References

  1. HYQVIA [prescribing information]. Westlake Village, CA: Baxalta US Inc.
  2. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% [prescribing information]. Westlake Village, CA: Baxalta US Inc.
  3. Hylenex recombinant (hyaluronidase human injection) [prescribing information]. Halozyme Therapeutics, Inc. September 2012.
  4. Clinical study report. Data on file. Baxalta US Inc.
  5. HYQVIA 100mg/mL solution for infusion for subcutaneous use [summary of product characteristics]. Vienna, Austria. Baxter Innovations GmbH.
  6. Springer Link. The 2015 IUIS Phenotypic Classification for Primary Immunodeficiencies. http://link.springer.com/article/10.1007/s10875-015-0198-5/fulltext.html. Accessed August 1, 2018.
  7. Blaese RM, Bonilla FA, Stiehm ER, Younger ME, eds. Patient & Family Handbook for Primary Immunodeficiency Diseases. 5th ed. Towson, MD: Immune Deficiency Foundation; 2013.
  8. Immune Deficiency Foundation. About primary immunodeficiencies. http://primaryimmune.org/about-primary-immunodeficiencies/. Accessed August 1, 2018.
  9. Rheumatoid Arthritis. Arthritis Foundation website. http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/. Accessed August 1, 2018.
  10. Immune Deficiency Foundation. Primary Immunodeficiency Diseases in America: 2007. The Third National Survey of Patients. Prepared by Abt. SRBI, Inc. May 1, 2009.
  11. Boyle JM, Buckley RH. Population prevalence of diagnosed primary immunodeficiency diseases in the United States. J Clin Immunol. 2007;27(5):497-502.
  12. Modell F, Puente D, Modell V. From genotype to phenotype. Further studies measuring the impact of a Physician Education and Public Awareness Campaign on early diagnosis and management of primary immunodeficiencies. Immunol Res. 2009;44(1-3):132-149.
  13. GAMMAGARD S/D, Immune Globulin Intravenous (Human), IgA less than 1 µg/mL in a 5% Solution [Prescribing Information]. Westlake Village, CA: Baxalta US Inc.
  14. 10 Warning Signs. Jeffrey Modell Foundation Web site. http://info4pi.org/library/educational-materials/10-warning-signs. Accessed August 1, 2018.
  15. de Viries E, Driessen G. Primary immunodeficiencies in children: a diagnostic challenge. Eur J Pediatr. 2011;170:169-177.
  16. Modell V, Gee B, Lewis David B, et al. Global study of primary immunodeficiency diseases (PI)—diagnosis, treatment, and economic impact: an updated report from the Jeffrey Modell Foundation. Immunol Res. 2011;51:61-70.
  17. Is it just an infection? Immune Deficiency Foundation Web site. http://primaryimmune.org/wp-content/uploads/2014/09/InfoCard.pdf. Accessed August 1, 2018.
  18. Blaese RM. LifeHealth Pro. Provider perspective: formulary changes can be dangerous. http://www.lifehealthpro.com/2012/03/08/provider-perspective-formulary-changes-can-be-dang. published March 8, 2012. accessed August 1, 2018.
  19. Immune Deficiency Foundation. Highmark is not my doctor. http://highmarkisnotmydoctor.com/IDF-Information/Highmark Proposed Policy Revisions 1.pdf. 2011. Accessed update: August 1, 2018.
  20. CUVITRU [Immune Globulin Subcutaneous (Human)] 20% [Prescribing Information]. Westlake Village, CA. Baxalta US Inc.
  21. Golding B. IGIV Endpoints. Presented at: Blood Products Advisory Committee, 65th Meeting. 17 Match 2000. Silver Spring, MD.

Please expand for Indication and Important Safety Information.

IMPORTANT SAFETY INFORMATION

What is the most important information that I should know about HYQVIA?

  • HYQVIA can cause blood clots.
  • Call your healthcare professional (HCP) if you have pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s), 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.

HYQVIA is a liquid medicine that is given under the skin (subcutaneously) to treat primary immunodeficiency (PI) in adults.

Important Safety Information
    • HYQVIA can cause blood clots.
    • Call your healthcare professional (HCP) if you have pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s), 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.
    • Your HCP may perform blood tests regularly to check your IgG level.
    • With your consent, your HCP may provide blood samples to Shire plc, to test for antibodies that may form against the hyaluronidase part of HYQVIA.
    • Do not infuse HYQVIA into or around an infected or red swollen area because it can cause infection to spread.
    • Talk to your HCP if you become pregnant. Women who become pregnant during HYQVIA treatment are encouraged to enroll in the HYQVIA Pregnancy Registry by calling 1-866-424-6724.

    Do not take HYQVIA if you:

    • Are allergic to IgG, hyaluronidase, other blood products, or any ingredient in HYQVIA.
    • HYQVIA can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your HCP that you take HYQVIA.

    Before starting HYQVIA, tell your HCP if you:

    • Have or had any kidney, liver, or heart problems or history of blood clots because HYQVIA can make these problems worse.
    • Have IgA deficiency or a history of severe allergic reactions to IgG or other blood products.
    • Are pregnant, trying to become pregnant or are breast feeding.

    HYQVIA can cause serious side effects. If any of the following problems occur after starting HYQVIA, stop the infusion immediately and contact your HCP or call emergency services:

    • Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
    • Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation and swelling of the lining around your brain.
    • Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
    • Pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s). These could be signs of a blood clot.
    • Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.
    • Chest pain or trouble breathing, blue lips or extremities. These could be signs of a serious heart or lung problem.
    • Fever over 100°F. This could be a sign of an infection.

    After HYQVIA infusion a temporary, soft swelling may occur around the infusion site, which may last 1 to 3 days, due to the volume of fluid infused. The following possible side effects may occur at the site of infusion and generally go away within a few hours, and are less likely after the first few infusions.

    • Mild or moderate pain
    • Redness
    • Swelling
    • Itching

    The most common side effects of HYQVIA are:

    • Headache
    • Fatigue
    • Nausea
    • Fever
    • Vomiting

    These are not all the possible side effects. Talk to your HCP about any side effect that bothers you or that does not go away.

    For additional safety information, click for Information For Patients and discuss with your HCP.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.