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.

Koate DVI is a prescription medication used to prevent and control bleeding in adults and children with hemophilia A, a genetic disorder that increases bleeding and is caused by a missing or defective protein called factor VIII clotting factor. Koate DVI may also be used to prevent bleeding during surgery.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Grifols Therapeutics, Inc.

• Kedrion Biopharma, Inc.

• Talecris Biotherapeutics

Serious side effects have been reported with Koate DVI. See the "Koate DVI Precautions" section.

Common side effects of Koate DVI include the following:

• tingling in the arm, ear, and face
• headache
• nausea
• stomach pain
• blurred vision
• jittery feeling

This is not a complete list of Koate DVI side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been evaluated by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

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.

Before taking Koate DVI, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Koate DVI or to any of its ingredients
• have been told that you have inhibitors to factor VIII
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Koate DVI falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Koate DVI should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Koate DVI comes in an injectable form to be given directly into a vein (IV) by a healthcare professional. Koate DVI is given as an infusion over a period of 5 to 10 minutes.

If you miss an appointment to receive a dose of Koate DVI, contact your healthcare provider for instructions on when to receive your next dose.

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.

• Keep all appointments with your doctor and laboratory. Your doctor will order lab tests to check your levels of factor VIII to determine your dose and frequency of Koate DVI.