Important Safety Information

Do Not Use If You:

• Have a personal or family history of medullary thyroid carcinoma (MTC)
• Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Are pregnant or planning to become pregnant
• Are breastfeeding
• Have had a serious allergic reaction to tirzepatide or any of its ingredients

Before Using Compounded GLP-1/GIP

Tell your healthcare provider about your full medical history, including if you have:

• Pancreatitis, gallbladder disease, or pancreas problems
• Kidney or liver disease
• Severe stomach or gastrointestinal problems (including gastroparesis)
• A history of diabetic retinopathy
• Depression, suicidal thoughts, or other mental health changes
• Any other medical conditions or allergies

Also inform your provider if you take:

• Diabetes medicines such as insulin or sulfonylureas (may increase risk of low blood sugar)
• Birth control pills (effectiveness may decrease for 4 weeks after starting or increasing your dose; an alternative form of contraception may be needed)
• Any prescription, over-the-counter, or herbal medicines

Pregnancy, Breastfeeding & Contraception

• Do not use if you are pregnant, planning to become pregnant, or breastfeeding.
• This medication may harm your unborn baby.
• Use effective contraception while on treatment.
• Discuss contraception options with your provider, as oral contraceptive effectiveness may be affected.

Serious Warnings: Call Your Doctor Immediately If You Experience:

• Thyroid C-cell tumor symptoms (see Black Box Warning above)
• Pancreatitis: severe abdominal pain (with or without vomiting) that may radiate to your back
• Gallbladder disease: upper abdominal pain, fever, yellowing of skin or eyes, clay-colored stools
• Kidney problems or failure: especially if dehydrated from nausea, vomiting, or diarrhea
• Serious allergic reaction: swelling of face, lips, tongue, or throat; difficulty breathing or swallowing; rash, itching, fainting, dizziness, or rapid heartbeat
• Low blood sugar (hypoglycemia): dizziness, sweating, confusion, blurred vision, shakiness, rapid heartbeat, hunger, or irritability, especially if on insulin or sulfonylureas
• Changes in vision
• Depression or suicidal thoughts: changes in mood, behavior, or thoughts

If any of these occur, stop treatment and seek immediate medical attention.

Common Side Effects

Some people experience no side effects. The most common include:

• Nausea, vomiting, diarrhea, constipation, abdominal pain
• Indigestion, acid reflux, belching
• Injection site reactions
• Fatigue
• Decreased appetite
• Hair loss

Side effects often lessen over time as your body adjusts. Contact your provider if they persist or worsen.

Drug Interactions

• Compounded tirzepatide slows gastric emptying and may affect the absorption of certain oral medications.
• Dose adjustments may be required for insulin, sulfonylureas, and medications with a narrow therapeutic index.
• Do not use with other tirzepatide-containing products or any GLP-1 receptor agonists.

Important Note on Compounded Medications

Compounded tirzepatide is prepared by a licensed compounding pharmacy and is not evaluated by the FDA for safety or effectiveness. It is not equivalent to FDA-approved tirzepatide products such as Zepbound® or Mounjaro®.

Emergency Information

• In case of a medical emergency, call 911 or go to the nearest emergency room.
• To report side effects, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.