Glyxambi

Primary Uses

Glyxambi is used along with diet and exercise to lower blood sugar levels in adults with type 2 diabetes mellitus. It combines two different medications that work in different ways to help the body manage glucose.

Cardiovascular Risk Reduction

This medication is also prescribed to reduce the risk of death from cardiovascular causes in adults who have both type 2 diabetes and established heart disease.

Important Limitations

• It is not used to treat type 1 diabetes.
• It is not for the treatment of diabetic ketoacidosis (a serious condition involving high levels of acid in the blood).
• It has not been specifically studied in people who have previously had inflammation of the pancreas (pancreatitis).

How Glyxambi Works

Glyxambi is a combination of two drugs, empagliflozin and linagliptin. Each component targets a different process in the body to manage blood glucose (sugar) levels.

Empagliflozin

Empagliflozin belongs to a class of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It works primarily in the kidneys. Under normal conditions, the kidneys filter sugar out of the blood and then reabsorb it back into the bloodstream. Empagliflozin blocks this reabsorption process, which allows the excess sugar to be removed from the body through urination.

Linagliptin

Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It works by increasing the levels of natural substances known as incretin hormones. These hormones help regulate blood sugar in two ways:

• They signal the pancreas to release more insulin, especially after eating a meal.
• They signal the liver to produce less glucose.

By combining these two mechanisms, Glyxambi helps the body remove excess sugar and improves the body's natural ability to regulate sugar levels throughout the day.

Common Side Effects

The most frequently reported side effects of Glyxambi include:

• Urinary tract infections
• Upper respiratory tract infections, such as the common cold or sore throat
• Stuffy or runny nose

Serious Side Effects

Glyxambi may cause serious health problems that require immediate medical attention. These include:

• Ketoacidosis: A life-threatening condition where the body produces high levels of blood acids called ketones. Symptoms include nausea, vomiting, stomach pain, confusion, and trouble breathing.
• Pancreatitis: Inflammation of the pancreas, which may cause severe pain in the upper stomach area that radiates to the back.
• Dehydration: This medication can cause the body to lose too much water and salt, leading to dizziness, lightheadedness, or fainting, especially when standing up.
• Genital Yeast Infections: Both men and women may develop yeast infections in the genital area.
• Heart Failure: Symptoms may include shortness of breath, unusual tiredness, or swelling in the legs, feet, or ankles.
• Severe Joint Pain: Some people may develop severe and disabling pain in their joints.
• Fournier’s Gangrene: A rare but life-threatening bacterial infection of the skin and tissue in the genital and anal area.
• Skin Reactions: A condition called bullous pemphigoid can cause large, fluid-filled blisters that require medical treatment.
• Serious Urinary Tract Infections: Severe infections of the urinary tract can lead to hospitalization.

Ketoacidosis

Empagliflozin, one of the components of Glyxambi, can cause ketoacidosis, a serious condition where the blood becomes too acidic. This can occur even if blood sugar levels are near normal. Symptoms may include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.

Pancreatitis

Inflammation of the pancreas (pancreatitis) has been reported in people taking linagliptin. This condition can be severe and lead to death. Persistent, severe abdominal pain that may radiate to the back is a primary symptom.

Serious Infections

• Fournier’s Gangrene: A rare but life-threatening bacterial infection of the skin and tissue around the genital area (necrotizing fasciitis of the perineum) has been reported.
• Urinary Tract Infections: Serious infections of the urinary tract, including those that spread to the kidneys or blood, can occur.
• Genital Yeast Infections: Both men and women may experience an increased risk of yeast infections due to the way the medication removes sugar through the urine.

Dehydration and Kidney Function

Glyxambi can cause the body to lose water and salt, leading to dehydration. This may cause low blood pressure (hypotension), dizziness, or fainting, particularly in older adults or people with existing kidney problems. Acute kidney injury has also been reported in some patients.

Heart Failure

Medicines in the same class as linagliptin have been linked to an increased risk of heart failure. This risk may be higher in individuals who already have heart or kidney disease. Symptoms to watch for include shortness of breath, swelling in the feet or legs, and rapid weight gain.

Joint Pain and Skin Reactions

Some people may experience severe and disabling joint pain while taking this medication. Additionally, a skin reaction called bullous pemphigoid, which causes large, fluid-filled blisters, has been reported with the use of DPP-4 inhibitors like linagliptin.

Pregnancy

There is limited data regarding the use of Glyxambi in the first trimester of pregnancy. However, based on animal studies, the medication may cause harm to a developing baby's kidneys if taken during the second and third trimesters. Because of these potential risks, healthcare providers typically recommend discontinuing Glyxambi during these stages of pregnancy.

If you become pregnant or plan to become pregnant, consult your healthcare provider to discuss alternative methods for controlling blood sugar levels. It is important to manage diabetes effectively during pregnancy to avoid complications for both the parent and the baby.

Breastfeeding

It is not known if the components of Glyxambi pass into human breast milk. Due to the potential for serious adverse reactions in a nursing infant, particularly concerning kidney development, using this medication while breastfeeding is not recommended. You should talk to your doctor about whether to stop breastfeeding or stop taking the medication, taking into account the importance of the drug to your health.

Available Forms

Glyxambi is supplied as a film-coated tablet for oral administration. It is a fixed-dose combination therapy, which means each tablet contains two separate active ingredients: empagliflozin and linagliptin.

Appearance

The tablets are triangular in shape and are film-coated. The color of the tablet varies to distinguish between the different available options.

FDA Approval Status

The U.S. Food and Drug Administration (FDA) approved Glyxambi in January 2015. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is not approved for the treatment of type 1 diabetes or diabetic ketoacidosis.

Regulatory Safety Communications

The FDA has issued several safety communications and required label changes for the classes of drugs contained in Glyxambi. These updates focus on the following risks:

• Ketoacidosis: Labels for SGLT2 inhibitors, such as the empagliflozin component of Glyxambi, were updated to include warnings about the risk of ketoacidosis. This is a serious condition where the body produces high levels of blood acids called ketones.
• Serious Infections: The FDA has identified risks of serious urinary tract infections that may lead to hospitalization. Additionally, regulatory monitoring has identified rare but severe necrotizing fasciitis of the perineum (Fournier's gangrene) associated with the SGLT2 inhibitor class.
• Heart Failure: Regulatory reviews have examined the potential risk of heart failure associated with DPP-4 inhibitors, the class of drugs that includes linagliptin.

Glyxambi is not a controlled substance and does not currently have a boxed warning.

Factors Influencing Cost

The price of Glyxambi can vary based on several factors:

• Insurance Coverage: Your out-of-pocket costs are determined by your specific health insurance plan, including your deductible and copayment tier. Most commercial plans and Medicare Part D plans provide coverage for Glyxambi, though it may be placed on a higher tier.
• Pharmacy Selection: Prices may differ between retail pharmacies, and mail-order options may offer different pricing structures.
• Generic Availability: Glyxambi is a brand-name medication containing two active ingredients (empagliflozin and linagliptin). There is currently no generic version available, which generally makes it more expensive than older, generic diabetes medications.

Financial Assistance Programs

The manufacturer may offer savings cards or patient assistance programs to help reduce the cost for eligible individuals. These programs are often available to patients with commercial insurance or those who are uninsured, though restrictions typically apply to those covered by government programs like Medicare or Medicaid.

Prior Authorization

Some insurance providers may require prior authorization before they will cover Glyxambi. This process involves your healthcare provider submitting documentation to the insurance company to justify the medical necessity of the medication.