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Kovaltry is the brand name for antihemophilic factor (recombinant) for IV use.

Kovaltry is available as a single-dose vial containing 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU.

Kovaltry is a recombinant,human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII
deficiency) for:

• On-demand treatment and control of bleeding episodes
• Perioperative management of bleeding
• Routine prophylaxis to reduce the frequency of bleeding episodes

Kovaltry is a clotting factor replacement for people who are missing special blood-clotting proteins called factor VIII (FVIII) due to hemophilia A. By replacing the missing clotting factor (FVIII, or antihemophilic factor) in people who naturally don’t have it, bleeding episodes can be reduced or treated.

Kovaltry is typically dosed as follows:

• Adults and adolescents: 20-40 IU/kg 2 or 3 times per week
• Children ≤12 years old: 25-50 IU/kg 2 times per week, 3 times per week or every other day

Kovaltry is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication if you have a history of hypersensitivity reactions to the active substance, mouse or hamster protein, or other constituents of the product.

Common side effects of Kovaltry:

• Fever
• Headache
• Rash

Serious side effects are rare with Kovaltry. Contact your healthcare provider immediately if you experience any of the following.

• Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue treatment with Kovaltry and administer appropriate treatment

• There are no major drug interactions listed for Kovaltry. However, always let your physician and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking

Bayer Healthcare

There are no data with Kovaltry use in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted using Kovaltry. It is not known whether Kovaltry can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity.

• Anitihemophilic Factor (Recombinant)