Dosing and infusion

Your guide to dosing VONVENDI®

Following proper dosing and infusion guidelines is critical in safely and effectively administering VONVENDI.

Doctor talking to his patient about taking VONVENDI®.

Infusing VONVENDI

In order to help you control and manage bleeding episodes VONVENDI is infused into your bloodstream. You can work with your healthcare provider to create a dosing and infusion plan that works best for you. This will include how and when to infuse VONVENDI, how much VONVENDI you should infuse, whether you might need additional recombinant FVIII (rFVIII), and any support you may need with mixing and administering.1

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Should I self-infuse?

Talk to your healthcare provider to see if self-infusion may be right for you. With self-infusion, you can administer VONVENDI on your own when a bleed occurs.1

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Where can I infuse?

You may infuse VONVENDI at a variety of locations, including a hemophilia treatment center, your healthcare provider's office, and your home.1

Headshot of Leslie, Real VWD patient smiling.

Leslie's story

Diagnosed with VWD in 2003

"Once I was trained on how to do my own infusion, I infused on the eve of the surgery and again right before. I also infused after surgery—this was my normal for any surgery. I was amazed at how well this treatment worked for me."

"I try not to let my blood disorder get me down. As I tell my son, life is what you make of it. My adventure is not done; my story is not finished."

See her story
Headshot of Erica, Real VWD patient smiling.

Erica's story

Diagnosed with VWD in 1981

"I feel fortunate that there's been an increase in awareness when it comes to VWD, from diagnosis and available information to patient care."

"The doctor came back with a diagnosis: VWD type 2B. It was something I had never heard of before… but something that would change my life forever."

See her story
Headshot of Nicole, Real VWD patient smiling.

Nicole's story

Diagnosed with VWD in 2009

"Although I've faced many battles since I was diagnosed, the amount of support I had from all the other patients fighting the same battle gave me strength."

"I was experiencing nosebleeds that lasted 15 minutes or more almost every day. My new doctor told me I needed to manage my bleeds, and discussed beginning a treatment called VONVENDI."

See her story

What to know before you infuse

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Finding the right dose

Your healthcare provider will determine the amount of VONVENDI that is recommended for you depending on your weight, your type of VWD, and the severity of the bleeding event you're experiencing.1

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Additional factor VIII (FVIII)

Because your own von Willebrand factor (VWF) may not be able to protect the FVIII in your blood, your own levels of FVIII may be too low to help form a blood clot.2 Your healthcare provider will determine if you should use additional recombinant FVIII (rFVIII) along with your first dose of VONVENDI.1

Positive sign icon.

rFVIII for subsequent doses of VONVENDI

If you need more than one dose of VONVENDI for a bleeding event, your healthcare provider will determine if you need additional rFVIII.1 Always follow your healthcare provider's specific instructions about how to use VONVENDI with or without rFVIII. If you continue to bleed without noticeable improvement, contact your healthcare provider.

Two circles of different sizes icon.

VONVENDI comes in two strengths

The actual strength will be printed on the vial label and on the box. Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider.1

Special dosing situations

Blood tube, VONVENDI® may be infused more then one time.

Dosing can depend on the bleed

To treat a bleed, you may require more than one infusion
of VONVENDI with or without rFVIII1
Doctor talking to his patient about taking VONVENDI®.

Dosing for surgery

If you're planning to have surgery, talk to your
healthcare provider for guidance on dosing and
administering VONVENDI with or without rFVIII.

YOUR GUIDE TO USING VONVENDI®

Your healthcare team will teach you to self-infuse VONVENDI—and there are lots of other resources to help guide you.

  • Use this guide as a handy reference; be sure to perform each step for each VONVENDI kit
  • Please see VONVENDI full Prescribing Information for complete Instructions for Use, and see Detailed Important Risk Information below

Always follow your healthcare provider's specific instructions for using VONVENDI, and contact them with any questions about dosing, infusion, or reconstitution.

Call your healthcare provider right away if bleeding is not controlled after using VONVENDI.

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alt VONVENDI device
alt Diluent vial

Gather your infusion supplies on a clean surface (Figure A)

VONVENDI® kit with two glass bottles, vial and container.
VONVENDI [von Willebrand factor (Recombinant)] product kit(s)
VONVENDI Vial
Diluent Vial
Mix2Vial
Infusion Items
Empty, sterile disposable plastic syringe(s)
Tourniquet
Alcohol swabs or other suitable sterile solution
Butterfly infusion set
Bandage
Gauze pad (optional)
Syringe stabilizer (optional)
Sharps container

Note: The plastic syringe and sharps container will be provided by the pharmacy.

