What is HyQvia®?

HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is a liquid medicine that is given under the skin (subcutaneously) to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

Please see additional Important Safety Information throughout this video, including Warning about Blood Clots, click accompanying link to see Information for Patients or visit www.hyqvia.com/information-for-patients

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.

Marc:

Everything changed for me in 2019. I was 33 years old. I was a, I was a new dad. I was working full time. Now the pressure’s on, like I have to deliver as a father, I have to I have to provide. I have to go to work. And then when I come home, I have to be there for my daughter.

And one day, I noticed my feet were tingling. I honestly was thinking my shoes were too small.

So, I tried to shrug it off, but then the moment came where I was giving my daughter a…

…bath, and I was like, oh, this is weird, I actually—I had like just started realizing that my hands were a little tingly.

Things went downhill quickly from there. One morning I was driving to work, and I could barely control the car.

I called my wife and told her I’m going to the E.R. By the time I got to the E.R., I wanted to just, collapse on the floor. It was like my body finally gave up on me.

They admitted me to the hospital, and I was there for two weeks. My healthcare team wasn’t exactly sure what was wrong with me. They tried several treatments that alleviated my symptoms enough to allow me to be released from the hospital.

I was home for a few weeks before my symptoms started to worsen again. I started using a walker to get around the house, and my parents moved in with us. Losing that side of independence during that time was really tough.

Because I think we’re all trying to wrap our head around it. Like, is this, is this life now? Have I lost who I was?

Eventually I went downhill again and ended up back in the E.R. This started a pattern where I would end up in the hospital, my symptoms would improve, and I would go home only to have to go back to the hospital because my symptoms would worsen again.

It wasn’t until nine months later that my neurologist finally diagnosed me with chronic inflammatory demyelinating polyneuropathy, or CIDP.

She told me that this was a chronic disease that may require consistent treatment.

I felt hopeless. I couldn’t be the, the husband, the father or the person that I wanted to be. I was under the impression that I would—I was not going to ever get better.

Luckily, I have an amazing, supportive wife and care partner. She stepped up, got an amazing new job, and reworked our approach to diet and nutrition.

This time, I was taking an intravenous immunoglobulin or IVIG treatments at home with a nurse. I was being infused with a high volume of IG for my symptoms, and it was taking a toll on my veins.

One of my veins even collapsed from the volume being infused so frequently. I really wanted to try something different that could be easier on my veins.

Between all the IVIG treatments, I continued to have venous access issues.

After I was placed on a stable dose of IVIG for a few months…

…my neurologist suggested we look at HyQvia, a subcutaneous treatment approved for adults with CIDP.

It was given subcutaneously, which was good for me because my veins were struggling from years of IV treatments.

I liked that I had options to infuse at a center or at home. But doing it at home worked better for my lifestyle.

Intervals could be two, three, even four weeks after the ramp-up period.

We also discussed the potential serious reactions that HyQvia can cause, like blood clots, serious allergic reactions, decreased kidney function, dark colored urine, severe headaches, and trouble breathing.

She warned me to expect some swelling, redness, itching and pain at the injection site.

I felt comfortable with all that, so we decided to proceed.

I had a nurse come to my house to help me infuse for the first few infusions before I went through training with a nurse on how to infuse HyQvia at home by myself.

I had to go through a ramp up period so my body could get used to the new process. A nurse came to my house to administer my infusions during the ramp up period which took place over several weeks.

My doctor and I worked out the plan and now I infuse at home every three weeks. I infuse in the evenings; I get everything prepped, I have dinner with family, put the kids to bed, and then infuse on the couch.

After my vein issues with IVIG, I like that I can still infuse a large volume of liquid IG.

After my infusion, I do experience swelling around my abdomen that takes a couple of days to slowly go away.

I do my infusions every three weeks. I make the most of my time between infusions by spending it with my wife and family.

Now that my CIDP symptoms have been stabilized with IVIG and transitioning to HyQvia maintenance therapy along with my doctor’s support, I felt confident in the decision to return to work full time, which was a big deal for us.

