Frequently Asked Questions - HYQVIA for Primary ... · Frequently Asked Questions ... Clinical study report. Data on File. Baxalta US Inc. 5. ... or Shire Drug Safety at 1-800-999-1785

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Frequently Asked Questions

Please see the Indication and Important Safety Information on pages 14-15, and the FDA-approved patient labeling.

About HYQVIA, the only once-a-month subQ Ig*1

For adults with primary immunodefi ciency

*subQ Ig, also known as subcutaneous immune globulin.

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 fi ght off bacterial and viral infections. The hyaluronidase part of HYQVIA helps more of the immune globulin get absorbed into the body to fi ght infection.

• HYQVIA is indicated for the treatment of Primary Immunodefi ciency (PI) involving the humoral immune system in adults.

• Safety and effi cacy of chronic use of Recombinant Human Hyaluronidase in HYQVIA have not been established in conditions other than PI.

• HYQVIA is infused under the skin (subcutaneous).

• If you and your healthcare professional decide that home self-infusion of HYQVIA is right for you, then be sure you get instructions and training from your healthcare professional before using HYQVIA at home.

Important Safety Information about HYQVIA• HYQVIA can cause blood clots. Call your healthcare professional or

go to your emergency department right away 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. These could be signs of a blood clot.

• Do not use HYQVIA if you are allergic to immune globulin (IgG), hyaluronidase, other blood products, human albumin (in the hyaluronidase solution), or have IgA defi ciency.

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.

© 2017 Shire US Inc., Lexington, MA 02421. All rights reserved. 1-800-828-2088.SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affi liates.HYQVIA is a trademark or registered trademark of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc.All other product brands or trademarks appearing herein are the property of their respective owners.

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References1. HYQVIA [Prescribing Information]. Westlake Village, CA: Baxalta US Inc. 2. HYLENEX recombinant (hyaluronidase human injection) [Prescribing Information].

San Diego, CA: Halozyme Therapeutics, Inc. February 2016. 3. Shire US Inc. Data on fi le. 4. Clinical study report. Data on File. Baxalta US Inc.5. HYQVIA 100 mg/ml solution for infusion for subcutaneous use [summary of product

characteristics]. Vienna, Austria: Baxter Innovations GmbH.

HYQVIA can cause serious side effects. Call your healthcare professional or go to your emergency department right awayif 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.

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 fl uid 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 fi rst 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.


Before starting HYQVIA, tell your healthcare professional 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 defi ciency or a history of severe allergic reactions to IgG or other blood products.

• Are pregnant, trying to become pregnant or are breast feeding.

You are encouraged to report suspected side effects by contacting FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Shire Drug Safety at 1-800-999-1785.

The risk information provided here is not comprehensive. To learn more, talk about HYQVIA with your healthcare provider or pharmacist. Please click here for FDA-approved patient labeling, also available at www.HYQVIA.com.

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NEEDLE INFUSION SITE TIME A MONTH

A second site can be used at the discretion of the physician and patient based on tolerability and total volume1

Q What is HYQVIA?

A HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is a liquid medicine containing Recombinant Human Hyaluronidase and immune globulin (Ig) and is used to treat adults with Primary Immunodefi ciency (PI) diseases.1

HYQVIA is infused under the skin into the fatty subcutaneous, or subQ, tissue. With HYQVIA you have the option to infuse using 1 needle, 1 infusion site, 1 time a month, in the comfort of your own home or in an infusion center. Your doctor may consider the use of a second infusion site based on the total volume to be infused and how well you tolerate your infusions.1

Important Safety Information

HYQVIA can cause serious side effects.

Call your healthcare professional or go to your emergencydepartment 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.








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Q Why am I being prescribed HYQVIA?

A HYQVIA is used to treat adults with PI. Just 1 subQ infusion a month can help your body fi ght off bacterial and viral infections. As demonstrated in the clinical trial, the rate of acute serious bacterial infections was 0.025 per patient per year, and there were 0 days spent in the hospital due to infection.1

Q How does HYQVIA work?

A The Immune Globulin Infusion 10% (Human), or IG, part of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] contains IgG antibodies collected from human plasma donated by healthy people. The antibodies help your body fi ght off bacterial and viral infections. The Recombinant Human Hyaluronidase part of HYQVIA helps more of the infused IG get absorbed into the body to fi ght infection.1

Q What is Recombinant Human Hyaluronidase?

A Recombinant Human Hyaluronidase enhances the fl ow of Ig into the subQ tissue and into the bloodstream.1 Visit www.HYQVIA.com for a short overview video on how HYQVIA works.

Q Is Recombinant Human Hyaluronidase used in the treatment of other things?

