Zepbound 10 mg/.5mL
tirzepatide · INJECTION, SOLUTION · Eli Lilly and Company
Zepbound is a injection, solution containing tirzepatide at 10 mg/.5mL, taken subcutaneous. Manufactured by Eli Lilly and Company.
Key Facts
- Brand Name
- Zepbound
- Generic Name
- tirzepatide
- NDC Code (Product)
0002-1340- Manufacturer
- Eli Lilly and Company
- Strength
- 10 mg/.5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA217806
- Drug Class
- Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]; GLP-1 Receptor Agonist [EPC]
- Marketing Start
- 03/28/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ZEPBOUND ® is indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ZEPBOUND is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ( 1 ) Limitations of Use: Coadministration with other tirzepatide-containing products or with any GLP-1 receptor agonist is not recommended. ( 1 ) Limitations of Use ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is no…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended Dose Escalation Schedule The recommended starting dosage is 2.5 mg injected subcutaneously once weekly for 4 weeks. Increase the dosage in 2.5 mg increments after at least 4 weeks until recommended maintenance dosage is achieved. ( 2.1 ) Consider treatment response and tolerability when selecting the maintenance dosage. ( 2.1 ) Recommended Maintenance and Maximum Dosage Weight Reduction and Long-Term Maintenance: 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly. ( 2.2 ) Obstructive Sleep Apnea: 10 mg or 15 mg injected subcutaneously once weekly. ( 2.2 ) Maximum Recommended Dosage: 15 mg injected subcutaneously once weekly. ( 2.2 ) Administration Instructions Refer to the Full Prescribing Information for additional important administration instructions about ZEPBOUND presentations. ( 2.4 ) 2.1 Recommended Dose Escalation Schedule The recommended starting dosage of ZEPBOUND for all indications is 2.5 mg injected subcutaneously once weekly for 4 weeks. The 2.5 mg dosage is for treatment initiation and is not approved as a maintenance dosage. Follow the dosage escalation below for all indications to reduce the risk of gastrointestinal ad…
Contraindications
4 CONTRAINDICATIONS ZEPBOUND is contraindicated in patients with: A personal or family history of MTC or in patients with MEN 2 [see Warnings and Precautions ( 5.1 )] . Known serious hypersensitivity to tirzepatide or any of the excipients in ZEPBOUND. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide [see Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6.2 )] . Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 ( 4 ) Known serious hypersensitivity to tirzepatide or any of the excipients in ZEPBOUND ( 4 )
Drug Interactions
7 DRUG INTERACTIONS ZEPBOUND delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. ( 7.2 ) 7.1 Concomitant Use with Insulin or an Insulin Secretagogue (e.g., Sulfonylurea) ZEPBOUND lowers blood glucose. When initiating ZEPBOUND, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (e.g., sulfonylureas) to reduce the risk of hypoglycemia [see Warnings and Precautions ( 5.7 )] . 7.2 Oral Medications ZEPBOUND delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with ZEPBOUND. Monitor patients on oral medications dependent on threshold concentrations for efficacy and those with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with ZEPBOUND. Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation with ZEPBOUND and for 4 weeks after each dose escalation. Hormonal contraceptives that are not administe…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.2 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.3 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.4 )] Acute Pancreatitis [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Hypoglycemia [see Warnings and Precautions ( 5.7 )] Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus [see Warnings and Precautions ( 5.8 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] The most common adverse reactions, 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545…
Frequently Asked Questions
What is Zepbound used for?
Zepbound contains tirzepatide. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Zepbound a controlled substance?
Zepbound is not classified as a controlled substance by the DEA.
What is the generic name for Zepbound?
The generic name for Zepbound is tirzepatide. There are 11 other brand versions of tirzepatide.
What is the NDC code for Zepbound 10 mg/.5mL?
The NDC (National Drug Code) for Zepbound 10 mg/.5mL is 0002-1340, listed by Eli Lilly and Company.