ACTOP11032 - Opsumit Brief Summary PI
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Giant Creative Strategy
OPSUMIT® (macitentan)
Hepatotoxicity
Other ERAs have caused elevations of aminotransferases, hepatotoxicity, and liver
failure. The incidence of elevated aminotransferases in the study of OPSUMIT in PAH
is shown in Table 1.
Table 1: Incidence of Elevated Aminotransferases in the SERAPHIN Study
OPSUMIT 10 mg
(N=242)
Placebo
(N=249)
>3 × ULN
3.4%
4.5%
>8 × ULN
2.1%
0.4%
Rx only
BRIEF SUMMARY
The following is a brief summary of the full Prescribing Information for OPSUMIT®
(macitentan). Please review the full Prescribing Information prior to prescribing
OPSUMIT.
WARNING: EMBRYO-FETAL TOXICITY
• Do not administer OPSUMIT to a pregnant female because it may cause
fetal harm [see Contraindications (Pregnancy), Warnings and Precautions
(Embryo-fetal Toxicity), Use in Specific Populations (Pregnancy)].
• 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 [see
Use in Special Populations (Females and Males of Reproductive Potential)].
• For all female patients, OPSUMIT is available only through a restricted
program called the OPSUMIT Risk Evaluation and Mitigation Strategy
(REMS) [see Warnings and Precautions (OPSUMIT REMS Program)].
INDICATIONS AND USAGE
Pulmonary Arterial Hypertension
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%).
CONTRAINDICATIONS
Pregnancy
OPSUMIT may cause fetal harm when administered to a pregnant woman. OPSUMIT
is contraindicated in females who are pregnant. OPSUMIT was consistently shown to
have teratogenic effects when administered to animals. If OPSUMIT is used during
pregnancy, apprise the patient of the potential hazard to a fetus [see Warnings and
Precautions (Embryo-fetal Toxicity) and Use in Specific Populations (Pregnancy)].
WARNINGS AND PRECAUTIONS
Embryo-fetal Toxicity
OPSUMIT may cause fetal harm when administered during pregnancy and is
contraindicated for use in females who are pregnant. In females of reproductive
potential, exc