Naltrexone-Bupropion XL for Chronic Weight Management
FDA-Approved Indications
- The FDA approves naltrexone-bupropion XL as an adjunct to reduced-calorie diet and increased physical activity for chronic weight management in adults with BMI ≥30 kg/m² (obesity) 1
- The FDA approves naltrexone-bupropion XL as an adjunct to reduced-calorie diet and increased physical activity for chronic weight management in adults with BMI ≥27 kg/m² (overweight) with at least one weight-related comorbidity 2
FDA-Approved Indications for Individual Components
- Bupropion is FDA approved for major depressive disorder (MDD) 3
- Naltrexone is FDA approved for alcohol dependence 2
- Naltrexone is FDA approved for opioid dependence 2
Clinical Considerations for Off-Label Use
- The combination of naltrexone-bupropion has limited evidence for the treatment of major depressive disorder (MDD) 1
- A small open-label study in women with MDD showed improvement in depressive symptoms with naltrexone-bupropion XL 1
- Most large clinical trials for naltrexone-bupropion excluded subjects with significant psychiatric disorders or those using antidepressants 1
- There is no FDA approval or strong evidence for the treatment of marijuana use disorder with naltrexone-bupropion XL 4
Important Safety Considerations
- Naltrexone-bupropion XL is contraindicated in patients requiring opioid therapy due to naltrexone's opioid antagonism 1
- Naltrexone-bupropion XL should be discontinued before procedures requiring opioid analgesia 1
- Naltrexone-bupropion XL should be avoided in patients with uncontrolled hypertension 1, 2
- Naltrexone-bupropion XL should be avoided in patients with seizure disorders (bupropion may lower seizure threshold) 1, 3
Dosing Considerations
- The standard titration schedule for naltrexone-bupropion XL for obesity starts with 1 tablet daily (8 mg naltrexone/90 mg bupropion) 1
- The dose should be escalated weekly to a maintenance dose of 2 tablets twice daily 1
- Dose adjustments are required for moderate to severe renal impairment and moderate to severe hepatic impairment 1, 3