HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciOrfor is a 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.

Limitations of Use

Concomitant use with another GLP-1 receptor agonist is not recommended.

DOSAGE AND ADMINISTRATION

• Take LuciOrfor orally once daily, with or without food.

• Swallow tablets whole. Do not break, crush, or chew.

• Do not take more than one tablet per day.

• Starting dosage is 0.8 mg once daily. After at least 30 days, increase dosage to 2.5 mg once daily.

• After at least 30 days on the 2.5 mg dosage, increase dosage to 5.5 mg once daily.

• Dosage may be increased to the next dosage level (9 mg, 14.5 mg, or 17.2 mg once daily) after at least 30 days on the current dosage, based on treatment response and tolerability.

• Maximum dosage is 17.2 mg once daily.

DOSAGE FORMS AND STRENGTHS

Tablets:

5.5mg×30 tablets

CONTRAINDICATIONS

• Personal or family history of MTC or in patients with MEN 2

• Known serious hypersensitivity to orforglipron or any of the excipients in LuciOrfor

WARNINGS AND PRECAUTIONS

• Acute Pancreatitis:

Has been observed in patients treated with GLP-1 receptor agonists, including LuciOrfor.

Discontinue if pancreatitis is suspected.

• Severe Gastrointestinal Reactions:

Use has been associated with gastrointestinal adverse reactions, sometimes severe. LuciOrfor is not recommended in patients with severe gastroparesis.

• Acute Kidney Injury Due to Volume Depletion:

Monitor renal function in patients reporting adverse reactions that could lead to volume depletion.

• Hypoglycemia:

Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dosage 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.

• Hypersensitivity Reactions:

Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with GLP-1 receptor agonists. If suspected, advise the patient to promptly seek medical attention and discontinue LuciOrfor.

• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes:

Has not been studied in patients with diabetic retinopathy and/or macular edema requiring acute treatment. Monitor patients with a history of diabetic retinopathy for progression.

• Acute Gallbladder Disease:

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

• Pulmonary Aspiration During General Anesthesia and 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

Most common adverse reactions, reported in ≥5% of patients treated with LuciOrfor, are nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, gastroesophageal reflux disease, flatulence, and hair loss.

DRUG INTERACTIONS

• Strong CYP3A4 Inhibitors: The maximum dosage of LuciOrfor is 9 mg once daily when used concomitantly with a strong CYP3A4 inhibitor. Avoid concomitant use with strong CYP3A4 inhibitors that also inhibit OATP1B.

• CYP3A4 Inducers: Avoid concomitant use with strong CYP3A4 inducers. Monitor LuciOrfor effectiveness and escalate dosage as needed when used concomitantly with moderate CYP3A4 inducers.

• Simvastatin: Do not exceed simvastatin 20 mg once daily when used concomitantly with LuciOrfor.

• LuciOrfor 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 LuciOrfor.

• 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 30 days after initiation and for 30 days after each dose escalation.

• Hepatic impairment: Not recommended for use in patients with severe hepatic impairment.

Storage

• Store LuciOrfor at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).

• LuciOrfor is light sensitive. Protect from light by keeping in the original bottle and carton and replacing the cap each time after opening. If the carton is no longer available, store bottle away from light.