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