Farxiga (Dapagliflozin) Dosing, Indications, Interactions, Adverse Effects, and More (Dapagliflozin Propanediol Monohydrate)

Key Takeaways

• Farxiga is indicated for the treatment of type 2 diabetes mellitus to improve glycemic control.

• The drug can also be used to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and cardiovascular disease.

• Study data suggests Farxiga reduces the risk of hospitalization and fatality for diabetic and non-diabetic patients.

• Farxiga can also reduce the risk of kidney disease progression, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease who are at risk of progression.

Indications for Farxiga

Farxiga (Dapagliflozin) is indicated for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is an effective medication that can help individuals with type 2 diabetes achieve improved blood sugar levels when used in conjunction with a healthy lifestyle. By enhancing glycemic control, Farxiga aids in managing the symptoms and complications associated with type 2 diabetes.

The use of Farxiga, in combination with diet and exercise, has been shown to reduce fasting blood sugar levels by an average of 28.8 mg/dL in some cases. In addition, it has been found to lower hemoglobin A1c levels by an average of 0.9% after 24 weeks of treatment. These improvements contribute to better overall glycemic control, allowing individuals to achieve their target blood sugar levels. For more information on studies as compiled by the drug's manufacturer, see this link.

It is important to note that Farxiga is not intended for use as a standalone treatment for type 2 diabetes. It should always be used in combination with a healthy diet and regular exercise. Furthermore, it is essential that individuals with type 2 diabetes consult with their healthcare provider to determine the appropriate dosing for optimal glycemic control.

Dosing Recommendations for Glycemic Control

The following discussion on dosing is for informational purposes only, and patients must consult with their physician who will make the final determination as to the most suitable regimen based on the patient's particulars. For more information on dosing, refer to the "Dosing and administration" section of the manufacture's product information sheet which may be found here.

To achieve optimal glycemic control in adults with type 2 diabetes mellitus, the dosing recommendations for Farxiga (dapagliflozin) involve assessing volume status and correcting volume depletion before initiating treatment. It is important to evaluate the patient's volume status and correct any volume depletion prior to starting Farxiga therapy. The recommended starting dose for glycemic control is 5 mg orally once daily at anytime of the day with or without food, which can be increased to 10 mg orally once daily for patients who require additional glycemic control. For other indications, such as reducing the risk of heart failure hospitalization or chronic kidney disease, the recommended starting dose is 10 mg orally once daily.

It is worth noting that for patients with an estimated glomerular filtration rate (eGFR) of 25 to less than 45, the recommended dose is 10 mg orally once daily. However, initiation of Farxiga is not recommended for patients with an eGFR less than 25. In such cases, patients may continue with the 10 mg dose for risk reduction purposes. Farxiga is available in tablet form, with strengths of 5 mg and 10 mg.

Dosing Recommendations for Other Indications

For the treatment of other indications, such as reducing the risk of heart failure hospitalization or chronic kidney disease progression, Farxiga is recommended to be taken orally once daily at a starting dose of 10 mg. It is important to assess volume status and correct volume depletion before initiating treatment with Farxiga. The dosage forms available for Farxiga are tablets in strengths of 5 and 10 mg.

Farxiga, also known as dapagliflozin or sodium-glucose co-transporter 2 (SGLT2) inhibitor. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Additionally, Farxiga is used to reduce the risk of hospitalization due to heart failure in adults with type 2 diabetes with and established cardiovascular disease or multiple cardiovascular risk factors. It is also indicated, in some cases, to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with a reduced ejection fraction. Furthermore, some studies show Farxiga may reduce the risk of sustained decline in kidney function, cardiovascular death, and hospitalization for heart failure - see this FDA report.

As with any medication, it is important to consider the contraindications, warnings, and precautions associated with Farxiga to ensure safe and effective use. Monitoring for adverse reactions and educating patients about potential side effects is also crucial. By following the recommended dosing guidelines and providing appropriate patient counseling, healthcare providers can play a vital role in helping patients achieve optimal outcomes with Farxiga.

