Nurse: This video is intended for patients 17 years of age or older taking HyQvia. HyQvia is for patients two years and older with either primary immunodeficiency, PI, or adult patients with chronic inflammatory demyelinating polyneuropathy, CIDP. If you have PI, it does not mean you have CIDP. And if you have CIDP, it does not mean you have PI.

Nurse: HyHub and HyHub Duo important information for patients. What is HyHub and HyHub Duo? HyHub and HyHub Duo are stand-alone, single use, disposable vial access devices. Who should use HyHub and HyHub Duo? HyHub and HyHub Duo are for patients 17 years of age and older to allow HyQvia, Immune Globulin Infusion, human, 10% with Recombinant Human Hyaluronidase, to be transferred from vials without using a needle as prescribed in a home environment or clinical setting.

Nurse: Do not use HyHub and HyHub Duo with a pooling bag. Do not connect HyHub and HyHub Duo to a syringe driver infusion pump. Selected information for patients. HyHub and HyHub Duo are for single use only, even if all docks are not used during a single infusion. Reuse will increase risk of infection. Always use a new HyHub and HyHub Duo for each infusion. 

Nurse: Only use HyHub and HyHub Duo when ready to administer HyQvia. Do not use HyHub and HyHub Duo at home until receiving instructions and training from a healthcare provider. HyQvia is the only medicine that may be used with HyHub and HyHub Duo. Do not exceed the maximum infusion volume per infusion site or infusion rate as indicated in the HyQvia prescribing information or as directed by a healthcare provider.

Nurse: For safe and proper use of HyHub and HyHub Duo, please refer to the complete instructions for use included with the devices. Talk to your healthcare provider if you have additional questions. For information about HyQvia, including warnings for blood clots, please see Patient Information for HyQvia. What is HyQvia?

Nurse: HyQvia is a liquid medicine that is given under the skin, subcutaneously, to treat primary immunodeficiency, PI, in people two years and older, and 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 sites, 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. Please see additional important safety information within this video. 

Nurse: Accompanying information for patients can be found on HyQvia.com. If you have questions about HyQvia, contact your doctor. For questions about HyHub or HyHub Duo, contact your healthcare provider, which may include your specialty pharmacy. 

Nurse: Remember, you must receive appropriate training before you're able to infuse at home by yourself. If you are an existing HyQvia patient who has received prior training, you will also require additional training if you and your HCP determine that infusing with HyHub is right for you. If you have a friend or caregiver who helps you infuse, they will follow the same steps in the exact same way.

Nurse: Please note that the instructions shown in this video are the same for both HyHub, which holds up to four dual-vial units, and HyHub Duo, which holds up to two dual-vial units. We'll be using the four-dock tray for this training. Hi, I'm Kristina, and I'm a nurse. I'm here to teach you how to use the HyHub infusion tray at home, designed to help to simplify the infusion process without use of transfer needles. 

Nurse: The HyHub tray allows you to infuse without a pooling bag and cuts down on the number of steps required to prepare hy and IG when using two, three, or four dual-vial units. Don't worry, I'll go over it all and explain the HyHub infusion process. Let's get started. If you're already a HyQvia patient, some of these steps might feel familiar. 

Nurse: However, it's still important to watch this video so you know exactly what to do when infusing with HyHub. If you have received your box of supplies, you might want to have it with you as you watch this video. In addition, there is a step-by-step guide available online in case you'd like to use it as a reference.

Nurse: To help with the training process, we've broken the infusion process down to five steps. We call them hy1, hy2, all the way to hy5, the perfect way to end an infusion. Hy5 is also what we call the whole infusion process. We start the process at hy1, checking the HyHub infusion tray and vials, gathering all the supplies, and preparing for infusion. 

Nurse: Do not begin the infusion procedure until you have all required supplies and you are ready to administer your prescribed medication. First, you'll need to clean the surface where you'll be infusing with antibacterial cleaner. Once clean, open the HyHub box and take out the HyHub infusion tray, which should be right on top. The HyHub infusion tray is the device that helps to simplify the infusion process without use of transfer needles. 

