Trulicity Online: How to Get Dulaglutide, Real Cost, and Who Qualifies

Do you need a prescription for Trulicity?

Yes. Dulaglutide is a prescription injectable, and FDA's advice to patients is to obtain a prescription from a doctor and fill it at a state-licensed pharmacy [1].

What an online visit can and cannot do

FDA's consumer checklist for telehealth sellers lists several warning signs: a company that does not require screening and a prescription by a licensed doctor before providing medicine, one with no licensed doctor available to answer questions after the medicine arrives, one offering deep discounts or prices that seem too good to be true, and one claiming a compounded drug is the same as an FDA-approved drug [1].

Dulaglutide also has a screening point built into its label. Trulicity is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 [2]. The boxed warning tells prescribers to counsel patients about the potential risk of MTC and about symptoms of thyroid tumors such as a mass in the neck, difficulty swallowing, difficulty breathing, or persistent hoarseness [2]. Routine calcitonin testing or thyroid ultrasound is of uncertain value for early detection [2].

Who qualifies for Trulicity?

The label lists two uses, and both require type 2 diabetes [2]:

• Blood sugar control. As an adjunct to diet and exercise in adults and in children 10 years and older with type 2 diabetes.
• Cardiovascular risk reduction. In adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors, to reduce the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke.

There is no obesity or chronic weight management indication in the label [2].

Beyond the indication, the label rules out two groups: anyone with a personal or family history of MTC or MEN 2, and anyone with a prior serious hypersensitivity reaction to dulaglutide or a product component [2]. The label also states that Trulicity is not recommended in patients with severe gastroparesis [2].

Dosing at a glance

The label says adults start at 0.75 mg once weekly; after 4 weeks the dose may go to 1.5 mg, then up in 1.5 mg steps after at least 4 weeks on the current dose, to a maximum of 4.5 mg weekly [2]. Children 10 and older start at 0.75 mg and top out at 1.5 mg weekly [2]. The label says injections go under the skin of the abdomen, thigh or upper arm, at any time of day, with or without food, rotating sites [2].

What the label says to watch for

The boxed warning: dulaglutide caused dose-related thyroid C-cell tumors in rats after lifetime exposure, and it is unknown whether it causes thyroid C-cell tumors, including medullary thyroid carcinoma, in humans [2].

The label warns about acute pancreatitis and states that Trulicity should be discontinued if pancreatitis is suspected. It also warns about hypoglycemia when the drug is combined with insulin or a sulfonylurea, serious hypersensitivity reactions including anaphylaxis and angioedema, acute kidney injury due to volume depletion, severe gastrointestinal reactions, diabetic retinopathy complications, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation [2].

Gastrointestinal side effects are the common ones. In the adult placebo-controlled pool (placebo, 0.75 mg, 1.5 mg), nausea was 5.3%, 12.4% and 21.1%; diarrhea 6.7%, 8.9% and 12.6%; vomiting 2.3%, 6.0% and 12.7% [2]. Any GI reaction was reported by 21%, 32% and 41%, and 0.2%, 1.3% and 3.5% stopped treatment for GI reasons [2].

Low blood sugar is the main interaction in the label. With insulin glargine, glucose below 54 mg/dL occurred in 14.7% on Trulicity 1.5 mg versus 9.3% on placebo; with glimepiride, 3.3% versus 0% [2]. The label says to consider reducing the insulin or sulfonylurea dose when starting Trulicity [2]. Trulicity also delays gastric emptying and can slow absorption of oral medicines; the label advises monitoring levels of narrow therapeutic index drugs such as warfarin [2].

What the trials show

REWIND was a double-blind, placebo-controlled cardiovascular outcomes trial run at 371 sites in 24 countries [3]. It enrolled men and women aged 50 and older with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors, and randomly assigned them to weekly dulaglutide 1.5 mg or placebo [3]. The primary outcome was the first occurrence of non-fatal heart attack, non-fatal stroke or death from cardiovascular causes, assessed in the intention-to-treat population [3]. The primary outcome occurred in 12.0% of the dulaglutide group and 13.4% of the placebo group (hazard ratio 0.88, 95% CI 0.79 to 0.99) [3].

AWARD-PEDS was a 26-week double-blind trial in 154 young people aged 10 to under 18 with type 2 diabetes [4]. HbA1c rose 0.6 points on placebo and fell 0.6 points on 0.75 mg and 0.9 points on 1.5 mg (P<0.001 for both comparisons) [4]. There was no difference in BMI change [4].

AWARD-11 assigned 1,842 adults on metformin to weekly dulaglutide 1.5, 3 or 4.5 mg for 52 weeks, with the primary comparison at week 36 [5]. At that point, 4.5 mg reduced HbA1c by 1.77 percentage points versus 1.54 points with 1.5 mg (estimated treatment difference -0.24, P<0.001) [5].

SUSTAIN 7 was a 40-week, open-label head-to-head comparison of semaglutide and dulaglutide in 1,201 adults with type 2 diabetes on metformin, testing semaglutide 0.5 and 1 mg against dulaglutide 0.75 and 1.5 mg [6]. HbA1c fell 1.5 and 1.8 points with semaglutide versus 1.1 and 1.4 points with dulaglutide 0.75 and 1.5 mg [6].

SURPASS-CVOT was a double-blind noninferiority trial comparing tirzepatide with dulaglutide 1.5 mg in adults with type 2 diabetes and atherosclerotic cardiovascular disease [7]. It randomized 13,299 people; the modified intention-to-treat population was 6,586 on tirzepatide and 6,579 on dulaglutide [7]. Cardiovascular death, heart attack or stroke occurred in 12.2% on tirzepatide and 13.1% on dulaglutide (hazard ratio 0.92, 95.3% CI 0.83 to 1.01): tirzepatide was noninferior, and superiority was not shown [7].

Is Trulicity approved for weight loss?

No. Weight change is a secondary finding in the trials, not an approved use [2]. The GLP-1 products FDA has approved specifically for weight reduction include Saxenda, Wegovy and Zepbound, each approved for weight reduction in people with obesity or overweight [8].

Compounded and unapproved GLP-1s sold online

FDA states that compounded drugs are not FDA approved, are not reviewed for safety, effectiveness or quality before marketing, and should only be used when a patient's medical need cannot be met by an FDA-approved drug [1]. It also states that retatrutide and cagrilintide cannot be used in compounding under federal law and have not been found safe and effective for any condition [1].