In the treatment of pulmonary arterial hypertension (PAH, WHO Group I )
HELP HER WRITE FUTURE CHAPTERS
OPSUMITĀ® (macitentan) is the only ERA approved to delay disease progression as
both monotherapy and in combination with PDE-5 inhibitors or inhaled prostanoids1
OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of
pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression.
Disease progression included: death, initiation of intravenous (IV) or subcutaneous
prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance,
worsened PAH symptoms and need for additional PAH treatment).
OPSUMIT also reduced hospitalization for PAH.
Effectiveness was established in a long-term study in PAH patients with
predominantly WHO Functional Class II-III symptoms treated for an
average of 2 years.
Patients were treated with OPSUMIT monotherapy or in
combination with phosphodiesterase-5 inhibitors or
inhaled prostanoids.
Patients had idiopathic and heritable PAH (57%), PAH caused
by connective tissue disorders (31%), and PAH caused by
congenital heart disease with repaired shunts (8%).
IMPORTANT SAFETY INFORMATION
BOXED WARNING: EMBRYO-FETAL TOXICITY
Do not administer OPSUMIT to a pregnant female because it may cause fetal harm.
Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after
stopping treatment. Prevent pregnancy during treatment and for one month after stopping treatment by using acceptable methods
of contraception.
For all female patients, OPSUMIT is available only through a restricted program called the OPSUMIT Risk Evaluation and Mitigation
Strategy (REMS).
CONTRAINDICATIONS
Pregnancy: OPSUMIT may cause fetal harm when administered to a pregnant woman. OPSUMIT is contraindicated in females who are pregnant.
If OPSUMIT is used during pregnancy, apprise the patient of the potential hazard to a fetus.
WARNINGS AND PRECAUTIONS
Embryo-fetal Toxicity and OPSUMIT REMS Program
Due to the risk of embryo-fetal toxicity, OPSUMIT is available for females only through a restricted program called the OPSUMIT REMS Program.
For females of reproductive potential, exclude pregnancy prior to initiation of therapy, ensure use of acceptable contraceptive methods, and
obtain monthly pregnancy tests.
Notable requirements of the OPSUMIT REMS Program include:
Prescribers must be certified with the program by enrolling and completing training.
All females, regardless of reproductive potential, must enroll in the OPSUMIT REMS Program prior to initiating OPSUMIT. Male patients are not
enrolled in the REMS.
Females of reproductive potential must comply with the pregnancy testing and contraception requirements.
Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive OPSUMIT.
6MWD: 6-minute walk distance; ERA: endothelin receptor antagonist; IV: intravenous; PAH: pulmonary arterial hypertension; PDE-5: phosphodiesterase type 5;
SC: subcutaneous; SERAPHIN: Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve CliNical Outcome; ULN: upper limit
of normal; WHO: World Health Organization.
Please see Important Safety Information throughout and Brief Summary of Prescribing Information,
including BOXED WARNING for embryo-fetal toxicity, on adjacent pages.