Check the expiration date and let VONVENDI warm up to room temperature, if it has been stored in the refrigerator. Wash your hands and put on clean exam gloves. If you are self-infusing, gloves are optional. If your healthcare provider has directed you to co-administer rFVIII to control bleeding, make sure you have enough rFVIII for your dose.

You can place the needle and empty VONVENDI and diluent vial(s) in a hard-walled sharps container for proper disposal. Do not dispose of these supplies in ordinary household trash. For more information on state-specific disposal, visit https://safeneedledisposal.org

Note: The plastic syringe and sharps container will be provided by the pharmacy.

alt Mix2Vial® device
alt VONVENDI device
alt Diluent vial

Remove the caps from the VONVENDI concentrate and diluent vials (Figure B)

Two VONVENDI® bottles, one has an open cap and shows the vial stopper.

Disinfect each vial stopper with separate sterile alcohol swabs (or other suitable sterile solution suggested by your healthcare provider or hemophilia center) and allow to dry.

alt Mix2Vial® device
alt VONVENDI device
alt Diluent vial

Place the diluent vial on a flat surface. Peel the cover off the Mix2Vial device package without touching the inside of the package. Flip it upside down and place it over the diluent vial (Figure C). Do not remove Mix2Vial device from its plastic package. Do not touch blue plastic spike.

Hands connecting the Mix 2 Vial device on top of the diluent vial stopper.

Firmly insert the blue plastic spike of the device into the center of the diluent vial stopper by pushing straight down. Grip the package at its edge and lift it off the Mix2Vial device. Be careful not to touch the clear plastic spike.

The diluent vial now has the Mix2Vial device connected to it and is ready to be connected to the VONVENDI vial.

Flip the Mix2Vial device with diluent over the VONVENDI product vial. Fully insert the clear plastic spike of the Mix2Vial device into the VONVENDI vial stopper by firmly pushing straight down (Figure D). The diluent will flow into the VONVENDI vial by vacuum. This should be done right away to keep the liquid free of germs.

Verify that diluent transfer is complete. Do not use if vacuum has been lost.

Hands placing the MIX 2 Vial over the VONVENDI® vial.

Verify that diluent transfer is complete. Do not use if vacuum has been lost.

alt Mix2Vial® device
alt VONVENDI device
alt Diluent vial

To ensure the powder is completely dissolved, swirl the connected vials gently and continuously or allow the reconstituted product to sit for 5 minutes then gently swirl (Figure E). Do not shake. Shaking will adversely affect the product.

Hand swirling the vials on top of each other.

Disconnect the two sides of the Mix2Vial device from each other by turning the blue plastic side of the Mix2Vial counterclockwise and gently pulling the two vials apart (Figure F). Do not touch the end of the plastic connector attached to the VONVENDI vial containing the dissolved product.
Discard empty diluent vial and the blue part of the Mix2Vial.

Hands disconnecting the two Mix 2 Vials. Do not touch exposed connector.

NOTE: The Mix2Vial is intended for one-time use with a single vial of VONVENDI and diluent only. If the dose requires more than one vial of VONVENDI, reconstitute each vial using a separate Mix2Vial device. Do not refrigerate after reconstitution. Repeat reconstitution steps above for all VONVENDI product vials needed for your dose prior to continuing on to the next step.

alt Mix2Vial® device
alt VONVENDI device
alt Diluent vial

Pull back on the plunger of the empty syringe to draw in air. The amount of air should equal the amount of reconstituted VONVENDI you will withdraw from the vial. For example, if using 5 mL of reconstituted VONVENDI, pull the plunger back until 5 mL of air is in syringe (Figure G). Do not touch exposed connector.

Hands pulling the empty syringe down. Do not touch syringe tip.

Placing the vial of reconstituted VONVENDI on a flat surface, connect the syringe by attaching it to the plastic connector and turning the syringe clockwise (Figure H).

Hands connecting the Mix 2 Vial vial to the syringe.

Slowly push all the air from the syringe down into the vial (Figure I). The required amount of product will not be drawn into the syringe if all the air is not pushed into the vial.

Hands pushing the syringe down into the vial.

A syringe stabilizer can provide stability when using the dosing syringe or if you are using multiple syringes. To use the syringe stabilizer, please refer to the instructions enclosed with it.

alt Mix2Vial® device
alt VONVENDI device
alt Diluent vial

Flip the connected syringe and VONVENDI product vial so the vial is on top (Figure J). Be sure to keep syringe plunger pressed in.

Hands flipping the vial on top of the syringe.

Slowly pull back the plunger to draw VONVENDI into the syringe (Figure K). Do not push and pull solution back and forth between syringe and vial. Doing so may harm the integrity of the product.

