Your medical provider may prescribe customized doses of compounded Tirzepatide based on your medical assessment. Compounded medications are not approved by the U.S. Food and Drug Administration (FDA) and have not been evaluated for safety, effectiveness, or quality standards.

This document summarizes key information but does not include all possible uses, side effects, or safety considerations. It is not a substitute for professional medical advice. Always consult your healthcare provider for diagnosis and treatment guidance.

Indications and Usage Compounded Tirzepatide is a glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist. It may support weight loss in adults and adolescents with a body mass index (BMI) of 27 kg/m² or higher who also have weight-related medical conditions. Compounded Tirzepatide must be used in conjunction with a reduced-calorie diet and increased physical activity.

FDA Status Compounded Tirzepatide is not FDA-approved. It does not undergo the FDA’s safety, efficacy, or manufacturing quality assessments. Compounded medications may be prescribed by licensed practitioners under federal law.

Limitations of Use

• Not to be used with other Tirzepatide-containing products or GLP-1/GIP receptor agonists.
• Safety and efficacy when used with other weight-loss medications have not been established.
• Not studied in patients with a history of pancreatitis.
• Not approved for use in individuals under 18 years of age.

Contraindications Do not use compounded Tirzepatide if:

• You or a family member has a history of medullary thyroid carcinoma (MTC).
• You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• You have known hypersensitivity to Tirzepatide or any of its components.

Administration Compounded Tirzepatide is self-injected once weekly into the abdomen, thigh, or upper arm. It may be administered with or without food. Dosage escalation typically occurs every four weeks, as determined by your provider.

Drug Interactions and Considerations Before starting therapy, inform your provider of all prescription and over-the-counter medications, vitamins, and supplements you use. Special considerations include:

• Diabetes medications (e.g., insulin, sulfonylureas).
• Drugs with narrow therapeutic indices.
• Other GLP-1/GIP medications (e.g., Wegovy®, Ozempic®, Saxenda®, Mounjaro®).
• Oral contraceptives may be less effective due to delayed gastric emptying.

Medical History Disclosure Disclose the following to your provider:

• Type 1 or type 2 diabetes
• History of pancreatitis or gallbladder disease
• Kidney or liver conditions
• Diabetic retinopathy
• Depression or suicidal thoughts
• Current pregnancy, breastfeeding, or plans to become pregnant

Warnings and Precautions

• Thyroid C-Cell Tumors: Studies in rodents showed an increased risk of MTC. Human relevance is unknown. Monitor for neck lumps, hoarseness, or swallowing difficulties.
• Acute Pancreatitis: Report persistent, severe abdominal pain.
• Gallbladder Disease: Watch for upper abdominal pain, jaundice, or fever.
• Hypoglycemia: Especially in combination with diabetes medications.
• Kidney Injury: Dehydration from GI side effects may worsen kidney function.
• Serious Allergic Reactions: Discontinue and seek emergency care if signs of anaphylaxis occur.
• Diabetic Retinopathy: Monitor vision changes.
• Suicidal Thoughts: Report mental health changes promptly.
• Increased Heart Rate: Notify your provider of a racing heartbeat at rest.

Side Effects Common side effects may include nausea, vomiting, diarrhea, constipation, headache, fatigue, dizziness, and injection site reactions. Most symptoms are transient and lessen with continued use.

Seek immediate care for severe reactions, including signs of pancreatitis, gallbladder disease, allergic reaction, or low blood sugar.

Pregnancy and Breastfeeding

• Discontinue at least 2 months prior to planned pregnancy.
• Do not use during pregnancy or while breastfeeding without provider consultation.

Dosing Schedule (Typical Titration)

• Weeks 1–4: 2.5 mg once weekly
• Weeks 5–8: 5 mg once weekly
• Weeks 9–12: 7.5 mg once weekly
• Weeks 13–16: 10 mg once weekly
• Weeks 17–20: 12.5 mg once weekly
• Weeks 21–24: 15 mg once weekly (as applicable)

Your provider may adjust this schedule based on your clinical response.

Safety Notice Do not share vials, syringes, or needles. Misuse can lead to infections or injury. Report any adverse events to your provider or to the FDA’s MedWatch program at www.fda.gov/medwatch or 1-800-FDA-1088.

Legal Disclaimers Compounded Tirzepatide is dispensed by Freya Meds. This medication is not approved by the FDA. All trademarks mentioned (e.g., Ozempic®, Mounjaro®, Zepbound™, Saxenda®) are property of their respective owners. Freya Meds does not claim any affiliation with trademark holders.