We’ve come a long way as a family from that point, when I almost gave up hope. Now, I’m able to be the father and the husband that I've always wanted to be.

Of course, this is my experience, and everyone reacts different to therapy. Work with your doctor to see if HyQvia would be a good option for you.

VO:

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
• Itching
• Redness
• Abdominal pain
• Back pain
• Pain in extremity

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 (PH2O). 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 Important Safety Information, including Warning about Blood Clots, click accompanying link to see Information for Patients or visit www.hyqvia.com/information-for-patients

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.

Nurse: What is HyQvia?

HyQvia is a liquid medicine that is given under the skin (subcutaneously) to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

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.

Nurse: Please see Important Safety Information including Warning about Blood Clots, at the end of this video, and review the Information for Patients located in the starter kit.

The Information for Patients is also available at HyQvia.com. Please discuss any questions with your healthcare provider.

Nurse: Hi, and welcome to HyQvia, a subQ IG + HY maintenance treatment for adult patients with chronic inflammatory demyelinating polyneuropathy, CIDP, that can be infused every 2, 3, or 4 weeks, as prescribed by your doctor.

HyQvia offers you the option for your treatment to be given at an infusion center or self-administered at home, after appropriate training.

My name is Rachel, and I’m a nurse. We’re going to walk through everything you’ll need to get started with HyQvia.

Ready?

This kit is full of useful information. It’s all here to guide you and help you get organized. So, it’s important to know how to use it all. You’ve got a welcome letter, a Getting Started Guide, Doctor Discussion Guide, a Wellness Journal, an infusion mat, and accompanying Information for patients.

If you have not yet received a kit, don’t worry, you can ask your HCP or order one yourself from HyQvia.com.

Nurse: First, let’s start with the Getting Started Guide, which is a great resource for basic information, like what HyQvia is, what supplies you’ll be using, what to do during your infusion, and more. This way, you can get familiar with HyQvia and the supplies you either have now or will receive soon from the specialty pharmacy.

Your CIDP

Nurse: Next, we have the Doctor Discussion Guide. This can help to be a conversation starter with your doctor about your CIDP maintenance treatment goals.

Nurse: You’ll also see an Infusion Mat. This gives you a space to lay out and organize all your supplies to prepare for your infusion.

Nurse: We’ve also included a Wellness Journal, which is a great tool for you to organize and track your treatments, any reactions, and jot down any notes, questions for your doctor, details about your infusion experience, stuff like that. It also includes an infusion log to fill in each time you infuse.

Nurse: All of this is meant to educate, yes—but also to guide and support you. You can always visit HyQvia.com for info, but your doctor is always your best resource.

If you’re interested in co-pay support, Takeda Patient Support Co-Pay Assistance Program can cover up to 100% of your out-of-pocket co-pay costs, if you're eligible.*

To learn more, visit TakedaPatientSupport.com or call our support specialists at 1-866-861-1750.

I hope you’ve found this helpful and are feeling confident. My advice to you is: absorb any info you can, ask your doctor questions, and be confident.

Nurse: IMPORTANT SAFETY INFORMATION (continued)

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.

Nurse: 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 arm the unborn baby or breastfed infant.

Nurse: 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.

Nurse: 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

Nurse: The most common side effects of HyQvia are:

• Headache
• Fatigue
• Nausea
• Fever
• Itching
• Redness
• Abdominal pain
• Back pain
• Pain in extremity

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.

Nurse: Please see Important Safety Information throughout this video, and accompanying Information for Patients, including Warning about Blood Clots, or visit www.hyqvia.com/information-for-patients.

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.

Nurse: What is HyQvia?

HyQvia is a liquid medicine that is given under the skin (subcutaneously) to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

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.

Nurse: Please see Important Safety Information throughout this video, and accompanying Information for Patients, including Warning about Blood Clots, or visit www.hyqvia.com/information-for-patients.

Nurse: Hi! I’m Rachel, and I’m a nurse. I’m here with Steve to help him learn how to self-infuse HyQvia, which just means after he’s trained correctly, he’ll be able to infuse at home by himself.

