Ertugliflozin

Primary Use

Ertugliflozin is primarily prescribed to improve blood sugar control in adults with type 2 diabetes mellitus. It belongs to a class of drugs known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. This medication is intended to be used as part of a comprehensive treatment plan that includes a healthy diet and regular physical activity.

How It Helps

Controlling high blood sugar is essential for managing diabetes and reducing the risk of serious complications. By maintaining better blood sugar levels, patients may lower their risk of:

• Kidney damage
• Nerve problems
• Loss of limbs
• Vision loss

Important Limitations

Ertugliflozin is specifically for the treatment of type 2 diabetes. It is not used for the following conditions:

• Type 1 diabetes: It is not intended for people with type 1 diabetes.
• Diabetic ketoacidosis: It should not be used to treat diabetic ketoacidosis, which is a serious condition involving increased ketones in the blood or urine.

Mechanism of Action

Ertugliflozin belongs to a class of medications known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. It works by changing the way the kidneys process sugar (glucose) in the bloodstream.

Under normal conditions, the kidneys filter blood and then reabsorb sugar back into the bloodstream to be used for energy. A specific protein called SGLT2 is responsible for the majority of this reabsorption. In people with type 2 diabetes, blood sugar levels are often elevated, and the body may continue to reabsorb sugar that it does not need.

Ertugliflozin works by blocking the SGLT2 protein. When this protein is inhibited, the following occurs:

• The kidneys stop reabsorbing as much sugar back into the blood.
• The excess sugar is instead passed out of the body through urination.
• The overall amount of sugar circulating in the bloodstream is reduced.

This medication is used alongside diet and exercise to improve glycemic control. Because its mechanism of action depends on the kidneys rather than insulin production, it provides a different method of managing blood sugar compared to many other diabetes treatments.

Common Side Effects

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

• Vaginal yeast infections, which may cause itching, odor, or discharge
• Yeast infections of the penis, which may cause redness, itching, swelling, or discharge
• Increased urination or needing to urinate more frequently, including at night
• Increased thirst
• Vaginal itching

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious symptoms:

• Ketoacidosis: This is a serious condition involving high levels of acid in the blood. Symptoms include nausea, vomiting, stomach-area pain, confusion, unusual tiredness, or trouble breathing.
• Dehydration: Losing too much body water can cause dizziness, lightheadedness, or fainting, especially when standing up quickly.
• Serious Urinary Tract Infections: Seek medical help for a burning sensation when urinating, frequent or urgent need to urinate, fever, or pain in the pelvis or back.
• Fournier’s Gangrene: This is a rare but life-threatening bacterial infection of the tissue under the skin in the genital or anal area. Seek immediate care for pain, tenderness, redness, or swelling in these areas along with a fever or general feeling of being unwell.
• Kidney Problems: Signs may include swelling in the legs or feet or a change in the amount of urine produced.

Ketoacidosis

Ertugliflozin can cause ketoacidosis, a serious condition where the blood becomes too acidic. This may occur even if blood sugar levels are near normal. Symptoms such as nausea, vomiting, abdominal pain, tiredness, or trouble breathing require immediate medical attention.

Infections

This medication increases the risk of serious infections, including:

• Genital infections: Yeast infections of the vagina or penis may occur.
• Urinary tract infections: Severe infections that may lead to hospitalization have been reported.
• Fournier's gangrene: A rare but life-threatening bacterial infection of the skin and tissue around the genital or anal area.

Dehydration and Kidney Health

Ertugliflozin can cause the body to lose too much fluid, leading to dehydration and low blood pressure (hypotension). This risk is higher for older adults or those taking blood pressure medications. Dehydration can also lead to sudden kidney injury.

Amputation Risk

There may be an increased risk of lower limb amputations, primarily involving the toes. It is important to monitor for any new pain, sores, or infections on the legs or feet.

Contraindications

This medication is not recommended for individuals with severe kidney disease or those receiving dialysis.

Pregnancy

There is limited information regarding the use of ertugliflozin in pregnant women. However, animal studies suggest that the medication may cause harm to the developing kidneys of a fetus, particularly when used during the second and third trimesters. Because of these potential risks, healthcare providers typically advise against using this medication during the later stages of pregnancy.

If you are pregnant or planning to become pregnant, it is important to discuss your treatment options with a healthcare professional. If you become pregnant while taking ertugliflozin, contact your doctor right away to determine the best course of action for managing your blood sugar levels.

Breastfeeding

It is not currently known if ertugliflozin passes into human breast milk. Due to the potential for serious side effects in a nursing infant, breastfeeding is generally not recommended while using this medication. Patients should consult with their healthcare provider to discuss the risks and benefits of breastfeeding versus continuing the medication.

Available Dosage Forms

Ertugliflozin is supplied as an oral medication in the following form:

• Tablet: This medication is taken by mouth, typically once daily in the morning.

Ertugliflozin may be prescribed as a single-ingredient medication or as part of a combination product with other diabetes medications. It is important to take the tablet exactly as directed by a healthcare provider.

FDA Approval Status

Ertugliflozin received approval from the U.S. Food and Drug Administration (FDA) in December 2017. It is approved for use alongside diet and exercise to lower blood sugar in adults with type 2 diabetes mellitus.

Safety Warnings and Label Revisions

The FDA has required updates to the labels of all SGLT2 inhibitors, including ertugliflozin, to address several safety concerns identified through post-marketing reports:

• Ketoacidosis: The FDA issued a safety communication warning that these medications may lead to ketoacidosis, a serious condition involving high levels of acid in the blood that may require hospitalization.
• Serious Urinary Tract Infections: Labels include warnings about the risk of severe urinary tract infections, such as urosepsis and pyelonephritis.
• Genital Infections: There is a recognized risk of genital mycotic (yeast) infections in both men and women.
• Necrotizing Fasciitis of the Perineum: Also known as Fournier’s gangrene, this is a rare but serious bacterial infection of the genital area that has been associated with this class of drugs.

Ertugliflozin is not indicated for the treatment of type 1 diabetes or for patients with diabetic ketoacidosis.

Factors Influencing Cost

Ertugliflozin is a prescription medication, and its price is not fixed. Several factors determine the final cost at the pharmacy counter:

• Insurance Coverage: Most health insurance plans, including private insurance and Medicare, may cover ertugliflozin. The out-of-pocket cost depends on the plan's formulary, which categorizes drugs into different cost tiers.
• Pharmacy Pricing: Retail prices can differ between pharmacies. Patients may find variations in cost between large retail chains, local independent pharmacies, and mail-order services.
• Brand vs. Generic Status: Ertugliflozin was approved by the FDA in 2017. It is currently available as a brand-name medication. Brand-name drugs generally have higher costs than generic versions, which may not be available for several years after a drug's initial approval.

Patients are encouraged to contact their insurance provider or pharmacist to obtain the most accurate pricing information for their specific situation.