HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciTir safely and effectively. See full prescribing information for LuciTir.

INDICATIONS AND USAGE

LuciTir® is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist：

• indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.

• 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.

Limitations of Use:

Coadministration with other tirzepatide-containing products or with any GLP-1 receptor agonist is not recommended.

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.

• Consider treatment response and tolerability when selecting the maintenance dosage.

Recommended Maintenance and Maximum Dosage

• Weight Reduction and Long-Term Maintenance: 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly.

• Obstructive Sleep Apnea: 10 mg or 15 mg injected subcutaneously once weekly.

Maximum Recommended Dosage: 15 mg injected subcutaneously once weekly.

Administration Instructions

• See full prescribing information for administration instructions.

DOSAGE FORMS AND STRENGTHS

Injection: 10 mg

CONTRAINDICATIONS

• Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2.

• Known serious hypersensitivity to tirzepatide or any of the excipients in LuciTir.

WARNINGS AND PRECAUTIONS

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

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

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

• Acute Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected.

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

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

• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus: Has not been studied in patients with non-proliferative 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 LuciTir 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.

ADVERSE REACTIONS

The most common adverse reactions, reported in ≥5% of patients treated with LuciTir are: nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, gastroesophageal reflux disease.

DRUG INTERACTIONS

LuciTir 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 LuciTir.

• 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.

Storage

• Store LuciTir in a refrigerator at 2°C to 8°C (36°F to 46°F).

• If needed, each single-dose syringe can be stored unrefrigerated at temperatures not to exceed 30°C (86°F) for up to 21 days. If LuciTir is stored at room temperature, it should not be returned to the refrigerator.

• Discard if not used within 21 days after removing from the refrigerator.

• Do not freeze LuciTir. Do not use LuciTir if frozen.

• Store LuciTir in the original carton to protect from light.