Generic Name and Formulations:
Liraglutide [rDNA origin] 6mg/mL; soln for SC inj.

Company:
Novo Nordisk
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).

Limitations Of use:
Not indicated for type 2 diabetes. Do not use with Victoza, other GLP-1 receptor agonists, or insulin. Effects on cardiovascular morbidity and mortality have not been established. Safety and efficacy with concomitant other weight loss products has not been established. Not studied in patients with history of pancreatitis.

Adult:
Give by SC inj into abdomen, thigh, or upper arm once daily. Escalate dose gradually. 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. Delay dose escalation 1 week if increased dose not tolerated; discontinue if 3mg not tolerated. If >3 days elapsed since last dose, reinitiate at 0.6mg/day, then titrate. eva luate response after 16 weeks. Discontinue if ≥4% weight loss is not achieved.

Children:
Not recommended.

Contraindications:
History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2. Pregnancy (Cat.X).

Warnings/Precautions:
Inform patients of thyroid cancer risk and symptoms. Monitor for signs/symptoms of 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 angioedema with other GLP-1 receptor agonist. Discontinue if hypersensitivity reactions occur. Renal or hepatic impairment. Gastroparesis. Nursing mothers: not recommended.

Interactions:
Risk of hypoglycemia with concomitant insulin secretagogues (eg, sulfonylureas); consider reducing their doses by ½. May affect absorption of other oral drugs (delayed gastric emptying).

Pharmacological Class:
Glucagon-like peptide-1 (GLP-1) receptor agonist.

Adverse Reactions:
Nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase.

REMS:
YES

Generic Availability:
NO

How Supplied:
Multi-dose, pre-filled pen (3mL)—3, 5