Contraindications for Farxiga

There are two contraindications for the use of Farxiga:

The first contraindication is a history of hypersensitivity reaction to Farxiga. Patients who have experienced a moderate to severe allergic reaction to this medication should not use it again. The second contraindication is for patients on dialysis.

It is important for healthcare professionals to be aware of these contraindications when considering prescribing Farxiga to their patients. Patients with a known hypersensitivity to Farxiga should be prescribed alternative medications to avoid any potential adverse reactions. Additionally, patients who are on dialysis should not use Farxiga, and alternative treatment options should be considered.

Warnings and Precautions for Farxiga

Below is a brief summary of some of the warnings and precautions associated with Farxiga, however, for a complete overview and more detailed discussion, please refer to the product's monograph which may be found here.

During treatment with Farxiga (dapagliflozin), healthcare professionals should be aware of the warnings and precautions associated with this medication. The first precaution to consider is the risk of ketoacidosis in patients with diabetes mellitus. There have been reports of ketoacidosis in patients receiving SGLT2 inhibitors, including Farxiga. It is important to note that ketoacidosis may be present even if blood glucose levels are less than 250 mg/dL.

Another precaution to keep in mind is the potential for volume depletion. Farxiga can cause intravascular volume depletion, which may manifest as symptomatic hypotension or acute transient changes in creatinine. There have been post-marketing reports of acute kidney injury in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors. Patients with impaired renal function, elderly patients, or patients on loop diuretics are at an increased risk for volume depletion or hypotension. Therefore, it is important to assess volume status and renal function before initiating Farxiga in these patients.

Additionally, healthcare professionals should be aware of the increased risk of urinary tract infections in patients receiving SGLT2 inhibitors. Treatment with Farxiga has been associated with serious urinary tract infections, including urosepsis and pyelonephritis. Patients should be evaluated for signs and symptoms of urinary tract infections and promptly treated. It is also important to monitor for urinary tract infections after initiating Farxiga, especially in patients with a history of genital mycotic infections.

Lastly, healthcare professionals should be cautious when using Farxiga in combination with insulin or insulin secretagogues, as it may increase the risk of hypoglycemia. It may be necessary to lower the dose of insulin or insulin secretagogue when used in combination with Farxiga. Monitoring for hypoglycemia is essential, and the dose of insulin or insulin secretagogue should be adjusted accordingly to minimize the risk.

Ketoacidosis Risk With Farxiga

Patients taking Farxiga should be aware of the risk of ketoacidosis associated with this medication. Ketoacidosis is a serious condition that occurs when the body produces high levels of acidic substances called ketones, due to a lack of insulin or insulin resistance. Farxiga, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, works by inhibiting the reabsorption of glucose in the kidneys, leading to increased glucose excretion in the urine. While Farxiga is an effective medication for managing glycemic control in patients with type 2 diabetes, it is important to note that there have been reports of ketoacidosis in patients taking the medication.

Studies have shown an increased risk of ketoacidosis in patients who received SGLT2 inhibitors, including Farxiga, compared to those who received a placebo. It is crucial for patients to be vigilant for symptoms of ketoacidosis, which include excessive thirst, frequent urination, nausea, vomiting, abdominal pain, fatigue, and confusion. It is also important to note that ketoacidosis, in some cases, can occur even if blood glucose levels are less than 250 mg/dL.

Volume Depletion Risk With Farxiga

The risk of volume depletion is associated with the use of Farxiga, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, in patients with type 2 diabetes mellitus. Farxiga can cause intravascular volume depletion, which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine levels. Post-marketing reports have indicated cases of acute kidney injury in patients with type 2 diabetes mellitus who were receiving SGLT2 inhibitors, including Farxiga. The risk for volume depletion or hypotension is increased in patients with impaired renal function, elderly patients, or those on loop diuretics. Therefore, it is important to assess volume status and renal function before initiating Farxiga in these patients. Monitoring and correcting volume depletion is essential to ensure the safety and efficacy of Farxiga treatment. Healthcare providers should be vigilant in identifying and managing volume depletion in patients with type 2 diabetes mellitus who are prescribed Farxiga. By closely monitoring volume status and renal function, healthcare providers can minimize the risk of adverse effects and optimize the therapeutic outcomes for their patients. More information about volume depletion and other aspects of Farxiga may be found on the manufacture's (AstraZeneca) website.

