LIRAGLUTIDE INJ,SOLN
Clinical Criteria Summary
Indications & Eligibility
- For chronic weight management in conjunction with comprehensive lifestyle intervention
- Offered to patients with a body mass index (BMI) > 30 kg/m² and to those with a BMI > 27 kg/m² who also have obesity-associated conditions
- Formulary status: VA National Formulary (VANF) with Prior Authorization at the Facility level (PA-F) with Criteria for Use (CFU); not a controlled substance
Inclusion Criteria
- Documented participation in a comprehensive lifestyle intervention targeting diet, physical activity, and behavioral changes within the past year
- Participation may include MOVE! programs, remote patient monitoring home telehealth (TeleMOVE!/L2), clinically supported web/mobile applications with clinical contact, or non-VA programs meeting the operational definition
Exclusion Criteria & Contraindications
- Pregnancy
- Breastfeeding
- Uncontrolled hypertension
- Seizure disorder
- Bulimia or anorexia nervosa
- Chronic opioid use or acute opioid withdrawal
- Monoamine oxidase inhibitor (MAOI) use during or within 14 days
- Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs
Efficacy & Monitoring Goals
- Initial weight loss goal: ≥5% weight loss by 12 weeks
- Discontinue if the 5% weight loss goal is not achieved at 12 weeks, as clinically meaningful reduction is unlikely with continued treatment
- Weight maintenance goals for continued therapy: Maintenance of ≥67% initial weight loss, >5% loss from baseline weight, or continued weight loss
- Discontinue if sufficient weight loss is not achieved within the first 3 months on a maximally tolerated dose or if significant weight gain/regain occurs after initial loss
Comorbidity Considerations
- Hypertension: Contraindicated in uncontrolled hypertension; may increase blood pressure or cause hypertension
- Cardiac/Cerebrovascular Disease: Monitor heart rate or blood pressure per usual practice; discontinue if sustained. Unknown impact on listed comorbidities as several conditions were excluded from clinical trials
- Diabetes: Improved glycemic parameters in diabetes mellitus
- Mental Health Conditions/Suicidality: Boxed warning for suicidal behavior and ideation; monitor patients especially during initial months and with dose changes. Post-marketing meta-analyses support no increased risk in suicidal ideation/behavior
- Seizure Disorder: Contraindicated; seizures may occur, with increased risk from factors that decrease seizure threshold
- Nephrolithiasis: May increase urinary oxalate and risk of oxalate nephrolithiasis; use caution in renal impairment or history of hyperoxaluria/calcium oxalate stones; discontinue if oxalate nephropathy develops
- Glaucoma: Pupillary dilation may precipitate an attack in those at risk for narrow-angle glaucoma
Safety Warnings & Precautions
- Boxed Warning: Suicidal behavior and ideation
- Neuropsychiatric adverse events and suicide risk (noted in smoking cessation context)
- Increased blood pressure and heart rate
- Hepatotoxicity; adjust dose in hepatic impairment, not recommended in severe hepatic impairment
- Activation of mania
- Angle-closure glaucoma
- Hypoglycemia with use of antidiabetic medications
- Adjust dose in moderate to severe renal impairment; avoid in end-stage renal disease (ESRD)
- Vulnerability to opioid overdose and precipitated opioid withdrawal
Prescribing & Refill Requirements
- Initial refill after 12 to 24 weeks: Patient must continue participation in a comprehensive lifestyle intervention or have completed one with a follow-up visit for ongoing education/support
- Refills every 6 months: Maintenance of ≥67% initial weight loss, >5% loss from baseline, or continued weight loss is the reasonable goal; no specific documentation requirement for CLI participation at this stage, though ongoing participation remains important for maintenance