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
Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie's syndrome). Perforations have involved varying regions of the GI tract (e.g., stomach, duodenum, colon).
Use RELISTOR with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with RELISTOR and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms.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.
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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