Koate DVI

Koate DVI is a prescription medication used to prevent bleeding episodes in children and adults with hemophilia A (also called "classical hemophilia"). 

Koate DVI belongs to a group of drugs called clotting factors. It works by replacing a protein in the blood that is needed to control bleeding that people with hemophilia A are missing.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Koate DVI include headache, nausea, and stomach pain.

Koate DVI can also cause blurred vision. Do not drive or operate heavy machinery until you know how Koate DVI affects you.

• Grifols Therapeutics, Inc.

• Kedrion Biopharma, Inc.

• Talecris Biotherapeutics

Serious side effects have been reported with Koate DVI including the following:

Risk of infections. Since Koate DVI is made from human plasma, there is a risk that it may contain infectious agents, such as viruses, that can cause disease. It is recommended that all patients with hemophilia A receive hepatitis A and hepatitis B vaccinations. Talk to your doctor about if these vaccines are right for you. Tell your doctor immediately if you develop any signs or symptoms of an infection, including the following:

• fever
• drowsiness
• chills
• runny nose
• rash
• joint pain
• poor appetite
• nausea or vomiting
• stomach pain
• dark urine
• yellowing of the skin

Hypersensitivity Reactions. Koate DVI can cause serious allergic reactions. Tell your healthcare provider immediately about any signs or symptoms of an allergic reaction, which include the following:

• chest pain
• swelling of the face, eyes, lips, tongue, arms, or legs
• difficulty breathing or swallowing
• rash

Neutralizing antibodies. Your body may form inhibitors to factor VIII, known as antibodies. Antibodies are proteins made by the body as a natural part of the immune system in response to something it recognizes as foreign. If your form these inhibitors, Koate DVI may not work properly. Your healthcare provider will monitor you for development of these inhibitors with blood tests.

You should not receive Koate DVI if you are allergic to it or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Koate DVI, there are no specific foods that you must exclude from your diet when receiving this medication.

The dose and duration of treatment of Koate DVI your doctor recommends will be based on the following:

• your weight
• the severity of factor VIII deficiency and your blood level of factor VIII
• the desired level of factor VIII
• the location of the bleeding
• how you respond to this medication

The recommended dose of Koate DVI for controlling a bleed will depend on how severe the bleeding is and the level of factor VIII your doctor wishes to acheive. Koate DVI may be given as a single dose that may be repeated every 8 to 12 hours if the bleeding is not controlled or your factor VIII level dose not increase to the desired level.

The recommended dose of Koate DVI when being given to prevent bleeding during surgery is 50 IU per kg body weight. This dose may be repeated every 6 to 12 hours initially, and for a total of 10 to 14 days until you are healed.

Koate DVI may also be given regularly to prevent bleeding, with the dose and frequency to be determined by your doctor.

Your doctor will perform blood tests to measure your level of factor VIII and may adjust your dose or frequency based on the results.

If Koate DVI is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

It is very important that your doctor check you or your child closely while you are receiving this medicine to make sure it is working properly. Blood tests may be needed.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child has a rash, itching, hoarseness, trouble breathing, trouble swallowing, lightheadedness or dizziness, or any swelling of your hands, face, or mouth after you receive this medicine.

It is recommended that you carry an identification (ID) card or letter stating that you have hemophilia A and the type of medicine you are using. If you have any questions about what kind of identification to carry, check with your doctor.

Check with your doctor right away if you have any symptoms of parvovirus infection: fever, chills, drowsiness, runny nose, and followed by a rash or joint pain.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

The stopper of the bottle (vial) contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

All products:

• If you have an allergy to antihemophilic factor, mice, or any other part of Koate-DVI (antihemophilic factor (human)).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

Hemofil M and Monoclate-P:

• If you are allergic to mouse proteins, talk with the doctor.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Koate-DVI with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use Koate-DVI as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.
• This medicine may be given at home.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• Wash your hands before and after use.
• This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
• Use within 3 hours of making.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Throw away any part of opened vial not used after use.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling nervous and excitable.
• Headache.
• Stomach pain.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.