Vonvendi

What is VONVENDI?

(VONVENDI) This product is used to prevent and control bleeding episodes in people with von Willebrand disease. It may also be used to prevent the loss of too much blood during surgery. Von Willebrand factor is a protein normally found in the blood that helps the blood to thicken (clot) and stop bleeding. People with this disease do not have enough of this factor. This product contains a man-made form of von Willebrand factor.

How should I use VONVENDI?

This medication is given by injection into a vein as directed by your doctor. After first receiving this medication in a hemophilia treatment center or hospital, some patients may be able to give it to themselves at home. If your doctor directs you to give this medication at home, read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. Learn all preparation and usage instructions in the product package. Learn how to store and discard medical supplies safely. If you have any questions, ask your health care professional. Depending on your factor VIII blood level and medical condition, your doctor may direct you to also give factor VIII with your first dose of von Willebrand factor for each bleeding episode. Ask your doctor for more details. If the medication and the solution used to mix it were refrigerated, bring both to room temperature before combining. After adding the solution to the powder, gently swirl the mixture to completely dissolve the powder. Do not shake. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Check your heartbeat during treatment. If your heart starts to beat faster, give this medication more slowly or briefly stop the infusion until your heart rate returns to normal. Ask your doctor for details on how fast to infuse your dose. The dosage is based on your medical condition, weight, blood test results, and response to treatment. Tell your doctor right away if your bleeding does not stop or if this medication stops working well.

What should I tell my health care provider before I take VONVENDI?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

What may interact with VONVENDI?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

What if I miss a dose of VONVENDI?

If more than one dose is needed, it is important to follow the dosing schedule as directed by your doctor. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

What side effects may I notice from receiving VONVENDI?

Flushing of the face, headache, nausea, or fast heartbeat may sometimes occur and can be lessened by giving this medication more slowly. Burning/irritation at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, coughing up blood, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headache, trouble speaking, weakness on one side of the body, sudden vision changes. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, numbness/tingling of the hands/feet. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Where should I keep VONVENDI?

Store the unmixed product in the refrigerator or at room temperature. If you store it at room temperature, use it within 12 months from the date that you removed it from the refrigerator or before the expiration date on the box, whichever is sooner. Do not put room temperature product back in the refrigerator. Do not freeze. Store the vials in the original box and protect from light. After the powder is mixed into solution, use it within 3 hours and discard any unused portion. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.