Zepbound®

Your safety is our first priority. Learn more about key medication details, side effects, and other important info about your treatment.

Prescribing information
Common Side effects

  • Nausea

  • Diarrhea

  • Vomiting

  • Constipation

  • Abdominal pain

  • Dyspepsia

  • Injection site reactions

  • Fatigue

  • Hypersensitivity reactions

  • Eructation

  • Hair loss

  • Gastroesophageal reflux disease

Important safety information

ZEPBOUND® (tirzepatide) Injection is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity:

  • to reduce excess body weight and maintain weight reduction long term in:

    • Adults with obesity

    • Adults with overweight in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease)

  • to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity.

Limitations of Use:

  • Co-administration with other tirzepatide-containing products or any GLP-1 receptor agonist is not recommended

  • The safety and efficacy of coadministration with other products for weight management have not been established

  • ZEPBOUND® has not been studied in patients with a history of pancreatitis

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning.

  • In rats, tirzepatide causes thyroid C-cell tumors. It is unknown whether ZEPBOUND® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined

  • ZEPBOUND® is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors

Do not use ZEPBOUND® if you:

  • Have a personal or family history of medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN2).

  • Have been diagnosed with Diabetes (Type 1)

  • Have been diagnosed with pancreatitis or history of pancreatitis

  • Have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food

  • Have a known allergy to tirzepatide/any other GLP-1 drug or any of the inactive ingredients in ZEPBOUND®. Inactive ingredients include: sodium chloride, sodium phosphate dibasic heptahydrate, and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH

  • Have a history of suicidal attempts or active suicidal ideation

WARNINGS AND PRECAUTIONS

  • Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.

  • Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated

  • Severe Gastrointestinal Disease: Use may be associated with gastrointestinal adverse reactions, sometimes severe. Has not been studied in patients with severe gastrointestinal disease and is not recommended in these patients

  • Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of insulin secretagogue or insulin may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia

  • Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting adverse reactions that could lead to volume depletion

  • Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported postmarketing with tirzepatide. If suspected, advise patients to promptly seek medical attention and discontinue ZEPBOUND®

  • Females of Reproductive Potential: Advise females using oral contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation

  • Females of Reproductive Potential: Discontinue at least 2 months before a planned pregnancy because of the long half-life of ZEPBOUND®

  • Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue ZEPBOUND®

  • Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has not been studied in patients with nonproliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Monitor patients with a history of diabetic retinopathy for progression

  • Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue ZEPBOUND® if symptoms develop

  • Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures.

Side Effects Most common side effects, reported in ≥ 5% of patients treated with ZEPBOUND® are: nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, gastroesophageal reflux disease

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS ZEPBOUND® delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications

USE IN SPECIFIC POPULATIONS

  • Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue ZEPBOUND®

  • Females of Reproductive Potential: Advise females using oral contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation

  • Females and Males of Reproductive Potential: Discontinue ZEPBOUND® at least 2 months before a planned pregnancy because of the long half-life of ZEPBOUND®