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Rx Product News: Profile: A Closer Look at New FDA Actions: NovoSeven RT

Monica Holmberg, PharmD
Published Online: Friday, August 1, 2008   [ Request Print ]


Mr. Eckel is professor and director of the Office of Practice Development and Education at the School of Pharmacy, University of North Carolina at Chapel Hill.



Novo Nordisk's NovoSeven RT

The FDA has approved Novo Nordisk's NovoSeven RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable). NovoSeven RT is approved for the treatment of bleeding episodes and the prevention of bleeding during surgery or invasive procedures in patients with hemophilia A or B with inhibitors to factor VIII or factor IX and in patients with acquired hemophilia or congenital factor VII deficiency.1

Hemophilia can be categorized into 2 classes: patients with hemophilia A (classic hemophilia) who lack factor VIII; patients with hemophilia B (Christmas disease) who lack factor IX. Severe cases may result in spontaneous internal bleeding or bleeding after an injury or surgery, often requiring management by replacing the missing factor via an intravenous (IV) infusion. In some cases, patients receiving IV factor preparations may develop inhibitors, which are antibodies that form in response to the supplemental factor products and neutralize clotting factors, thus resulting in continued bleeding. Cases of strong or high-responding inhibitors may require bypassing agents, such as recombinant factor VIIa or activated prothrombin complex concentrates.2

NovoSeven RT is a new formulation of Novo Nordisk's NovoSeven (Coagulation Factor VIIa [Recombinant]) and no longer requires refrigeration during storage. Unopened vials of NovoSeven RT can be stored for up to 2 years, or until the manufacturer's expiration date, at a temperature between 36?F and 77?F (2?C-25?C).2,3 The original formulation of NovoSeven required storage between 36?F and 46?F (2?C-8?C).3,4

Mechanism of Action

NovoSeven RT complexes with tissue factor to activate coagulation factor X to factor Xa and factor IX to factor IXa. After activation, factor Xa complexes with other factors to convert prothrombin to thrombin, which then prompts fibrinogen to convert to fibrin, and thus leads to local hemostasis.1

Dosage

For the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors, the recommended dose of NovoSeven RT is 90 ?g/kg via IV bolus infusion every 2 hours until either hemostasis occurs or treatment has been determined as inadequate. The duration of dosing after hemostasis is achieved has not been studied; however, treatment of a severe bleed is recommended to continue at 3- to 6-hour intervals after hemostasis is established.

When used for surgical interventions in patients with hemophilia A or B with inhibitors, the recommended initial dose of NovoSeven RT is 90 ?g/kg immediately before the procedure and at 2-hour intervals throughout the surgery. After minor surgery, dosing should continue at 2-hour intervals for 48 hours, then at 2- to 6-hour intervals until the patient has healed. After major surgery, dosing should continue at 2-hour intervals for 5 days, then at 4-hour intervals until the patient has healed.

For the treatment of bleeding episodes or surgical interventions in patients with congenital factor VII deficiency, the recommended dose of NovoSeven RT is 15 to 30 ?g/kg every 4 to 6 hours until hemostasis occurs. For the treatment of patients with acquired hemophilia, the recommended dose is 70 to 90 ?g/kg every 2 to 3 hours until hemostasis occurs.

NovoSeven RT should be administered within 3 hours of reconstitution. NovoSeven RT should never be frozen or mixed with other infusion solutions.1

Contraindications, Warnings, and Precautions

No documented contraindications to treatment exist with NovoSeven RT. One study demonstrated an increased risk of arterial thromboembolic events in elderly patients; however, the indications for which NovoSeven RT was used in these cases were outside its licensed indications. NovoSeven RT should be used cautiously in patients with a known hypersensitivity to any of its components. Patients with factor VII deficiency should have their prothrombin time and factor VII coagulant activity monitored before and after treatment with NovoSeven RT. NovoSeven RT should not be used concomitantly with any other forms of NovoSeven.

NovoSeven RT is a Pregnancy Category C drug. It is unknown if NovoSeven RT is excreted into human milk; however, many drugs are excreted into breast milk and given the potential for adverse harm in nursing infants—either nursing or the drug should be discontinued as based on the importance of treatment to the mother.

The most common adverse reactions to NovoSeven RT include fever, bleeding, reactions at the injection site, arthralgia, headache, hypertension, hypotension, nausea, vomiting, pain, edema, and rash.1

References

  1. NovoSevenRT [package insert]. Princeton, NJ: Novo Nordisk Inc; 2008. www.novosevenrt.com/pdfs/PI_novosevenrt.pdf. Accessed June 2008.
  2. FDA approves Novo Nordisk's NovoSeven RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) for Hemophilia Patients with Inhibitors [press release]. Princeton, NJ: Novo Nordisk Inc; May 13, 2008. press.novonordisk-us.com/novopress.Actions.ShowPressReleaseAction.do?rid=422&type=pdf. Accessed June 2008.
  3. News Briefs. Am J Health Syst Pharm. 2008;65(12):1114.
  4. FDA approves new formulation of Coagulation Therapy: NovoSeven RT Can Be Stored at Room Temperature. FDA Web site. www.fda.gov/bbs/topics/NEWS/2008/NEW01833.html. Accessed June 2008.
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