So, Steve, just so you know, if you wanted to have a family member or a friend help because of any dexterity limitations, like it’s hard or awkward to reach somewhere, all the steps I’m going to walk you through stay the same.

Patient: OK.

Nurse: Are you ready?

Patient: I think so. I’m a little nervous.

Nurse: That’s normal. I’m going to walk you through everything. And with proper training, you will be able to do this. So, I see you’ve got some supplies here. Since you’re infusing at home, the specialty pharmacy likes to make sure you have everything you need ahead of time.

Each person’s supplies may look different from the ones shown here.

Is this all they sent you?

Patient: Yeah, I think that’s everything. It’s…a lot.

Nurse: I know. It IS a lot, and I’m sure it was a bit overwhelming looking at all of this for the first time, but that’s why I’m here. It’ll all make sense.

Remember to always reach out to your doctor if you have questions or concerns.

Nurse: Let’s start with the obvious. Here are your HyQvia vials. The number of vials each person will have will depend on their dose. This guy’s your pump with power supply and its tubing. You’ve got an IV pole and syringe. This is your pooling bag and tubing. There’s your sharps container. This is what you put things in, like your needles, to dispose of when you’re done. We’ll get to that at the end of the infusion. And you’ve got an infusion mat and a Wellness Journal here. These help you organize your supplies and then track your treatments, any reactions, and has space to write down any notes or questions. We’ll get to this at the end of your infusion, too.

Nurse: OK, these are your gloves, obviously. You’ll wear these if your doctor recommends that you should. There’s a bag of saline solution, needle, or needle-less transfer device, one per Hy vial, needle set, tape, bandages, and alcohol swabs to clean the tops of your vials and your body where you infuse.

Nurse: I just said a ton, and I can see the look on your face. What are you thinking?

Patient: Well, that’s…so much, but I think I caught most of it.

Nurse: I understand. I know it’s a lot. You’ll start to remember everything. So, now that we know you’ve got everything, ready to get started?

Patient: I’m a little nervous, but let’s do it.

Nurse: Great. To help remember how to infuse HyQvia, we use Hy5, like the Hy in both HyQvia and hyaluronidase, this little vial.

Hy5 is the 5 steps to infuse HyQvia.

Get ready, prepare hyaluronidase or HY, prepare the immune globulin or IG, infuse HyQvia, and finish up.

Nurse: Oh, good. Your vials are at room temperature, just like they should be before you infuse HyQvia. Vials can be stored in the refrigerator or at room temperature, just remember that once you take the vials out of the refrigerator, you shouldn’t put them back in.

Nurse: They do last longer if they’re refrigerated. But, if they’ve been refrigerated, the HyQvia may take up to 60 minutes when taken out of the boxes to get to room temperature. Just something to remember to help you plan when you’ll infuse.

Nurse: Always let it come to room temperature naturally. So, don’t ever shake it, apply heat or place it in the microwave.

Patient: Got it.

Nurse: Before we dig in, let’s take a look at your vials.

Nurse: You always want to make sure they’re the correct dose, what your doctor prescribed for you.

Nurse: Check the expiration date and make sure they’re not expired. Don’t ever use them if they’re past the expiration date or if the purple cap is missing or broken. You want to handle them normally. So, no shaking. Look at the color. The Hy should be clear and colorless. And the IG should be clear and colorless, or it may be pale yellow. That’s OK. Neither should be cloudy or have any floating particles.

Patient: OK, these look OK, right?

Nurse: Yep! They look good to me. We just need to finish gathering our supplies, and clean our work area. Then we’ll program the infusion pump if needed, wash our hands, and we’re ready to move on.

Nurse: OK, let’s wash our hands and we’re ready for Hy2 of Hy5: Preparing the Hy.

Patient: OK, sounds good. The sink’s right over here.

Nurse: Now when we say “Hy”, we’re talking about the recombinant human hyaluronidase.