A Hyaluronidase was approved in 2005 under the brand name HYLENEX as an adjuvant (an aide in treatment)2:

• In subcutaneous fl uid administration for achieving hydration• To increase the dispersion and absorption of other injected drugs• In subcutaneous urography (method for examining urinary system)

for improving resorption (reabsorption) of radiopaque (unable to be seen through radiation) agents

VS

3

Q What makes HYQVIA different from other subQ Ig treatments?

A Conventional subQ Ig treatments require multiple infusions a month, with multiple needles, to receive your monthly dose.3

HYQVIA is the only once-a-month subQ Ig with Recombinant Human Hyaluronidase and Ig. The hyaluronidase temporarily opens up the subQ space, allowing a larger amount of Ig to reach the subQ tissue and be absorbed into the bloodstream to help fi ght infection.1

It’s the reason you can infuse your monthly dose of HYQVIA using 1 needle, 1 infusion site, 1 time a month. A second site can be used at the discretion of the physician and patient based on tolerability and total volume.1

Q How can HYQVIA be administered?

A You can self-administer HYQVIA after receiving the appropriate training, or a caregiver can administer HYQVIA in your home after receiving appropriate training. Do not use HYQVIA at home until you get instructions and training from your healthcare professional. If you would feel more comfortable, HYQVIA can also be administered by a healthcare professional at your doctor’s offi ce, clinic, or hospital.1


What is the most important information 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 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 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.


4

Q How often do I need to infuse HYQVIA?

A HYQVIA is infused under the skin into the fatty subcutaneous (subQ) tissue, using 1 needle, 1 infusion site, 1 time a month. Your doctor may consider the use of a second infusion site based on the total volume to be infused and how well you tolerate your infusions. Follow your healthcare professional’s instructions regarding the dose, schedule, and how to infuse, so your treatment with HYQVIA can be individualized for you. Your healthcare professional may perform blood tests from time to time after you start HYQVIA to check your serum IgG level.1

Q How long does it take to infuse HYQVIA?

A Infusing 1 time a month doesn’t mean your infusions will take longer. Typically, HYQVIA infusions take less than 3 hours. During the clinical trial, the median duration of an individual HYQVIA infusion was 2 hours and 5 minutes after the initial ramp-up period.1

Q How do I infuse HYQVIA?

A HYQVIA is infused under the skin into the fatty, or subQ, tissue.1

• Infuse the 2 components of HYQVIA sequentially, beginning with the Recombinant Human Hyaluronidase

• Initiate the infusion of the full dose of the Immune Globulin Infusion 10% (Human) through the same subcutaneous needle set within approximately 10 minutes of the Recombinant Human Hyaluronidase infusion

HYQVIA can be self-administered at home after receiving the appropriate training or at your doctor’s offi ce, clinic, or hospital by a healthcare professional. If you and your doctor decide that self-administration is right for you, a healthcare professional will train you on how to infuse HYQVIA at home and make sure you’re comfortable doing it on your own. Do not use HYQVIA at home until you get instructions and training from your healthcare professional.

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Q What does HYQVIA look like?

A The Recombinant Human Hyaluronidase component should be clear and colorless. The IG component should be clear and colorless or pale yellow.1

Q Which vial do I infuse first?

A The 2 vials are infused sequentially through the same subcutaneous needle set. The vial of Recombinant Human Hyaluronidase is infused first by manually hand pushing it. The vial of IG of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is administered within approximately 10 minutes of the Recombinant Human Hyaluronidase using a variable rate infusion pump at a rate recommended by your physician.1

Q What supplies will I need for infusing at home?

A When you infuse at home, you will need the HYQVIA dual vials, ancillary supplies for infusions, 24 gauge subcutaneous needle set labeled for high flow rates, a sharps container, an infusion log, and an infusion pump. The infusion pump should be programmed according to your healthcare professional’s recommendation and the manufacturer’s instructions.1 Visit www.HYQVIA.com for a short administration overview video.

Q What infusion sites should I use?

A The suggested sites for the infusion of HYQVIA are the middle to upper abdomen and thighs. If 2 sites are used, the 2 infusion sites should be on opposite sides of the body. Avoid bony areas, visible blood vessels, or areas that are scarred, inflamed, or infected. HYQVIA should not be infused into or around an infected or red swollen area because it could cause an infection to spread.1



• 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.



6

Q How should I store HYQVIA at home?

A Protect HYQVIA from light by keeping the vials in their original boxes.1

Do not freeze HYQVIA. It can be stored in a refrigerator (36°F to 46°F [2°C to 8°C]) for up to 36 months from the date of manufacture. Check the box and vial label for the date of expiration.1

You can store HYQVIA at room temperature up to 77°F (25°C) for up to 3 months within the first 24 months from the date of manufacturing printed on the carton.

After you remove HYQVIA from the refrigerator and store it at room temperature, do not refrigerate it again.1

Always check the expiration date printed on the box and vial label. You should not use HYQVIA after the expiration date.1

Q Do I use the same pump as I did for other Ig treatments?

