One infusion, once a week—that's how you Factor UP!

INDICATION

ALTUVIIIO^® [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is an injectable medicine that is used to control and reduce the number of bleeding episodes in people with hemophilia A (congenital Factor VIII deficiency).

Your healthcare provider may give you ALTUVIIIO when you have surgery.

Who should not use ALTUVIIIO?
You should not use ALTUVIIIO if you have had an allergic reaction to it in the past.

Please see Important Safety Information at the end of the video.

During this video, we’ll walk you through how to prepare and infuse ALTUVIIIO. If this is your first time, work with your doctor or caregiver who will guide you through the process. No matter how many times you’ve done this, you should always refer to the Instructions for Use, which can be found inside the Prescribing Information. And be sure to ask your doctor if you have any questions. Now you’ll need to wait until the ALTUVIIIO vial and the diluent come to room temperature. Don’t use an external heat source to try to speed this part up. Here’s what you’ll need to get started. First, make sure you have a clean, flat surface in front of you…and that you’ve washed your hands with soap and water.

You’ll need the vial containing the powdered ALTUVIIIO, the prefilled diluent syringe, the packaged vial adapter, and plunger rod—all of which are included with your kit. You’ll also need alcohol wipes, infusion set tubing, and a tourniquet. If your dose requires more than one vial, you may also need a luer lock syringe to complete an additional step called “pooling.” Now, remove the plastic cap from the ALTUVIIIO vial.

Wipe the rubber stopper of the vial with an alcohol wipe, and allow it to dry. After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface.

Next, completely remove the backing from the vial adapter by peeling off the lid. Keeping the vial on a flat surface, hold the vial with one hand and use the other hand to place the vial adapter in its package over the vial. The spike should be directly above the center of the rubber stopper. Push the vial adapter straight down until the adapter spike punctures the center of the vial stopper and is fully inserted. Lift the package cover away from the vial adapter...and throw it away. Now take your plunger rod and, holding it by the circular disk, place the tip into the end of the syringe. Turn it to the right, in a clockwise motion, until it’s securely attached.

Once the plunger rod is attached, use one hand to hold the diluent syringe by the ribbed section right under the cap. The cap should be pointed directly up. With your other hand, grasp the cap and bend it at a 90-degree angle until it snaps off and you see the glass tip of the syringe. With the vial sitting on a flat surface, insert the tip of the syringe into the adapter opening on the vial. Turn the syringe to the right until it is securely attached to the adapter.

Now we can begin reconstitution, which is the process of adding the diluent to the dry ingredient to make it a liquid. Slowly depress the plunger rod to inject all of the diluent into the vial. The plunger rod may rise slightly after this process. Don’t stress: this is normal. With the syringe still connected to the adapter, gently swirl the vial until the product is completely dissolved. The solution should be clear to slightly opalescent and colorless. If you need more than one vial for your prescribed dose, jump to the “pooling” part of this video. Now that ALTUVIIIO is reconstituted, make sure the plunger rod is completely depressed and then turn the vial upside down. Slowly pull on the plunger rod to draw the solution into the syringe. Be careful not to pull the plunger completely out of the syringe. Next, gently unscrew the syringe from the vial adapter and dispose of the vial with the adapter. If you’re not ready to inject, carefully put the syringe cap back onto the syringe tip. Do not touch the syringe tip or the inside of the cap. Once reconstituted, ALTUVIIIO should be administered as soon as possible or within three hours. Keep reconstituted ALTUVIIIO away from direct sunlight and note that it cannot be refrigerated.

If you need more than one vial to complete your dose, this step is for you. Pooling is the process of combining two or more reconstituted vials into a larger syringe prior to intravenous administration. Be sure to leave the vial adapter attached to the vial, as you will need it to help attach it to the large luer lock syringe. Start pooling by turning the diluent syringe to the left until it is completely detached from the vial adapter. Attach the separate large luer lock syringe by turning it to the right or clockwise until it is securely in place. Now that the large luer lock syringe is attached to the vial, turn the vial upside down and slowly pull on the plunger rod to draw the solution into the syringe. For every vial you use, you’ll need to repeat the same reconstitution process for each vial and draw the solution into the larger syringe. Once you have pooled the required dose, proceed to administration using the large luer lock syringe.

Your healthcare provider should teach you how to infuse ALTUVIIIO. Once you have been taught to self-infuse, you can follow the Instructions for Use and this video. Now that we have reconstituted ALTUVIIIO, you’re ready to administer it. Start by attaching the syringe to the connector end of the infusion set tubing by turning it to the right until it is securely attached. Next, you’ll need to find a vein for infusion. Apply the tourniquet to your arm just above where you’ll be infusing. This will help make your veins larger and easier to find. Once your tourniquet is on, use an alcohol wipe to clean the area of skin where you’ll be infusing. Depress the plunger until all the air is removed from the syringe and ALTUVIIIO has reached the end of the infusion set tubing. Remove the protective cover from the needle on the infusion set tubing to insert the needle into the vein. Now you can remove the tourniquet. Slowly push the plunger on the syringe to administer ALTUVIIIO. This should take several minutes. The rate of administration should be determined by your comfort level.

After you’re done, remove the infusion set and use a sterile gauze to put pressure on the infusion site for several minutes. You can use an adhesive bandage, if necessary. Throw away all used and unused medical supplies, including empty vials and unused solution, in the appropriate waste container.

And that’s it—you did it! You successfully administered ALTUVIIIO. Remember whether you’re using ALTUVIIIO prophylactically, for on-demand bleed control, or prior to surgery, you can expect the same infusion process.

INDICATION
ALTUVIIIO^® [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is an injectable medicine that is used to control and reduce the number of bleeding episodes in people with hemophilia A (congenital Factor VIII deficiency).

Your healthcare provider may give you ALTUVIIIO when you have surgery.

IMPORTANT SAFETY INFORMATION
What is the most important information I need to know about ALTUVIIIO?
Do not attempt to give yourself an injection unless you have been taught how by your healthcare provider or hemophilia center. You must carefully follow your healthcare provider's instructions regarding the dose and schedule for injecting ALTUVIIIO so that your treatment will work best for you.

Who should not use ALTUVIIIO?
You should not use ALTUVIIIO if you have had an allergic reaction to it in the past.

What should I tell my healthcare provider before using ALTUVIIIO?
Tell your healthcare provider if you have had any medical problems, take any medications, including prescription and non-prescription medicines, supplements, or herbal medicines, are breastfeeding, or are pregnant or planning to become pregnant.

What are the possible side effects of ALTUVIIIO?
You can have an allergic reaction to ALTUVIIIO. Call your healthcare provider or emergency department right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.

Your body can also make antibodies called “inhibitors” against ALTUVIIIO. This can stop ALTUVIIIO from working properly. Your healthcare provider may give you blood tests to check for inhibitors.

The common side effects of ALTUVIIIO are headache and joint pain.

These are not the only possible side effects of ALTUVIIIO. Tell your healthcare provider about any side effect that bothers you or does not go away.

Please see full Prescribing Information.