Hepatitis B patients taking Sebivo (telbivudine) should not take any interferon drug because of the risk of severe drug interactions, Health Canada is warning patients. Taking both could increase the risk of peripheral neuropathy, or weakness, numbness, tingling, and burning in the arms and/or legs.
In a small clinical trial, serious peripheral neuropathy occurred in five of 48 patients taking both Sebivo and the interferon Pegasys, said Sebivo's maker, Novartis Pharmaceuticals Canada Inc. Symptoms typically manifested about three months into treatment.
It is not known whether the condition is reversible once the combination is stopped, or whether it could also be caused by interferon products other than Pegasys, Health Canada said. Peripheral neuropathy has been reported in five of 2,000 patients taking Sebivo alone during clinical trials. The condition affected an average of 1-5 percent of patients taking Pegasys during clinical trials. But the risk is increased when the treatments are combined, compared to either treatment alone, officials said.
Patients are advised to tell their doctors if they are taking Sebivo and an interferon product, rather than discontinue therapy and risk making the hepatitis infection worse. Product information on Sebivo is being updated, and Novartis has issued an alert to health professionals about the new safety information.
Sebivo is approved for use alone in Canada, not for combination with any interferon products, including standard or pegylated types of interferon alpha (Pegasys, Pegatron, Intron A, Unitron Peg, Rebetron, Roferon A and Infergen) and interferon beta (Rebif, Betaseron and Avonex).
03/14/08
CANADA: Taking Hepatitis B Drug with Interferon Potentially Dangerous: Health Canada
Source: Daily Herald-Tribune:: Canadian Press; Courtesy of the CDC National Center for HIV, STD, and TB Prevention