Obesity:

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.

Adult Dosage:

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.

Children Dosage:

<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.

SAXENDA Contraindications:

History (personal or family) of medullary thyroid carcinoma (MTC). Multiple endocrine neoplasia syndrome type 2 (MEN 2). Pregnancy.

Boxed Warning:

Risk of thyroid C-cell tumors.

SAXENDA Warnings/Precautions:

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.

SAXENDA Classification:

Glucagon-like peptide-1 (GLP-1) receptor agonist.

SAXENDA Interactions:

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).

Adverse Reactions:

Nausea, diarrhea, constipation, vomiting, inj site reactions, headache, hypoglycemia, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase, pyrexia, gastroenteritis; hypersensitivity reactions.

Generic Drug Availability:

NO

How Supplied:

Multi-dose, pre-filled pen (3mL)—3, 5

Pricing for SAXENDA

five 3ml pens of 3mg/0.5ml carton (Qty: 1)
Appx. price $1353
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