Shire HyQvia User manual

This guide is intended for use only as a supplement to in-person
training from your healthcare professional.
Please see the Indication and Important Safety Information
on pages 24-25, and the FDA-approved patient labeling.
Please scroll for additional Important Safety Information, and click for
Information for Patients, and discuss with your healthcare provider.
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.
• 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.
• 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
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.
How to Infuse HYQVIA
With a Syringe Driver Pump
This guide is intended for use only as a supplement to
in-person training from your healthcare professional.
Your Step-by-Step Guide

PREPARE THE HY PREPARE THE IG INFUSE HYQVIA FINISH UPGET READY
1 2 3 4 5
• Inspect vials
• Gather supplies
• Wash hands
• Draw HY into syringe(s)
• Attach to needle set
• Fill needle set
• Draw IG into syringe(s) • Insert and secure needle(s)
• Infuse HY manually
(first)
• Infuse IG with pump
(second)
• Remove needle(s)
• Log infusion
=HY + IG
HY 1st
HY=Recombinant Human Hyaluronidase.
IG=Immune Globulin Infusion 10% (Human).
IG 2nd
THE 5 STAGES TO INFUSE HYQVIA
Infuse HYQVIA only after you have been trained by your healthcare
professional, have the Information for Patients, and are comfortable
that you can perform all the steps on your own.
If you have any questions about
your HYQVIA infusion, contact a
Nurse Advocate at 1-855-250-5111.
Infusion Overview
This guide is designed to help you infuse HYQVIA [Immune Globulin Infusion 10% (Human)
with Recombinant Human Hyaluronidase] Solution using a syringe driver pump, but is not
meant as stand-alone instructions. Please refer to your Information for Patients for a
complete list of steps.
Important Safety Information (continued)
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.
Please scroll for additional Important Safety Information, and click for Information for Patients,
including Warning about Blood Clots, and discuss with your healthcare provider.

Sharps container and trash canSyringe driver pump, power supply,
and manual
Sterile tip caps—1 per syringe
Needle or needle-less transfer device*—
1 per HY vial
60 mL syringe(s) Vented spike(s)Subcutaneous needle set with a clear
dressing—1 per infusion site
Infusion log
HYQVIA vial(s) 20 mL or 30 mL syringe(s)
*Use an 18-22 gauge sterile needle to draw from the 1.25 mL vial of HY.
Alcohol swabs, antibacterial cleaner, soap,
tape, and bandages. Gloves can be used if
recommended by your healthcare professional
WHAT YOU’LL NEED
Below are the supplies you will need to infuse HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]
Solution. The supplies you receive from your pharmacy may look different.

Infuse HY manually (first)
Infuse IG using syringe driver pump (second)
Transfer HY into syringe(s) (first)
Transfer IG into syringe(s) (second)
IG (second)
HY (rst)
60 mL syringe
Needle or needle-less
transfer device*
20 mL or 30 mL
syringe
Vented spike
Prepare Infuse†
HY (rst)
10 20 30 40 50 60
10 20 30 40 50 60
10 20 30 40 50 60
10 20 30 40 50 60
10 20 30 40 50 60
10
20
30
40
50
60
5
10 15 20 25 30
5
10
15
20
25
30
Syringe driver pump
Subcutaneous
needle set
IG
IG
IG
IG
20 mL or 30 mL syringe
60 mL syringe
IG (second)
ADMINISTRATION AT A GLANCE
*Use an 18-22 gauge sterile needle to draw from the 1.25 mL vial of HY.
†The number of syringes required is dependent on your prescribed dose. This diagram is an example.

Get Ready
STAGE1
• Inspect vials
• Gather supplies
• Wash hands
Please scroll for additional Important Safety
Information, and click for Information for Patients,
including Warning about Blood Clots, and discuss
with your healthcare provider.
Important Safety Information (continued)
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.

