Requirements for Medical Doctors Before Prescribing Sublaxtone
Before prescribing Sublaxtone, medical doctors must verify patient eligibility based on BMI criteria (≥30 kg/m² or ≥27 kg/m² with significant complications), conduct appropriate screening for contraindications, and establish a monitoring plan for potential side effects.
Patient Selection Criteria
Required BMI Thresholds
- BMI ≥30 kg/m², or
- BMI ≥27 kg/m² with significant weight-related complications 1
Patient Assessment Before Prescription
Medical History Review:
- Document personal or family history of:
- Pancreatitis
- Medullary thyroid cancer or MEN2
- Gallbladder disease
- Suicidal ideation or behavior 1
- Document personal or family history of:
Contraindication Screening:
- Pregnancy or breastfeeding status
- Severe renal impairment
- History of cholelithiasis 1
Medication Review:
- Check for potential drug interactions
- Document all current medications including over-the-counter and herbal supplements 1
Documentation Requirements
Required Documentation in Patient Record
Patient Education:
- Document that patient education has been provided regarding:
- Medication name (generic and brand)
- Dosing schedule
- Potential adverse effects and management
- Treatment goals and expected duration 1
- Document that patient education has been provided regarding:
Informed Consent:
- Obtain signed informed consent after reviewing:
- Treatment intent
- Potential risks and benefits
- Alternative treatment options 1
- Obtain signed informed consent after reviewing:
Follow-up Plan:
Dosing and Administration Protocol
Initial Dosing and Titration
- For semaglutide formulation:
- Start with 0.25 mg SC weekly for 4 weeks
- Titrate dose every 4 weeks as tolerated:
- 0.5 mg SC weekly
- 1.0 mg SC weekly
- 1.7 mg SC weekly
- 2.4 mg SC weekly (maintenance dose) 1
Monitoring Requirements
- Monitor for:
- Gastrointestinal side effects (nausea, vomiting, diarrhea)
- Signs of acute gallbladder disease
- Hypoglycemia (especially in patients with T2DM)
- Injection site reactions
- Suicidal ideation 1
Continuation Criteria
Treatment Efficacy Assessment
- Evaluate weight loss at 16 weeks after reaching maintenance dose
- If patient has not lost at least 4% of body weight, discontinue medication 1
Common Pitfalls and Caveats
Failure to screen for contraindications - Always verify absence of pregnancy, medullary thyroid cancer history, and severe renal impairment before prescribing.
Inadequate documentation - Ensure all patient education, informed consent, and follow-up plans are thoroughly documented in the patient record.
Insufficient monitoring - Schedule and document regular follow-up visits to assess efficacy and monitor for adverse effects.
Missing drug interactions - Review all current medications including over-the-counter drugs and supplements for potential interactions.
Improper patient selection - Verify that patients meet BMI criteria and have appropriate indications for weight management therapy.
By following these requirements, medical doctors can ensure safe and appropriate prescribing of Sublaxtone for eligible patients while minimizing risks and optimizing outcomes.