Farxiga (Dapagliflozin Propanediol Monohydrate)

Farxiga (Dapagliflozin Propanediol Monohydrate)

Dapagliflozin belongs to a group of drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors.

Farxiga is also used to lower the risk of stroke, heart failure or heart attacks in adults with type 2 diabetes. Patients taking Farxiga can reduce their chances of visiting the hospital for heart failure if the already have heart disease and type 2 diabetes.

It is often used in combination with diet an exercise to further improve blood sugar levels.

How does Farxiga work?

Farxiga works by assisting the kidneys to reabsorb sugar, prevents glucose from being reabsorbed in the bloodstream and helps get rid of blood sugar through urine.

This medication also slows or stops the production of a protein called SGLT2 found in the kidneys.

Farxiga is unlike other medications typically used to treat type 2 diabetes which involve the hormone insulin.

Farxiga is also used to reduce the risk of worsening kidney disease, avoid hospitalization for heart failure in adults with kidney disease, end-stage kidney disease (ESKD) and lower risk of death.

Side Effects

Most side effects typically go away within a few days or weeks. If they persist, consult your doctor right away.

Studies have linked to Farxiga to include mild to serious side effects that can result in problems with the bladder or kidney.

Common side effects of Farxiga include:

• back pain
• constipation
• increased cholesterol levels
• increased urination
• genital infection (for men)
• nausea
• pain in your extremities
• respiratory infections (i.e. common cold, flu)
• sore throat
• stuffy or runny nose
• urinary tract infection
• vaginal yeast infection
• vaginal changes such as itching, abnormal discharge or odor
• increased percentage of red blood cells in the blood;

Serious Side Effects

Serious side effects associated with Farxiga include:

• Symptoms related to dehydration which can include:
  • dizziness
  • feeling fain or lightheaded
  • weakness

• Symptoms related to low blood sugar (hypoglycemia) which may include:
  • confusion
  • drowsiness
  • headache
  • hunger
  • feeling jittery
  • increased heartbeat
  • irritability
  • weakness
  • sweating

• Fournier’s gangrene
• Ketoacidosis
• Kidney damage
• Severe allergic reactions
• Serious urinary tract infections

Farxiga Side Effects in Detail

The following information describes the side effects associated with Farxiga in greater detail.

Allergic Reaction

With any medication, patients may experience allergic reactions. In a clinical study it was found that only 0.3% of subjects experienced an allergic reaction.

Symptoms of an allergic reaction may include:

• itchiness
• skin rash
• skin flushing (a warmth or redness of the skin)

Severe allergic reactions may include:

• swelling of the skin including eye lids, lips, hands or feet
• difficulty breathing
• swelling of mouth, tongue or throat

Weight Loss

Weight loss is one of the benefits from using this medication. In a clinical study, subjects taking Farxiga lost an average of 7 pounds over a 24 week period.

Bladder Cancer

While not conclusive, there may be a connection between this medication and bladder cancer.

According to the FDA, there isn’t enough evidence to link Farxiga to bladder cancer from studies showing subjects having bladder cancer while taking this medication.

Back Pain

4% of people taking Farxiga during a clinical study experienced back pain. With continued use of this drug, symptoms may go away over time. Consult your doctor if your back pain does not go away.

Kidney Damage

Farxiga may increase the risk of kidney damage. This was not reported in any studies but after approval. Symptoms of kidney damage may include:

• confusion
• reduced urination
• swelling of the ankles and legs

Kidney issues typically result in those over the age of 65, have existing kidney or heart problems, result from other medications or those who are dehydrated.

Your doctor should test your kidney levels before starting Farxiga. If you have existing kidney issues your doctor may not prescribe it. Your doctor may stop treatment if they detect problems with your kidneys.

Yeast Infection

Patients may increase their chances of developing a genital yeast infection while taking Farxiga. It was found during clinical studies that 3% of men and 8% of women developed yeast infections.

