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Saxenda ( L iraglutide ). Samuel Gyawu-Amoateng. Indication & Approval. Saxenda , is FDA approved as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity Drug was approved in December 23 rd 2014
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Saxenda (Liraglutide) Samuel Gyawu-Amoateng
Indication & Approval • Saxenda, is FDA approved as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity • Drug was approved in December 23rd 2014 • It is approved in adults with BMI of 30 or greater (obesity) or adults with BMI of 27 or greater (overweight) with at least one weight-related condition such as HTN, T2DM, or Dyslipidemia.
Drug Class • Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist also known as incretinmimitic. Therefore is should not be used with other drugs belonging to the same class such as Victoza, for T2DM.
MOA • A long acting analog of human glucagon-like peptide- (GLP-1) (an incretin hormone) which • increases glucose-dependent insulin secretion, • decreases inappropriate glucagon secretion, • increase's B-cell growth/replication, • slows gastric emptying, and decreases food intake. • It’s administration results in decreases in hemoglobin A1c by ~1%
Dosage & Formulation • Initial 0.6mg SubQ once daily for 1 week, increase by 0.6mg daily at weekly intervals to target the dose of 3mg once daily. • If 3mg dose is not tolerated, d/c therapy since efficacy has not been established at lower doses. • Evaluate changes in body weight 16 weeks after starting of therapy. d/c if at least 4% of baseline body weight loss has not been achieved. • No dosage adjustments for renal or mild-to-severe hepatic impairment patient.
Administration & Storage • Drug is administered SuBQ in the upper arm, thigh or abdomen. • Should not be injected IV, or IM. • Can be administered w/o food at any time of the day • Store at 36 to 46 degree F, prior to initial use, and same temp after initial use • Do not freeze, discard if freezing occurs • Discard pen 30 days after initial use
PK , PD • It is highly protein bound. Approximately 98% • VdSubQ is ~ 13- 25 L • Endogenously metabolized by dipeptidyl peptidase IV (DPP-IV) and endogenous endopeptidases • Metabolism is slower than native GLP-1 • T1/2 ~ 13 hours • Peak plasma ~ 8-12 hours
Side Effects and Adverse Effects • Nausea, vomiting, diarrhea, tiredness, decrease appetite, headache • Renal impairment • Hypoglycemia, • Gall bladder problems • BBW : Thyroid Tumors: Dose dependent and treatment duration-dependent thyroid C-cell tumors.
Contraindications • Saxenda is contraindicated in patients with: • 1. Hypersensitive to liraglutide or an component of the product [2] • 2. Personal or family history of medullary thyroid carcinoma [1, 2] • 3. Personal or family history of multiple endocrine neoplasia syndrome type 2 (MEN2) [1, 2] • Pregnancy [1]
CO$T! CO$T!! CO$T!!! • 6 mg/mL (3 mL) : $256.39 [1]
Counseling Pearls & Monitoring • Saxenda approved with a Risk Evaluation and Mitigation Strategy (REMS) program. • Pregnancy Category X: Do not use if pregnant or plan on getting pregnant soon. • If dose is missed for 3 days or more, contact doctor on how to restart • Alternate injection site • Monitor for signs & symptoms of hypoglycemia • Monitor for signs and symptoms of pancreatitis, • Monitor for mood changes or behavioral changes.
Credits • [1.] Lexicomphttp://0-online.lexi.com.wildpac.wne.edu/lco/action/doc/retrieve/docid/patch_f/2144379 • [2.] Micromedex http://0-www.micromedexsolutions.com.wildpac.wne.edu/micromedex2/librarian/ND_T/evidencexpert/ND_PR/evidencexpert/CS/984F15/ND_AppProduct/evidencexpert/DUPLICATIONSHIELDSYNC/CFB70A/ND_PG/evidencexpert/ND_B/evidencexpert/ND_P/evidencexpert/PFActionId/evidencexpert.IntermediateToDocumentLink?docId=2814&contentSetId=31&title=LIRAGLUTIDE&servicesTitle=LIRAGLUTIDE# • [3.] Liraglutide med guide