Empagliflozin

Type 2 Diabetes Management

Empagliflozin is used to improve blood sugar control in adults with type 2 diabetes mellitus. It is intended to be used alongside diet and exercise. It is not used to treat type 1 diabetes or diabetic ketoacidosis.

Heart Health

This medication is prescribed to reduce the risk of cardiovascular death in adults who have both type 2 diabetes and established heart disease. It is also used to treat heart failure in adults to reduce the risk of:

• Hospitalization for heart failure
• Death from cardiovascular causes

Empagliflozin may be used for heart failure regardless of whether the patient also has diabetes.

Chronic Kidney Disease

Empagliflozin is used to treat adults with chronic kidney disease (CKD) who are at risk of the condition progressing. In these patients, it is used to reduce the risk of:

• Sustained decline in kidney function
• End-stage kidney disease
• Cardiovascular death
• Hospitalization

Mechanism of Action

Empagliflozin works by targeting the kidneys to help lower blood sugar levels in people with type 2 diabetes. In a healthy body, the kidneys filter glucose (sugar) out of the blood and then reabsorb most of it back into the bloodstream. Empagliflozin blocks a specific protein called sodium-glucose co-transporter 2 (SGLT2), which is responsible for this reabsorption process.

Glucose Removal

By blocking SGLT2, the medication prevents the kidneys from returning sugar to the blood. Instead, the excess sugar is passed out of the body through urination. This process helps lower overall blood glucose levels and may also lead to a slight reduction in blood pressure and weight due to the loss of sugar and associated fluids.

Heart and Kidney Protection

In addition to managing blood sugar, empagliflozin is used to reduce the risk of cardiovascular death and hospitalization in people with heart failure. It is also used to slow the progression of chronic kidney disease. While the exact ways it protects the heart and kidneys are still being studied, it is believed to work by reducing the workload on the heart and lowering the pressure within the filtering units of the kidneys.

Common Side Effects

Some people taking empagliflozin may experience mild side effects. These often include:

• Urinary tract infections
• Yeast infections of the vagina or penis
• Increased urination or needing to urinate more often at night
• Thirst
• Nausea
• Upper respiratory tract infections
• Joint pain

Serious Side Effects

While less common, some side effects can be severe and require immediate medical attention. Contact a healthcare provider right away if you experience:

• Ketoacidosis: This is a serious condition where the blood becomes too acidic. Symptoms include nausea, vomiting, stomach-area pain, confusion, unusual sleepiness, or trouble breathing.
• Dehydration: Losing too much body water can cause you to feel dizzy, lightheaded, faint, or weak, especially when you stand up.
• Fournier's gangrene: This is a rare but life-threatening bacterial infection of the skin and tissue in the genital or anal area. Seek help for pain, tenderness, redness, or swelling in these areas along with a fever.
• Serious urinary tract infections: Symptoms include burning during urination, pelvic pain, or blood in the urine.
• Low blood sugar (hypoglycemia): This is more likely if you take other diabetes medications. Symptoms include headache, drowsiness, irritability, hunger, dizziness, confusion, sweating, or feeling shaky.
• Allergic reactions: Signs include rash, hives, or swelling of the face, lips, tongue, or throat.

Ketoacidosis

Ketoacidosis is a serious, life-threatening condition where the blood becomes too acidic. This can occur even if blood sugar levels are not significantly elevated. Symptoms may include nausea, vomiting, abdominal pain, generalized weakness, and trouble breathing.

Serious Infections

This medication can increase the risk of several types of infections:

• Genital infections: Both men and women may experience an increased risk of yeast infections.
• Urinary tract infections: Serious infections of the urinary tract, including those that spread to the kidneys or blood, have been reported.
• Fournier’s gangrene: A rare but life-threatening bacterial infection can occur in the area between the anus and the genitals (perineum). This requires immediate medical attention if pain, tenderness, redness, or swelling develops in that area along with a fever.

