each ml contains 10 mg of drug. For example, a 10 gm vial of HYQVIA will have a volume of 100 ml. The 10% product is a very common product in the IG market, proven to be safe when administered as an IV or SCIG product. When administering the IG in HYQVIA, it is only recommended to administer as a SCIG product.
The HYQVIA products (hyaluronidase and IG) are packaged in separate vials packaged together as one unit. It is designed to "open" both vials at the same time; when you remove a vial top for one drug, the other vial top is removed as well. Since this drug must be administered in a specific manner, proper training is needed when considering the administration of this drug.
In Part 2 of HYQVIA, we'll discuss administration and some important tips to keep in mind to ensure a successful infusion.
For more information on How HYQVIA Works, click on the video below -
