Adult Dosing
Treatment of congenital fibrinogen deficiency
- Dose (mg/kg body weight) = [Target plasma fibrinogen level (mg/dL) - measured plasma fibrinogen level (mg/dL)]/1.7 (mg/dL per mg/kg body weight)
- For patients with unknown fibrinogen level, the recommended dose is 70 mg/kg body weight
Notes:- Indicated for intravenous use only; reconstitute prior to use
- Individualize therapy dose, duration, and frequency of administration based on the extent of bleeding, lab values, and clinical condition of the patient
- Monitor fibrinogen level regularly during treatment. Maintain a target fibrinogen level of 100 mg/dL until hemostasis is obtained
- Administer at room temperature by slow IV injection not exceeding a rate of 5 mL/min
Pediatric Dosing
Treatment of congenital fibrinogen deficiency
- Dose (mg/kg body weight) = [Target plasma fibrinogen level (mg/dL) - measured plasma fibrinogen level (mg/dL)]/1.7 (mg/dL per mg/kg body weight)
- For patients with unknown fibrinogen level, the recommended dose is 70 mg/kg body weight
Notes:- Indicated for intravenous use only; reconstitute prior to use
- Individualize therapy dose, duration, and frequency of administration based on the extent of bleeding, lab values, and clinical condition of the patient
- Monitor fibrinogen level regularly during treatment. Maintain a target fibrinogen level of 100 mg/dL until hemostasis is obtained
- Administer at room temperature by slow IV injection not exceeding a rate of 5 mL/min
[Outline]
See Supplemental Patient Information
- Therapy may cause allergic reactions. Immediately discontinue therapy if symptoms of allergic or early signs of hypersensitivity reactions occur and institute appropriate treatment
- Thrombosis may occur spontaneously in patients with congenital fibrinogen deficiency with/without the use of fibrinogen replacement therapy. Thromboembolic events have been reported during therapy
- Prior to therapy initiation, weigh the benefits of fibrinogen replacement therapy versus the risk of thrombosis. Monitor for signs and symptoms of thrombosis in patients treated with this product
- Therapy is derived from pooled human plasma. Products made from human plasma may contain infectious agents, including viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, that can cause disease. Screen plasma donors for prior exposure to certain viruses in order to reduce the risk of transmitting an infectious agent. Despite these measures, potential for transmitting human pathogenic agents may still exist
Supplemental Patient Information
- Inform patients of the early signs of allergic/hypersensitivity reactions such as hives, chest tightness, generalized urticaria, wheezing, hypotension, and anaphylaxis; advise them to discontinue therapy and contact their physician if such symptoms occur
- Instruct patients to promptly report any symptoms of thrombotic events including unexplained pleuritic chest or leg pain or edema, hemoptysis, dyspnea, tachypnea or unexplained neurologic symptoms to their physician
Pregnancy Category:C
Breastfeeding: Safety unknown.
