Patient dramatization
when hepatic enzyme levels normalize in patients who
have not experienced clinical symptoms of hepatotoxicity.
Hemoglobin Decrease
Decreases in hemoglobin concentration and hematocrit
have occurred following administration of other ERAs
and in clinical studies with OPSUMIT. These decreases
occurred early and stabilized thereafter.
In the SERAPHIN study, OPSUMIT caused a mean decrease
in hemoglobin (from baseline to 18 months) of about
1.0 g/dL vs no change in the placebo group. A decrease
in hemoglobin to below 10.0 g/dL was reported in 8.7%
of the OPSUMIT group vs 3.4% for placebo. Decreases in
hemoglobin seldom require transfusion.
Initiation of OPSUMIT is not recommended in patients
with severe anemia. Measure hemoglobin prior to
initiation of treatment and repeat during treatment as
clinically indicated.
Pulmonary Edema with Pulmonary Veno-occlusive
Disease (PVOD)
Should signs of pulmonary edema occur, co