Description
Antihemophilic factor VIII and von Willebrand factor injection combination is used to treat and control serious bleeding episodes in patients with a bleeding problem called von Willebrand disease (VWD). This medicine 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.
Antihemophilic factor VIII and von Willebrand factor injection combination is also used treat, control, and decrease the frequency of bleeding episodes in patients with hemophilia A.
Antihemophilic factor VIII and von Willebrand factor are normally produced in the body. They help clot the blood when an injury occurs. Patients with von Willebrand disease or hemophilia A do not make enough of these substances to prevent bleeding, so this product is given to increase the levels of these substances in the blood.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of Wilate® in children younger than 12 years of age to treat, control, and decrease the frequency of bleeding episodes in patients with hemophilia A. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Wilate® in the elderly.
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Concizumab-mtci
- Fitusiran
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—Use with caution. May make this condition worse.
Proper Use
A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins.
This medicine comes with a patient information leaflet and patient instructions. 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 use:
- 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 a foam in the mixture.
- Check the mixture to make sure it is clear or slightly opalescent, colorless or slightly yellow. Do not use the medicine if the powder is not dissolved or if you can see particles in the mixture.
- 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:
- For bleeding episodes in patients with hemophilia A:
- Adults and children 12 years of age and older—Dose is based on body weight and the type of bleeding episode. The dose must be determined by your doctor.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For bleeding episodes in patients with von Willebrand disease:
- Adults and children—Dose is based on body weight and the type of bleeding episode. The dose must be determined by your doctor.
- For bleeding episodes in patients with hemophilia A:
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 in the refrigerator. Do not freeze.
You may store the medicine at room temperature for up to 6 months. Do not put it back in the refrigerator. Throw the medicine away after 6 months.
Use the mixture within 4 hours after it is prepared. Do not store it for later use.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check you closely while you or your child are receiving this medicine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have back pain, chest tightness, chills, fever, flushing, headache, rash, itching, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you get the injection.
This medicine may increase your risk of having blood clots. Tell your doctor right away if you or your child have a sudden or severe headache, problems with vision or speech, chest pain, trouble breathing, or numbness or weakness after receiving this medicine.
This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.
Side Effects
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 or nurse immediately if any of the following side effects occur:
More common
- Difficulty with breathing or swallowing
- dizziness
- fast heartbeat
- fever
- hives, itching, rash
- nausea
- reddening of the skin, especially around the ears
- swelling of the face, throat, or tongue
- unusual tiredness or weakness
Incidence not known
- Blurred vision
- chest tightness
- confusion
- cough
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- headache
- nervousness
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- slow or fast heartbeat
- stomach pain
- sweating
- vomiting
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.
DRG-20073496
