Opsumit Adverse Reactions

Summary of the safety profile: The most commonly reported adverse drug reactions are nasopharyngitis (14.0%), headache (13.6%) and anaemia (13.2%, see Precautions). The majority of adverse reactions are mild to moderate in intensity.
Tabulated list of adverse reactions: The safety of macitentan has been evaluated in a long-term placebo-controlled trial of 742 patients with symptomatic PAH. The mean treatment duration was 103.9 weeks in the macitentan 10 mg group, and 85.3 weeks in the placebo group. Adverse reactions associated with macitentan obtained from this clinical study are tabulated as follows.
Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000). (See Table 2.)

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Laboratory abnormalities: Liver aminotransferases: The incidence of aminotransferase elevations (ALT/AST) >3 x ULN was 3.4% on macitentan 10 mg and 4.5% on placebo in a double-blind study in patients with PAH. Elevations >5 x ULN occurred in 2.5% of patients on macitentan 10 mg versus 2% of patients on placebo.
Haemoglobin: In a double-blind study in patients with PAH, macitentan 10 mg was associated with a mean decrease in haemoglobin versus placebo of 1 g/dL. A decrease from baseline in haemoglobin concentration to below 10 g/dL was reported in 8.7% of patients treated with macitentan 10 mg and 3.4% of placebo-treated patients.
White blood cells: In a double-blind study in patients with PAH, macitentan 10 mg was associated with a decrease in mean leucocyte count from baseline of 0.7 x 10⁹/L versus no change in placebo-treated patients.
Platelets: In a double-blind study in patients with PAH, macitentan 10 mg was associated with a decrease in mean platelet count of 17 x 10⁹/L, versus a mean decrease of 11 x 10⁹/L in placebo-treated patients.
Paediatric population: The safety and efficacy of macitentan in children have not yet been established.