Koāte (human antihemophilic factor) for hemophilia
Last updated Sept. 16, 2025, by Marisa Wexler, MS
Fact-checked by Joana Carvalho, PhD
What is Koāte for hemophilia?
Koāte (human antihemophilic factor) is a plasma-derived factor replacement therapy approved to prevent and control bleeding episodes or help manage bleeds during surgery in people with hemophilia A.
Hemophilia A is caused by a deficiency in a clotting protein called factor VIII (FVIII). Koāte contains a version of this protein purified from human plasma, the non-cellular part of blood. By supplying the body with a working version of the missing clotting protein, Koāte can help promote normal clotting in people with hemophilia A.
Marketed by Kedrion Biopharma, Koāte is administered via intravenous (into-the-vein) injections.
Therapy snapshot
| Brand name: | Koāte |
| Chemical name: | Human antihemophilic factor |
| Usage: | Used to prevent and control bleeding episodes or help manage bleeds during surgery in hemophilia A patients |
| Administration: | Intravenous injection |
Who can take Koāte?
Koāte is approved in the U.S. to control and prevent bleeding episodes or to help control bleeding during emergency or elective surgeries in people with hemophilia A.
The therapy is contraindicated or should not be used by anyone with a history of allergic reactions to Koāte or any of its components. It is also not indicated for anyone with von Willebrand disease, another bleeding disorder.
How is Koāte administered?
Koāte is given by intravenous injections, which can be self-administered by patients or given by caregivers after proper training.
The therapy is generally given twice daily, though the exact dose and frequency of administration are tailored based on the individual’s needs. These will typically depend on the severity of FVIII deficiency, the location and extent of bleeding, and the patient’s clinical condition.
Koāte in clinical trials
Koāte’s approval in the U.S. was based on data from a two-stage clinical trial. The first stage tested unheated Koāte against heat-treated Koāte in 19 people, and results showed the two were pharmacologically equivalent.
In the second stage, Koāte was used to treat a total of 306 bleeding episodes in 19 patients over the course of six months. Results showed 82% of bleeding episodes were successfully treated with a single infusion of Koāte.
Common side effects of Koāte
The most common side effects reported in the clinical trial of Koāte include:
- nervousness
- headache
- abdominal pain
- nausea
- paresthesia (tingling or pins-and-needles sensation)
- blurred vision.
Allergic reactions, including serious reactions (anaphylaxis), can happen with Koāte. Early signs of an allergic reaction that can progress to anaphylaxis include:
- swelling
- chest tightness
- low blood pressure
- nausea and vomiting
- paresthesia
- restlessness
- wheezing and shortness of breath.
If an allergic reaction occurs, the therapy should be discontinued and appropriate emergency treatment given.
Some patients given factor replacement therapies like Koāte develop inhibitors, which are neutralizing antibodies that can make the therapy less effective. If Koāte does not increase FVIII activity as expected or if bleeding cannot be controlled with an appropriate dose, patients should be tested for FVIII inhibitors.
Patients with certain blood types (A, B, or AB) who are receiving high and/or frequent doses of Koāte should be monitored for signs of intravascular hemolysis (red blood cell destruction inside blood vessels) and low hematocrit values (low proportion of red blood cells in the blood). If this occurs, Koāte should be discontinued and appropriate treatment given.
Because Koāte is made from human blood, there’s a theoretical risk that it could pass on bloodborne infectious agents, though with modern safety procedures, this risk is extremely low.
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