HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciSemag is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use

•Has not been studied in patients with a history of pancreatitis.

•Not for treatment of type 1 diabetes mellitus.

DOSAGE AND ADMINISTRATION

•Instruct patients to take LuciSemag at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only. Waiting less than 30 minutes, or taking with food, beverages (other than plain water) or other oral medications will lessen the effect of LuciSemag. Waiting more than 30 minutes to eat may increase the absorption of LuciSemag.

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

•Start LuciSemag with 3 mg once daily for 30 days. After 30 days on the 3 mg dosage, increase the dosage to 7 mg once daily.

•Dosage may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dosage.

DOSAGE FORMS AND STRENGTHS

Tablets: 14 mg×30 tablets.

CONTRAINDICATIONS

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

•Prior serious hypersensitivity reaction to semaglutide or any of the excipients in LuciSemag.

WARNINGS AND PRECAUTIONS

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

•Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin secretagogue or insulin may be necessary.

•Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.

•Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue LuciSemag if suspected and promptly seek medical advice.

•Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated. 

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥5%) are nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation.

DRUG INTERACTIONS

Oral Medications: LuciSemag delays gastric emptying. Instruct patients to closely follow LuciSemag administration instructions.

USE IN SPECIFIC POPULATIONS

•Pregnancy: May cause fetal harm .

•Lactation: Breastfeeding not recommended.

•Females and Males of Reproductive Potential: Discontinue LuciSemag in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.