Contraindications for Ozempic (Semaglutide)
Ozempic (semaglutide) is absolutely contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), as well as in those with known hypersensitivity to semaglutide or any product components. 1
Absolute Contraindications
- Personal or family history of medullary thyroid carcinoma (MTC) 1, 2
- Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) 1, 2, 3
- Known hypersensitivity to semaglutide or any product components 1
Cautions and Relative Contraindications
Gastrointestinal Conditions
- History of pancreatitis (Ozempic has not been studied in this population) 1, 4
- Severe gastroparesis (may worsen symptoms due to delayed gastric emptying) 2, 5
- Prior gastric surgery (requires careful consideration) 2, 5
Endocrine and Metabolic Conditions
- Risk of hypoglycemia when used with insulin or insulin secretagogues (dose adjustments of these medications may be required) 2
- Diabetic retinopathy (particularly in patients at risk for rapid improvement in glycemic control) 1, 4
Renal Considerations
- Severe renal impairment (requires careful monitoring due to increased risk of gastrointestinal side effects and potential dehydration) 2
- Exenatide (another GLP-1 RA) is contraindicated if eGFR is <30 mL/min/1.73 m², but semaglutide can be used with caution in severe renal impairment 2
Other Medical Conditions
- Untreated closed-angle glaucoma (caution advised) 2
- Pregnancy and breastfeeding (safety not established) 2, 6
Monitoring Recommendations
- Monitor for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back, with or without vomiting) 1, 4
- Monitor renal function, especially in patients experiencing severe gastrointestinal side effects that could lead to dehydration 2, 5
- Monitor for diabetic retinopathy complications, especially in patients with pre-existing retinopathy 1, 4
- Monitor for gallbladder disease (increased risk of cholelithiasis) 2, 4
Clinical Implications and Pitfalls
- Routine monitoring of serum calcitonin or thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with semaglutide 1, 5
- When initiating semaglutide, slow dose titration is recommended to minimize gastrointestinal side effects 2, 6
- If pancreatitis is suspected, discontinue semaglutide immediately; if confirmed, do not restart 1, 4
- For patients using oral hormonal contraceptives, consider switching to a non-oral contraceptive method or adding a barrier method for 4 weeks after initiation and after each dose escalation due to potential reduced efficacy from delayed gastric emptying 2
Practical Prescribing Considerations
- Start with 0.25 mg subcutaneously once weekly for 4 weeks (for treatment initiation only, not effective for glycemic control) 1
- After 4 weeks, increase to 0.5 mg once weekly 1
- If additional glycemic control is needed after at least 4 weeks on 0.5 mg, may increase to 1 mg once weekly (maximum recommended dose) 1
- If a dose is missed, administer as soon as possible within 5 days; if more than 5 days have passed, skip the missed dose and resume regular schedule 1
By understanding these contraindications and following appropriate monitoring protocols, healthcare providers can safely prescribe Ozempic while minimizing risks to patients.