Farxiga

Primary Uses

Farxiga is primarily prescribed for the following conditions:

• Type 2 Diabetes: It is used in combination with diet and exercise to improve blood sugar control in adults and children aged 10 years and older. It is not used to treat type 1 diabetes.
• Heart Failure: It is used in adults to reduce the risk of death from cardiovascular causes and to prevent hospitalization for heart failure. It may be prescribed for patients with or without type 2 diabetes for this purpose.
• Chronic Kidney Disease: It is used in adults to reduce the risk of a significant decline in kidney function, kidney failure, and death related to cardiovascular or kidney issues.

Additional Benefits

For adults who have type 2 diabetes along with established heart disease or multiple risk factors for heart disease, Farxiga is used to lower the risk of needing to stay in the hospital for heart failure.

Mechanism of Action

Farxiga works by targeting a specific protein in the kidneys known as sodium-glucose co-transporter 2 (SGLT2). Under normal conditions, the kidneys filter sugar from the blood and then use this protein to absorb it back into the body. By blocking SGLT2, Farxiga prevents this reabsorption process.

When the protein is blocked, the following occurs:

• Glucose removal: Excess sugar stays in the urine rather than returning to the blood and is eliminated from the body during urination.
• Blood sugar reduction: Because the sugar is being removed through the urine, the overall level of glucose in the blood decreases.
• Sodium and fluid balance: The medication also increases the amount of sodium and water filtered out of the body.

By increasing the removal of sodium and water, Farxiga can help reduce the volume of fluid in the bloodstream. This action may help lower the strain on the heart and reduce pressure within the filtering units of the kidneys, which can be beneficial for individuals with certain heart or kidney conditions.

Common Side Effects

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

• Genital yeast infections in both men and women
• Urinary tract infections (UTIs)
• Increased urination
• Sore throat or runny nose
• Back pain
• Nausea or constipation

Serious Side Effects

Farxiga can cause serious health problems that require immediate medical attention. These include:

• Ketoacidosis: A life-threatening condition where the blood becomes too acidic. Symptoms include nausea, vomiting, stomach pain, confusion, and tiredness.
• Dehydration: Loss of body water and salt, which can lead to dizziness, lightheadedness, or fainting, especially when standing up.
• Fournier’s gangrene: A rare but very serious bacterial infection of the tissue under the skin in the genital area. Symptoms include pain, tenderness, redness, or swelling in the genital or anal area, along with a fever.
• Severe urinary tract infections: Infections that may spread to the kidneys or bloodstream.
• Low blood sugar (hypoglycemia): This risk increases if Farxiga is taken with other diabetes medicines like insulin or sulfonylureas.
• Kidney problems: Sudden changes in kidney function or acute kidney injury.

Ketoacidosis

Farxiga can cause ketoacidosis, a serious and life-threatening condition where the blood becomes too acidic. This can happen even if blood sugar levels are near normal. Symptoms may include nausea, vomiting, abdominal pain, tiredness, and trouble breathing. Healthcare providers may advise stopping the medication before scheduled surgeries to reduce this risk.

Serious Infections

• Fournier’s Gangrene: A rare but life-threatening bacterial infection of the tissues under the skin in the genital and anal areas has been reported. Immediate medical attention is required for symptoms like pain, swelling, or redness in the genital area accompanied by fever.
• Genital Yeast Infections: There is an increased risk of yeast infections in both the vagina and the penis.
• Urinary Tract Infections: Serious infections of the urinary tract and kidneys, including urosepsis and pyelonephritis, may occur.

Dehydration and Kidney Function

This medication causes the body to lose water and salt through urine, which can lead to dehydration and low blood pressure (hypotension). This may cause dizziness or fainting and can lead to sudden kidney injury, especially in people already taking blood pressure medications or those with existing kidney disease. Kidney function is usually checked before starting and during treatment.

Low Blood Sugar (Hypoglycemia)

The risk of low blood sugar increases if Farxiga is taken with other diabetes medications, such as insulin or sulfonylureas. A healthcare provider may need to adjust the doses of these other medications to prevent hypoglycemia.

Contraindications

Farxiga should not be used by people with a history of serious allergic reactions to dapagliflozin. It is also not recommended for use by individuals on dialysis.

Pregnancy

Farxiga is not recommended for use during the second and third trimesters of pregnancy. Research in animal studies has shown that the medication may interfere with the development and maturation of the fetal kidneys. If you are pregnant or planning to become pregnant, discuss the risks and benefits of your treatment options with your healthcare provider.

If you discover you are pregnant while taking Farxiga, contact your doctor right away. They will help determine if you should stop the medication and switch to a different treatment to manage your condition during pregnancy.

Breastfeeding

It is currently unknown if Farxiga passes into human breast milk. However, because the drug may pose a risk to the developing kidneys of a nursing infant, healthcare providers generally advise against breastfeeding while taking this medication. You should talk to your doctor about the best way to feed your baby if you need to take Farxiga.

Dosage Forms

Farxiga is available in the following form:

• Oral Tablet: These are film-coated tablets intended to be swallowed whole.

The tablets are available in different shapes and colors to distinguish between different versions of the medication. No other forms, such as liquids or injections, are currently available for this drug.

FDA Approval and Indications

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

• Improving blood sugar control in people with type 2 diabetes, when used alongside diet and exercise.
• Reducing the risk of hospitalization for heart failure in adults with type 2 diabetes who also have cardiovascular disease or multiple cardiovascular risk factors.
• Treating heart failure in adults with reduced ejection fraction to lower the risk of cardiovascular death and hospitalization.
• Reducing the risk of kidney function decline, end-stage kidney disease, and cardiovascular death in adults with chronic kidney disease at risk of progression.

Safety Communications and Label Changes

The FDA has issued several safety communications and required label updates for Farxiga and other drugs in the SGLT2 inhibitor class due to identified risks:

• Ketoacidosis: The FDA revised labels to include warnings about the risk of ketoacidosis, a serious condition where the blood becomes too acidic. This condition can occur even if blood sugar levels are not highly 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: In 2018, the FDA warned about a rare but life-threatening bacterial infection of the genital area, known as necrotizing fasciitis of the perineum or Fournier’s gangrene, associated with SGLT2 inhibitors.

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

Insurance and Pharmacy Pricing

The out-of-pocket cost for Farxiga is largely determined by your health insurance plan. Most Medicare Part D and private insurance plans cover the medication, but it is often classified as a preferred brand or non-preferred brand, which affects the copay amount. Prices may also vary between different retail pharmacies and mail-order services.

Generic Options

Dapagliflozin is the active ingredient in Farxiga. Although generic versions have received FDA approval, their availability in pharmacies can be limited by patent protections. When available, generic drugs generally offer a more affordable alternative to brand-name medications.

Ways to Save

There are several options that may help reduce the cost of Farxiga:

• Manufacturer Savings Cards: Eligible patients with commercial insurance may be able to use a savings card from the manufacturer to lower their monthly copay.
• Patient Assistance Programs: Individuals without insurance or those with limited financial resources may qualify for programs that provide the medication at a reduced cost or for free based on income requirements.
• 90-Day Supplies: Some insurance providers offer lower costs if the medication is purchased in a 90-day supply rather than a 30-day supply, particularly through mail-order pharmacy programs.