Nurse: Let's look at what else is in the box and take a few minutes to get you familiar with the supplies. Here is your hyaluronidase, or hy, and your IG vials. The size and number of the vials may vary depending on the dose you've been prescribed. This is your pump. And here is your pump tubing. Here's the syringe and subcutaneous needle set. 

Nurse: Then here's your sharps container. This is where you dispose of the needle set when you're done. We'll get to that at the end of the infusion. The rest of the box should contain gloves, a prefilled saline syringe, or dextrose 5% in water, tape, a bandage, gauze, and alcohol swabs to clean the tops of your vials and your body where you infuse. 

Nurse: And last but not least, here is your wellness journal. This is where you keep track of your treatments, any reactions after each infusion, and write down your thoughts for yourself or questions for your doctor. If you did not receive a wellness journal in your shipment and would like one, you can request one through Takeda Patient Support if you are a PI patient, or order one through HyQvia.com if you're a CIDP patient.

Nurse: If this feels different than what you're used to, I get it. Once you learn what's what, infusing with HyHub will help simplify the process without the use of transfer needles. And remember, there are a few ways to get more information. There's a step-by-step guide that outlines the steps in an easy-to-use format, and your healthcare provider, which may include your specialty pharmacy, is also an excellent resource if you have questions. 

Nurse: Your infusion mat also has a QR code linking to this video if you ever want a refresher. Let's begin. First, be sure that the infusion pump is programmed according to your prescribed infusion rate and the manufacturer instructions. If using more than one infusion site, do not exceed pump infusion rate of 600 milliliters per hour. 

Nurse: For example, 300 milliliters per hour per site for two sites or 200 milliliters per hour per site for three sites. Whenever you do an infusion, it's important to remember that the hy comes before the IG, or immune globulin infusion. To help yourself remember, try saying "hi" before IG. It's just like starting a conversation. You always start with "hi." I tell people to start with "hi" even when they are laying things out just so they can remember. 

Nurse: Make sure your vials are room temperature by leaving them out for about an hour. Never apply heat or put your vials in the microwave to warm them up. You always want the medication to come to room temperature naturally. Also be sure to check the expiration dates on your vials. Don't use your vials if the expiration date has passed or if the purple protective cap is missing or broken.

Nurse: If you observe any expired or damaged materials, contact your doctor as soon as possible. Next, you always want to confirm you have the correct dose, which is what your doctor prescribed for you. Now, look at the labels on the vials. The small dual-vial is recombinant human hyaluronidase. We call that hy for short. The larger one is immunoglobulin 10%, or IG for short.

Nurse: You want to handle them carefully, so don't shake the vials. 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 okay. Neither should be cloudy or have any floating particles. Now you'll want to wash your hands thoroughly with soap and let them dry.

Nurse: Wearing gloves is optional, but you should wear them if that's what has been recommended by your doctor. Before we go any further, let's look at the HyHub infusion tray in its packaging. You want to check the expiration date, which is located right on the packaging. Never use an expired HyHub tray or other expired infusion materials. Open and inspect the supply packaging. 

Nurse: You don't ever want to use HyHub if its sterile packaging or components appear to be broken, missing, or expired. That may cause infection, leaks from the product, or other hazardous conditions that could result in serious injury. If observed, contact your healthcare provider, which may include your specialty pharmacy. You'll notice HyHub is numbered and color-coded to help with following the instructions. 

Nurse: The tubing is built inside, and these are the hy and IG connectors which will be used to transfer the medication from the vials. The purple hy connector connects to the syringe to pool hy from all dual-vial units docked into HyHub. The orange IG connector connects to the pump tubing to deliver IG from all dual-vial units docked into HyHub.

Nurse: This is where your vials dock in. You'll push them down and lock them into place. Next, remove the purple caps from both dual-vial units. This should make the blue caps underneath pop right off. If they don't, remove them manually. You'll need to clean the tops of all the vials using a separate alcohol swab for each, and give them 30 seconds to dry. 

Nurse: Start with the hy vials and then do the IG vials. Now that they're clean, dock the vials into the HyHub infusion tray. See the numbers on the covers? That's to show the order for adding the vials. You can add up to four dual-vial units, but as you can see, we only use two in this example. 