A Infusion of HYQVIA requires an infusion pump capable of infusing a patient’s therapeutic dose at infusion rates up to 300 mL/hr/site. The pump must have the ability to titrate the flow rate up or down if required to improve tolerability.1

Q How will my skin feel and look after my HYQVIA infusions?

A After infusing with HYQVIA, a temporary soft swelling, which may last 1-3 days, can occur due to the volume of fluid infused.

Mild-to-moderate pain, itching, swelling, and redness at the infusion site are common local infusion-site reactions, but they usually go away within a few hours. Local infusion-site reactions are less likely to occur after the first few infusions.1

More than 98% of infusion-site reactions were mild to moderate.1

* Volume infused as per the doctor’s guidance based on this patient’s specific clinical condition; it may be different for you.

Q Will HYQVIA affect my skin long term?

A In the clinical trials, there were no observable changes in the skin or subcutaneous tissue in almost 3000 infusions and maximum exposure of over 3 years (2959 infusions and 188 subject-years).1

Pre-Infusion Post-Infusion 24 Hours After Infusion

HYQVIA infused: 500 mL*

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Q Is there a numbing cream or something I can put on my skin to make infusing more comfortable?

A Some patients use EMLA Cream, which contains 2 local anesthetics called lidocaine and prilocaine.4 EMLA Cream works by temporarily numbing the surface of the skin to prevent pain on the skin. However, it’s normal to still feel pressure on touch.

Talk to your healthcare professional if you’d like to have them prescribe a topical anesthetic.

Q What if I have trouble infusing HYQVIA?

A Your healthcare professional will train you on how to self-infuse HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] at home and make sure you’re comfortable doing it on your own. Talk to your healthcare professional immediately if you have trouble infusing HYQVIA. The frequency and number of infusion sites of HYQVIA can be adjusted by your healthcare professional, taking into consideration volume, total infusion time, tolerability, and clinical response.1

Q What will my infusion schedule be like when I start HYQVIA?

A To help you become comfortable with your treatment, you will receive the first dose of HYQVIA and will ramp up gradually.1 Your dose will eventually shift from 1 time a week to 1 time a month (every 3 to 4 weeks).1

If you were previously on another Ig treatment, you will receive your first dose of HYQVIA approximately 1 week after your last infusion.1

Everyone taking HYQVIA will start with the ramp-up period, regardless of whether you are new to SubQ Ig treatment or just new to HYQVIA. Your HYQVIA dose and infusion frequency may need to be adjusted based on your clinical response.1




• Have IgA deficiency or a history of severe allergic reactions to IgG or other blood products.



8

Q Why do I need to ramp up my dose?

A The initial ramp-up period allows you to become familiar with the large volumes required for a subQ infusion of a full 3- or 4-week dose of HYQVIA. You will receive your first dose of HYQVIA and gradually increase the dose and decrease the frequency from once a week to once every 3 to 4 weeks.1

Q How much will I need to infuse after the ramp-up?

A Follow your healthcare professional’s instructions regarding the dose, schedule, and how to infuse, so that your treatment with HYQVIA will be individualized for you. Your healthcare professional may perform blood tests from time to time after you start HYQVIA to check your IgG level.

7-Week Ram

p-UpOnce-a-M

onth HYQVIA Maintenance Interval

1st Infusion

2nd Infusion

3rd Infusion

No InfusionWeek 3

Week

Week

Week

Week

Week

Week

Rate changes of the ramp-up may be adjusted

4th Infusion

3rd Infusion

5th Infusion

6th Infusion

No Infusion

No Infusion

No Infusion

No Infusion

No Infusion

No Infusion

No Infusion

No Infusion

5

6

8

9

10

12

13

14

Week

Week

Week

Week

Week

Week

Week

Week

2

1

4

7

11

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Q I’m on intravenous Ig treatment now. Will my infusion schedule change with HYQVIA?

A For most people who switch from intravenous Ig (IVIG) infusion, HYQVIA will be administered at the same dose and frequency as IVIG (after the ramp-up period). However, if HYQVIA is administered at a different interval than your previous treatment, your doctor may need to adjust the dose of HYQVIA based on your clinical response.1

Q I’m on a different subQ Ig treatment now. Will my infusion schedule change with HYQVIA?

A For most people who switch from a different subQ Ig, HYQVIA will be administered at 300 to 600 mg/kg at 3- to 4-week intervals, after initial ramp-up. However, your healthcare professional may need to adjust the dose and frequency of HYQVIA based on your clinical response.1

Q Does HYQVIA offer steady-state Ig levels?

A The peak-to-trough variation is more similar to conventional subcutaneous administration, even with once-a-month administration (every 3 to 4 weeks). Also, HYQVIA does not have the high peak Ig level experienced with intravenous administration.1

Q Does HYQVIA cost more than other Ig treatments?