For men, a genital yeast infection can lead to redness or rash on the penis. Depending on what part of the penis is affected, the condition is called either balanitis or balanoposthitis.

Speak to you doctor if you are experiencing rash or redness in the genital area as they can prescribe medication to treat the affected area.

Urinary Tract Infection

Farxiga may increase the chances of developing a urinary tract infection UTI) however not common. Only 6% of people taking this medication experienced UTI.

Symptoms of urinary tract infections may include:

• increased frequency of urination
• need to urinate abruptly
• burning sensation while urinating
• blood present in urine
• pain in lower abdomen

If you suspect you have UTI, consult your doctor to receive necessary treatment.

Ketoacidosis

Despite being uncommon, diabetic ketoacidosis is a side effect that may occur in some people.

Ketoacidosis typically occurs when the cells in your body are not getting the sufficient amount of glucose for energy. Your body turns to using fat as an energy source which can cause high levels of a chemical called ketones. This may also cause your body to become acidic. Severe cases of ketoacidosis can lead to coma or even death.

Symptoms of ketoacidosis include:

• dry mouth or thirst
• high blood sugar levels
• increased frequency of urination
• nausea or vomiting
• fatigue or weakness
• fruity or acetone breath
• stomach pain
• difficulty breathing
• confusion

Consult your doctor immediately if you are experiencing symptoms. If you feel your symptoms are serious, go to the nearest hospital or call 911.

Fournier’s gangrene

Fournier’s gangrene (also known as necrotizing fasciitis of the perineum) is a condition that is uncommon however can be life threatening. it has been reported in reported in those taking Farxiga and similar medications.

Symptoms of Fournier’s gangrene may include:

• pain, swelling and tenderness in the genital/rectal area
• fever
• feeling of discomfort (malaise)

However rare, this condition affects both men and women and can be life threatening. If you experience this condition, seek medical attention immediately.

This page does not include all possible side effects. The Food & Drug Administration tracks side effects for approved medications. You can report unlisted side effects to the FDA through MedWatch.

Speak to your pharmacist or doctor if you have any questions or concerns about side effects related to Farxiga.

Call 911 if you feel symptoms are life threatening or you may require medical emergency.

Warnings & Precautions

Farxiga is not used for treating type 1 diabetes.

It should not be used by type 2 diabetes patients who also have kidney problems as it may not work effectively.

Do not take if taking immunosuppressive medications to treat kidney disease or have certain genetic forms of polycystic kidney disease. If you have these conditions, Farxiga may not work.

Notify your doctor or pharmacist if you have any allergies prior to starting treatment with dapagliflozin. Patients may have an allergy to its inactive ingredients.

Inform your doctor of any pre-existing conditions such as high use of alcohol, dehydration, kidney disease/dialysis, heart failure, low blood pressure or yeast infection.

Dizziness, blurred vision or drowsiness are common side effects to those with diabetes. As a result it is not recommended to drive or operate heavy machinery unless cleared by your doctor.

Limit alcohol consumption while taking Farxiga as it may lead to low blood sugar levels and high ketone levels.

Blood sugar levels may be difficult to control for those with diabetes. Especially from factors such as fever, infections, surgery, injury or stress. If you find your eating habits have been affected since starting Farxiga, speak to your doctor as this may lead to high ketone levels.

Inform doctors or dentists that you are taking this Farxiga and any other medication, especially if you are going for surgery.

Older adults may be more sensitive to this medication and more susceptible to its side effects such as dehydration, dizziness and kidney disease.

Inform your doctor if you are pregnant and discuss potential risks. Symptoms may worsen during pregnancy. Your doctor may suggest modifying your diet and treatment. This medication should only be taken when needed.

Let your doctor know if you are breast feeding or planning to breast feed. It is unknown whether this medication passes through breast milk.

Drug Interactions

Certain drugs taken in combination may affect this drugs effectiveness or increase the risk of serious side effects. Inform your doctor of any drugs you are taking including OTC medications and herbal supplements.

You should not start, stop or modify dosage without your doctors approval.