Mounjaro

タイトルまたは説明

---------- INDICATIONS AND USAGE --------------------------- MOUNJARO™ 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 with type 2 diabetes mellitus. (1) Limitations of Use: • Has not been studied in patients with a history of pancreatitis (1, 5.2) • Is not indicated for use in patients with type 1 diabetes mellitus (1) ------------------------DOSAGE AND ADMINISTRATION----------------------- • The recommended starting dosage is 2.5 mg injected subcutaneously once weekly (2.1) • After 4 weeks, increase to 5 mg injected subcutaneously once weekly (2.1) • If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. • The maximum dosage is 15 mg subcutaneously once weekly (2.1). • Administer once weekly at any time of day, with or without meals. (2.2) • Inject subcutaneously in the abdomen, thigh, or upper arm. (2.2) • Rotate injection sites with each dose. ----------------------DOSAGE FORMS AND STRENGTHS--------------------- Injection: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL in single-dose pen (3)

INDICATIONS AND USAGE MOUNJARO™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use • MOUNJARO has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)]. • MOUNJARO is not indicated for use in patients with type 1 diabetes mellitus. 2 DOSAGE AND ADMINISTRATION 2.1 Dosage • The recommended starting dosage of MOUNJARO is 2.5 mg injected subcutaneously once weekly. The 2.5 mg dosage is for treatment initiation and is not intended for glycemic control. • After 4 weeks, increase the dosage to 5 mg injected subcutaneously once weekly. • If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. • The maximum dosage of MOUNJARO is 15 mg injected subcutaneously once weekly. • If a dose is missed, instruct patients to administer MOUNJARO as soon as possible within 4 days (96 hours) after the missed dose. If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule