Vonvendi

Vonvendi injection is used to treat serious bleeding episodes in patients with a bleeding problem called von Willebrand disease (VWD).

Von Willebrand factor is normally produced in the body and it helps you form blood clots. Patients with von Willebrand disease do not make enough of this substance prevent bleeding, so this product is given to increase the blood levels.

This medicine is to be given only by or under the direct supervision of your doctor. This product is available in the powder for solution dosage form.

Before using Vonvendi, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric Population: Appropriate studies have not been performed on the relationship of age to the effects of von Willebrand factor recombinant injection in the pediatric population. Safety and efficacy have not been established.

Geriatric Population: Appropriate studies have not been performed on the relationship of age to the effects of von Willebrand factor recombinant injection in geriatric patients.

Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary.

Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems: The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots
• Disseminated intravascular coagulation (DIC, blood clots all over the body)
• Heart attack
• Pulmonary embolism (blood clot in lungs)
• Stroke, history of—Use with caution. May make these conditions worse

Proper usage of Vonvendi requires strict adherence to your doctor’s orders. A nurse or other trained health professional will give you this medicine in a hospital or clinic.

This medicine is given through a needle placed in one of your veins. This medicine may also be given at home to patients who do not need to be in a hospital or clinic.

If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Make sure you understand all of the instructions before giving yourself an injection.

Your dose may change based on where you are bleeding. Do not use more medicine or use it more often than your doctor tells you to.

Before using Vonvendi, there are some precautions you must take. Blood tests may be needed to check for unwanted effects. This medicine may increase your chance of having blood clots.

Tell your doctor right away if you have a sudden or a severe headache, problems with vision or speech, chest pain, shortness of breath, or numbness or weakness with this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention.

Tell your doctor right away if you have a cough, difficulty with swallowing, dizziness, a fast heartbeat, trouble breathing, chest tightness, swelling of your face, hands, tongue, or throat, a fever, chills, a runny nose or sneezing, itching or hives, or lightheadedness or faintness after you get the injection.

As with many medications, there are several potential side effects associated with Vonvendi. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common:

• chest discomfort
• fast, pounding, or irregular heartbeat or pulse

Incidence not known:

• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• confusion
• cough
• coughing or spitting up blood
• the difficulty with swallowing
• discoloration of the skin
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• hives or welts, itching, or skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nausea
• pain
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• restlessness
• sweating
• swelling
• tightness in the chest
• trouble breathing
• unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common:

• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feeling at the infusion site
• change in taste
• the feeling of warmth
• loss of taste
• redness of the face, neck, arms, and occasionally, upper chest
• shakiness in the legs, arms, hands, or feet
• sudden sweating
• trembling or shaking of the hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.