From the Guidelines
Patients with a history of cholestasis taking Ozempic (semaglutide) should undergo regular liver function tests, particularly monitoring of alkaline phosphatase, gamma-glutamyl transferase, bilirubin levels, and aminotransferases (ALT, AST), to rule out redevelopment or exacerbation of cholestasis. These tests should be performed at baseline before starting treatment, then at 1-3 month intervals for the first 6 months, and periodically thereafter based on clinical judgment 1.
Monitoring Parameters
- Alkaline phosphatase
- Gamma-glutamyl transferase
- Bilirubin levels
- Aminotransferases (ALT, AST)
Clinical Assessment
Physical examinations should include assessment for jaundice, pruritus, right upper quadrant pain, and other signs of liver dysfunction. Patients should be educated to report symptoms such as yellowing of skin or eyes, dark urine, light-colored stools, severe abdominal pain, or unusual itching.
Management of Suspected Cholestasis
If cholestasis is suspected, Ozempic should be temporarily discontinued while further evaluation is conducted. This monitoring is important because GLP-1 receptor agonists like semaglutide are primarily metabolized in the body rather than excreted by the liver, but they can potentially affect gallbladder function and bile acid metabolism. While Ozempic is not contraindicated in patients with a history of cholestasis, caution is warranted as severe liver disease may affect drug metabolism and clinical response. A careful history of previous or current use of prescribed and over-the-counter medications and herbal products is demanded in any case of unexplained serum liver test elevations 1.
From the FDA Drug Label
• Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated (5. 3).
The patient with a history of cholestasis taking Ozempic (semaglutide) should be monitored for signs of cholelithiasis or gallbladder disease during titration and while on the medication.
- Gallbladder studies and
- clinical follow-up are indicated if cholelithiasis is suspected 2.
From the Research
Monitoring for Cholestasis in Patients Taking Ozempic
To monitor a patient with a history of cholestasis taking Ozempic (semaglutide), the following should be considered:
- Liver function tests, including serum alkaline phosphatase, aminotransferases, gamma-glutamyl transferase, and bilirubin, as these are useful in distinguishing between benign and malignant diseases causing jaundice and/or cholestasis 3
- Regular assessment of liver enzymes and bilirubin levels to monitor for signs of cholestasis or liver injury 4
- Consideration of the patient's medical history, including any previous episodes of cholestasis, and the potential for Ozempic to exacerbate or reactivate cholestasis 4
Laboratory Tests
The following laboratory tests may be useful in monitoring patients with a history of cholestasis taking Ozempic:
- Serum bilirubin levels, as elevated levels can indicate cholestasis or liver injury 3, 4
- Alkaline phosphatase levels, as elevated levels can indicate cholestasis or bone disorders 3
- Aminotransferase levels, including aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT), as elevated levels can indicate liver injury 3
- Gamma-glutamyl transferase (GGT) levels, as elevated levels can indicate liver or biliary disease 3
Clinical Considerations
When monitoring patients with a history of cholestasis taking Ozempic, the following clinical considerations should be taken into account:
- The potential for Ozempic to cause or exacerbate cholestasis, as reported in a case study of a patient who developed progressive cholestasis and biliary cirrhosis after initiating oral semaglutide 4
- The importance of regular monitoring and follow-up to quickly identify any signs of cholestasis or liver injury 4
- The need to consider alternative etiologies for liver injury or cholestasis, and to rule out other potential causes of these conditions 4