Dehydration and Low Blood Pressure

Empagliflozin causes the body to lose salt and water through the urine, which can lead to dehydration. This may cause a sudden drop in blood pressure, especially when standing up. People at higher risk include the elderly, those with kidney problems, or those taking blood pressure medications like diuretics.

Kidney Function

There is a risk of acute kidney injury associated with this medication. Healthcare providers usually check kidney function before starting the medication and periodically during treatment. It is generally not recommended for individuals with severe kidney disease or those on dialysis.

Low Blood Sugar

When used with other diabetes medications, such as insulin or sulfonylureas, the risk of low blood sugar (hypoglycemia) increases. Symptoms of low blood sugar include headache, drowsiness, irritability, hunger, dizziness, confusion, and sweating.

Allergic Reactions

Serious allergic reactions, including swelling of the face, lips, or throat and severe skin rashes, can occur. If these symptoms appear, medical help is needed immediately.

Pregnancy

Information regarding the use of empagliflozin during pregnancy is limited. Based on animal studies, the medication may cause harm to a developing fetus, specifically affecting kidney development during the second and third trimesters. Because of these potential risks, empagliflozin is usually not recommended for use during the last two trimesters of pregnancy.

If you become pregnant while taking this medication, notify your healthcare provider immediately. They will help determine the best course of action for managing your condition, as maintaining stable blood sugar levels is essential for a healthy pregnancy.

Breastfeeding

It is currently unknown if empagliflozin is excreted in human breast milk. However, because the drug could potentially cause serious side effects in a nursing infant, particularly related to kidney growth, healthcare providers generally advise against breastfeeding while using this medication. Discuss your options with your doctor to determine whether to stop breastfeeding or switch to a different treatment.

Available Forms

Empagliflozin is supplied as a film-coated tablet for oral administration. It is designed to be swallowed whole and is typically taken once daily, either with or without food.

This medication is not available in other formulations such as liquids, injections, or topical applications.

FDA Approval and Indications

Empagliflozin was first approved by the U.S. Food and Drug Administration (FDA) in 2014. It is currently indicated for several uses in adults:

• Improving blood sugar control in people with type 2 diabetes, alongside diet and exercise.
• Reducing the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.
• Reducing the risk of cardiovascular death and hospitalization for heart failure.
• Reducing the risk of sustained decline in kidney function, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease.

Safety Communications and Labeling Changes

The FDA has issued several safety communications regarding the class of drugs known as SGLT2 inhibitors, which includes empagliflozin:

• Ketoacidosis: In 2015, the FDA revised labels to include warnings about the risk of ketoacidosis, a serious condition where the body produces high levels of blood acids. This can occur even if blood sugar levels are not significantly elevated.
• Serious Urinary Tract Infections: Warnings were added regarding the risk of severe urinary tract infections, including urosepsis and pyelonephritis, which may require hospitalization.
• Fournier’s Gangrene: The FDA has identified a rare but serious risk of necrotizing fasciitis of the perineum (Fournier’s gangrene), a life-threatening bacterial infection of the tissue under the skin surrounding the genital area.

Empagliflozin does not currently carry a Boxed Warning, the FDA's most serious type of warning.

How Empagliflozin Affects Weight

Empagliflozin belongs to a class of medications called SGLT2 inhibitors. It works by blocking the kidneys from reabsorbing sugar back into the bloodstream. Instead, the excess sugar is removed from the body through urination. Because sugar contains calories, the process of excreting it leads to a loss of calories, which can result in weight loss.

Clinical Observations

In clinical studies, people taking empagliflozin for type 2 diabetes or heart failure frequently experienced a decrease in body weight. This weight loss is generally considered a secondary effect of the medication's primary function of managing blood sugar or heart health. It is intended to be used alongside a reduced-calorie diet and regular physical activity.

Important Considerations

• Empagliflozin is not FDA-approved as a weight management or weight loss drug.
• The amount of weight lost varies among individuals and may depend on other factors like diet and exercise.
• Some initial weight loss may be due to the loss of fluids, as the medication has a mild diuretic effect when it increases sugar excretion.
• Weight loss is typically more pronounced in people using the medication to manage type 2 diabetes.