FDA Approves Antihemophilic Factor Preparation

by pharmacy on October 21, 2015

Nuwiq_Recombinant_AntihemophilicA recombinant antihemophilic factor preparation produced by human cells has been approved by the FDA for use in patients who have hemophilia A.

According to the product labeling, it is intended to provide “on-demand” treatment and control of bleeding episodes. It is also intended to help with routine bleeding prophylaxis and the management of bleeding prior to an operation.

The new medication, known as Nuwiq, is manufactured by Swedish company, Octapharma AB. It will be distributed by Octapharma USA, Inc. here in the United States. The company aims to have the product available in the United States in early 2016.

The product will be available in single-use vials, containing 250, 500, 1000, or 2000 IU of the freeze-dried factor. Each vial is to be packaged with a syringe filled with 2.5 mL of water for injection, with a vial adapter, a butterfly needle, and a couple of alcohol swabs.

The vials are intended to be stored at 35.6 to 46.4 degrees. They can be stored at room temperature, up to 77 degrees, for up to three months.

After the vial is reconstituted, the solution must be kept at room temperature, and has to be used within three hours.

Adolescents aged 12 to 17 and adults should be given 30 to 40 IU/kg of body weight every other day for routine prophylaxis. Children aged two to 11 should be given 30 to 50 IU/kg of body weight every other day, or three times a week.

The frequency and duration of therapy will depend on the severity of the FVIII deficiency, the location and extent of blending, and the clinical condition of the patient.

In pediatric use for children aged two to five, higher doses and more frequent dosing is suggested for prophylactic treatment. There is a lower recovery, shorter half life, and faster clearance in children aged two to 11, so this should be considered.

Minor bleeding episodes can be treated with 20 to 40 IU/dL every 12 to 24 hours for at least a day or until the bleeding episode stops. Moderate to major bleeding episodes should be treated with 30 to 60 IU/dL every 12 to 24 hours for at least three to four days, or until the bleeding stops. For life-threatening episodes, 50 to 100 IU/dL should be administered every eight to 24 hours until the bleeding risk is resolved.

Clinical trials showed the following frequently reported side effects: headache, injection site pain and inflammation, vertigo, dry mouth, paresthesia, back pain, and the formation of non neutralizing antibodies to factor VIII, though they don’t present any inhibitory activity.

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