Jardiance

Type 2 Diabetes

Jardiance is used along with diet and exercise to lower blood sugar levels in adults and children 10 years of age and older with type 2 diabetes. It helps the kidneys remove glucose from the bloodstream through urine. It is not intended for the treatment of type 1 diabetes or diabetic ketoacidosis.

Heart Health

This medication is prescribed for adults with type 2 diabetes who also have established heart disease to help reduce the risk of death from a heart attack or stroke. It is also used in adults with heart failure to reduce the risk of being hospitalized and to lower the risk of death from cardiovascular causes.

Chronic Kidney Disease

Jardiance is used in adults with chronic kidney disease to help reduce the risk of:

• The disease getting worse (decline in kidney function).
• End-stage kidney disease.
• Death from cardiovascular causes.
• Hospitalization for any reason related to heart or kidney health.

Filtering Glucose

In a healthy body, the kidneys filter waste products out of the blood while reabsorbing important substances like glucose (sugar) back into the bloodstream. Jardiance works by blocking a specific protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2). This protein is responsible for most of the sugar reabsorption.

Removing Sugar Through Urine

When Jardiance blocks the SGLT2 protein, the kidneys are unable to put as much sugar back into the blood. Instead, the excess sugar is passed out of the body through urination. This process helps lower overall blood glucose levels in people with type 2 diabetes.

Effects on the Heart and Kidneys

Beyond lowering blood sugar, Jardiance provides benefits for the heart and kidneys. It helps the body remove extra salt and water, which can reduce blood pressure and decrease the workload on the heart. This mechanism is particularly helpful for patients with heart failure or chronic kidney disease, as it helps protect these organs from further damage and reduces the risk of hospitalization.

Common Side Effects

The most common side effects associated with Jardiance include:

• Yeast infections of the vagina or penis
• Urinary tract infections (UTIs)
• Increased urination
• Thirst
• Nausea
• Upper respiratory tract infections
• Joint pain

Serious Side Effects

While less common, Jardiance can cause serious side effects that require immediate medical attention:

• Ketoacidosis: This is a serious condition where the body produces high levels of blood acids. Symptoms include nausea, vomiting, abdominal pain, confusion, and difficulty breathing.
• Dehydration: This medication can cause you to lose body water and salt, leading to dizziness, lightheadedness, or fainting, especially when you stand up.
• Fournier's Gangrene: A rare but life-threatening bacterial infection of the tissue under the skin in the genital or anal area. Seek help if you experience pain, swelling, or redness in the genital area along with a fever.
• Severe Urinary Tract Infections: Some infections may become serious or spread to the kidneys. Signs include burning during urination, pelvic pain, or blood in the urine.
• Allergic Reactions: Signs include rash, hives, or swelling of the face, lips, tongue, or throat.
• Low Blood Sugar (Hypoglycemia): The risk of low blood sugar increases if Jardiance is taken with other diabetes medications, such as insulin or sulfonylureas.

Ketoacidosis

Jardiance can cause ketoacidosis, a life-threatening condition where the blood becomes too acidic. This may occur even if blood sugar levels are not significantly elevated. Symptoms requiring immediate medical attention include nausea, vomiting, abdominal pain, confusion, and difficulty breathing.

Serious Infections

• Fournier's Gangrene: A rare but severe bacterial infection of the tissues under the skin in the genital and perineal area has been reported with SGLT2 inhibitors.
• Urinary Tract and Yeast Infections: There is an increased risk of serious urinary tract infections and genital yeast infections in both men and women.

Dehydration and Low Blood Pressure

The medication can cause the body to lose too much fluid, leading to dehydration and low blood pressure (hypotension). This risk is higher for older adults, people with kidney disease, or those taking blood pressure medications like diuretics.

Kidney Health

Jardiance may cause acute kidney injury. Healthcare providers typically monitor kidney function through blood tests before starting the medication and periodically during treatment.

Contraindications

Jardiance should not be used by people with severe kidney disease, end-stage renal disease, or those on dialysis. It is also not for use in patients with a history of serious allergic reactions to empagliflozin.

Pregnancy

Jardiance is not recommended for use during the second and third trimesters of pregnancy. Animal studies have indicated that exposure to the medication during these stages may lead to adverse effects on the developing kidneys of the fetus. If you are pregnant or planning to become pregnant, it is important to discuss the potential risks and benefits of this medication with your healthcare provider. If you discover you are pregnant while taking Jardiance, contact your doctor immediately.

Breastfeeding

It is not known whether Jardiance passes into human breast milk. However, because the medication could potentially interfere with the kidney development of a nursing infant, healthcare providers generally advise against breastfeeding while using this drug. You should consult with your doctor to determine the safest way to feed your baby while managing your condition.

Dosage Forms

Jardiance is supplied in the following form:

• Oral tablet

This medication is taken by mouth.

FDA Approval and Indications

Jardiance (empagliflozin) received its initial FDA approval in 2014. It is currently approved for use in adults for the following indications:

• To improve blood sugar control in adults with type 2 diabetes, when used alongside diet and exercise.
• To reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.
• To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.

Jardiance is not approved for the treatment of type 1 diabetes or for treating diabetic ketoacidosis.

Safety Communications and Labeling Changes

The FDA has issued several safety communications and required label updates for the class of drugs known as SGLT2 inhibitors, which includes Jardiance. Key regulatory updates include:

• Ketoacidosis: The FDA revised labels to include warnings about the risk of ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones. This condition 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 lead to hospitalization.
• Fournier’s Gangrene: The FDA required a warning about a rare but life-threatening bacterial infection of the tissue under the skin surrounding the genitals and anus (necrotizing fasciitis of the perineum).

Regulatory Status

Jardiance is a prescription-only medication. While it carries significant warnings regarding the risks mentioned above, it does not currently have a Boxed Warning or a Risk Evaluation and Mitigation Strategy (REMS) program.

Weight Changes and Jardiance

Jardiance (empagliflozin) is primarily prescribed to treat type 2 diabetes, heart failure, and chronic kidney disease. Although it is not a weight loss drug, weight loss is a common side effect observed in clinical studies.

How It Affects Weight

Jardiance belongs to a class of drugs called SGLT2 inhibitors. It works by preventing the kidneys from reabsorbing glucose (sugar) back into the bloodstream. Instead, the excess sugar is excreted through the urine. Because sugar contains calories, this process results in a loss of calories from the body, which can lead to weight loss over time.

What to Expect

• Modest weight loss: Most people taking Jardiance for type 2 diabetes lose a small amount of weight, typically a few pounds, during the first several months of treatment.
• Not for weight management: Healthcare providers do not prescribe Jardiance solely for the purpose of losing weight. It is intended to manage blood sugar levels and reduce cardiovascular risks.
• Diet and exercise: For patients with type 2 diabetes, Jardiance is meant to be used alongside a healthy diet and regular physical activity, which also contribute to weight management.

If you experience sudden or extreme weight loss while taking this medication, you should contact your healthcare provider, as it could be a sign of a different medical issue or dehydration.