Kovaltry (Recombinant Factor VIII): Uses, Dosage, Side Effects, and More

Kovaltry (antihemophilic factor VIII, recombinant) is a prescription medication for the treatment of hemophilia A, also known as congenital factor VIII deficiency. Kovaltry is used to help control active bleeding episodes, prevent future bleeds, and manage surgery-associated bleeding in people with hemophilia A. 

Kovaltry is a recombinant coagulation factor VIII replacement therapy. The FDA approved it in 2016 after clinical studies showed its safety and effectiveness in people with hemophilia A. 

Clinical trials found that Kovaltry provided effective bleeding prevention in people with hemophilia A when used as routine prophylaxis (prevention) two or three times per week. Common side effects such as fever, rash, and headache were also reported. 

If your healthcare provider has prescribed you Kovaltry, read on to learn how this medication is used, the potential side effects it can cause, and the important safety information you must know before treatment. 

Kovaltry: FDA-Approved Uses

Kovaltry (antihemophilic factor VIII, recombinant) is only approved to treat adults and children with hemophilia A. It is typically prescribed for the following:

• Prophylaxis to prevent or reduce the frequency of bleeding episodes
• As an on-demand treatment to control bleeding episodes 
• As perioperative management to control bleeding during and after surgery 

Kovaltry is not indicated for the treatment of von Willebrand disease. Von Willebrand disease is an inherited bleeding disorder caused by deficient or dysfunctional von Willebrand factor, a protein that plays an important role in normal blood clotting. 

Mode of Action

People with hemophilia A have deficient or dysfunctional clotting factor VIII, a protein needed for normal blood clotting. Deficient factor VIII activity can result in bleeding into joints, muscles, or internal organs, either spontaneously or following accidental or surgical trauma. 

Kovaltry is a recombinant drug made in the laboratory. The active substance in Kovaltry, Octocog alfa, is designed to mimic the function of natural clotting factor VIII. Once infused into the bloodstream, Kovaltry replaces deficient factor VIII and helps promote blood clotting. By temporarily increasing factor VIII activity, Kovaltry helps control or prevent bleeding in people with hemophilia A. 

Drug Form

Kovaltry is available as a single-use vial containing dry, white-to-slightly-yellow factor VIII powder. The medication comes in five FVIII dosage strengths, expressed in international units (IUs). They are labeled and color-coded:

• Blue: 250 IU dosage strength
• Green: 500 IU dosage strength
• Red: 1,000 IU dosage strength
• Yellow: 2,000 IU dosage strength
• Gray: 3,000 IU dosage strength

Each vial with the labeled strength of recombinant factor VIII is mixed with the provided diluent (sterile water) before infusion. 

Dosage and Administration

Kovaltry is given as an intravenous infusion (injected directly into a vein) over several minutes. Your healthcare provider will infuse the first dose and determine the rate of administration that is best for you. 

Your healthcare provider will determine your individual dose based on factors such as your weight, factor VIII levels, bleeding severity, clinical response, and treatment goals. 

Dosage of Kovaltry for Routine Prophylaxis

The recommended dose for adults and adolescents (≥ 12 years of age) is 20 to 40 IU/kg, given two or three times a week. For children younger than 12 years, the recommended dose is 25 to 50 IU/kg, given two or three times a week or every other day. 

Dosage of Kovaltry for On-Demand Treatment of Bleeding

The dosage of Kovaltry is adjusted according to the severity of bleeding. The following are the dosages for treating bleeding ranging from minor to major: 

• Minor bleed: The target factor VIII level is 20–40 IU/dl. Kovaltry may be administered every 12–24 hours for at least 1 day, or until the bleeding is resolved. 
• Moderate bleed: The target factor VIII level is 30–60 IU/dl. Kovaltry may be administered every 12–24 hours for 3–4 days or longer, depending on the clinical response. 
• Major bleed: The target factor VIII level is 60–100 IU/dl. Kovaltry may be administered every 8–24 hours until the bleeding is resolved.

Dosage of Kovaltry for Bleeding Associated with Surgery

For surgery, the recommended factor VIII levels are:

• Minor surgery: 30–60 IU/dl before and after surgery; repeat every 24 hours for at least 1 day or until healing is achieved. 
• Major surgery: 80–100 IU/dl before and after surgery; repeat every 8–24 hours until adequate wound healing, followed by continued therapy to maintain factor VIII activity at 30–60 IU/dl for at least another 7 days.

Possible Side Effects

The most frequently reported side effects of Kovaltry include: 

• Headache
• Fever
• Itching and rash
• Injection-site reactions such as burning and stinging at the injection site
• Chills
• Flushing

Some people receiving Kovaltry may develop neutralizing antibodies called factor VIII inhibitors. These antibodies can reduce or prevent Kovaltry from working effectively. Your healthcare provider may perform blood tests to check for inhibitors, particularly if bleeding is not adequately controlled. 

Although less common, serious allergic reactions, including life-threatening anaphylaxis, can occur with Kovaltry. Symptoms of an allergic reaction may include:

• Chest or throat tightness
• Difficulty breathing or wheezing
• Dizziness
• Hives or rash
• Nausea
• Low blood pressure

Stop using Kovaltry and seek immediate medical attention if you develop signs of a severe allergic reaction.

Precautionary Measures

To ensure Kovaltry is safe for you, tell your healthcare provider if you:

• Have any medical problems such as heart disease or are at risk for heart disease
• Have any planned surgeries or procedures
• Are pregnant or plan to become pregnant 
• Are breastfeeding or plan to breastfeed
• Have any allergies, including allergies to Kovaltry or hamster or mouse proteins 
• Are taking any over-the-counter medications or other coagulation factors, supplements, or herbal products
• Have been told that you have factor VIII inhibitors, as they may reduce the effectiveness of Kovaltry 

Kovaltry: Cost

The cost of Kovaltry can vary from person to person. Your dose, how often you receive treatment, insurance coverage, pharmacy, and location can all affect how much you pay. Since Kovaltry dosing is based on body weight and individual treatment needs, costs may differ considerably between patients.

Insurance and financial assistance programs may help lower your out-of-pocket costs. Contact us for help finding financial assistance and copay assistance for Kovaltry.