(Coagulation Factor VIIa [Recombinant], Novo Nordisk A/S)

A new formulation of recombinant factor VIIa that can be stored at room temperature for up to 2 years, approved by the Food and Drug Administration in May for the same indications as NovoSeven Coagulation Factor VIIa (Recombinant):

* Recommended Dosage: Administered only as an IV bolus injection and at various intervals depending on the indication and factors such as when homeostasis is achieved. Dosing is based on weight.

* Special Considerations: Fever, bleeding, injection site reaction, joint discomfort, headache, nausea, vomiting, pain, swelling, rash, and elevations or drops in blood pressure are the most common adverse reactions. An increased risk of arterial thromboembolic events has been reported in some elderly patients treated with NovoSeven for off-label indications. Not recommended for use in combination with other NovoSeven formulations.

* Comment: Because it contains sucrose and L-methionine, this new formulation is stable at room temperature (up to 77[degrees] F), which is helpful for facilities with limited refrigeration space, according to the FDA statement announcing approval. The original formulation, also manufactured by Novo Nordisk, could be stored for 3 years at temperatures between 36[degrees] and 46[degrees] F. "Approval of this product for room temperature storage creates greater flexibility in disease management for patients and physicians," Dr. Jesse Goodman, director of the FDKs Center for Biologics Evaluation and Research, said in the statement.

BY ELIZABETH MECHCATIE, SENIOR WRITER