Nurse: Keep in mind, HyHub Duo has two docks and can hold up to two DVUs. The following steps will be the same for each set of vials, whether you are using one, two, three, or four. If you use more than four dual-vial units per infusion, please contact your healthcare professional for instructions. No matter how many you need to use, adding them to the HyHub infusion tray is the same. 

Nurse: Remove the cover, being careful not to touch or remove anything under it. Touching anything under the cover will increase the risk of contamination and interfere with the normal function of HyHub. Insert the vials into dock one with the stoppers facing down. Push down so that the vials lock into place. You may hear a click, which is an indicator that the dual-vial unit is locked in place. 

Nurse: Once the vials have been locked into place, don't try to remove them from the dock. Don't rotate the vials after docking either. This may cause leaks or damage to the spikes. And notice which vial is at the front? Hy before IG. It is important to insert the DVUs in the order of the dock numbers. 

Nurse: If using more than one dual-vial unit, repeat docking steps for the remaining dual-vial units and insert them in order into docks two, three, and four as needed. Depending on the infusion dose and number of dual-vial units, you may not use all docks. Next, you're going to remove the syringe from the packaging and attach the syringe to the hy connector on the HyHub infusion tray.

Nurse: The hy connector is this purple piece right here. You never want to touch the tip of the hy connector because you don't want to accidentally contaminate it. Now go ahead and pull it gently away from the infusion tray. That will reveal the tubing. Before connecting the syringe to the hy connector, make sure to remove all the air from the syringe by pushing down on the syringe plunger. 

Nurse: Now attach the syringe to the end of the purple hy connector by pushing in and twisting the syringe onto the hy connector. It's time to slowly pull back on the syringe's plunger to draw all the hy up into the syringe. Do not push any air into your HyHub. Remove the syringe from the hy connector with a twist to the left.

Nurse: More than one syringe may be needed to administer your complete dose, depending on the total volume of your infusion. Now that you've got all the hy you need into the syringe, point the syringe tip up and push the syringe's plunger up to remove air. Next, you'll attach the syringe to the needle set. To do this, remove the cap from the end of the needle set tubing. 

Nurse: Twist the syringe filled with hy onto the tubing connected to the end of the needle set. Fill the needle set tubing with hy until it reaches the needle wings. Don't push the hy beyond the needle wings. At this point, you'll attach the pump tubing to the IG connector on the HyHub infusion tray. That's this orange piece right here.

Nurse: You'll twist the pump tubing onto the IG connector to log it in place. But remember, you never want to touch the tip of the IG connector because you don't want to accidentally increase the risk of contamination and infection. Once it's in there nice and tight, insert the pump tubing into the pump itself. The top flips open and the tubing fits right in here.

Nurse: Go ahead and put the tubing in and fill it according to the pump manufacturer's instructions. When using HyHub, you will need to add one milliliter to your IG filling volume. Great, you're ready for hy2, prepare the infusion site. You'll need to decide where you want to infuse, either in your middle to upper abdomen or thighs.

Nurse: Avoid bony areas like the ribs, visible blood vessels, scars, and any areas of inflammation or infection. Remember to rotate your sites for each infusion by choosing opposite sides of the body between future infusions. If your doctor tells you to infuse in two sites, select sites on opposite sides of the body. If you have a wellness journal, write down your infusion sites. If you don't have a journal, use a dedicated notebook to record your infusion sites. 

Nurse: Use a new alcohol swab to clean your abdomen and allow it to dry at least 30 seconds. If you're using more than one infusion site, you will need to follow these steps again. Okay, we're at hy3, infuse hy. Now that you've prepared the infusion site, remove the needle cover and then firmly grasp and pinch at least one inch of skin between two fingers.

Nurse: Hold the needle set so that the needle is pointed at a 90-degree angle straight at where you want it to go in. Insert the needle with a rapid motion straight into your skin. Use some of the sterile tape to secure the needle in place. You'll want to repeat these steps if you're using more than one infusion site. 

Nurse: Now, let's do a needle check with the syringe filled with hy to make sure the placement is good. Pull back on the syringe's plunger to check for blood return in the tubing of the needle set. If you see blood in the tubing, remove and discard the subcutaneous needle and repeat hy2 and hy3 with a new subcutaneous needle and infusion site. 

