FDA Approves Triple Combination Drug for Adults With Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) has approved Trijardy™ XR to lower blood sugar in adults with type 2 diabetes, along with diet and exercise.

Triple combination drug: Trijardy™ XR

Trijardy™ XR is a triple-combination medicine. It includes the drugs empagliflozin, linagliptin, and metformin hydrochloride. It combines three well-established drugs in one tablet.1

The announcement was made by drug makers Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company. The FDA approval highlights the importance of combining three type 2 diabetes medicines in one pill. They are Jardiance® (empagliflozin), Tradjenta® (linagliptin), and metformin hydrochloride extended-release.1

Treating type 2 diabetes can involve complex treatment regimens. New options that can improve blood sugar control without adding additional drugs can make a meaningful difference to patients according to the developers.1

Things to know about Trijardy™ XR

Trijardy™ XR is a new drug that combines three common type 2 diabetes medicines. It includes:1

  1. Extended - release metformin, the most common initial treatment for type 2 diabetes
  2. Jardiance® - the most prescribed SGLT2 inhibitor
  3. Tradjenta® - the only single-dose DPP-4 inhibitor

Trijardy™ XR is also indicated for adults with type 2 diabetes who have known cardiovascular disease (heart and blood vessels) when empagliflozin, is needed to reduce the risk of cardiovascular death.1

Trijardy™ XR can help people with type 2 diabetes to manage their treatment with fewer medications.1 This new drug is not yet on the market but is hoped to be available soon.

There are different kinds of treatments available for type 2 diabetes. Many people with diabetes require multiple drugs, along with diet and exercise, to control their A1C levels.

Drug trial findings

The findings of the two randomized open-label trials evaluated the bioequivalence (the way the drugs work) of an extended-release fixed-dose combination tablet compared with the individual components in healthy adults. The safety profile of Trijardy™ XR is consistent with each of its 3 individual drugs. The way Trijardy™ XR works is consistent with each of its 3 individual drugs.1

Dosing information

Trijardy™ XR is taken once a day and will be available in four different dosages.1

  • 5 mg empagliflozin/2.5 mg linagliptin/1000 mg extended-release metformin HCl
  • 10 mg empagliflozin/5 mg linagliptin/1000 mg extended-release metformin HCl
  • 12.5 mg empagliflozin/2.5 mg linagliptin/1000 mg extended-release metformin HCl
  • 25 mg empagliflozin/5 mg linagliptin/1000 mg extended-release metformin HCl

When considering any new medications, tell your doctor about all the drugs you take, including prescription or over-the-counter drugs, vitamins, or herbal supplements.

What are the possible side effects?

The most common side effects of Trijardy™ XR include:1

  • upper respiratory tract infection
  • urinary tract infection
  • stuffy or runny nose
  • sore throat
  • constipation
  • headache
  • stomach or intestinal inflammation

This is not an exhaustive list of all potential side effects of Trijardy™ XR. Talk to your healthcare provider or pharmacist for further information. There are more severe side effects associated with certain preexisting conditions.

Contraindications

Trijardy™ XR is not recommended for people with type 1 diabetes. It is also not for people with severe kidney problems, end-stage renal disease, or those who are on dialysis. Nor is it appropriate for metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine). People who are allergic to Jardiance®, Tradjenta®, metformin, or any other ingredients in Trijardy™ XR should not take this new drug.1

Before taking Trijardy™ XR tell your doctor if you have:1

  • type 1 diabetes
  • moderate to severe kidney problems
  • liver problems
  • heart problems, including heart failure
  • history of infection of the urinary tract, vagina, or penis
  • history of gallstones
  • history of pancreatitis or other pancreas problems
  • history of alcoholism or binge drinking
  • low levels of vitamin B12
  • are pregnant or plan to become pregnant or breastfeeding or plan to breastfeed. Trijardy™ RX may harm your baby.

The full prescribing information for Trijardy™ XR is not yet available from the FDA.

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