Use of RELISTOR beyond 4 months has not been studied.1
Contraindications
- RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.1
Warnings and precautions
- If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician.1
- Use of RELISTOR has not been studied in patients with peritoneal catheters.1
Adverse reactions from all doses in double-blind, placebo-controlled clinical studies of RELISTOR1*
*Doses: 0.075, 0.15, and 0.30 mg/kg.
- In placebo-controlled trials, the discontinuation rate due to adverse events was 1.2% for RELISTOR and 2.4% for placebo.1,3
Low potential for drug interactions
- In in vitro drug metabolism studies, RELISTOR did not significantly inhibit the activity of cytochrome P450 (CYP) isozymes CYP1A2, CYP2A6, CYP2C9, CYP2C19, or CYP3A4, while it is a weak inhibitor of CYP2D6.1
- In a study of healthy adult male subjects, a subcutaneous dose of RELISTOR 0.30 mg/kg did not significantly affect the metabolism of dextromethorphan, a CYP2D6 substrate. 0.30 mg/kg is not an approved dosing regimen for RELISTOR.1
- The potential for drug interactions between RELISTOR and drugs that are actively secreted by the kidney has not been investigated in humans.1
The safety and efficacy of RELISTOR have not been established in pediatric patients, pregnant women, or nursing mothers1
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