Nurse: Hyaluronidase is always first, so it’s infused before the IG, and Hy allows more IG to be absorbed into your body. It does this because it’s infused subcutaneously, meaning just under your skin, which allows a larger amount of IG to be absorbed into the bloodstream in one to three sites.

Nurse: So, remove the purple protective cap and ensure the blue vial caps are removed. If not, manually remove the blue caps. To prepare the Hy, without shaking the vials, first wipe them with an alcohol swab and give it 30 seconds to dry.

Nurse: Next, remove a sterile syringe from its package and attach it to the needle or needle-less transfer device.

Nurse: Next, remove the cap on the needle or needle-less transfer device and pull back on the plunger to fill the syringe with air. The amount of air should equal the amount of Hy in the vial.

Nurse: Then, insert the needle or needle-less transfer device into the center of the Hy vial stopper and push the air into the vial.

Nurse: Now, turn the vial upside down and pull back on the plunger to withdraw all of the Hy into the syringe.

Patient: Like this?

Nurse: Yes, you’ve got it.

Nurse: Now, remove the needle or needle-less transfer device from the Hy vial.

Place the cap back on the needle or needle-less transfer device.

If you have multiple Hy vials, you would repeat the previous steps for each Hy vial, using the same syringe, if possible.

Nurse: Great! So, we’ve got all the Hy we need into the syringe.

First thing we’ll want to do is hold the syringe upright and tap it to remove air bubbles. Slowly push the plunger until the Hy reaches the tip of the barrel.

Hy can also be infused manually, but we’re going to use a pump.

Clean the upper port of the pump tubing with an alcohol swab and allow to dry for approximately 30 seconds.

Remove the cap from the syringe and discard it.

Attach the syringe to the upper port of the pump administration tubing.

Then remove the cap from the subcutaneous needle set and attach it to the opposite end of the pump administration tubing.

Close the clamp on the pump administration tubing closest to the needle set.

Nurse: Hold the syringe straight up and remove the air from the pump administration tubing between the upper port and the spike. Keep the syringe upright.

Push the plunger to fill the pump tubing between the upper port and the spike. Close the clamp above the upper port. Open the clamp on the lower port.

Slowly push the plunger of the syringe to remove the air. The syringe size may vary due to a larger volume. Fill the rest of the pump administration tubing up to the needle wings with hyaluronidase. Like this. See?

Patient: Yep. Got it.

Nurse: Lay the syringe and pump administration tubing down on the clean work surface. Close the clamp or clamps on the needle set tubing.

Guess what? You’re already to Hy3.

Patient: OK!

Nurse: If using the push method to deliver Hy, transfer into the syringe or syringes, preferably using a needle-less transfer device.

Attach the syringe filled with hyaluronidase to the needle set.

Push the plunger of the syringe to remove the air and fill the needle set up to the wings with hyaluronidase.

Nurse: Hy3 is preparing the IG. First, clean each IG vial by wiping the stopper with an alcohol swab and give it 30 seconds to dry, making sure not to shake the vials as you wipe.

Nurse: OK, now tighten the connection between the pooling bag and the gravity fill set tubing.

Now take the pooling bag and pinch the white clamps to close off all the tubes that are coming out of the pooling bag. Open the package of the sterile cap and make sure to keep this little cap nearby. Here, it’s in sterile packaging. You would then want to keep it on a sterile and clean surface. OK, do you see where the pooling bag connects to the tubes? That’s the port.

Patient: Yes, this little white piece?

Nurse: Yep, right there. You want to make sure that’s tight because sometimes it can become loose in the packaging. You may want to have your caregiver or friend help you with this.

Patient: Got it. It’s tight.

Nurse: Now, remove the cap from the spike on the gravity fill set tubing—we sometimes call these tubes legs.

Nurse: Insert the spike straight down into the center of the IG vial stopper.

The tip of the spike should be all the way inside the vial.

Patient: OK, it is now.

Nurse: Great! Now turn the IG vial upside down, unclamp on the gravity fill set tubing and then open the vent on the spike. You may need to gently flick the gravity fill set tubing to float air bubbles to the top of the vial.