Hands pulling the syringe back.

When ready to infuse, disconnect the syringe by turning it counterclockwise. Inspect syringe visually for particulate matter; the solution should be clear and colorless. If flakes or particles are seen, do not use the solution and notify your healthcare provider.
The contents of up to two vials may be drawn into a single syringe. When pushing air into a second vial of VONVENDI to be pooled into a syringe, position the vial and connected syringe so that the vial is on top. If you are using more than one vial, leave syringe attached to the vial or cover syringe tip with a suitable sterile cap until ready to infuse to reduce risk of contamination.

  • For specific steps for pooling VONVENDI, please click here to see the Instructions For Use within the full Prescribing Information.

Make sure all syringes are ready before continuing with administration. See step 7 for administration instructions. You should administer immediately or within 3 hours, keeping it at room temperature (no warmer than 25°C/77°F). Do not refrigerate. Discard any unused reconstituted product after 3 hours.

If you need to infuse recombinant factor VIII (rFVIII), reconstitute it as instructed in the package insert for that product now. Make sure all syringes are ready before continuing with administration.

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alt VONVENDI device
alt Diluent vial

VONVENDI should be administered before any needed recombinant factor VIII (rFVIII)

Hold the syringe containing VONVENDI so the vial is on top. Turn the vial counterclockwise to disconnect it (Figure L). Do not touch the exposed connector.

Hands disconnecting the vial from the syringe.

Using a butterfly infusion set, attach the infusion needle to the syringe of VONVENDI. Point the needle up and remove any air bubbles by gently tapping the syringe with your finger and slowly and carefully pushing air out of the syringe and needle.

Apply a tourniquet and prepare the injection site by wiping your skin well with a sterile alcohol swab (or other suitable sterile solution).

Insert the needle into your vein, secure the needle in place, and remove the tourniquet. Slowly push the syringe plunger to administer VONVENDI (Figure M). Do not infuse any faster than 4 mL per minute. If your heart rate increases, you must stop administration and call your healthcare provider immediately for further instruction.

Hands administering VONVENDI® in the vein. Do not touch connector.

After you have administered all the VONVENDI, disconnect the syringe. If your dose requires multiple syringes, attach and administer them one at a time. Do not remove the butterfly needle until you have infused all syringes. Do not touch the Luer port that connects to the syringe.

If you are also infusing rFVIII, be sure to administer your complete dose of VONVENDI first, and then, if needed, infuse rFVIII within 10 minutes. No saline flushing is required prior to infusing rFVIII.

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alt VONVENDI device
alt Diluent vial

Remove the needle from your vein. With sterile gauze, apply pressure to infusion site for several minutes (Figure N). Do not recap the needle.

Hand pressing sterile gauze.

Dispose of all used infusion supplies in your hard-walled sharps container (Figure O). Do not dispose of these supplies in ordinary household trash.

Hazardous materials bin.

IMPORTANT: If you experience any problems, contact your healthcare provider or local hematology treatment center immediately.

US-VON-0095v1.0 08/20

VONVENDI®medicine bottles.

Proper storage of VONVENDI

Store VONVENDI at refrigerated temperature 2°C to 8°C (36°F to 46°F) or room temperature not to exceed 30°C (86°F). Do not freeze. Store VONVENDI in the original box and protect it from extreme exposure to light. Do not use beyond the expiration date printed on the VONVENDI vial label or carton.1

Additional infusion information1

Always follow the specific instructions given by your healthcare provider. The steps listed on this page are general guidelines for using VONVENDI. If you are unsure of the procedures, please call your healthcare provider before using.

Call your healthcare provider right away if bleeding is not controlled after using VONVENDI.

Confirm your dosage. Your healthcare provider will prescribe the VONVENDI dose that you should take. If this is your first infusion to control a new bleeding episode, and if rFVIII is needed, be sure you also have the correct dose of rFVIII as instructed by your physician.

Occasional blood tests may be ordered by your healthcare provider.

Talk to your healthcare provider before traveling. Plan to bring enough VONVENDI for your treatment during this time.

Dispose of all materials in an appropriate container, including any leftover reconstituted VONVENDI product.

Nicole, Real VWD patient smiling.
Try for free

You may be eligible to try VONVENDI for free with
our FREEDOM OF CHOICE program.

Learn more
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Real VWD patients

Our patient ambassadors share their stories
of living with VWD.1

See their stories

References

  1. VONVENDI Prescribing Information
  2. Von Willebrand disease. National Organization for Rare Disorders website. Accessed July 9, 2020. https://rarediseases.org/rare-diseases/von-willebrand-disease/
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