SAXENDA Rx

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SAXENDA

Obesity
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Generic Name and Formulations:

Liraglutide 6mg/mL; soln for SC inj.

Company:

Novo Nordisk

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Select therapeutic use:

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 with the following escalation 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 >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:

Not recommended.

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.

Warnings/Precautions:

Risk of thyroid C-cell tumors; inform patients of potential 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 impairment: caution with initiating or escalating doses. Hepatic impairment: use with caution (limited data). Gastroparesis: not studied. Nursing mothers.

Pancreatic Cancer Powered by Novo Nordisk Medical Affairs

The below information is supplied to you as a professional service in response to your specific request. This letter is meant to supplement information you have gathered from other sources and is not intended to promote or advocate the use of Novo Nordisk products in any manner other than described in the Prescribing Information.

Summary

Background on Pancreatic Cancer

Appendix

References

Pharmacological Class:

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

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).

Adverse Reactions:

Nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase; hypersensitivity reactions.

Gallbladder-Related Adverse Events Powered by Novo Nordisk Medical Affairs

The below information is supplied to you as a professional service in response to your specific request. This letter is meant to supplement information you have gathered from other sources and is not intended to promote or advocate the use of Novo Nordisk products in any manner other than described in the Prescribing Information.

Summary

Gallstones

Saxenda® and Gallbladder-Related Adverse Events

Additional Information

References

REMS:

YES

Generic Availability:

NO

How Supplied:

Multi-dose, pre-filled pen (3mL)—3, 5

SAXENDA five 3ml pens of 3mg/0.5ml cartons (Qty:1)

appx. price $1237.00