Patient: Like this?

Nurse: Exactly!

Nurse: Keep holding the IG vial upside down and transfer the IG into the pooling bag. Gently wiggle the spike back and forth to make sure you transfer all the IG from the vial.

Once all of the IG has been transferred, close the clamp and the vent on the gravity fill set tubing. Remove the spike from the IG vial.

If you have multiple IG vials to achieve the desired dose, you would repeat the previous steps for each IG vial, using the same pooling bag.

When you finish with the last vial, hold the gravity fill set tubing upright with the spike in the air.

Nurse: Open the clamp and tap the gravity fill set tubing to get the last drops of IG into the pooling bag.

The tip of the spike should be all the way inside the vial.

Patient: OK, it is now.

Nurse: Great! Now turn the IG vial upside down, unclamp on the gravity fill set tubing and then open the vent on the spike. You may need to gently flick the gravity fill set tubing to float air bubbles to the top of the vial.

Patient: Like this?

Nurse: Exactly!

Nurse: Keep holding the IG vial upside down and transfer the IG into the pooling bag. Gently wiggle the spike back and forth to make sure you transfer all the IG from the vial.

Once all of the IG has been transferred, close the clamp and the vent on the gravity fill set tubing. Remove the spike from the IG vial.

If you have multiple IG vials to achieve the desired dose, you would repeat the previous steps for each IG vial, using the same pooling bag.

When you finish with the last vial, hold the gravity fill set tubing upright with the spike in the air.

Nurse: Open the clamp and tap the gravity fill set tubing to get the last drops of IG into the pooling bag.

Patient: Whoa, OK, I was with you up right until when you talked about when I’m finished with the last vial.

Nurse: That was a lot. No worries. OK, once the last vial is finished, you want to hold the pooling bag tubing upright. Tap the pooling bag tubing to get the last drops of IG into the pooling bag.

Patient: OK, got it.

Nurse: Good. Hold the pooling bag so the tubes are coming out of the top and then detach the pooling bag tubes, or legs from the pooling bag.

Patient: Is this right?

Nurse: Just like that! Next, detach the gravity fill set tubing from the pooling bag. Gently push air out of the pooling bag through the fill port. Cap the end of the fill port and close the clamp on the fill port.

Nurse: Remove the tab from the administration port of the pooling bag.

If you wanted to, you could also spike the IG vial directly using the vented pump administration tubing.

Nurse: Now, remove the protective cap from the spike on the pump administration tubing.

Nurse: Insert the spike into the administration port of the pooling bag. Hang the pooling bag onto an IV pole. Then, insert the pump administration tubing into the pump.

Nurse: If using syringes, first attach a sterile syringe to a vented spike. Then insert the vented spike into the center of the IG vials.

Next, turn the vial upside down and pull back on the plunger to pull the IG into the syringe. Repeat these steps if you are using multiple vials, to achieve the desired dose.

If using a sterile needle, attach a sterile syringe to the sterile needle and pull back the plunger of the syringe to fill with air, which should equal the amount of the liquid you will be taking from the vial.

Then insert the needle into the center of the vial and inject air in. Finally, pull back on the plunger to withdraw the desired volume.

Nurse: OK, so now we’ve prepared both the Hy and IG. Ready to infuse your HyQvia?

Patient: I am.

Nurse: Yes, that’s the attitude I’m talkin’ about.

Nurse: On to Hy4: Infusing HyQvia. The Hy and the IG will be infused the same way.

Nurse: We’ll use the infusion pump to infuse the Hy first, then the IG. Always in that order. Remember, Hy before IG.

Patient: Yes, I’ll remember.

Nurse: OK, we’ll start by choosing an infusion site. Any ideas?

Patient: Well…I’m…not exactly sure. I was kind of confused about that. Where should I?

Nurse: Totally fine. And I can help with that. You’ve got a couple of options. You can infuse in either thigh or either side of your middle to upper abdomen. And the area or place you want to infuse in can change over time after you’ve infused a few times and realized one area is more comfortable for you than another.

