Reduction of excess body weight and the long-term maintenance of a reduced body weight in adults who have at least one weight-related comorbid condition.
PREGNANCY: May cause fetal harm. When pregnancy is recognized, discontinue orforglipron. 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.
Not recommended for use in patients with severe hepatic impairment.
Orforglipron delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications.
Orforglipron is administered as a calcium salt.
WARNING: RISK OF THYROID C-CELL TUMORS
IN PRODUCTS WITH GLUCAGON-LIKE PEPTIDE-1 (GLP-1) RECEPTOR AGONIST ACTIVITY THAT ARE PHARMACOLOGICALLY ACTIVE IN RATS AND MICE, RODENT THYROID C-CELL TUMORS (ADENOMAS AND CARCINOMAS) HAVE BEEN OBSERVED AT CLINICALLY RELEVANT EXPOSURES AND ARE CONSIDERED GLP-1 RECEPTOR-DEPENDENT EFFECTS IN RODENTS.
ORFORGLIPRON IS NOT PHARMACOLOGICALLY ACTIVE IN RATS OR MICE AND DID NOT PRODUCE TUMORS IN RODENTS. WHILE ORFORGLIPRON IS PHARMACOLOGICALLY ACTIVE AT THE HUMAN GLP-1 RECEPTOR, THE HUMAN RELEVANCE OF GLP-1 RECEPTOR-DEPENDENT THYROID C-CELL TUMORS OBSERVED IN RODENTS HAS NOT BEEN DETERMINED.
ORFORGLIPRON IS CONTRAINDICATED IN PATIENTS WITH A PERSONAL OR FAMILY HISTORY OF MEDULLARY THYROID CARCINOMA OR IN PATIENTS WITH MULTIPLE ENDOCRINE NEOPLASIA SYNDROME TYPE 2. COUNSEL PATIENTS REGARDING THE POTENTIAL RISK OF MEDULLARY THYROID CARCINOMA AND SYMPTOMS OF THYROID TUMORS.
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