Nurse: Secure the needle set by applying a sterile clear dressing. You want to infuse the hy manually at an initial rate per infusion site of approximately one to two milliliters per minute and increase as tolerated. If you're using more than one infusion site, divide the hy equally between sites. After infusing all the contents in the syringe, remove the empty hy syringe from the needle set. 

Nurse: Remove the sterile cap on the pump tubing and twist the pump tubing filled with IG to the right onto the same needle set. You're ready to infuse IG. This is hy4. HyHub usually comes with a peristaltic pump. You want to make sure the pump tubing is properly secured to the needle set within 10 minutes of completing the infusion of hy. 

Nurse: Start the pump to infuse the IG from all docked IG vials. Your pump will make a little humming sound. That's good. It means it's working. Never rotate the vials during the infusion. This may cause leaking or damage to the spikes. And be sure to keep the HyHub infusion tray level during infusion to prevent air from entering the system. 

Nurse: You may notice a soft, wide swollen area around your infusion site due to the amount of fluid you infused. This is normal. If you have trouble with any swelling or pain, it is recommended to use a warm or cold compress, but do not leave it on for more than 10 minutes at a time. The swelling should go away after one to three days, but if it doesn't or begins to worsen, call your doctor. 

Nurse: Other than that, you may experience mild or moderate pain, redness, swelling, and itching at the infusion site. The most common general side effects are headache, vomiting, fatigue, nausea, and fever. Remember, these are not all the possible side effects. You'll want to contact your doctor if a reaction concerns you or does not go away. This takes us to hy5. 

Nurse: Complete the infusion and dispose of the infusion set and HyHub. At the end of the infusion, check to ensure all the medicine has been infused from the IG vial. If medicine remains, resume the infusion until the entire dose of IG has been infused. Next, remove the IG connector from the pump tubing. This next step is optional, but you can flush the tubing if directed to do so by your doctor. 

Nurse: You do this by twisting a prefilled flush syringe of saline, approximately five milliliters, onto the tubing. Push the syringe's plunger to receive the entire IG dose prescribed. Remove the needle set by loosening the tape on all edges. Pull the needle wings straight up and out. Gently press a small piece of gauze over the infusion site and cover with a bandage. 

Nurse: After removing the needle or needles from your skin, you will discard the infusion set, including the tray with the vials attached and all the other disposable supplies as directed by your doctor in accordance with local requirements. And remember, the HyHub infusion tray is for single use only. You will receive a new one for each infusion with your prescription, which you will use and dispose of as directed. 

Nurse: You can't re-sterilize the tray. Reuse will increase your risk of infection. This is really important. The last thing is to record the infusion details in your wellness journal if you have one. Look at the batch numbers on the vials and write those in, as well as the date and time, sites of infusion, any reactions after each infusion, and any notes you want to remember or experiences you want to talk about with your treatment team.

Nurse: You can peel your labels off your vials and place them in your wellness journal or dedicated infusion notebook as well. Congratulations, you're done. That's the hy5. Don't forget, if you have questions about HyQvia, talk to your doctor. If you have questions about HyHub or HyHub Duo and the infusion process, contact your healthcare provider, which may include your specialty pharmacy. 

Nurse: You can also visit HyQvia.com. What is HyQvia? HyQvia is a liquid medicine that is given under the skin, subcutaneously, to treat primary immunodeficiency, PI, in people two years and older, and 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 sites, 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 IG level. 

Nurse: 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. 

Nurse: 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. 

Nurse: If you have IgA deficiency or a history of severe allergic reactions to IgG or other blood products, if you are pregnant, trying to become pregnant, or are breastfeeding. 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. 

Nurse: 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.

Nurse: 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 sites. 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. 

Nurse: These could be signs of a serious heart or lung problem. Fever over 100 degrees Fahrenheit. This could be a sign of an infection. After HyQvia infusion, a temporary soft swelling may occur around the infusion site, which may last one to three 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.

Nurse: Mild or moderate pain, redness, swelling, itching. The most common side effects of HyQvia in PI are headache, fatigue, nausea, fever, vomiting. The most common side effects of HyQvia in CIDP 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. 

Nurse: 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 additional important safety information throughout this video and accompanying information for patients found on HyQvia.com and discuss with your healthcare provider. 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.