The numbers speak for themselves.

Protection from infection, backed by data.

When it comes to success in managing PI, less is more.

HyQvia^®[Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] was studied in a clinical trial of 83 people living with PI, with the main goal of measuring how many acute serious bacterial infections (ASBIs) they experienced over the course of 1 year.

Not familiar with ASBIs? They’re short-term but serious infections caused by bacteria that require immediate medical care. The FDA standard for efficacy—that is, if an immunoglobulin works—is less than 1 ASBI per year. In the clinical trial, people taking HyQvia experienced significantly less than that.

The study showed:

0.025
serious infections per year

This is equivalent to 25 acute serious bacterial infections (ASBIs) out of 1,000 patients over the course of the 12-month study period.

ASBIs included 2 episodes of pneumonia. Both episodes were treated as outpatients with oral antibiotics. An additional episode of pneumonia requiring hospitalization occurred during the ramp-up.

0 days
in the hospital per year

There was a mean of 0.037 days spent in the hospital due to infection during the study.

<4 days
off work or school per year

On average, patients taking HyQvia missed 3.31 days of work or school due to an infection.

POTENTIAL REACTIONS

There are 2 types of side effects. Which is which?

There are general (systemic) side effects, which happen throughout the body and not just in one part; and there are local side effects, which occur at the infusion site.

What does “systemic” mean?

Good question. Systemic is when a side effect happens throughout the body, not just in one part. Examples of systemic side effects are a headache or feeling more tired than usual.

Systemic side effects compared to IVIG

52%

52% lower rate of systemic side effects with HyQvia in clinical trials

The rate of general side effects per HyQvia infusion was 0.20, or 222 out of 1,129, versus 0.42, or 154 out of 365 per IVIG infusion.

Most common systemic side effects*

Headache

Headaches have been reported during or after the infusion with HyQvia.

Percentage of side effects per infusion

IVIG (10%)

(365 infusions)

12%

IVIG

HyQvia

(1,129 infusions)

HyQvia

Fatigue

People have reported feeling more tired than usual after infusing with HyQvia and may need to rest.

Percentage of side effects per infusion

IVIG (10%)

(365 infusions)

IVIG

HyQvia

(1,129 infusions)

HyQvia

Nausea

Some people have reported feeling stomach discomfort or the sensation of wanting to vomit during or after the infusion.

Percentage of side effects per infusion

IVIG (10%)

(365 infusions)

IVIG

HyQvia

(1,129 infusions)

HyQvia

Fever

People have reported experiencing a fever, or a temporary increase in body temperature, during or after the infusion.

Percentage of side effects per infusion

IVIG (10%)

(365 infusions)

IVIG

HyQvia

(1,129 infusions)

HyQvia

Vomiting

Some people have vomited (thrown up) during or after the infusion.

Percentage of side effects per infusion

IVIG (10%)

(365 infusions)

IVIG

HyQvia

(1,129 infusions)

HyQvia

Antibody formation

Some people developed antibodies against Hy, but the antibodies were not capable of neutralizing Hy.

This happened in 15 out of 83 people who infused HyQvia in the clinical trial.

*Excluding infections.

Please talk to your doctor about any side effects that you may experience from your infusion

HyQvia was studied in a clinical trial of 83 adults with PI with the main goal of measuring how many acute serious bacterial infections (ASBIs) they experienced over the course of 1 year
Percentage/Rate = total number of events divided by total number of infusions (% = Rate x 100)
IVIG was administered for a median of 91 days and HyQvia for a median of 366 days per patient during the efficacy period
These adverse events occurred within 72 hours of infusion or were considered to be caused by the infusion

Now, let’s switch to local, or infusion site, side effects.

These are reactions like redness, pain, itching, or swelling, to name a few.

~99%
mild to moderate

In the clinical study, ~99% of side effects at the infusion site, or local side effects, were considered mild to moderate.

These side effects generally go away in a few hours, and—great news—they are less likely to happen after the first few infusions.

Since HyQvia is given subcutaneously, these can be more common.

70.5%
were mild (n=165)

Mild side effects cause temporary discomfort that goes away on its own or with little medical intervention.

