RELISTOR has not been shown to significantly inhibit or induce the activity of the CYP3A4 pathway.1*
*The clinical significance of these in vitro data is unknown.
Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.
Safety was evaluated in 4 double-blind, placebo-controlled trials as well as open-label studies, including:
†In advanced illness trials.
‡Daily opioid use did not vary in RELISTOR-treated patients.
§In RELISTOR-treated patients, there were no clinically relevant differences in pain scores.
Adverse reactionsll in 4-week double-blind, placebo-controlled period of clinical study of RELISTOR tablets in adult patients with OIC and CNCP1
llAdverse reactions occurring in ≥2% of patients receiving RELISTOR tablets 450 mg once daily and at an incidence greater than placebo.
Adverse reactions¶ in a 4-week double-blind, placebo-controlled period of clinical study of RELISTOR injection in adult patients with OIC and CNCP1
¶Adverse reactions occurring in ≥1% of patients receiving RELISTOR 12 mg SC once daily and at an incidence greater than placebo.
Adverse reactions from all doses in double-blind, placebo-controlled clinical studies of RELISTOR injection in adult patients with OIC and advanced illness1#
#Adverse reactions occurring in ≥5% of patients receiving all doses of RELISTOR injection (0.075, 0.15, and 0.3 mg/kg) and at an incidence greater than placebo.
To report SUSPECTED ADVERSE REACTIONS, contact Salix at 1-800-508-0024 or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch/
Please click here for full Prescribing Information for RELISTOR tablets and RELISTOR injection.