A Your costs for HYQVIA will depend on many factors, including your specialty pharmacy provider and your insurance plan. To help support patients with commercial insurance, Shire has created the MyIgCoPayCard. More information about the copay assistance program and eligibility is available at MyIgSource.com.

Q Will my insurance cover HYQVIA?

A HYQVIA is covered similarly to other subcutaneous Ig treatments for PI, but coverage may vary by plan. If you need help navigating your insurance plan or understanding your coverage, talk to your infusion provider, call 1-855-250-5111, or visit MyIgSource.com to learn more.

Q What if I need help paying for HYQVIA?

A If you are an eligible patient with PI, you may be able to save up to $5,000* on your out-of-pocket deductible, co-payment, or co-insurance costs within a 12-month period for all Shire Immune globulin (Ig) products. Call 1-855-250-5111 or visit MyIgSource.com to learn more.


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Q What if I have a medical question or experience side effects?

A If you have a medical question regarding the use of HYQVIA, or if you experience side effects, please contact your healthcare provider.

Q Where can I turn if I have general questions or need support?

A MyIgSource is a free support program for people living with or caring for someone with PI. With MyIgSource, you’ll receive insurance and fi nancial support, emotional support from Patient Advocates, HYQVIA administration support from Nurse Advocates, plus educational tools and resources to help you manage PI. Reach out for support today. Call 1-855-250-5111 or visit MyIgSource.com to enroll in the program.

What supportis available?

* Not valid for prescriptions reimbursed, in whole or in part, by Medicaid, Medicare, Medigap, VA, DoD, TRICARE or any other federal or state healthcare programs, including state pharmaceutical assistance programs, and where prohibited by the health insurance provider or by law. Commercial insurance must cover medication costs for prescribed Shire Immune Globulin (Ig) treatment for primary immunodefi ciency (PI) and allow for copay or co-insurance assistance. Shire reserves the right to change or discontinue this program at any time without notice. Please see full treatment-specifi c Terms and Conditions on product web sites for additional program restrictions and eligibility requirements or call MyIgSource for more information (1-855-250-5111).

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Please see the Indication and Important Safety Information onpages 14-15, and the FDA-approved patient labeling.

What else should I know about HYQV A?I

Q When was HYQVIA approved in the US?

A On September 12, 2014, the FDA approved HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of adult patients with PI.

What is HYQVIA?






12

Q How long has HYQVIA been approved in Europe?

A It was approved for use in the EU in May 2013.5

Q Why is HYQVIA only approved for adults?

A Safety has not been established in children.1

Q Has Recombinant Human Hyaluronidase been used chronically in other conditions?

A Safety and efficacy of chronic use of Recombinant Human Hyaluronidase in HYQVIA have not been established in conditions other than PI.1

Q Can pregnant women take HYQVIA?

A Studies in pregnant women have not been conducted with HYQVIA. Talk to your healthcare professional if you become pregnant.1 Women who become pregnant during HYQVIA treatment are encouraged to enroll in the HYQVIA Pregnancy Registry by calling 1-866-424-6724. Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of pregnancy.

Q Can taking HYQVIA affect fertility?

A Long-term studies on fertility have not been conducted with the Immune Globulin Infusion 10% (Human) component of HYQVIA. Studies do not indicate direct or indirect harmful effects of Recombinant Human Hyaluronidase with respect to reproductive potential at the doses used for facilitating administration of IG 10%. It is not known whether HYQVIA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.1

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 on human fertility. In theory, these antibodies could react with your body’s own hyaluronidase. Hyaluronidase is present in the male reproductive tract. So far, these antibodies have not been associated with increased or new side-effects.1


Who should not take HYQVIA?

Do not take HYQVIA if you1:

• Are allergic to IgG, hyaluronidase, other blood products, or human albumin (in the hyaluronidase solution)

• Have IgA deficiency with antibodies to IgA

13










What is HYQVIA?











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15

Indication and Important Safety InformationWhat 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.

• HYQVIA is indicated for the treatment of Primary Immunodeficiency (PI) involving the humoral immune system in adults.

• Safety and efficacy of chronic use of Recombinant Human Hyaluronidase in HYQVIA have not been established in conditions other than PI.




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 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 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.

Who should not take HYQVIA?

Do not take HYQVIA if you:• Are allergic to IgG, hyaluronidase, other blood products, or human

albumin (in the hyaluronidase solution).

• Have IgA deficiency with antibodies to IgA.

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What is HYQVIA?











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Documents

Frequently Asked Questions - HYQVIA for Primary ... · Frequently Asked Questions ... Clinical study report. Data on File. Baxalta US Inc. 5. ... or Shire Drug Safety at 1-800-999-1785