Refacto Warnings, Precautions, Pregnancy, Nursing, Abuse - Antihemophilic Factor

Refacto Warnings, Precautions, Pregnancy, Nursing, Abuse - Antihemophilic Factor

WARNINGS

As with any intravenous protein product, allergic type hypersensitivity reactions are possible. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physicians if these symptoms occur.

General

Activity-neutralizing antibodies (inhibitors) have been detected in patients receiving factor VIII-containing products. There is no evidence that ReFacto® Antihemophilic Factor (Recombinant) is associated with a higher-than-historical incidence of inhibitors. As with all coagulation factor VIII products, patients should be monitored for the development of inhibitors that should be titrated in Bethesda Units using appropriate biological testing.

Formation of Antibodies to Mouse and Hamster Protein

As Antihemophilic Factor (Recombinant), ReFacto contains trace amounts of mouse protein (maximum of 5 ng/1000 IU) and hamster protein (maximum of 30 ng/1000 IU), the remote possibility exists that patients treated with this product may develop hypersensitivity to these non-human mammalian proteins.

Carcinogenicity, Mutagenicity, Impairment of Fertility

ReFacto® Antihemophilic Factor (Recombinant) has been shown to be nonmutagenic in the mouse micronucleus assay. No other mutagenicity studies and no investigations on carcinogenesis or impairment of fertility have been conducted.

Pregnancy Category C

Animal reproduction and lactation studies have not been conducted with ReFacto® Antihemophilic Factor(Recombinant). It is not known whether ReFacto can affect reproductive capacity or cause fetal harm when given to pregnant women. ReFacto should be administered to pregnant and lactating women only if clearly indicated.

Pediatric Use

ReFacto® Antihemophilic Factor (Recombinant) is appropriate for use in children of all ages, including newborns. Safety and efficacy studies have been performed both in previously treated children and adolescents (N=22, ages 8-15 years) and in previously untreated neonates, infants, and children (N=101, ages 0-52 months) (see CLINICAL PHARMACOLOGYand

PRECAUTIONS

Geriatric Use

Clinical studies of ReFacto did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. As with any patient receiving ReFacto, dose selection for an elderly patient should be individualized.