What are the requirements for prescribing Wegovy (semaglutide)?

Wegovy (Semaglutide) Prescribing Requirements

Wegovy is indicated for chronic weight management in adults with BMI ≥30 kg/m² or BMI ≥27 kg/m² with at least one weight-related comorbidity (such as hypertension, type 2 diabetes, or dyslipidemia), used as an adjunct to reduced-calorie diet and increased physical activity. 1

Patient Eligibility Criteria

BMI Requirements

• BMI ≥30 kg/m² (obesity) without additional conditions, OR 1
• BMI ≥27 kg/m² (overweight) with at least one weight-related comorbidity including: 1
  • Type 2 diabetes
  • Hypertension
  • Dyslipidemia (high cholesterol)
  • Obstructive sleep apnea
  • Cardiovascular disease

Additional Requirements

• Inadequate response to lifestyle interventions (reduced-calorie diet and increased physical activity) must be documented before initiating pharmacotherapy 1
• Age ≥12 years for pediatric patients with obesity 2
• For cardiovascular risk reduction indication: Age ≥45 years with established CVD (prior MI, stroke, peripheral arterial disease, or revascularization) 1

Mandatory Screening and Contraindications

Absolute Contraindications

• Personal or family history of medullary thyroid carcinoma (MTC) 1, 3
• Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) 1, 3
• Pregnancy - all weight loss medications are contraindicated in pregnancy 1
• Concurrent use with other GLP-1 receptor agonists or DPP-4 inhibitors 4

Precautions and High-Risk Conditions

• History of pancreatitis: Do not initiate if at high risk; discontinue immediately if pancreatitis is suspected 1
• Gallbladder disease risk: Evaluate for cholelithiasis or cholecystitis if symptoms develop; avoid in at-risk individuals 1
• Diabetic retinopathy: Close monitoring required in high-risk patients (diabetes duration ≥10 years) 1
• Gastroparesis: Not recommended for individuals with pre-existing gastroparesis 1
• Severe gastrointestinal disease: Use caution due to delayed gastric emptying effects 1, 4

Women of Childbearing Potential

• Reliable contraception required during treatment 1
• Discontinue 2 months before planned pregnancy (due to long half-life of approximately 1 week) 3
• Oral contraceptive users: Add or switch to non-oral contraception for 4 weeks after initiation and each dose escalation due to potential impaired absorption 1

Required Baseline Assessments

Laboratory Monitoring

• Renal function (eGFR/creatinine clearance) - though no dose adjustment needed for any level of renal impairment, including ESRD 1, 3
• Hepatic function - no dose adjustment needed but baseline assessment recommended 3
• Lipid panel (if dyslipidemia is present) 1
• Hemoglobin A1c (if diabetes or prediabetes) 1
• Thyroid function if clinically indicated 1

Clinical Assessments

• Blood pressure and heart rate at baseline and periodically during treatment 1
• Cardiovascular risk assessment 1
• Screen for eating disorders (bulimia, anorexia nervosa) 1
• Mental health screening for depression and suicidal ideation risk 1

Dosing Protocol Requirements

Mandatory Titration Schedule

Gradual dose escalation is essential to minimize gastrointestinal adverse effects: 4

• Week 0-4: 0.25 mg subcutaneously once weekly 4
• Week 5-8: 0.5 mg once weekly 4
• Week 9-12: 1.0 mg once weekly 4
• Week 13-16: 1.7 mg once weekly 4
• Week 17+: 2.4 mg once weekly (maintenance dose) 4

Dosing Flexibility

• Some patients may achieve adequate response at submaximal doses (e.g., 1.0 mg or 1.7 mg) and can continue long-term at that dose 4
• Slower titration may be considered for patients experiencing significant GI side effects 1, 4

Efficacy Assessment Requirements

Early Response Evaluation

• Assess efficacy monthly for first 3 months, then at least quarterly thereafter 1
• Early responders (≥5% weight loss after 3 months) should continue therapy 1
• Inadequate response: If <5% weight loss after 3-4 months at maximum tolerated dose, consider discontinuation or intensification with additional interventions 1

Long-Term Monitoring

• Continue therapy indefinitely to maintain weight loss benefits - discontinuation typically results in weight regain and worsening cardiometabolic risk factors 1
• Monitor for malnutrition in patients achieving significant weight loss 1

Concomitant Medication Management

Required Adjustments

• Insulin or insulin secretagogues (sulfonylureas): Reduce doses to minimize hypoglycemia risk when initiating Wegovy 1, 4
• Oral medications with narrow therapeutic index (e.g., warfarin): Monitor closely due to delayed gastric emptying affecting absorption 1, 3
• Review and minimize weight-promoting medications when possible (antipsychotics, certain antidepressants, glucocorticoids, beta-blockers) 1

Surgical Considerations

• Discontinue 3-4 days before scheduled surgery due to delayed gastric emptying and aspiration risk 1
• Discontinue during critical illness or prolonged fasting 1

Patient Counseling Requirements

Gastrointestinal Side Effects Management

• Counsel on expected GI effects: nausea (most common), vomiting, diarrhea, constipation - typically transient and mild-to-moderate 1, 4, 5
• Dietary modifications: Reduce meal size, practice mindful eating (stop when full), decrease high-fat and spicy foods 1, 4
• Hydration: Maintain adequate fluid intake, especially if experiencing vomiting or diarrhea 1

Administration Instructions

• Can be given at any time of day, with or without meals 4
• Rotate injection sites (abdomen, thigh, or upper arm) 3
• Missed dose protocol: 4
  • If <5 days since missed dose: administer as soon as possible
  • If ≥5 days since missed dose: skip and resume regular schedule
  • If 2 consecutive doses missed: consider resuming at same dose or lowering dose
  • If ≥3 consecutive doses missed: consider restarting titration schedule

Storage Requirements

• Refrigerate at 36°F to 46°F (2°C to 8°C) 4
• May be kept at room temperature up to 28 days 4

Special Populations

Renal Impairment

• No dose adjustment required for any degree of renal impairment, including end-stage renal disease (ESRD) 1, 3
• Use caution when initiating or escalating doses in patients with renal disease due to potential acute kidney injury risk from dehydration secondary to GI side effects 1

Hepatic Impairment

• No dose adjustment required for any degree of hepatic impairment 3

Cardiovascular Disease

• Wegovy is specifically indicated to reduce cardiovascular death, MI, and stroke risk in adults with obesity/overweight and established CVD 1
• Monitor blood pressure and heart rate as semaglutide may cause modest increases 1

Diabetes Management

• Semaglutide provides glucose-lowering benefits and can be used for both weight management and glycemic control 1
• Prioritize semaglutide over other anti-obesity medications in patients with type 2 diabetes due to added cardiometabolic benefits 1