"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Dose limiting toxicities of NovoSeven (coagulation factor viia (recombinant)) Coagulation Factor VIIa (Recombinant) have not been investigated in clinical trials. The following are examples of accidental overdose. One hemophilia B patient (16 years of age, 68 kg) received a single dose of 352 μg/kg and one hemophilia A patient (2 years of age, 14. 6 kg) received doses ranging from 246 μg/kg to 986 μg/kg on five consecutive days. There were no reported complications in either case. A newborn female with congenital factor VII deficiency was administered an overdose of rFVIIa (single dose: 800 μg/kg). Following additional administration of rFVIIa and various plasma products, antibodies against rFVIIa were detected, but no thrombotic complications were reported. A Factor VII deficient male (83 years of age, 111. 1 kg) received two doses of 324 μg/kg (10-20 times the recommended dose) and experienced a thrombotic event (occipital stroke). The recommended dose schedule should not be intentionally increased, even in the case of lack of effect, due to the absence of information on the additional risk that may be incurred.
NovoSeven Coagulation Factor VIIa (Recombinant) should not be administered to patients with known hypersensitivity to NovoSeven (coagulation factor viia (recombinant)) or any of the components of NovoSeven (coagulation factor viia (recombinant)) . NovoSeven (coagulation factor viia (recombinant)) is contraindicated in patients with known hypersensitivity to mouse, hamster, or bovine proteins.
Last reviewed on RxList: 1/12/2009
This monograph has been modified to include the generic and brand name in many instances.
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