Compounded Tirzepatide - Safety Information

Overview
Compounded tirzepatide is an injectable medication used to assist in weight management for adults who are obese or overweight with associated medical conditions. It functions as a dual agonist of the glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, which help regulate blood sugar levels and control appetite. It is important to note that compounded tirzepatide is not FDA-approved and has not undergone the rigorous testing for safety, efficacy, or manufacturing quality that FDA-approved medications receive.

Indications for Use
Compounded tirzepatide may be used for chronic weight management in adults with:
- Obesity: Body mass index (BMI) ≥ 30 kg/m².
- Overweight: BMI ≥ 27 kg/m² with at least one weight-related comorbidity, such as hypertension, type 2 diabetes, or dyslipidemia.

Important Safety Information
Warning: Risk of Thyroid C-Cell Tumors
In animal studies, tirzepatide caused thyroid C-cell tumors. It is unknown if this risk extends to humans, but tirzepatide should not be used in individuals with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Signs to watch for:
- Lump or swelling in the neck.
- Hoarseness, trouble swallowing.
- Shortness of breath.

Contraindications
Do not use compounded tirzepatide if you:
- Have a history of medullary thyroid carcinoma or MEN 2.
- Are allergic to tirzepatide or any other ingredients in the formulation.
- Are pregnant or planning to become pregnant. Compounded tirzepatide should not be used during pregnancy.

Common Side Effects
- Gastrointestinal Issues: Nausea, vomiting, diarrhea, constipation, abdominal pain, and indigestion.
- Injection Site Reactions: Redness, pain, or swelling at the site of injection.
- Fatigue: Feeling unusually tired or lethargic.
- Dizziness: Lightheadedness or a spinning sensation.
- Increased Heart Rate: Noticeable racing of the heart even while at rest.

Serious Side Effects
- Acute Pancreatitis: Severe abdominal pain that may radiate to the back, with or without vomiting.
- Acute Kidney Injury: Nausea, vomiting, or diarrhea leading to dehydration and worsening kidney function.
- Gallbladder Disease: Gallstones or inflammation, marked by upper abdominal pain, jaundice, or clay-colored stools.
- Diabetic Retinopathy: Worsening of eye disease in individuals with type 2 diabetes.
- Hypoglycemia: Severe low blood sugar, particularly when used with other glucose-lowering medications.
- Serious Allergic Reactions: Swelling of the face, lips, tongue, or throat, rash, rapid heartbeat, or trouble breathing.

Drug Interactions
Compounded tirzepatide may interact with other medications, especially:
- Diabetes Medications: Insulin or sulfonylureas, which could increase the risk of hypoglycemia.
- Oral Medications: Delayed gastric emptying caused by tirzepatide can affect the absorption of oral medications.

Usage Guidelines
- Administration: Compounded tirzepatide is injected subcutaneously (under the skin) once weekly, in the abdomen, thigh, or upper arm.
- Missed Dose: If a dose is missed, administer it as soon as possible within 4 days after the missed dose. If more than 4 days have passed, skip the missed dose and resume the regular dosing schedule.

Special Precautions
- Renal Function: Monitor kidney function, especially in patients with a history of kidney disease.
- Mental Health: Be vigilant for changes in mood, behavior, or thoughts, especially concerning depression or suicidal thoughts.

Monitoring and Follow-up
- Regular monitoring of blood glucose, kidney function, and mental health is recommended during treatment.
- Report any new or worsening symptoms to your healthcare provider immediately.

Note on FDA Approval
Compounded tirzepatide is not FDA-approved and lacks the rigorous testing and quality control associated with FDA-approved medications. It should be used under the guidance of a healthcare provider, and patients should be fully informed of its risks and benefits.

Disclaimer
Always consult your healthcare provider to ensure the information displayed here applies to your specific circumstances. Report any adverse reactions or concerns to your healthcare provider and consider reviewing additional resources or seeking a second opinion if needed.

Mounjaro® is a registered trademark of Eli Lilly. Dharma Nutrition Clinic has no affiliation with Eli Lilly. The compounded products available as part of Dharma Nutrition Clinic’s Weight Loss Program are not made by Eli Lilly or any company affiliated with this entity.

For more detailed information, consult your healthcare provider or refer to the medication guide provided with your prescription.