C
Clean your work area with an antibacterial cleaner. If you
have an infusion mat or antibacterial towel, lay it out.
PLASTIC BANDAGE
PLASTIC BANDAGE
B
Gather your supplies.
D E
Open your supplies. Keep them in their packages and place
near the clean work area.
A
You’re ready for Stage 2!
1 GET READY
2 PREPARE HY 3 PREPARE IG 4 INFUSE HYQVIA 5 FINISH UP
• Take HYQVIA out of the box and allow to reach room
temperature. This may take up to 60 minutes. Do not apply
heat or place in the microwave.
• Do not return HYQVIA back to the refrigerator if you take
it out to room temperature.*
• Do not shake HYQVIA.
• Do not use HYQVIA after the expiration date.
• Do not use HYQVIA if the vials are missing a protective
cap, or are broken.
• Check the vials for color—the HY should be clear
and colorless and the IG should be clear and colorless
or pale yellow. Do not use HYQVIA if the liquid is cloudy
or contains particles.
Wash your hands with antibacterial soap. If instructed by
your healthcare professional, put gloves on when your
hands are dry.
*HYQVIA can be stored in the refrigerator (36ºF-46ºF [2ºC-8ºC]) for up to 36 months, or at room temperature (up to 77ºF [25ºC]) for up to 3 months
during the first 24 months from the date of manufacturing. Do not freeze HYQVIA. To protect from light, store HYQVIA in its original box.

Prepare the HY
STAGE 2
• Draw HY into syringe(s)
• Attach to needle set
• Fill needle set
Please scroll for additional Important Safety
Information, and click for Information for Patients,
including Warning about Blood Clots, and discuss
with your healthcare provider.
Important Safety Information (continued)
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.
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.

Remove the cap from the subcutaneous needle set. Attach
the needle set to the HY syringe. Slowly push the plunger
to fill the needle set. Stop when the HY reaches the needle
hub. Lay the syringe down on the clean work surface.
Clamp the needle set tubing. Label the syringe HY.
B C
Remove a 20 mL or 30 mL sterile syringe from the package.
Attach a needle/needle-less transfer device* to the syringe.
Pull back on the plunger to fill the syringe with air (the
amount of air should equal the amount of HY in the vial).
Remove the cap from the needle/needle-less transfer device.
D E
Turn the vial upside down. Pull back on the plunger to
withdraw the full amount of HY. Remove the needle/
needle-less transfer device from the HY vial. Re-cap the
needle/needle-less transfer device.†Remove it from the
HY syringe and discard it in the sharps container. Repeat
steps C and D for each HY vial, using the same syringe,
if possible.
F
When the full dose of HY has been transferred into the
syringe, hold the syringe upright and tap it to remove air
bubbles. Then slowly push the plunger until the HY reaches
the tip of the barrel.
Syringe for HY
AA
*Use an 18-22 gauge sterile needle to draw from the 1.25 mL vial of HY.
†Re-cap the needle/needle-less transfer device with a one-handed scooping technique as demonstrated by your healthcare professional.
90o
90o
Take the cap off of the dual-vial unit(s). Without shaking
the vials, clean each vial of HY by wiping the stopper with
an alcohol swab and let it dry. Prepare a label for the HY
syringe and set it aside.
Insert the needle/needle-less transfer device into the center
of the HY vial stopper at a 90-degree angle. Push the air
into the vial.
You’re ready for Stage 3!
2 PREPARE HY
3 PREPARE IG 4 INFUSE HYQVIA 5 FINISH UP

Prepare the IG
STAGE 3
• Draw IG into syringe(s)
Please scroll for additional Important Safety
Information, and click for Information for Patients,
including Warning about Blood Clots, and discuss
with your healthcare provider.
Important Safety Information (continued)
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 deficiency or a history of severe allergic
reactions to IgG or other blood products.
• Are pregnant, trying to become pregnant or are breast
feeding.