Urosepsis and Pyelonephritis Risk With Farxiga

Continuing with the discussion on the risk of volume depletion associated with Farxiga, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, it is important to also address the potential risk of urosepsis and pyelonephritis in patients using this medication. Urosepsis is a severe infection that occurs when a urinary tract infection (UTI) spreads to the bloodstream, leading to a systemic infection. Pyelonephritis, on the other hand, is a type of UTI that involves inflammation of the kidneys.

Studies have shown that treatment with SGLT2 inhibitors, including Farxiga, increases the risk for urinary tract infections - see this link for one such study. This is of particular concern for patients with a history of genital mycotic infections, as they have an increased risk for developing urinary tract infections. Therefore, it is crucial to evaluate patients for signs and symptoms of urinary tract infections and promptly initiate treatment when necessary. Additionally, it is recommended to monitor for urinary tract infections after initiating Farxiga.

Hypoglycemia Risk With Farxiga and Insulin or Insulin Secretagogues

How does the combination of Farxiga and insulin or insulin secretagogues affect blood sugar and increase the risk of hypoglycemia?

When Farxiga is combined with insulin or insulin secretagogues there is an increased risk of hypoglycemia. Insulin and insulin secretagogues are known to lower blood sugar levels, and Farxiga can further enhance this effect. Hypoglycemia occurs when blood sugar levels drop too low, leading to symptoms such as dizziness, confusion, sweating, and even loss of consciousness. To minimize the risk of hypoglycemia, it may be necessary to lower the dose of insulin or insulin secretagogue when using them in combination with Farxiga. Close monitoring of blood sugar levels is essential when using Farxiga with insulin or insulin secretagogues to ensure that blood sugar remains within the target range. It is important for healthcare providers and individuals with diabetes to be aware of this potential interaction and take appropriate precautions to prevent hypoglycemia.

Necrotizing Fasciitis Risk With Farxiga

Necrotizing fasciitis is a serious and potentially life-threatening infection that has been reported in some cases in patients with diabetes mellitus who are taking Farxiga (dapagliflozin), a sodium-glucose co-transporter 2 (SGLT2) inhibitor.

This rare but severe condition, also known as Fournier's gangrene, requires urgent surgical intervention and can affect both males and females. Symptoms of necrotizing fasciitis include pain or tenderness, erythema, swelling in the genital or perineal area, fever, and malaise. If necrotizing fasciitis is suspected, immediate treatment with antibiotics and surgical debridement is necessary. It is important to discontinue the use of Farxiga, monitor blood glucose levels, and provide alternative therapy for glycemic control.

While the risk of necrotizing fasciitis with Farxiga is relatively low, healthcare providers should be aware of this potential complication, especially in patients with diabetes mellitus. Understanding the population characteristics of Farxiga users can also help identify individuals who may be more susceptible to this infection.

Possible Side Effects of Farxiga

It is important to mention that if you are experiencing any of the adverse reactions mentioned below, or any other side effects, please make sure to consult with your physician before continuing treatment. In addition to side effects if overdose is suspected, contact an emergency room or poison control center immediately.

Several adverse reactions have been associated with the use of Farxiga (dapagliflozin). These adverse reactions were reported in patients who took Farxiga at a dose of 5 mg or 10 mg and were more common compared to those who took a placebo. You may find detailed information about adverse reactions of Farxiga in the product monograph here.

Common adverse reactions observed in females were genital mycotic infections, nasopharyngitis and urinary tract infections. In males, balanitis were reported.

These adverse reactions were not present at baseline and occurred more frequently in patients taking Farxiga. Therefore, healthcare providers should be aware of these potential adverse reactions and monitor patients closely for any signs or symptoms.

Furthermore, patients receiving SGLT2 inhibitors such as Farxiga should not relay on urine glucose tests to monitor their glucose control as taking Farxiga will lead to positive urine glucose tests. Healthcare providers may use alternative methods to monitor glucose control.

