CardioSource WorldNews December 2014 | Page 61

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, consider the possibility
of associated PVOD. If confirmed, discontinue OPSUMIT.

ADVERSE REACTIONS
Most common adverse reactions (more frequent
than placebo by ≥3%) were anemia (13% vs 3%),
nasopharyngitis/pharyngitis (20% vs 13%), bronchitis
(12% vs 6%), headache (14% vs 9%), influenza (6% vs 2%),
and urinary tract infection (9% vs 6%).
DRUG INTERACTIONS
Strong inducers of CYP3A4 such as rifampin significantly
reduce macitentan exposure. Concomitant use of OPSUMIT
with strong CYP3A4 inducers should be avoided.
Strong inhibitors of CYP3A4 like ketoconazole
approximately double macitentan exposure. Many HIV
drugs like ritonavir are strong inhibitors of CYP3A4.
Avoid concomitant use of OPSUMIT with strong CYP3A4
inhibitors. Use other PAH treatment options when strong
CYP3A4 inhibitors are needed as part of HIV treatment.
Please see Brief Summary of Prescribing Information,
including BOXED WARNING for embryo-fetal toxicity,
on adjacent pages.

Decreased Sperm Counts
Other ERAs have caused adverse effects on spermatogenesis.
Counsel men about potential effects on fertility.

® OPSUMIT is a registered trademark of Actelion Pharmaceuticals, Ltd.
© 2014 Actelion Pharmaceuticals US, Inc. All rights reserved. MAC-00323 0114

www.OpsumitHCP.com