LISBON — Recombinant factor VIIa is potentially lifesaving for women undergoing massive hemorrhage after delivery, Dr. Claire McLintock said at the annual meeting of the International Society of Obstetric Medicine.
Although little information is available on the benefits and risks of treatment with recombinant factor VIIa in postpartum women, it's an option when all other treatments have failed to stop bleeding, said Dr. McLintock, an obstetric physician and hematologist at National Women's Health at Auckland City Hospital, New Zealand.
“I'm not sure that a randomized trial will ever be done” to test the drug's safety and efficacy, so for the time being, registry reviews provide the only data, she said.
A registry of factor VIIa recipients in Australia and New Zealand with a total of 289 patients includes eight cases of obstetric use. Each of the eight women received a single dose. In two women, the bleeding stopped immediately after treatment, and in the other six, bleeding slowed. Treatment also led to reduced transfusions with red cells, platelets, cryoprecipitate, and fresh frozen plasma.
The registry is sponsored by Novo Nordisk, which markets recombinant factor VIIa (NovoSeven). Novo Nordisk also provided travel funds for Dr. McLintock.
Another registry for obstetric patients receiving recombinant factor VIIa is kept by 475 hospitals in several northern European countries. This registry recently included 77 women who received the drug for bleeding, and bleeding improved in 82%. Three of the women (4%) had a thromboembolism after treatment.
“There is no doubt that treatment with factor VIIa has a thromboembolism risk that may be as high as 2%–4%, but this risk may be outweighed by benefits,” said Dr. McLintock. “In addition, the risks from massive blood transfusion cannot be underestimated.”
Cost is an issue. In the United States, the average wholesale cost for the drug is $1.48/mcg, according to the 2005 Red Book. The effective dose in hemorrhage has not been established, but 100 mcg/kg is recommended when factor VIIa is used for hemophilia patients. Dr. McLintock recommended a dose of 100 mcg/kg that is rounded off to the nearest vial size. For a 60-kg woman, the dose would be 6,000 mcg, which would cost almost $9,000. Factor VIIa works quickly; if the patient doesn't respond to the first dose within 20 minutes, consider giving a second dose, she said.
Once a patient has received a massive transfusion with red cells, platelets, cryoprecipitate, and fresh frozen plasma, dilution of clotting factors worsens the coagulopathy and makes it harder to stop bleeding. Such cases are “hard to rescue without a dramatic treatment” such as factor VIIa, Dr. McLintock said.
If the patient doesn't respond to the first dose within 20 minutes, consider giving a second dose. DR. MCLINTOCK