Adjunct to reduced-calorie diet & increased physical activity for wt management in adults w/ initial BMI of ≥30 kg/m2 (obesity), or ≥27 kg/m2 to <30 kg/m2 (overwt) in the presence of at least 1 wt-related comorbidity eg, dysglycaemia (pre-diabetes or type 2 DM), HTN, dyslipidaemia or obstructive sleep apnoea. Adjunct to healthy nutrition & increased physical activity for wt management in adolescents ≥12 yr w/ obesity (BMI corresponding to ≥30 kg/m2 for adults by international cut-off points) & body wt >60 kg.
SC Inj in abdomen, thigh or upper arm. Adult & adolescent ≥12 yr Initially 0.6 mg once daily, increased to 3 mg once daily in increments of 0.6 mg w/ at least 1 wk interval. Max & maintenance dose: 3 mg daily.
Not to be administered IV or IM. Not to be used as substitute for insulin in patients w/ DM. Discontinue treatment after 12 wk on 3 mg daily dose if patients have not lost at least 5% (in adults) or 4% (in adolescent ≥12 yr) of initial body wt or BMI; if pancreatitis is suspected & not to be restarted if acute pancreatitis is confirmed in patients who experience clinically relevant sustained increase in resting heart rate. Increased risk of cholelithiasis & cholecystitis; hypoglycaemia in patients w/ type 2 DM receiving concomitant insulin &/or sulfonylurea. Not recommended in patients w/ CHF NYHA class IV; treated w/ other products for wt management; obesity secondary to endocrinological or eating disorders or treatment w/ medicinal products causing wt gain; inflammatory bowel disease & diabetic gastroparesis. Patients w/ thyroid disease. Potential risk of dehydration in relation to GI side effects. Avoid fluid depletion. Monitor heart rate at regular intervals. Self-monitor blood glucose in reducing dose of insulin or insulin secretagogues eg, sulfonylureas. Not to be used in combination w/ another GLP-1 receptor agonist. May affect ability to drive & use machines. Not recommended in severe renal impairment (CrCl <30 mL/min); ESRD; severe hepatic impairment. Mild or moderate hepatic impairment. Not to be used during pregnancy & lactation. Childn <12 yr. Hypoglycaemia in adolescents ≥12 yr. Not recommended in elderly ≥75 yr.
Concomitant use w/ warfarin or other coumarin derivatives. Reduced AUC & decreased Cmax of digoxin & lisinopril. Lowered Cmax of ethinylestradiol & levonorgestrel.
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