Koāte: Uses, Dosage, Side Effects, Warnings, and Cost

Koāte-DVI (also marketed as KOĀTE) is an FDA-approved injectable drug used for the control and prevention of bleeding in people with hemophilia A. It works by temporarily replacing the clotting factor VIII protein and helps the blood clot properly.  

Koāte-DVI is also known by its generic name, antihemophilic factor (human), meaning it is derived from donated human plasma. Koāte-DVI belongs to the coagulation factors and hemostatic drug class and is only available with a doctor’s prescription. 

This article discusses everything you need to know about Koāte-DVI, including its uses, benefits, recommended dose, possible side effects, and important safety information. 

Indication

Koāte-DVI (antihemophilic factor [human]) is used to control and prevent bleeding episodes in people with hemophilia A. It is also used to manage bleeding during emergency or elective surgery in people with hemophilia A. 

This drug is not indicated for the treatment of von Willebrand disease. 

Mechanism of Action

In patients with hemophilia A, the clotting factor VIII is either missing or not functioning properly. As a result, people with hemophilia A may bleed longer and more frequently than people with a normal amount of clotting factor VIII in their body. 

Koāte-DVI, a human plasma-derived Factor VIII, temporarily replaces the missing or nonfunctional clotting factor VIII when infused and helps control bleeds in people with hemophilia A. The half-life of Koāte-DVI can vary between patients. 

Koāte-DVI: Drug Form

Koāte-DVI is available as a lyophilized powder for reconstitution in single-use vials containing 250 IU (yellow), 500 IU (blue), and 1,000 IU (red) of Factor VIII activity. 

Every vial of Koāte-DVI comes with a Mix2Vial transfer device, allowing for needle-free reconstitution. You can ask your healthcare provider about the Mix2Vial Practice Kit for step-by-step Koāte-DVI administration instructions to help you become comfortable with the reconstitution process. 

Koāte-DVI: Dosage 

The dosage and frequency of Koāte-DVI are adjusted according to the patient’s clinical condition, the severity of the Factor VIII deficiency, and the location and extent of bleeding. 

Koāte-DVI Dosage by Type of Bleeding Episodes

The recommended dosage of Koāte-DVI based on the type of bleeding is as follows:

Minor bleeding

If you experience a minor bleed such as large bruises, significant cuts or scrapes, or uncomplicated joint hemorrhage, a dose of 15 IU/kg may be given every 12 hours until bleeding stops and healing occurs (usually 1–2 days). 

Moderate bleeding

If you experience moderate bleeding (e.g., from the nose, mouth, or gums), dental extractions, or hematuria, a dose of 25 IU/kg may be given every 12 hours until healing occurs (an average of 2–7 days). 

Major bleeding

If you experience major bleeding such as joint or muscle hemorrhage, major trauma, hematuria, or intracranial or intraperitoneal bleeding, an initial dose of 40–50 IU/kg may be given, followed by a maintenance dose of 25 IU/kg every 12 hours. Treatment may continue until healing is achieved, for up to 10 days. Intracranial bleeding may require prophylactic therapy for up to 6 months. 

Koāte-DVI Dosage for Surgery 

The recommended dosage of Koāte-DVI for surgery is as follows: 

• Before surgery, you may receive a dose of 40–50 IU/kg once to achieve an FVIII level of 80–100%.
• After surgery, a dose of 30–50 IU/kg every 12 hours is recommended to maintain FVIII levels of 60–100% for 7–10 days or until healing is achieved.

How Koāte-DVI Is Given

Koāte-DVI is given intravenously (IV) after the powder is mixed with sterile water. Follow your healthcare provider’s instructions for preparing and administering Koāte-DVI. 

The prepared solution should be used within 3 hours and should not be refrigerated after mixing. The IV administration rate should not exceed 10 ml per minute. Your healthcare provider will adjust the administration rate according to your tolerance and condition. 

Side Effects

The most common side effects associated with Koāte-DVI infusion include:

• Nervousness
• Headache
• Abdominal pain (stomach ache)
• Nausea
• Tingling sensation, “pins and needles” in your face, arms, or ears
• Blurred vision

Severe Side Effects

While less common, it is possible that you may experience severe allergic reactions to Koāte-DVI. The common signs and symptoms of allergic reactions are as follows:

• Hives
• Chest tightness
• Wheezing
• Difficulty breathing
• Feeling light-headed
• Fainting
• Swelling of your face, lips, tongue, or throat
• Stomach cramps
• Joint pain
• Low blood pressure

Get immediate medical help if you experience symptoms of a severe allergic reaction. In that case, your healthcare provider will discontinue the Koāte-DVI treatment and administer the appropriate treatment. 

Warnings and Precautions

There are some important warnings and precautions to be aware of before starting and during treatment with Koāte-DVI: 

• Develop Factor VIII inhibitors: Your body may make antibodies that reduce or stop Koāte-DVI from working properly. Tell your healthcare provider if the medicine does not control your bleeding as well as expected.
• Develop anemia from red blood cell breakdown: Large or frequent doses of Koāte-DVI may cause red blood cells to break down, especially if you have blood type A, B, or AB. Your healthcare provider may do blood tests to check for this problem.
• Transmission of infectious agents: Because Koāte-DVI is made from human blood, it may carry a risk of transmitting infectious agents. Measures are used during manufacturing to reduce this risk, but the possibility of transmitting infectious diseases cannot be completely eliminated. 

Information to Tell Your Healthcare Provider

To make sure Koāte-DVI treatment is safe for you, it is important to share your medical history with your doctor. Tell your healthcare provider if you:

• Are pregnant or plan to become pregnant (because there are not enough data to determine the drug-associated risk during pregnancy) 
• Are breastfeeding (because it is not known whether Koāte-DVI passes into human milk or affects a breastfed baby or milk production) 
• Have any planned surgeries or dental procedures
• Are taking any over-the-counter medications or other coagulation factors, supplements, or herbal products
• Have been told that you have inhibitors to factor VIII because Koāte-DVI may not work for you

Koāte-DVI: Cost

The cost of Koāte-DVI can vary depending on your Factor VIII requirements, body weight, treatment frequency, insurance coverage, and the number of vials needed. 

Eligible patients with commercial insurance and financial need may qualify for the manufacturer’s copay assistance program, subject to program terms and eligibility requirements. Contact us if you are interested in exploring financial assistance or copay assistance for Koāte-DVI.

The manufacturer also offers the KOĀTE TRY-IT Program, which allows eligible patients to try Koāte-DVI for up to 2 weeks at no cost, with a maximum of 50,000 IU. To qualify, patients must not currently be using Koāte-DVI and must not have a currently diagnosed Factor VIII inhibitor.