BA
Without shaking the vials, clean each vial of IG you will use
by wiping the stopper with an alcohol swab and let it dry.
C
D
Insert the vented spike straight down into the center of the
IG vial stopper.
E
Open a larger (60 mL) sterile syringe. Attach the larger
sterile syringe to a vented spike. Remove the cap from the
spike and discard it in the trash.
Turn the vial upside down and pull on the plunger to
withdraw the desired dose of IG. When the syringe is full or
you have reached your dose, turn the vial right side up and
remove the syringe from the spike. Leave the spike in the
vial. (You’ll leave the spike in the vial each time.)
Tap the syringe to remove bubbles. Slowly push the plunger
until medication is at the tip of the barrel. Cover the syringe
with the sterile tip cap.
If the full dose of IG hasn’t been drawn up and there is
still fluid in the vial, or if the full dose requires multiple vials
of IG, repeat steps A through E.
Syringe for IG
90o
STAGE 3 CONTINUED
3 PREPARE IG
4 INFUSE HYQVIA 5 FINISH UP

Infuse HYQVIA
STAGE 4
• Insert and secure needle(s)
• Infuse HY manually (first)
• Infuse IG with pump
(second)
Please scroll for additional Important Safety
Information, and click for Information for Patients,
and discuss with your healthcare provider.
Important Safety Information
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.

A
Choose an infusion site (or sites) in either the middle or
upper abdomen or thigh. Avoid bony areas, visible blood
vessels, scars, and any areas of inflammation, irritation, or
infection. Rotate your sites by choosing opposite sides of
the body for each infusion.
BC
D E
Check for proper needle placement. Open the clamp on the
needle set and gently pull back on the syringe plunger. Make
sure there is no blood in the tubing.Secure the needle set
in place by applying a clear dressing over the site. If blood
is seen in the tubing, remove and discard the subcutaneous
needle and repeat steps 2A-2F and 4A-4C with a new needle
and infusion site.
F
Administer the HY at a rate of 1 to 2 mL per minute per
infusion site. (For example, infusing 15 mL of HY should
take about 7.5 to 15 minutes for a 30 gram HYQVIA dose.)
Divide content equally between sites, if more than one site
is used. REMEMBER: HY before IG.
When all the HY has been infused, detach the syringe from
the subcutaneous needle set. Do not remove the needle(s)
from your infusion site(s).
90o
Wash your hands with antibacterial soap. Wipe each
infusion site with a sterile alcohol wipe (beginning at the
center of the site and moving outward in a circular motion)
and let dry (at least 30 seconds).
Remove the subcutaneous needle cover. Firmly grasp and
pinch at least 1 inch of skin. Insert the needle with a rapid
motion straight into the skin at a 90-degree angle. Secure
the needle in place with sterile tape. Repeat this step for
additional infusion sites.
STAGE 4 CONTINUED
4 INFUSE HYQVIA
5 FINISH UP

Infuse HYQVIA (continued)
STAGE 4
• Insert and secure needle(s)
• Infuse HY manually (first)
• Infuse IG with pump
(second)
Please scroll for additional Important Safety
Information, and click for Information for Patients,
including Warning about Blood Clots, and discuss
with your healthcare provider.
Important Safety Information (continued)
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.

You’re almost done!
GHI
Remove the sterile tip cap from the larger (60 mL)
IG syringe and attach it to the same needle set.
Insert the IG syringe into the pump and start the pump at
the rates prescribed by your healthcare professional.
Start the IG infusion right after the HY infusion is complete
(approximately within 10 minutes).
When the IG syringe is empty, remove the syringe from
the pump and detach it from the needle set. Repeat
steps G through I for each additional syringe of IG.
4 INFUSE HYQVIA 5 FINISH UP

Finish Up
STAGE 5
• Remove needle(s)
• Log infusion
Please scroll for additional Important Safety
Information, and click for Information for Patients,
including Warning about Blood Clots, and discuss
with your healthcare provider.
Important Safety Information (continued)
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.
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.

A
Loosen the clear dressing and pull the subcutaneous
needle wings straight up and out. Place a bandage over
the site. Dispose of the needle set in the sharps container.
Check with your specialty pharmacy to learn how to
dispose of your sharps container.
B C
Follow up with your healthcare professional as directed.Record the infusion details as instructed by your healthcare
professional and as outlined in your infusion log.
Your infusion with HYQVIA
[Immune Globulin Infusion 10% (Human) with
Recombinant Human Hyaluronidase] Solution is complete!
If you have any questions about infusing HYQVIA, contact a Nurse Advocate
at 1-855-250-5111 or your healthcare provider, or visit www.HYQVIA.com
Congratulations!
5 FINISH UP