Patient: I think I’d like my upper abdomen.

Nurse: That will work! Remember to rotate your sites for each infusion, too. Also, most patients will need to infuse at two sites to help spread out the volume across the abdomen. This potentially allows a faster infusion time than if just one site is used. If a second site is used, you want to select sites on the opposite sides of your body and infuse half the total volume of Hy in each site. If using three sites, the sites should be 4 inches or 10 centimeters apart. And be sure to rotate sites by choosing opposite sides of the body between your infusions.

Nurse: OK, use a new alcohol swab to clean your abdomen, beginning at the center of each infusion site and moving outward in a circular motion. Be sure to let it dry completely—about 30 seconds.

Good.

Nurse: Now, I want to make sure I mention a few things about the needles. You want to avoid any bony areas, blood vessels, scars, and any areas of inflammation, irritation, or infection.

Your goal is to insert the needle just under the skin, into the fatty layer. Now, if the needle is too short, you may experience a burning sensation or leakage, but, on the other hand, if it’s too long, you’ll reach the muscle layer, and you don’t want to do that because it could be painful. If you feel that you need a needle of a different length, speak with your doctor and reach out to your specialty pharmacy, because that’s where you can get the new needle or needles.

Nurse: Remove the needle cap and firmly grasp and pinch at least one inch of skin between two fingers. Insert the 24-gauge subcutaneous needle with a rapid motion straight into your skin at a 90-degree angle. Alright, you just gotta do it!

Nurse: Yes! Just like that. You did it. You OK?

Patient: Surprisingly, yes.

Nurse: You did great. Now, secure the needle in place with the sterile tape.

Close the clamp above the lower port of the pump administration tubing.

Clean the lower port with an alcohol swab and allow to dry for at least 30 seconds.

Nurse: Great. Ready to start?

Patient: Well, I’ve come this far. Let’s do it.

Nurse: OK, here we go!

Attach a 5-milliliter syringe to the lower port. Open the needle set tubing and gently pull back on the syringe plunger. Look for blood return in the tubing. If there’s no blood, remove the syringe keeping the needle in place. Secure the needle set by applying a sterile, clear dressing over the site. If more than one infusion site is needed, you'll follow these steps to check for proper needle placement in all sites at the same time.

Nurse: If blood is seen in the tubing, remove and discard the needle and start at a new site with a new subcutaneous needle.

Check to make sure the clamp above the lower port is open.

Then, insert the pump administration tubing into the pump.

Nurse: To infuse the Hy, first turn on the pump. Your specialty pharmacy will have already pre-programmed it for you—in this case, sixty to one hundred twenty milliliters per hour per infusion site and increase it as you can tolerate it, whatever you feel comfortable with.

When the syringe is empty, the pump will say that there is an occlusion alarm. Right here.

Patient: I see that.

Nurse: OK, so now pause the pump and remove the empty syringe. Next, open the clamp above the upper port and restart the pump. The IG will then help to push the Hy into the infusion sites. Now, if more than 1 site is used, divide the IG equally between sites.

Patient: Ah, OK.

Nurse: Now, make sure to start the IG infusion within 10 minutes of completing the infusion of Hy.

Nurse: I’m sure at some point you’ve heard or read about ramping up, right?

Patient: Yes, my doctor talked to me about it. She said I’d start at a lower volume and increase over several infusions.

Nurse: That’s exactly right. It’s a way to help your body adjust to your new medicine.

Nurse: So when the IG infusion is complete, flush any remaining IG from the pump administration tubing with saline to ensure that you receive your full dose. To do that, first remove the pump tubing spike from the pooling bag administration port. Then, pull the tab off the saline bag administration port and insert the pump tubing spike into the administration port. Finally, restart the pump to flush the remaining IG from the pump tubing.

Nurse: So the whole infusion time of Hy followed by IG typically takes about 2 hours if the dose of HyQvia is being infused monthly, but as far as setting up your infusion goes, that’s a wrap! You did it.

