Copegus Side Effects

Copegus Information

Copegus Side Effects

The safety of combination Copegus/Pegasys therapy was evaluated in controlled trials of 1010 HCV-infected adults who were previously untreated with interferon therapy and were subsequently treated for 24 or 48 weeks with combination Copegus/Pegasys therapy and in 173 HCV-infected patients who had relapsed after interferon therapy and were subsequently treated for 24 weeks with combination Copegus/Pegasys therapy. Overall, 19% and 6% of previously untreated and relapse patients, respectively, discontinued therapy due to adverse events in the combination arms compared to 13% and 3% in the interferon arms.

The primary event amongst Copegus side effects is hemolytic anemia. Reductions in hemoglobin levels occurred within the first 1-2 weeks of therapy (see WARNINGS ). Cardiac and pulmonary events associated with anemia occurred in approximately 10% of patients treated with Copegus/Pegasys therapy.

The most common psychiatric events occurring in US studies of previously untreated and relapse patients treated with Copegus/Pegasys A therapy, respectively, were insomnia (39%, 26%), depression (34%, 23%), and irritability (27%, 25%). Suicidal behavior (ideation, attempts, and suicides) occurred in 1% of patients. In addition, the following spontaneous adverse events have been reported during the marketing surveillance of Copegus/Pegasys A therapy: hearing disorder and vertigo. Very rarely, combination Copegus/Pegasys A therapy may be associated with aplastic anemia.

Copegus Information