Relistor: US FDA label indications
US FDA labelNot medical advice
Label details
- Brand name
- Relistor
- Generic name
- Methylnaltrexone Bromide
- Manufacturer
- Salix Pharmaceuticals, Inc.
- Route
- Oral
- Product type
- Human Prescription Drug
- Substance
- Methylnaltrexone Bromide
- Application number
- NDA208271
Indications and usage (label excerpt)
1 INDICATIONS AND USAGE • RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. ( 1.1 ) • RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. ( 1.2 ) 1.1 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. 1.2 Opioid-Induced Constipation in Adult Patients with Advanced Illness RELISTOR injection is indicated for the treatment of OIC in adult patients with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.
Warnings (label excerpt)
5 WARNINGS AND PRECAUTIONS • Gastrointestinal Perforation : Consider the overall risk benefit in patients with known or suspected lesions of the GI tract. Monitor for severe, persistent or worsening abdominal pain; discontinue if development of symptoms. ( 5.1 ) • Severe or Persistent Diarrhea : Discontinue if severe or persistent diarrhea occurs during treatment. ( 5.2 ) • Opioid Withdrawal : Consider the overall risk benefit in patients with disruptions to the blood-brain barrier. Monitor closely for symptoms of opioid withdrawal. ( 5.3 ) 5.1 Gastrointestinal Perforation Cases of gastrointestinal perforation have been reported in adult patients with OIC and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overa…
Excerpts are shortened. Read the full label, and ask a pharmacist or prescriber about any medicine. Full label on DailyMed(opens in a new tab) For products sold in Canada, see the Health Canada Drug Product Database(opens in a new tab).
Trials whose interventions mention this drug
Canadian trials first. A match on the drug name does not mean the trial studied this specific product.
3 trials, recruiting first
| Phase | Countries | ||||
|---|---|---|---|---|---|
| Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics NCT04787848 | Recruiting | Not applicable | United States | Florida International University | 2021-11-15 |
| Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain NCT00547586 | Completed | Phase 2 | United States | Bausch Health Americas, Inc. | 2007-10 |
| Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain NCT00529087 | Completed | Phase 3 | United States | Bausch Health Americas, Inc. | 2007-08 |
Source: openFDA drug label (US FDA), snapshot October 2026. Not a Health Canada Product Monograph.