Patient: You mean that’s it?

Nurse: For the infusion, yes.

Nurse: We’re at Hy5: Finish up.

Nurse: You’re going to loosen all the edges of the dressing and pull the needle wings straight up and out. Place a bandage over the infusion site. Then, dispose of the needle set in the sharps container.

Nurse: I do have to say that patients typically experience swelling at the infusion site. People call it a “pancake” because your skin swells in the shape of a pancake. However, it is common and nothing to panic about. This means the Hy is doing what it’s supposed to do. It will go down, usually in one to three days, and it occurs because of the volume of fluid infused. Contact your doctor though if an infusion site reaction increases in severity or lasts more than a few days.

Patient: That sounds a little weird, but I’m definitely glad you told me about it, so I know what to expect.

Nurse: I know it does, but I want you to know and not be surprised when it happens. It’s common.

Nurse: Other than that, you may experience infusion site reactions, local reactions, like mild or moderate pain, redness, swelling, and itching at the infusion site. The most common side effects are headache, fatigue, nausea, fever, itching, redness, abdominal pain, back pain, and pain in extremity. Keep in mind these are not all the possible side effects of HyQvia. Talk to your doctor about any side effects that bother you or don’t go away.

Nurse: I’m sure you’ve heard or read about side effects, but just making sure we go over them too. You’ll want to contact your doctor if any reaction concerns you or doesn’t go away.

Nurse: Now, you’ll want to record your infusion details in your Wellness Journal. You’ll want to write down the date, time, dose, and infusion site or sites to assist in rotating sites and any reactions after each infusion. A trick for your Wellness Journal, most patients just pull the labels right off their IG vials, which have the product lot number, vial size, and expiration date, and put them in their journal.

There’s even space to write down questions and thoughts, like how long a certain step took or just notes about remembering what to do. It’s a good place to write down any questions you may have for your healthcare team as well.

Nurse: You did it! You just learned how to use Hy5 as a way to help remember how to infuse HyQvia. Seriously, you did great. I hope you’re proud of yourself.

Patient: I am. I was so nervous, but I think I can do this. Thank you so much.

Nurse: Of course! I know you’ve got this. You can have more training, until you and your healthcare team feel comfortable with self-infusing HyQvia. You also have resources to rely on, should you need them. And, if you have questions about anything, talk to your doctor. You can also visit HyQvia.com. Remember to use the patient log in your wellness journal to keep track of your infusions.

Patient: Yeah, I will.

Nurse: Now, I’ll help you gather this stuff up so it’s ready to go next time, and then you take it easy the rest of the day.

Patient: Thanks!

Please stay tuned to the remainder of this video for additional Important Safety Information.

Nurse: What is HyQvia?

HyQvia is a liquid medicine that is given under the skin (subcutaneously) to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

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.

Nurse: Who should not take HyQvia?

Do not take HyQvia if you:

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

Nurse: 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.

Nurse: 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.

Nurse: 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

Nurse: The most common side effects of HyQvia are:

• Headache
• Fatigue
• Nausea
• Fever
• Itching
• Redness
• Abdominal pain
• Back pain
• Pain in extremity

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.

Nurse: 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.

Nurse: Please see Important Safety Information throughout this video, and accompanying Information for Patients, including Warning about Blood Clots, or visit www.hyqvia.com/information-for-patients.

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.

Nurse: What is HyQvia?

HyQvia is a liquid medicine that is given under the skin (subcutaneously) to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

IMPORTANT SAFETY INFORMATION

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

• HyQvia can cause blood clots.

Nurse:

• 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.

Nurse: Please see Important Safety Information throughout this video, and accompanying Information for Patients, including Warning about Blood Clots, or visit www.hyqvia.com/information-for-patients.

Nurse: Hi, and welcome! My name is Rachel, and I’m a nurse. I’m here to tell you about HyQvia, a treatment that can be used as a maintenance therapy for adults with CIDP. We’re going to briefly go over what HyQvia is and how it works.