28%
were moderate (n=66)

Moderate side effects cause a slight decline in function that goes away on its own, or with little medical intervention, and has no further consequences.

1.3% were severe (n=3)

Severe side effects result in impairment of function and can lead to temporary inability to resume a normal lifestyle, as they require prolonged medical intervention and/or result in further consequences.^†

^†Three local severe reactions occurred during the clinical study: local infusion site pain, infusion site swelling, and infusion site swelling that extended from the abdominal infusion site to the genitalia.

Some people had irritation where the medicine is given:
– IVIG (10%) (365 infusions): 1% per infusion
– HyQvia (1,129 infusions): 21% per infusion

Most common local side effects reported in more than 1% of infusions

(from a total of 1,129 studied HyQvia infusions)

Infusion-site reaction	Percentage (per infusion) and number of local side effects
Discomfort/pain	11% (122)
Swelling	3% (35)
Redness	3% (32)
Itching	2% (22)

Local side effects may occur at the site of infusion and generally go away in a few hours.
These side effects are less likely to occur after the first few infusions.

More things to be aware of:

HyQvia can cause blood clots. Call your doctor 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, or numbness or weakness on one side of the body.

Tell your doctor if you are pregnant, trying to become pregnant, or are breastfeeding. Also let your doctor know if you have or had any kidney, liver, or heart problems because HyQvia can make these problems worse.

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.

Do not infuse HyQvia into or around an infected or red swollen area because it can cause infection to spread.

HyQvia can cause serious side effects. If any of the following problems occur after starting HyQvia, stop the infusion immediately and contact your doctor or call 911:

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.
These are not the only possible side effects. Talk to your doctor about any side effects that you may experience.

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Hear what others' HyQvia infusion experiences are like first-hand.

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IMPORTANT SAFETY INFORMATION and serious warnings regarding blood clots

What is HYQVIA?

HYQVIA is a liquid medicine that is given under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people 2 years and older.

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.
Your HCP may perform blood tests regularly to check your IgG level.
Do not infuse HYQVIA into or around an infected or red swollen area because it can cause infection to spread.

Who should not take HYQVIA?

Do not take HYQVIA if you:

Are allergic to IgG, hyaluronidase, other blood products, or any ingredient in HYQVIA.

What should I avoid while taking 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.

What should I tell my HCP before I start using or while using 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. It is not known whether HYQVIA can harm the unborn baby or breastfed infant.

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

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

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 hyaluronidase (PH20). PH20 is present in the male reproductive tract. So far, these antibodies have not been associated with increased or new side-effects.

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.

What is HYQVIA?

HYQVIA is a liquid medicine that is given under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people 2 years and older.

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.
Your HCP may perform blood tests regularly to check your IgG level.
Do not infuse HYQVIA into or around an infected or red swollen area because it can cause infection to spread.

Who should not take HYQVIA?

Do not take HYQVIA if you:

Are allergic to IgG, hyaluronidase, other blood products, or any ingredient in HYQVIA.

What should I avoid while taking 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.

What should I tell my HCP before I start using or while using 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. It is not known whether HYQVIA can harm the unborn baby or breastfed infant.

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

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.

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.

©2023 Takeda Pharmaceuticals U.S.A., Inc., 300 Shire Way, Lexington, MA 02421. 1-877-TAKEDA-7 (1-877-825-3327). All rights reserved. TAKEDA^®, the TAKEDA Logo^®, and the TAKEDA Patient Support Logo^® are registered trademarks of Takeda Pharmaceutical Company Limited. HYQVIA^® and MYIGSOURCE™ are trademarks or registered trademarks of Baxalta Incorporated. US-HYQ-1025v2.0 11/23

The numbers speak for themselves.

Protection from infection, backed by data.

There are 2 types of side effects. Which is which?

Percentage of side effects per infusion

Percentage of side effects per infusion

Percentage of side effects per infusion

Percentage of side effects per infusion

Percentage of side effects per infusion

This happened in 15 out of 83 people who infused HyQvia in the clinical trial.

Study information