Xyntha Special Precautions

Hypersensitivity: As with any intravenous protein product, allergic type hypersensitivity reactions are possible. Patients should be informed of the early signs of hypersensitivity (including hives, generalized urticaria, tightness of the chest, wheezing, and hypotension) and anaphylaxis (see Adverse Reactions).
If allergic or anaphylactic reactions occur, administration of XYNTHA should be stopped immediately, and appropriate medical management should be given, which may include treatment for shock. Patients should be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care, depending on the type/severity of the reaction, if any of these symptoms occur.
Activity-neutralizing antibodies (Inhibitors): Activity-neutralizing antibodies (inhibitors) may develop in patients receiving coagulation factor VIII-containing products. As with all coagulation factor VIII products, patients should be monitored for the development of inhibitors that should be titrated in Bethesda Units (BUs) using appropriate biological testing. If expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present. See also Adverse Reactions.
These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in BUs using the Bethesda assay. The risk of developing inhibitors is correlated to the exposure to anti-hemophilic factor VIII, this risk being highest within the first 20 exposure days. Rarely, inhibitors may develop after the first 100 exposure days. Inhibitors are common in previously untreated patients (PUPs) and have been observed in previously treated patients (PTPs) on factor VIII products.
Reports of lack of effect, mainly in prophylaxis patients, have been received in the clinical trials and in the post-marketing setting for the predecessor product, ReFacto. The reported lack of effect with ReFacto has been described as bleeding into target joints, bleeding into new joints or a subjective feeling by the patient of new onset bleeding. When prescribing XYNTHA it is important to titrate and monitor each patient's factor level in order to ensure an adequate therapeutic response. See also Dosage & Administration and Adverse Reactions.
It is recommended that, whenever possible, every time that XYNTHA is administered to patients, the name and batch number of the product is documented.
Abuse and dependence: Antihemophilic Factor (Recombinant), Plasma/Albumin-Free has no potential for abuse. There is no evidence of dependence with Antihemophilic Factor (Recombinant), Plasma/Albumin-Free.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and to use machines have been performed.