美国制药商礼来于11月25日称，欧盟批准该公司注射剂药物Trulicity用于2型糖尿病成人患者治疗。这款一周注射一次的药物属于一种GLP-1受体激动剂药物，这类药物包括有诺和诺德日常广泛应用的利拉鲁肽。这类药物的作用类似人体自身的激素GLP-1，在患者服用后可促使人体释放胰岛素。
Trulicity (dulaglutide)在一天内可随时使用，不管是否用餐，这款药物可单独使用，也可与其它最常见的2型糖尿病治疗药物一块使用，2型糖尿病与肥胖高度相关。这款药物于9月18日在美国获得上市批准。
与其它糖尿病药物如胰岛素一样，Trulicity可引起低血糖，即一种潜在危险的血糖下降，可导致昏厥、恶心及其它症状。
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.
TRULICITY(dulaglutide) injection, for subcutaneous use
Initial U.S. Approval: 2014
WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning.
Dulaglutide causes thyroid C-cell tumors in rats. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance could not be determined from clinical or nonclinical studies (5.1, 13.1).
TRULICITY is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) (4.1).
INDICATIONS AND USAGE
TRULICITY™ is a glucagon-like peptide (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:
Not recommended as first-line therapy for patients inadequately controlled on diet and exercise (1, 5.1).
Has not been studied in patients with a history of pancreatitis. Consider another antidiabetic therapy (1, 5.2).
Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Not for patients with pre-existing severe gastrointestinal disease.
Has not been studied in combination with basal insulin.
DOSAGE AND ADMINISTRATION
Administer once weekly at any time of day (2.1).
Inject subcutaneously in the abdomen, thigh, or upper arm (2.1).
Initiate at 0.75 mg subcutaneously once weekly. Dose can be increased to 1.5 mg once weekly for additional glycemic control (2.1).
If a dose is missed administer within 3 days of missed dose (2.1).
DOSAGE FORMS AND STRENGTHS
Injection: 0.75 mg/0.5 mL solution in a single-dose pen (3)
Injection: 1.5 mg/0.5 mL solution in a single-dose pen (3)
Injection: 0.75 mg/0.5 mL solution in a single-dose prefilled syringe (3)
Injection: 1.5 mg/0.5 mL solution in a single-dose prefilled syringe (3)
CONTRAINDICATIONS
Do not use in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (4.1, 5.1, 13.1).
Do not use if history of serious hypersensitivity to TRULICITY or any product components (4.2, 5.4).
WARNINGS AND PRECAUTIONS
Thyroid C-cell tumors in animals: Counsel patients regarding the risk of medullary thyroid carcinoma and the symptoms of thyroid tumors (5.1).
Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with history of pancreatitis (5.2).
Hypoglycemia: When TRULICITY is used with an insulin secretagogue (e.g., a sulfonylurea) or insulin, consider lowering the dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia (5.3).
Hypersensitivity Reactions: Discontinue TRULICITY if suspected. Monitor and treat promptly per standard of care until s |
