Important Safety Information for Compounded Tirzepatide

What is tirzepatide and how is it used?

Tirzepatide is a dual GIP and GLP-1 receptor agonist. In its FDA-approved branded forms, it is prescribed along with a reduced-calorie diet and increased physical activity for chronic weight management, and to help manage type 2 diabetes. It is given as an injection under the skin, usually once a week.

The tirzepatide provided through Zanason is compounded by a licensed pharmacy to your provider's prescription. Compounded medications are not FDA-approved and do not undergo the FDA's review for safety, effectiveness, or manufacturing quality.

Ozempic® and Wegovy® (semaglutide) are trademarks of Novo Nordisk A/S. Mounjaro® and Zepbound® (tirzepatide) are trademarks of Eli Lilly and Company. Zanason is not affiliated with the manufacturers of FDA-approved brand-name medications.

Who should NOT use tirzepatide?

Do not use tirzepatide if:

• You or a family member has had medullary thyroid carcinoma (MTC), or you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• You have had a serious allergic reaction to tirzepatide or any of its ingredients
• You are pregnant, trying to become pregnant, or breastfeeding — tirzepatide may harm an unborn baby. Stop well before a planned pregnancy. Use effective contraception while taking it.

What should I tell a licensed provider before starting tirzepatide?

Tell a licensed provider about all medications you take, including prescription and over-the-counter medicines, vitamins, and herbal or dietary supplements.

Tirzepatide slows stomach emptying and can change how oral medications are absorbed. Medications with a narrow therapeutic window (for example, warfarin) and thyroid hormone timing may need closer monitoring.

Birth control: Tirzepatide may reduce the effectiveness of oral hormonal birth control. If you use oral contraceptives, talk to a licensed provider — they may recommend switching to a non-oral method, or adding a barrier method, for 4 weeks after you start and for 4 weeks after each increase in your dose.

Share your full medical history. In particular, tell a licensed provider if you have a history of:

• Pancreatitis, gallbladder disease, or kidney or liver problems
• Type 2 diabetes — especially if you take insulin or a sulfonylurea
• Diabetic retinopathy or other vision problems
• Depression, mood changes, or suicidal thoughts or behavior

Warnings and precautions

Pancreatitis

Acute pancreatitis, including fatal cases, has been reported in patients treated with GLP-1 receptor agonists. Stop taking tirzepatide and contact a licensed provider immediately if you have severe, lasting pain in your stomach or back, with or without vomiting.

Gallbladder disease

Treatment with tirzepatide is associated with cholelithiasis and cholecystitis. Tell a licensed provider about upper-stomach pain, fever, yellowing of the skin or eyes, or clay-colored stools.

Low blood sugar (hypoglycemia)

Tirzepatide lowers blood glucose. The risk of hypoglycemia is higher if you also take insulin or an insulin secretagogue such as a sulfonylurea. Watch for dizziness, weakness, shakiness, headache, anxiety or mood changes, rapid heartbeat, confusion, slurred speech, sweating, or lightheadedness.

Kidney problems

Nausea, vomiting, and diarrhea can cause dehydration that may worsen kidney function, in some cases requiring hemodialysis. Stay well hydrated. Kidney problems are more likely in people with pre-existing kidney conditions.

Serious allergic reactions

Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported. Stop tirzepatide and get medical help right away for swelling of the face, lips, tongue, or throat; trouble breathing or swallowing; severe rash or itching; fainting or dizziness; or very rapid heartbeat.

Diabetic retinopathy

Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Patients with a history of diabetic retinopathy should be monitored for progression. Tell a licensed provider about any vision changes.

Heart rate increase

Tirzepatide was associated with increases in resting heart rate. Tell a licensed provider about palpitations or a racing heartbeat while at rest.

Mood changes

Suicidal behavior and ideation have been reported in clinical trials with other weight-management products. Monitor for new or worsening depression, suicidal thoughts or behavior, or unusual changes in mood or behavior. Tell a licensed provider right away. Avoid tirzepatide in patients with a history of suicidal attempts or active suicidal ideation.

Pulmonary aspiration during surgery

Tirzepatide delays gastric emptying. There have been rare reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing surgery requiring general anesthesia or deep sedation who had residual gastric contents despite preoperative fasting. Tell your surgeon or proceduralist before any planned surgery if you are taking tirzepatide.

Drug interactions

Tirzepatide can interact with alcohol and certain prescription and non-prescription medications and herbal products:

• Oral hormonal contraceptives: tirzepatide may reduce their effectiveness — use an additional non-oral method for 4 weeks after starting and 4 weeks after each dose increase
• Insulin / sulfonylureas: increased risk of hypoglycemia — dose adjustments may be needed
• Oral medications: tirzepatide delays gastric emptying and may change how oral medications are absorbed
• Thyroid hormone medication: review timing with the clinician who prescribes your thyroid medication, as it may need to be adjusted
• Medications with a narrow therapeutic window (for example, warfarin): drug levels should be monitored closely
• Alcohol: avoid alcohol while taking tirzepatide — alcohol can worsen nausea and affect blood sugar

Common side effects

The side effects reported most often affect the stomach and digestion:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach (abdominal) pain
• Decreased appetite
• Dyspepsia / indigestion
• Fatigue
• Headache
• Dizziness
• Injection site reactions

These are not all of the possible side effects. Talk to a licensed provider about any side effects that bother you or don't go away.

How to take tirzepatide

Inject tirzepatide under the skin once a week, on the same day each week, with or without food. Rotate injection sites — stomach, thigh, or upper arm.

A licensed provider will usually start you at a low dose and increase gradually to ease stomach-related side effects.

If you miss a dose, take it as soon as possible within 4 days. If more than 4 days have passed, skip the missed dose and resume on your regular day. Never take two doses at once.

Never share your tirzepatide or injection device with anyone else, even if they have the same condition. Sharing may transmit infection and cause harm.

Pregnancy and breastfeeding

Do not use tirzepatide if you are pregnant, trying to become pregnant, or breastfeeding. Tirzepatide may cause fetal harm and causes fetal harm in animal studies. Stop well before a planned pregnancy. Use effective contraception while taking tirzepatide. Tell a licensed provider immediately if you become pregnant.

Tirzepatide may reduce the effectiveness of oral hormonal birth control — see Drug interactions above.