Pronunciation:

Von WILL-a-brand FAK-tor re-KOM-bin-ant

Brand Names:

• Vonvendi

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Hemostatic

Uses of This Medicine:

Von Willebrand factor recombinant injection is used to treat and control 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 to prevent bleeding, so this product is given to increase the blood levels.

Von Willebrand factor recombinant injection is also used to manage bleeding during or after surgery and reduce the number of bleeding episodes when used regularly in patients with von Willebrand disease.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. 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.

Children—

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.

Older adults—

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

Breast-feeding—

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.

Other medicines—

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

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or clinic. It is given through a needle placed into one of your veins.

This medicine comes with a patient information leaflet and instructions for use. Read and follow the instructions carefully. Ask your doctor if you have any questions.

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.

To prepare the medicine using 2 bottles (vials):

• Take the bottles of powder medicine and liquid (diluent) out of the refrigerator and warm them to room temperature.
• Wipe the rubber surface of the bottles with an alcohol swab and allow them to dry.
• Add the liquid to the powder by turning it upside down.
• Swirl the bottle gently to dissolve the medicine. Do not shake the bottle. Shaking will create foam in the mixture.
• Check the mixture to make sure it is clear. Do not use the medicine if you can see particles or flakes in the mixture or if the mixture is cloudy.
• Use a sterile plastic disposable syringe to remove the mixture from the bottle.
• Give the injection as directed by your doctor.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (injection):
  • For bleeding episodes in patients with von Willebrand disease:
    • Adults—Dose is based on body weight and the type of bleeding episode. The dose must be determined by your doctor.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature or in the refrigerator, away from heat, moisture, and direct light. Keep from freezing.

Use the mixture within 3 hours after it is prepared. Do not store and use later.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure it is working properly. Blood tests are 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 severe headache, problems with vision or speech, chest pain, or numbness or weakness with this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you get the injection.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor 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

chest tightness

confusion

cough

coughing or spitting up blood

difficulty with swallowing

discoloration of the skin

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

hives, itching, or skin rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

nausea

pain

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

restlessness

sweating

swelling

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

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.