Liraglutide Online: Cost, Candidacy, and the Real Prescription Process

Prescription status and FDA's telehealth red flags

Liraglutide products are prescription-only injections, and current US GLP-1 products are prescription-only injections or tablets [5][6][2][3]. In its discussion of compounded GLP-1 drugs, FDA recommends that patients obtain a prescription from their doctor and fill it at a state-licensed pharmacy [1]. FDA's telehealth red flags for consumers include a company that does not require a screening and prescription by a licensed doctor before providing medicine, one that has no licensed doctor available to answer questions after delivery, and one that claims a compounded drug equals an FDA-approved drug [1].

Generic liraglutide is FDA-approved, with labels for generics that reference Saxenda (weight management) and generics that reference Victoza (type 2 diabetes) [4]. Compounded liraglutide is not FDA approved and is not reviewed for safety, effectiveness or quality [1].

Who the Labels Cover

Saxenda is labeled, with a reduced-calorie diet and more physical activity, for adults and children 12 and older weighing more than 60 kg with obesity, and for adults with overweight plus at least one weight-related condition [3]. The Saxenda label says not to combine it with another liraglutide product or any other GLP-1 receptor agonist [3]. Victoza is labeled for glycemic control in adults and children 10 and older with type 2 diabetes and to reduce major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease; it is not a weight-loss drug [2]. Both are contraindicated with a personal or family history of medullary thyroid carcinoma or MEN 2, or after serious hypersensitivity, and both carry a boxed warning for rodent thyroid C-cell tumors of unknown human relevance [3][2].

Dosing and the 16-Week Weight Check

Saxenda starts at 0.6 mg once daily for a week and rises weekly through 1.2, 1.8 and 2.4 mg to 3 mg daily from week 5; the label says to discontinue if 3 mg is not tolerated [3]. For adults, the label says to evaluate weight 16 weeks after starting Saxenda and to stop it if less than 4% of baseline body weight has been lost [3]. Victoza starts at 0.6 mg daily for a week, then 1.2 mg, maximum 1.8 mg [2].

What the Trials Showed

SCALE Obesity and Prediabetes randomized 3,731 adults without diabetes and with a BMI of 30 or higher, or 27 or higher with a weight-related condition, to liraglutide 3.0 mg (n=2,487) or placebo (n=1,244) for 56 weeks [8]. The Saxenda label reports body weight change of -7.4% versus -3.0%, with 62.3% versus 34.4% losing at least 5% [3]. LEADER followed 9,340 adults with type 2 diabetes and high cardiovascular risk for a median of 3.8 years; cardiovascular death, nonfatal heart attack or nonfatal stroke occurred in 13.0% on liraglutide versus 14.9% on placebo (hazard ratio 0.87, 95% CI 0.78 to 0.97) [9]. Victoza's label includes reduction of major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease [2].