Genital Mycotic Infections in Females

Genital mycotic infections, including vulvovaginal mycotic infections, is one of the adverse reactions observed in some females taking Farxiga. These infections occur more frequently in females compared to males. Symptoms of genital mycotic infections may include itching, burning, redness, swelling, and abnormal discharge in the genital area.

It is important for healthcare providers to inform female patients about the increased risk of genital mycotic infections when prescribing Farxiga. Patients should be educated on the signs and symptoms of these infections and encouraged to seek medical attention if they occur.

Patients should also be counseled on preventive measures to reduce the risk of genital mycotic infections. These measures may include maintaining good genital hygiene, avoiding tight-fitting clothing, wearing breathable cotton underwear, and avoiding excessive moisture in the genital area.

Urinary Tract Infections in Farxiga Users

Urinary tract infections are a potential adverse effect observed in individuals taking Farxiga (dapagliflozin).

It is important to consider that there is a risk of urinary tract infections in individuals taking Farxiga. This risk is particularly higher in patients with a history of genital mycotic infections. It is crucial to monitor patients for signs and symptoms of urinary tract infections and treat them promptly. It is also recommended to assess volume status and correct volume depletion before initiating Farxiga to minimize the risk of adverse effects.

Genital Mycotic Infections in Males

Males taking Farxiga (dapagliflozin), in some cases may experience genital mycotic infections. Genital mycotic infections refer to fungal infections in the genital area, such as balanitis or genital candidiasis. These infections can cause symptoms such as itching, redness, swelling, and discomfort in the genital region. If a patient experiences any of these side effects while prescribed Farxiga it is important to promptly seek medical attention. Healthcare providers can provide appropriate treatment options to manage these infections and alleviate symptoms.

Preventative measures including good hygiene in the genital area, wearing breathable underwear and avoiding tight-fitting clothing can mitigate any potential discomfort associated with Farxiga. Additionally, individuals should follow the prescribed dosage and administration instructions as instructed by their physician.

Farxiga's Approval for Type 2 Diabetes

For more detailed information on this topic, please refer to the product's monograph which may be found here.

In addition to improving blood sugar levels, Farxiga has also been approved for other indications. It can reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. It has also been shown to reduce the risk of cardiovascular death and hospitalization for heart failure. Furthermore, Farxiga can reduce the risk of sustained decline in kidney function, in adults with chronic kidney disease at risk of progression.

Farxiga's Approval for Heart Failure

After its initial approval for the treatment of type 2 diabetes, Farxiga (dapagliflozin) has also been approved for the management of heart failure. This medication has shown efficacy in reducing the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. Please refer to pages 3 and 4 of the monograph here.

Additionally, Farxiga has been found to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction. These approvals provide healthcare professionals with an important tool in the management of heart failure, a condition that affects a significant number of individuals worldwide.

Heart failure is a chronic condition that requires ongoing management to improve patients' quality of life and reduce the risk of hospitalization and mortality. Farxiga's approval for heart failure highlights its role as a possible option for individuals with both type 2 diabetes and heart failure.

Now, let's explore Farxiga's approval for another important indication: chronic kidney disease.

Farxiga's Approval for Chronic Kidney Disease

Farxiga (Dapagliflozin) has received FDA approval for the treatment of chronic kidney disease, providing healthcare professionals with an alternative therapeutic option for managing the condition. Please refer to the FDA News Release here.

Before we continue with the article, it is worth noting that patients should avoid taking Farxiga, and consult with their physician if they are on dialysis treatment or have hypersensitive reaction to the medication.

Chronic kidney disease (CKD) is a progressive condition that results in a decline in kidney function over time. It is a serious condition that sometimes can result in various complications, including cardiovascular disease and ultimately, kidney failure.

The approval of Farxiga for CKD is significant because it has been shown to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death, and hospitalization as a result of heart failure. This means that Farxiga can help slow down the progression of CKD and reduce the risk of complications associated with the disease.

Details about Farxiga as a medication will be discussed in the subsequent section, including dosing, indications, interactions, and adverse effects. By providing this information, healthcare professionals can make informed decisions about the use of Farxiga in their patients and ensure optimal outcomes in the management of chronic kidney disease.

