Active Ingredients: Tirzepatide, Vitamin B6

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Warnings:

• Watch for signs of a thyroid tumor and call your doctor at once if you notice the following signs: lump or swelling in your neck, shortness of breath, trouble swallowing, or hoarse voice. Tirzepatide has caused thyroid tumors in rats, and it is unknown if it can cause tumors in humans.
• If you have multiple endocrine neoplasia type 2 (tumors in glands), or a history or family history of medullary thyroid cancer, you should not use Tirzepatide.

Before taking this medication:You should not use Tirzepatide if you are allergic to it, or:

• You have a family or personal history of medullary thyroid cancer
• You have multiple endocrine neoplasia type 2 (tumors in glands)
• You are using other GLP-1 receptor agonist medications
• Diabetic ketoacidosis

Let your doctor know if you have ever had:

• A hypersensitivity reaction to Tirzepatide or other GLP-1 RA medications
• Pancreatitis
• Stomach or intestinal disorders
• Kidney disease
• Gallbladder disease
• Hypoglycemia
• Diabetic eye problems (retinopathy)
• Suicidal ideation or severe mood disorders

‍In animal studies, Tirzepatide was shown to cause thyroid cancers or thyroid tumors. It is not clear whether these effects can occur in people as well. Talk to your doctor about your risk for these diseases.‍Both men and women should stop using Tirzepatide at least 2 months before they plan on becoming pregnant or making someone pregnant. Your doctor may have safer options for you to use during this time period, pregnancy, and breastfeeding.‍It is unknown if it is safe to use injectable Tirzepatide while you are pregnant or breastfeeding, so it should be avoided.‍Tirzepatide should not be used in anyone under 18 years of age.Drug Interactions:

• Since Tirzepatide can slow your digestion, it may change how long it takes for your body to absorb other medications that you take by mouth. This may cause them to work differently for you. This includes oral birth control medications. Tell your doctor about all other medications you are currently using so they can identify and potential interactions.
• If you are using oral birth control measures, your doctor may recommend you switch to non-oral methods of contraception or add on a barrier method to reduce your risk of pregnancy. This is normally advised for the first 4 weeks after initiation, and 4 weeks after each dose increase.
• Your doctor will need to know about any other medications meant for diabetes that you take including: Insulin, Byetta, Dulaglutide, Exenatide, Liraglutide, Trulicity, Victoza, and more. Taking these medications together with Tirzepatide may increase your risk of hypoglycemia.
• It may be possible that other drugs, over-the-counter medications, or supplements interact with Tirzepatide. Be sure to tell your doctor about all other medications and supplements that you use before starting on this treatment.

Side Effects:Get emergency medical help if you have signs of an allergic reaction to Tirzepatide:

• Hives, itching, dizziness, fast heartbeat, difficulty breathing, swelling of your face, lips, tongue, or throat.

More serious side effects of Tirzepatide include:(Call your doctor at once if these occur)

• Mood changes
• Thoughts of harming yourself
• Changes in your vision
• Fluttering in your chest or a pounding heartbeat
• Feeling lightheaded or like you might pass out
• Thyroid tumor signs: Lump or swelling in your neck, shortness of breath, a hoarse voice, difficulty swallowing
• Signs of gallbladder problems: Clay-colored stool, fever, upper stomach pain, jaundice (yellowing of the eyes or skin)
• Signs of low blood sugar (hypoglycemia): Weakness, sweating, confusion, headache, hunger, irritability, fast heart rate, dizziness, jittery feeling.
• Signs of kidney injury: Swelling, tiredness, shortness of breath, urinating less.
• Symptoms of severe gastrointestinal disease: Vomiting, stomach cramps, loss of appetite, diarrhea that may be watery or bloody.
• Signs of pancreatitis: Pain in the upper belly that may radiate to the back, abdominal tenderness, rapid pulse, fever, vomiting, upset stomach, stomach pain that worsens after eating, oily and smelly stool.

Common Tirzepatide side effects may include:

• People with diabetes experiencing low blood sugar levels
• Bloating, burping, heartburn, gas, upset stomach, GERD, indigestion
• Stomach pain, nausea and vomiting
• Constipation or diarrhea
• Hair loss
• Low blood pressure
• Dizziness, tiredness, fatigue
• Hypersensitivity reactions

‍This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.