Not to be administered into areas where skin is red, bruised, tender or hard, or areas w/ moles or scars. Discontinue treatment w/ bypassing agents the day before starting therapy. Thrombotic microangiopathy & thromboembolism associated w/ treatment & activated prothrombin complex conc. Immunogenicity. Lab coagulation test interference eg, aPTT, Bethesda assays (clotting-based) for FVIII inhibitor titers, 1-stage, aPTT-based, single-factor assays (eg, FVIII activity), aPTT-based activated protein C resistance, activated clotting time. Pregnancy & lactation.