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Trulicity (Dulaglutide) After Bariatric Surgery: Clinical Guide

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At a glance

  • Approved uses / Type 2 diabetes in adults and children 10 and older; cardiovascular risk reduction in adults with type 2 diabetes [1]
  • Adult dosing / 0.75 mg weekly, then 1.5 mg after 4 weeks; later steps of 1.5 mg; maximum 4.5 mg weekly [1]
  • Pediatric dosing / 0.75 mg weekly, maximum 1.5 mg weekly [1]
  • Nausea, 1.5 mg vs placebo / 21.1% vs 5.3% [1]
  • Glucose under 54 mg/dL with insulin glargine / 14.7% on 1.5 mg vs 9.3% on placebo [1]
  • Severe gastroparesis / Trulicity is not recommended [1]
  • Contraindicated / Personal or family history of medullary thyroid carcinoma or MEN 2 [1]

Dosing the label specifies

The label says adults start at 0.75 mg subcutaneously once weekly. The dose may go to 1.5 mg after 4 weeks, and later increases are made in 1.5 mg steps after at least 4 weeks on the current dose, up to 4.5 mg once weekly [1]. For children 10 and older, the label gives a starting dose of 0.75 mg and a maximum of 1.5 mg once weekly, reached after at least 4 weeks at 0.75 mg [1]. For a missed dose, the label says to give it as soon as possible if at least 3 days (72 hours) remain before the next scheduled dose; otherwise the dose is skipped [1].

What the label says to watch for

Stomach and gut. In the adult placebo-controlled pool, nausea occurred in 5.3% on placebo, 12.4% on 0.75 mg and 21.1% on 1.5 mg, and vomiting in 2.3%, 6.0% and 12.7% [1]. Any gastrointestinal reaction was reported by 21%, 32% and 41%, and 0.2%, 1.3% and 3.5% stopped treatment because of one [1]. The label states Trulicity is not recommended in patients with severe gastroparesis [1].

Low blood sugar. With insulin glargine, glucose under 54 mg/dL occurred in 14.7% on 1.5 mg versus 9.3% on placebo, and with glimepiride in 3.3% versus 0% [1]. The label says to consider reducing the insulin or sulfonylurea dose when Trulicity is started [1].

Kidneys, pancreas and gallbladder. Acute kidney injury from volume depletion is a labeled warning; most reported cases involved nausea, vomiting or diarrhea [1]. The label also says to discontinue Trulicity if pancreatitis is suspected, and lists acute gallbladder disease as a warning [1].

Thyroid. The boxed warning describes dose-related thyroid C-cell tumors in rats; whether this applies to humans is unknown [1]. Trulicity is contraindicated with a personal or family history of medullary thyroid carcinoma or MEN 2 [1].

What REWIND showed

In the REWIND cardiovascular outcomes trial, 9,901 adults aged 50 or older with type 2 diabetes and cardiovascular disease or risk factors were randomized to dulaglutide 1.5 mg weekly or placebo, with a median follow-up of 5.4 years [2]. The primary composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death occurred in 12.0% on dulaglutide versus 13.4% on placebo (hazard ratio 0.88, 95% CI 0.79 to 0.99; p=0.026) [2].

Frequently asked questions

Can Trulicity be used after gastric bypass?
The label's indications are type 2 diabetes in adults and children 10 and older, and cardiovascular risk reduction in adults with type 2 diabetes who have established cardiovascular disease or multiple risk factors [1]. The label gives the usual dosing schedule but no surgery-specific dosing instructions [1].
What starting dose does the label give?
0.75 mg subcutaneously once weekly for adults and for children 10 and older. Adults may move to 1.5 mg after 4 weeks, then in 1.5 mg steps after at least 4 weeks at each dose, to a maximum of 4.5 mg weekly; the pediatric maximum is 1.5 mg weekly [1].
Does Trulicity cause low blood sugar after bariatric surgery?
The rates below come from general type 2 diabetes trials. Low blood sugar was more frequent when Trulicity was used with insulin or a sulfonylurea: glucose under 54 mg/dL occurred in 14.7% on 1.5 mg versus 9.3% on placebo with insulin glargine, and 3.3% versus 0% with glimepiride [1].
Is Trulicity approved for weight loss?
No. The labeled indications are glycemic control in type 2 diabetes and cardiovascular risk reduction in adults with type 2 diabetes; there is no weight-management indication [1].
What does the label say about slow stomach emptying?
Trulicity slows gastric emptying and can reduce the rate of absorption of oral medicines, with the delay largest after the first dose and diminishing with later doses [1]. The label states that Trulicity is not recommended in patients with severe gastroparesis and lists severe gastrointestinal reactions as a warning [1].

References

  1. U.S. National Library of Medicine, DailyMed. Trulicity injection (dulaglutide) prescribing information. Trulicity injection (dulaglutide) label
  2. Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019;394(10193):121-130. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial
Evidence overview for Trulicity (Dulaglutide) After Bariatric Surgery: Clinical Guide