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liraglutide
Overview
What is Saxenda?
Saxenda contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is CHNO and the molecular weight is 3751.2 Daltons. The structural formula (Figure 1) is:
Saxenda is a clear, colorless solution. Each 1 mL of Saxenda solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. Each pre-filled pen contains a 3 mL solution of Saxenda equivalent to 18 mg liraglutide (free-base, anhydrous).
What does Saxenda look like?
What are the available doses of Saxenda?
Solution for subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL).
What should I talk to my health care provider before I take Saxenda?
How should I use Saxenda?
Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of
Limitations of Use
The recommended dosage of Saxenda is 3 mg daily. The dose escalation schedule in Table 1 should be used to reduce the likelihood of gastrointestinal symptoms. If patients do not tolerate an increased dose during dose escalation, consider delaying dose escalation for approximately one additional week. Saxenda should be discontinued, however, if a patient cannot tolerate the 3 mg dose, as efficacy has not been established at lower doses (0.6, 1.2, 1.8, and 2.4 mg).
Saxenda should be taken once daily at any time of day, without regard to the timing of meals. Saxenda can be injected subcutaneously in the abdomen, thigh, or upper arm. The injection site and timing can be changed without dose adjustment. Saxenda must not be administered intravenously or intramuscularly.
When initiating Saxenda in patients taking insulin secretagogues (such as sulfonylureas), consider reducing the dose of the insulin secretagogue (for example, by one-half) to reduce the risk for hypoglycemia, and monitor blood glucose. Saxenda and insulin should not be used together Conversely, if discontinuing Saxenda in patients with type 2 diabetes, monitor for an increase in blood glucose.
Evaluate the change in body weight 16 weeks after initiating Saxenda and discontinue Saxenda if the patient has not lost at least 4% of baseline body weight, since it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
If a dose is missed, the once-daily regimen should be resumed as prescribed with the next scheduled dose. An extra dose or increase in dose should not be taken to make up for the missed dose. If more than 3 days have elapsed since the last Saxenda dose, patients should reinitiate Saxenda at 0.6 mg daily and follow the dose escalation schedule in Table 1, which may reduce the occurrence of gastrointestinal symptoms associated with reinitiation of treatment.
Prior to initiation of Saxenda, patients should be trained by their healthcare professional on proper injection technique. Training reduces the risk of administration errors such as needle sticks and incomplete dosing. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations.
Saxenda solution should be inspected prior to each injection, and the solution should be used only if it is clear, colorless, and contains no particles.
BMI is calculated by dividing weight in (kilograms) by height (in meters) squared. A chart for determining BMI based on height and weight is provided in Table 2.
What interacts with Saxenda?
Sorry No Records found
What are the warnings of Saxenda?
Sorry No Records found
What are the precautions of Saxenda?
Sorry No Records found
What are the side effects of Saxenda?
Sorry No records found
What should I look out for while using Saxenda?
Saxenda is contraindicated in:
What might happen if I take too much Saxenda?
Overdoses have been reported in clinical trials and post-marketing use of liraglutide. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.
How should I store and handle Saxenda?
Asacol HD (mesalamine) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “WC 800” in black.NDC Store and dispense in the original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant pouch (silica gel) from bottle.Store at controlled room temperature, 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]Asacol HD (mesalamine) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “WC 800” in black.NDC Store and dispense in the original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant pouch (silica gel) from bottle.Store at controlled room temperature, 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]Asacol HD (mesalamine) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “WC 800” in black.NDC Store and dispense in the original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant pouch (silica gel) from bottle.Store at controlled room temperature, 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]Asacol HD (mesalamine) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “WC 800” in black.NDC Store and dispense in the original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant pouch (silica gel) from bottle.Store at controlled room temperature, 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]Asacol HD (mesalamine) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “WC 800” in black.NDC Store and dispense in the original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant pouch (silica gel) from bottle.Store at controlled room temperature, 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]Asacol HD (mesalamine) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “WC 800” in black.NDC Store and dispense in the original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant pouch (silica gel) from bottle.Store at controlled room temperature, 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]Asacol HD (mesalamine) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “WC 800” in black.NDC Store and dispense in the original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant pouch (silica gel) from bottle.Store at controlled room temperature, 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Liraglutide is an acylated human glucagon-like peptide-1 (GLP-1) receptor agonist with 97% amino acid sequence homology to endogenous human GLP-1(7-37). Like endogenous GLP-1, liraglutide binds to and activates the GLP-1 receptor, a cell-surface receptor coupled to adenylyl cyclase activation through the stimulatory G-protein, Gs. Endogenous GLP-1 has a half-life of 1.5-2 minutes due to degradation by the ubiquitous endogenous enzymes, dipeptidyl peptidase 4 (DPP-4) and neutral endopeptidases (NEP). Unlike native GLP-1, liraglutide is stable against metabolic degradation by both peptidases and has a plasma half-life of 13 hours after subcutaneous administration. The pharmacokinetic profile of liraglutide, which makes it suitable for once-daily administration, is a result of self-association that delays absorption, plasma protein binding, and stability against metabolic degradation by DPP-4 and NEP.
GLP-1 is a physiological regulator of appetite and calorie intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation. In animal studies, peripheral administration of liraglutide resulted in the presence of liraglutide in specific brain regions regulating appetite, including the hypothalamus. Although liraglutide activated neurons in brain regions known to regulate appetite, specific brain regions mediating the effects of liraglutide on appetite were not identified in rats.
Non-Clinical Toxicology
Saxenda is contraindicated in:Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice . Malignant thyroid C-cell carcinomas were detected in rats and mice. It is unknown whether Saxenda will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.
Cases of MTC in patients treated with liraglutide have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and liraglutide use in humans.
Saxenda is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of Saxenda and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).
Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Saxenda. Such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin may indicate MTC, and patients with MTC usually have calcitonin values greater than 50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
The following serious adverse reactions are described below or elsewhere in the prescribing information:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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