Feiba Vh (Anti-Inhibitor Coagulant Complex)

WARNING

THROMBOEMBOLIC EVENTS

Thromboembolic events have been reported during post-marketing surveillance following infusion of Feiba, particularly following the administration of high doses and/or in patients with thrombotic risk factors. Monitor patients receiving Feiba for signs and symptoms of thromboembolic events.

The most frequently reported adverse reactions observed in > 5% of subjects in the prophylaxis trial were

• anemia,
• diarrhea,
• hemarthrosis,
• hepatitis B surface antibody positive,
• nausea, and
• vomiting.

The serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including

• stroke,
• pulmonary embolism and
• deep vein thrombosis.

For intravenous use after reconstitution only.

Dose

A guide for dosing Feiba is provided in Table 1.

Table 1 : Dosing Guidelines

• Dosage and duration of treatment depend on the location and extent of bleeding, and the patient's clinical condition. Careful monitoring of replacement therapy is necessary in cases of major surgery of life-threatening bleeding episodes.
• Each vial of Feiba contains the labeled amount of factor VIII inhibitor bypassing activity in units.
• Base the dose and frequency of Feiba on the individual clinical response. Clinical response to treatment with Feiba may vary by patient, and may not correlate with the patient's inhibitor titer.
• Record the name of the patient and batch number of the product in order to maintain a link between the patient and the batch of the product.
• Do not exceed a single dose of 100 units per kg body weight and a daily dose of 200 units per kg body.

Concomitant Medications

• Consider the possibility of thrombotic events when systemic antifibrinolytics such as tranexamic acid and aminocaproic acid are used during treatment with Feiba.
• No adequate and wellcontrolled studies of the combined or sequential use of Feiba and recombinant factor VIIa or antifibrinolytics have been conducted.
• Use of antifibrinolytics within approximately 6 to 12 hours after the administration of Feiba is not recommended.

• There are no adequate and well-controlled studies in pregnant women. It is also not known whether Feiba can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
• Feiba should be administered to pregnant women only if clearly needed.
• It is not known whether this drug is excreted in human milk.
• Because many drugs are excreted in human milk, caution should be exercised when Feiba is administered to a nursing woman.