Details About Farxiga as a Medication

It is important to note that Farxiga is not approved for the treatment of type 1 diabetes mellitus and is not recommended for use in adults with type 2 diabetes mellitus and an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m2. Additionally, it is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or a recent history of immunosuppressive therapy. This article provides more information regarding Farxiga and cautions regarding its use for patients with polycystic kidney disease.

As discussed prior, in some cases Farxiga may have potential adverse effects, including genital mycotic infections, urinary tract infections, increased urination, and back pain. Addition, serious side effects are rare, but still may occur occasionally, and these include severe allergic reactions, kidney damage, serious urinary tract infections, ketoacidosis, and Fournier's gangrene (link to the FDA Safety Announcement on SGLT2 Inhibitors). Healthcare professionals should closely monitor patients for these adverse effects and take appropriate measures if they occur.

Side Effects of Farxiga

As with many medications, Farxiga may manifest certain side effects in some individuals. While the medication is effective in lowering blood sugar levels and reducing the risk of certain complications in patients with type 2 diabetes, it is important to be aware of the potential adverse reactions. Consequently, consulting with a physician prior to starting a treatment regimen that includes Farxiga is crucial.

Drug Interactions With Farxiga[]

There are several drug interactions that patients should be aware of when taking Farxiga.

It is important to inform your healthcare provider about all medications, including prescription, over-the-counter, recreational drugs and herbal supplements, that you are currently taking or plan to take while using Farxiga.

One important drug interaction to be aware of is with diuretics. Taking Farxiga with diuretics, such as loop diuretics, can increase the risk of dehydration and low blood pressure. It is important to consult with your healthcare provider on how you should approach taking Farxiga with diuretics.

Another potential drug interaction could be with insulin or insulin secretagogues, such as sulfonylureas. Farxiga can increase the risk of hypoglycemia when used in combination with these medications. Your healthcare provider may need to adjust your insulin or insulin secretagogue dose to minimize the risk of low blood sugar. Please refer to the page 6 of monograph - here.

Dosage Considerations

Before you proceed with the following article it is important to note, that you will read through broad recommendations, and before starting the treatment, please make sure to consult with your physician to get personalized guidance. In addition, please refer to the monograph (page 26) - here.

The recommended dosage of Farxiga varies depending on specific patient populations. For glycemic control in adults with type 2 diabetes mellitus, the recommended starting dose is 5 mg orally once daily, which may be increased to 10 mg orally once daily if additional glycemic control is required.

For reducing the risk of heart failure hospitalization, a dose of 10 mg orally once daily may be a good starting point. It is important to assess volume status and correct volume depletion before initiating Farxiga in the 10 mg dose.

It is not recommended to use Farxiga to improve glycemic control for patients with type 2 diabetes mellitus, if an (eGFR) is less than 45 mL/min/1.73 m2. In this scenario, the medication is likely to be ineffective.

It is worth noting that Farxiga is available in tablet form with strengths of 5 mg and 10 mg. Before initiating treatment, it is important to assess volume status and renal function, especially in patients with impaired renal function, elderly patients, or patients on loop diuretics. By considering the specific patient population and individual needs, healthcare providers can determine the appropriate dosage of Farxiga for their patients, ensuring optimal therapeutic outcomes.

Mechanism of Action of Farxiga

Building upon the previous discussion of dosage considerations, the mechanism of action of Farxiga can be understood by examining its effects on the body's glucose regulation and renal function. Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, which means it works by blocking the reabsorption of glucose in the kidneys. By inhibiting SGLT2, Farxiga allows for increased glucose excretion in the urine, leading to lower blood glucose levels. This mechanism of action helps improve glycemic control in adults with type 2 diabetes mellitus.

In addition to its effects on glucose regulation, Farxiga also has beneficial effects on renal function. By reducing glucose reabsorption in kidneys, it leads to a mild diuretic effect, increasing urine volume and aiding in the elimination of excess fluid from the body. It can be particularly beneficial for patients with heart failure, as it helps reduce fluid overload and decrease the risk of hospitalization.