Indications for SAXENDA:
Adjunct to reduced-calorie diet and increased physical activity for chronic weight management: in adults with an initial BMI of ≥30kg/m2 (obese), or ≥27kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, T2DM, dyslipidemia); in children aged ≥12yrs with body weight ≥60kg and an initial BMI corresponding to ≥30kg/m2 for adults (obese) by international cut-offs.
Limitations of Use:
Do not use with other liraglutide-containing products or GLP-1 receptor agonists. Safety and efficacy in children with T2DM or with concomitant other weight loss products (including prescription or OTC drugs, herbal preps) have not been established.
Give by SC inj into abdomen, thigh, or upper arm once daily. Escalate dose with the following schedule (to mitigate risk of GI effects): Week 1: 0.6mg daily; Week 2: 1.2mg daily; Week 3: 1.8mg daily; Week 4: 2.4mg daily; Week 5 and onward: 3mg daily (recommended dose). Delay dose escalation 1 week if increased dose not tolerated; discontinue if 3mg not tolerated. If concurrent insulin secretagogues (eg, sulfonylureas) or insulin; consider reducing their doses by ½. If >3 days elapsed since last dose, reinitiate at 0.6mg/day, then follow dose escalation schedule. Evaluate response after 16 weeks. Discontinue if ≥4% weight loss is not achieved.
<12yrs: not established. Give by SC inj into abdomen, thigh, or upper arm once daily. ≥12yrs: escalate dose with the following schedule (to mitigate risk of GI effects): Week 1: 0.6mg daily; Week 2: 1.2mg daily; Week 3: 1.8mg daily; Week 4: 2.4mg daily; Week 5 and onward: 3mg daily (recommended dose). Lower escalation dose to previous level if increased dose not tolerated; dose escalation may take up to 8wks. Reduce maintenance dose to 2.4mg daily if 3mg not tolerated; discontinue if 2.4mg not tolerated. If >3 days elapsed since last dose, reinitiate at 0.6mg/day, then follow dose escalation schedule. Evaluate response after 12 weeks. Discontinue if ≥1% weight loss is not achieved.
History (personal or family) of medullary thyroid carcinoma (MTC). Multiple endocrine neoplasia syndrome type 2 (MEN 2). Pregnancy.
Risk of thyroid C-cell tumors.
Risk of thyroid C-cell tumors; inform patients of potential risk and symptoms. Monitor for pancreatitis; discontinue if suspected; do not restart if confirmed. Risk of acute gallbladder disease. History of suicidal attempts or ideation: avoid. Monitor for emergence or worsening depression, suicidal thinking or behavior; discontinue if occurs. Monitor blood glucose prior to and during treatment in type 2 diabetics. Monitor heart rate periodically; discontinue if sustained increases. History of anaphylaxis or angioedema with other GLP-1 receptor agonist. Discontinue if hypersensitivity reactions occur. Renal impairment: caution with initiating or escalating doses. Hepatic impairment. Gastroparesis: not studied. Nursing mothers.
Glucagon-like peptide-1 (GLP-1) receptor agonist.
Increased risk of hypoglycemia with concomitant insulin secretagogues (eg, sulfonylureas) or insulin; may need a lower dose of these (see Adults); monitor. May affect absorption of other oral drugs (delayed gastric emptying).
Nausea, diarrhea, constipation, vomiting, inj site reactions, headache, hypoglycemia, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase, pyrexia, gastroenteritis; hypersensitivity reactions.
Generic Drug Availability:
Multi-dose, pre-filled pen (3mL)—3, 5