1. Disorder of cardiovascular system; Prophylaxis - Type 2 diabetes mellitus.
2. Obesity, Or overweight in the presence of at least one weight-related comorbidity.
3. Type 2 diabetes mellitus (For children >10 years, adolescents, and adults)<20210401>
#仿單變更2021
藥理
Liraglutide is a long acting analog of human glucagon-like peptide-1 (GLP-1) (an incretin hormone) which increases glucose-dependent insulin secretion, decreases inappropriate glucagon secretion, increases B-cell growth/replication, slows gastric emptying, and decreases food intake. Liraglutide administration results in decreases in hemoglobin A1c by approximately 1%.(UTD)
藥動學
Absorption:
Bioavailability: subQ: 55%
Distribution:
Vd, subQ: 13 L ; 20 to 25 L (patients weighing 100 kg)
Vd, IV: 0.07 L/kg
Metabolism: not significant
Excretion:
Renal excretion: 0% unchanged; 6% changed
Dialyzable: No (hemodialysis)
Elimination Half Life:
13 hours
禁忌症
Hypersensitivity to liraglutide or any component of the product
Personal or family history of medullary thyroid carcinoma
Personal of family history of multiple endocrine neoplasia syndrome type 2
Pregnancy, in patients treated for obesity.
懷孕分類
X (FDA)
哺乳分類
Infant risk cannot be ruled out.(MDX)
副作用
Common:
Endocrine metabolic: Hypoglycemia (monotherapy, 9.7% to 23%; combination therapy, 3.6% to 43.6% )
Gastrointestinal: Constipation (Type 2 diabetes, 5% to 9.9%; weight management, 19.4% ), Decrease in appetite (9% to 10% ), Diarrhea (10% to 20.9% ), Indigestion (4% to 9.6% ), Nausea (Type 2 diabetes, 18% to 28.4% ; weight management, 39.3% ), Vomiting (6% to 15.7% )
Neurologic: Headache (9.1% to 13.6% )
Respiratory: Upper respiratory infection (6% to 9.5% )
Serious:
Endocrine metabolic: Breast cancer (0.6% ), C-cell hyperplasia of thyroid, Medullary thyroid carcinoma, Papillary thyroid carcinoma (0.2% )
Gastrointestinal: Cholecystitis (0.8% ), Cholelithiasis (1.15 to 2.2% ), Colorectal cancer (0.2% ), Pancreatic cancer, Pancreatitis (0.3% )
Immunologic: Anaphylaxis
Psychiatric: Suicidal thoughts (0.3% )
Renal: Acute renal failure
Other: Angioedema, Breast c ancer (0.7% ), Pancreatic cancer
劑量和給藥方法
Disorder of cardiovascular system; Prophylaxis - Type 2 diabetes mellitus:
Initial, 0.6 mg subQ once daily for 1 week (to reduce gastrointestinal symptoms during titration), then increase to maintenance dose of 1.2 mg once daily; may increase to 1.8 mg/day if needed
Type 2 diabetes mellitus:
Initial, 0.6 mg subQ every day for 1 week; this dose is to reduce gastrointestinal symptoms during titration and is not effective for glycemic control; maintenance, 1.2 mg once daily; may increase to 1.8 mg/day if needed; MAX 1.8 mg/day
小兒調整劑量
Initial 0.6 mg subQ once daily, then increase to maintenance dose of 1.2 mg once daily after at least one week; may increase to 1.8 mg/day if needed <20210401>
腎功能調整劑量
肝功能調整劑量
安定性
Store unopened prefilled pens refrigerated, between 2 and 8 degrees C . Store opened pens up to 30 days at controlled room temperature, between 15 and 30 degrees C , or refrigerated, between 2 and 8 degrees C . Protect from excessive heat and sunlight. Avoid storing directly adjacent to cooling compartment in refrigerator. Do not freeze or use a pen that has been frozen.