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*Calculate the injection volume for these patients by multiplying the patient weight in kilograms by 0.0075 and then rounding up the volume to the nearest 0.1 mL.
PERCENTAGE OF PATIENTS
STUDY DESIGN: Study 2 was a 4-week, multicenter, double-blind, randomized, placebo-controlled, phase 3 study. The efficacy of RELISTOR injection was evaluated in 312 patients with CNCP for which they were taking opioids. All patients had OIC, defined as <3 SBMs per week and at least one additional symptom of constipation.1
†A responder was defined as a patient with 3 or more SBMs per week for each of the 4 weeks in the double-blind period.1
‡SBM is defined as bowel movement without the use of any laxative in previous 24 hours.1
STUDY DESIGNS: IN ADULT PATIENTS WITH ADVANCED ILLNESS
STUDY 4 was a multicenter, double-blind, randomized, placebo-controlled study; 154 patients with advanced illness and OIC received a single subcutaneous dose of RELISTOR injection or placebo.1,12
STUDY 5 was a 2-week, multicenter, double-blind, randomized, placebo-controlled trial followed by a subsequent 3-month, open-label extension study. The efficacy of RELISTOR was evaluated in 133 patients.1,13
Approximately 50% of patients who had an SBM within 4 hours of first dose in Studies 4 and 5 experienced an SBM§ within 30 minutes12,13
§SBM is defined as laxation without the use of a rescue laxative.12,13
||Adverse reactions occurring in at least 1% of patients receiving RELISTOR injection 12 mg subcutaneously once daily and at an incidence greater than placebo.1
¶Includes: abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness.1
#Adverse reactions occurring in at least 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.1
**Includes: abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness.
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