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Take a proactive approach to OIC
RELISTOR tablets offer convenient once-daily dosing1
RELISTOR tablets are indicated for the treatment of OIC in adult patients with chronic non-cancer pain:
The recommended dosage is 450 mg (three 150-mg tablets) taken orally once daily in the morning.1
- Take RELISTOR tablets with water on an empty stomach at least 30 minutes before the first meal of the day
- Discontinue all maintenance laxative therapy prior to initiation of RELISTOR. Laxative(s) can be used as needed if there is a suboptimal response to RELISTOR after 3 days
- RELISTOR therapy should be continued only during opioid use
- Reevaluate the continued need for RELISTOR when the opioid regimen is changed to avoid adverse reactions
- Please refer to full Prescribing Information for dose adjustments in patients with renal or hepatic impairment
RELISTOR helps to restore gut function by increasing the number of spontaneous bowel movements (SBMs)1
Significantly more patients taking RELISTOR experienced at least 3 SBMs* per week1,11,†
In a clinical study of RELISTOR tablets in adult patients with chronic non-cancer pain:
STUDY DESIGN: In a 4-week, randomized, multicenter, double-blind, placebo-controlled, phase 3 study, the efficacy of RELISTOR tablets was evaluated in 401 patients (200 RELISTOR tablets, 201 placebo) 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.1,11
*SBM is defined as bowel movement without the use of any laxative in previous 24 hours.1,11
†Responder is defined as a patient with 3 or more SBMs per week, with an increase of 1 or more SBM(s) per week over baseline, for 3 or more out of the first 4 weeks of the treatment period.1
‡Three RELISTOR 150-mg tablets (450 mg total) once daily in the morning with water on an empty stomach at least 30 minutes before the first meal of the day.1
SIGNIFICANTLY MORE PATIENTS EXPERIENCED RELIEF* WITHIN 4 HOURS1,11,§
- 27% of dosing days in the RELISTOR tablets 450-mg‡ treatment group (n=200)
- 18% placebo (n=201)
- Significant difference (P<.0001)
§During the 4-week, double-blind period.1
- 27% of dosing days in the RELISTOR tablets 450-mg‡ treatment group (n=200)
- 18% placebo (n=201)
- Significant difference (P<.0001)
§During the 4-week, double-blind period.1
RELISTOR has a well-established safety profile1
Most common adverse reactions
IN THE 4-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED PERIOD OF THE CLINICAL STUDY (N=401) (STUDY 1)1
||Adverse reactions occurring in at least 2% of patients receiving 3 RELISTOR 150-mg tablets (450 mg total) 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 of abdominal pain, diarrhea, hyperhidrosis, anxiety, rhinorrhea, and chills may reflect symptoms of opioid withdrawal1
RELISTOR’s molecular properties
- RELISTOR is a uniquely methylated peripherally acting mu-opioid receptor antagonist (PAMORA)1
- – Restricted from crossing the blood-brain barrier#
- – No compromise of opioid-mediated analgesia in the central nervous system in clinical trials
- RELISTOR is minimally metabolized and is excreted from the body primarily unchanged1:
- – No significant pharmacokinetic drug-drug interactions1,11,**
- – Only PAMORA for OIC not metabolized through the CYP3A4 pathway1,11
#Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.1
**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.1