Nurse: HyQvia is the unique combination of IG with hyaluronidase

HyQvia is a CIDP maintenance therapy that can meet you where you are

HyQvia can be administered across multiple sites of care, including hospitals, infusion centers, offices, or at home, whether it’s self-infused after appropriate training, or with the support of a healthcare professional or care partner.

Nurse: But first, what is CIDP?

Nurse: CIDP stands for chronic inflammatory demyelinating polyneuropathy, an autoimmune disorder that may get worse over time.

People who have CIDP are believed to have an autoimmune disease in which the body's immune system targets the nerves, leading to muscle weakness and numbness, usually in the arms and legs.

Nurse: So, what makes HyQvia different?

Nurse: Hyaluronidase, or Hy, which can be found in your body naturally.

Hy is the first part of your infusion, and it allows a larger amount of IG to be absorbed into your subcutaneous tissue – a layer of tissue under your skin – and then into your bloodstream. This is how you’re able to infuse every 2, 3, or 4 weeks as prescribed by your doctor.

Nurse: Don’t use HyQvia if you’ve had a severe reaction to IG, hyaluronidase, other blood products, or any ingredient in HyQvia.

Nurse: When it comes to getting your CIDP maintenance treatment, HyQvia may provide you with choices for your infusion experience.

HyQvia offers you the option for your treatment to be given at an infusion center or at home with the help of a nurse, or even by yourself after appropriate training.

Nurse: And along the way, you can change where you get your infusions. For example, you could start at the infusion center and then have an infusion nurse come to your house and help with your infusions. Or, after you or your caregiver have received instruction and appropriate training from your HCP, you can do it without a nurse. Always talk with your doctor about which option might work best for you.

Nurse: Whichever location you choose, HyQvia is infused subcutaneously, or the subQ way, meaning it’s given under your skin rather than into a vein.

So, no IV.

Nurse: HyQvia, a liquid medicine, is the only combination of IG + Hy that has up to monthly infusions, every 2, 3, or 4 weeks.

So HyQvia could allow you to go up to 28 days between infusions, as prescribed by your doctor, based on administration every 2 to 4 weeks.

Which may give you time for the things you enjoy.

V/O Nurse: Now, in a study, the average infusion time to deliver the monthly HyQvia dose is about 2 hours, and there is also travel time to and from the infusion center to consider.

Nurse: HyQvia can make live viral vaccines not work as well for you. Talk to your doctor before you get any vaccines while you are taking HyQvia.

Nurse: 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.

Nurse: There’s a free trial program called HelloHYQVIA that can help you and your doctor determine if HyQvia is right for you.

With HelloHYQVIA, eligible patients will receive training with a nurse, access to a step-by-step video that walks you through the infusion process, and access to multiple resources. Talk to your doctor and visit HyQvia.com to learn more.

Nurse: If you’re interested in co-pay support, Takeda Patient Support Co-Pay Assistance Program can cover up to 100% of your out-of-pocket co-pay costs, if you're eligible.*

To learn more, visit TakedaPatientSupport.com or call our support specialists at 1-866-861-1750.

Nurse: All of us behind HyQvia want to see you succeed.

Ask your doctor about HyQvia, and you can always visit HyQvia.com to learn more.

Nurse: There’s even a doctor discussion guide on the website to help you navigate the conversation with your doctor. You’ll see me again in the infusion video if you and your doctor decide HyQvia is right for you.

Nurse: Hope to see you there.

Nurse: What is HyQvia?

HyQvia is a liquid medicine that is given under the skin (subcutaneously) to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

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.

Nurse: Who should not take HyQvia?

Do not take HyQvia if you:

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

Nurse: 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.

Nurse: 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.

Nurse: 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, 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: HyQvia [Immune 10% (Human) with Recombinant Human SUPER: ISI scrolls 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
• Itching
• Redness
• Abdominal pain
• Back pain
• Pain in extremity

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.

Nurse: 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.

Please see Important Safety Information throughout this video, and accompanying Information for Patients, including Warning about Blood Clots, or visit www.hyqvia.com/information-for-patients.

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.