(BPT) - Cheryl Jackson spent much of her childhood and early adult life plagued by chronic infections. Sinus infections, bronchitis, urinary tract infections and gastrointestinal issues were commonplace. She endured countless doctor visits, medical tests and procedures searching for answers to no avail. Feeling sick was Jackson’s normal.

After 43 years of uphill battles against chronic sickness, Jackson visited an immunologist and was ultimately diagnosed with Common Variable Immune Deficiency, or CVID – a type of Primary Immunodeficiency (PI). PI is a group of nearly 300 rare, chronic disorders in which part of the body’s immune system is missing or functions improperly.^{[1] [2]}

Jackson’s lengthy journey to a PI diagnosis is not unique. According to a national survey conducted by the Immune Deficiency Foundation, on average, it takes 12.4 years from symptom onset to a PI diagnosis.^[3] Additionally, an estimated 70 to 90 percent of PI cases worldwide are undiagnosed.^[4] Though with a diagnosis comes relief, it can be overwhelming and bittersweet as the reality of PI sets in.

One treatment option for PI requires an infusion of immunoglobulin (or lg) to replace antibodies in a patient’s immune system, but the frequency of treatment and resulting potential side effects can be daunting.^[5] Although Jackson finally had an answer to a lifetime of health questions, she struggled to cope with her diagnosis and adjust to her new weekly subcutaneous lgG treatment regimen. She was sticking herself with a dozen needles each month.

“For once in my life, I felt good. I didn’t feel sick anymore,” said Jackson. “But it seemed that my life revolved around my weekly infusion. I was starting to feel like a prisoner to my treatment schedule. I wanted to take charge of my disease and feel in control of my own life, but I was feeling hopeless and defeated.”

Managing PI is a daily and lifelong challenge, and survey results taken from PI patients and caregivers show that many desire treatment options with less frequent dosing and fewer needles.^[6] About six months into her demanding weekly treatment regimen, Jackson learned about an alternative subcutaneous lgG treatment option for adults with PI called HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] and she spoke to her doctor.^[7]

Today, Jackson uses HYQVIA to deliver a full subcutaneous dose of treatment via one needle at one infusion site, once monthly.^[7] This allows Jackson to experience more time between treatments compared to her weekly subcutaneous lgG treatment.

“With less time managing and recovering from infusions, I have more time to be a mom, a wife and a business owner. HYQVIA gave me my life back,” said Jackson. “PI will always be a part of who I am, but it no longer defines me.”

As with any lgG, HYQVIA does have important safety considerations to discuss with your healthcare professional before starting treatment. Tell your healthcare professional if you have or had any kidney, liver, or heart problems, a history of blood clots, because HYQVIA can make these problems worse. Also tell your healthcare professional if you have IgA deficiency or a history of severe allergic reactions to IgG or other blood products, or are pregnant, trying to become pregnant or are breast feeding. For additional information, please see the Indication and Usage and Detailed Important Risk Information provided at the end of this article.

To learn more about PI or about HYQVIA, visit www.HYQVIA.com.

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]

Indication and Usage

HYQVIA is an immune globulin with a recombinant human hyaluronidase indicated for the treatment of Primary Immunodeficiency (PI) in adults. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Limitation of Use:

Safety and efficacy of chronic use of recombinant human hyaluronidase in HYQVIA have not been established in conditions other than PI.

Detailed Important Risk Information

HYQVIA can cause serious side effects. Call your healthcare professional or go to your emergency department right away if you get:

• 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 swelling in 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 lung problem.

These are not all the possible side effects with HYQVIA. Talk to your healthcare professional about any side effects that bother you or that don’t go away.

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

• HYQVIA can cause blood clots.
• Call your healthcare professional 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 healthcare professional may perform blood tests regularly to check your IgG level.
• With your consent, your healthcare professional may provide blood samples to Baxalta US Inc. 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 healthcare professional if you become pregnant. Women who become pregnant during HYQVIA treatment are encouraged to enroll in the HYQVIA Pregnancy Registry by calling Medical Information at 1-866-424-6724.

What are the possible or reasonably likely side effects of HYQVIA?

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. Mild or moderate pain, redness, swelling, or itching may occur at the site of infusion and generally go away in a few hours. Local reactions are less likely after the first few infusions. The most common side effects of HYQVIA are headache, fatigue, nausea, fever, and vomiting. Antibodies to the hyaluronidase component of HYQVIA were formed in some patients taking HYQVIA. It is not known if there is any long term effect. In theory, these antibodies could react with your body’s own PH20. PH20 is present in the male reproductive tract. So far, these antibodies have not been associated with increased or new side effects.

What is HYQVIA?

HYQVIA is a liquid medicine containing immune globulin and recombinant human hyaluronidase. HYQVIA contains IgG antibodies, collected from human plasma donated by healthy people. The antibodies help your body to fight off bacterial and viral infections. The hyaluronidase part of HYQVIA helps more of the immune globulin get absorbed into the body to fight infection.

Before starting HYQVIA, tell your healthcare professional if you have or had any kidney, liver, or heart problems, a history of blood clots, because HYQVIA can make these problems worse. Also tell your doctor if you have IgA deficiency or a history of severe allergic reactions to immune globulin (IgG) or other blood products, or are pregnant, trying to become pregnant or are breast feeding.

How should I take HYQVIA?

HYQVIA is infused under the skin (subcutaneously) up to once every 4 weeks. You can get HYQVIA at your healthcare professional’s office, clinic, or hospital. You can use HYQVIA at home. You and your healthcare professional will decide if home self-infusion is right for you. Do not use HYQVIA at home until you get instructions and training from your healthcare professional.

Who should not take HYQVIA?

Do not take HYQVIA if you are allergic to IgG, hyaluronidase, or other blood products, or have IgA deficiency with antibodies to IgA.

Please find Full Prescribing Information and Patient Product Information, including Boxed Warning at Baxalta.com.

To report suspected side effects, contact Baxalta US Inc. at 1-800-999-1785 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

[1] Blaese RM, Bonilla FA, Stiehm ER, Younger ME, eds. Patient & Family Handbook for Primary Immunodeficiency Diseases. 5th ed. Towson, MD: Immune Deficiency Foundation; 2013.

[2] Bousfiha A, Jeddane I, Al-Herz W, et al. The 2015 IUIS phenotypic classification for primary immunodeficiencies. J Clin Immunol. 2015; 35(8): 727-738.

[3] Immune Deficiency Foundation, “Primary Immuondeficiency Diseases in America: 2007 – The Third National Survey of Patients.” https://primaryimmune.org/wp-content/uploads/2011/04/Primary-Immunodeficiency-Diseases-in-America-2007The-Third-National-Survey-of-Patients.pdf.

[4] World PI Week, “World Primary immunodeficiency Week: Let’s talk about PI!” http://www.worldpiweek.org/sites/default/files/basic_page_documents/World%20PI%20Week%20Official%20PR%202011.pdf. Accessed November 2, 2015

[5] Immune Deficiency Foundation, “Immunoglobulin Therapy & Other Medical Therapies for Antibody Deficiencies:” http://primaryimmune.org/treatment-information/immunoglobulin-therapy/. Accessed November 23, 2015.

[6] International Patient Organisation for Primary Immunodeficiencies (IPOPI), “PID Patient Needs & Outlooks Survey.” 2011

[7] HYQVIA [Prescribing Information]. Westlake Village, CA: Baxalta US Inc.

USBS/MG89/16-0001 April 2016