Important Safety Information for Oral Trizepatide
General Information
Tirzepatide is a novel glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist used for the treatment of type 2 diabetes. It helps to improve glycemic control by enhancing insulin secretion and inhibiting glucagon release in a glucose-dependent manner1.
Contraindications
- Allergy: Do not use tirzepatide if you are allergic to it or any of its ingredients2.
- Medical Conditions: Inform your doctor if you have a history of:
- Pancreatitis
- Severe gastrointestinal disease
- Diabetic retinopathy
- Kidney disease2
Warnings and Precautions
- Thyroid C-cell Tumors: Tirzepatide has been associated with an increased risk of thyroid C-cell tumors in animal studies. It is not known if this risk applies to humans. Patients with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) should not use tirzepatide3.
- Pancreatitis: There have been reports of acute pancreatitis in patients using GLP-1 receptor agonists. Monitor for signs and symptoms of pancreatitis, such as severe abdominal pain1.
- Hypoglycemia: When used in combination with insulin or insulin secretagogues, there is an increased risk of hypoglycemia. Adjustments in the dose of insulin or insulin secretagogues may be necessary1.
- Kidney Function: Use with caution in patients with renal impairment. Monitor renal function periodically2.
Common Side Effects
- Gastrointestinal Issues: The most common side effects include nausea, vomiting, diarrhea, and decreased appetite. These are usually mild to moderate and tend to decrease over time14.
- Injection Site Reactions: Although rare, some patients may experience reactions at the injection site, such as redness or swelling1.
Serious Side Effects
- Pancreatitis: Symptoms include severe abdominal pain that may radiate to the back, with or without vomiting1.
- Kidney Problems: Symptoms include changes in urination, swelling in the legs or ankles, and fatigue2.
- Allergic Reactions: Symptoms include rash, itching, swelling, severe dizziness, and trouble breathing2.
Drug Interactions
Use in Specific Populations
- Pregnancy: There is limited data on the use of tirzepatide in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus2.
- Breastfeeding: It is not known whether tirzepatide is excreted in human milk. Caution should be exercised when administered to a nursing woman2.
- Pediatric Use: Safety and effectiveness in pediatric patients have not been established2.
Monitoring
- Blood Glucose Levels: Regular monitoring of blood glucose levels is essential to ensure effective glycemic control1.
- Renal Function: Periodic monitoring of renal function is recommended2.
- Thyroid Monitoring: Monitor for signs of thyroid tumors, especially in patients with a history of thyroid disease1.
Overdose
In case of overdose, seek immediate medical attention. Symptoms of overdose may include severe nausea, vomiting, and hypoglycemia2.
Storage
Store tirzepatide at room temperature away from moisture and heat. Keep out of reach of children2.
Always consult your healthcare provider for personalized medical advice and before starting any new medication.
This information is not comprehensive.