Compounded Tirzepatide (injection)

The safety information for this product was compiled by NextMeds and has not been reviewed by the FDA. This information is provided for your reference and may not address all potential risks or considerations that may apply to you. Please consult your healthcare provider regarding the risks associated with this medication and whether it is appropriate for you.

⚠️ WARNING: RISK OF THYROID C-CELL TUMORS

Although compounded drugs are permitted to be prescribed under federal law, they are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. They are prepared by state-licensed pharmacies. Your provider may recommend certain doses of compounded Tirzepatide based on your medical evaluation. FDA-approved medicines containing Tirzepatide are available.

What is the most important information I should know about compounded Tirzepatide?

Tirzepatide may cause serious side effects, including possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats, Tirzepatide and medicines that work like Tirzepatide caused thyroid tumors, including thyroid cancer. It is not known if Tirzepatide will cause thyroid tumors, or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in humans.

Do not use Tirzepatide if:

• You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
• You have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Before using Tirzepatide, tell your healthcare provider if you have any other medical conditions, including if you:

• Have or have had problems with your pancreas or kidneys.
• Have type 2 diabetes and a history of diabetic retinopathy.
• Have or have had depression, suicidal thoughts, or mental health issues.
• Are pregnant or plan to become pregnant. Tirzepatide may harm your unborn baby. You should stop using Tirzepatide 2 months before you plan to conceive.
• Are breastfeeding or plan to breastfeed. It is not known if Tirzepatide passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tirzepatide may affect the way some medicines work and some medicines may affect the way Tirzepatide works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Tirzepatide slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

Tirzepatide may cause serious side effects, including:

Inflammation of the pancreas (pancreatitis): Stop using Tirzepatide and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Low blood sugar (hypoglycemia): Your risk for getting low blood sugar may be higher if you use Tirzepatide with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery.

Serious allergic reactions: Stop using Tirzepatide and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.

Kidney problems (kidney failure): In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.

Severe stomach problems: Stomach problems, sometimes severe, have been reported in people who use Tirzepatide. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Changes in vision: Tell your healthcare provider if you have changes in vision during treatment with Tirzepatide.

Gallbladder problems: Gallbladder problems have happened in some people who use Tirzepatide. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools.

Serious allergic reactions: Stop using Tirzepatide and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.

Side Effects

Many people experience no side effects. Some of the most common or potential side effects of Tirzepatide include:

• Nausea
• Diarrhea
• Decreased Appetite
• Vomiting
• Constipation
• Indigestion
• Stomach (Abdominal) Pain

These are not all the possible side effects of Tirzepatide. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.

Drug Interactions

As with other medications, compounded Tirzepatide can interact with alcohol and certain prescription and non-prescription medications and herbal products. The risk of hypoglycemia is increased when combined with insulin or insulin secretagogues such as sulfonylureas. Tirzepatide delays gastric emptying and may impact the absorption of oral medications. If you are on thyroid hormone medication, prior to starting Tirzepatide, please review the timing of taking your thyroid hormone medication with the doctor who prescribes it as it may need to be adjusted. The drug levels of medications with narrow therapeutic windows (i.e., warfarin) should be monitored closely while on Tirzepatide.

This summary provides basic information about compounded Tirzepatide but does not include all information known about this medicine. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about compounded Tirzepatide and how to take it. Your healthcare provider is the best person to help you decide if compounded Tirzepatide is right for you.

Please review all information provided by your compounding pharmacy and healthcare provider, including information about potential side effects, warnings, precautions, drug interactions, dosing instructions, and other important safety information. Contact your healthcare provider or pharmacist if you have any questions. Compounded medications are not FDA-approved and may not be accompanied by FDA-approved prescribing information.

You are encouraged to report negative side effects of compounded Tirzepatide to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088. In case of emergencies, please call 911 or go to the nearest emergency room.

Note: The above statements have not been evaluated by the Food and Drug Administration.