First major development in 20 years to help manage chronic kidney disease

WAUSAU, Wis. (WSAW) - Chronic kidney disease is a life-threatening disease that is vastly underdiagnosed and affects an estimated 37 million, or 1 in 7, American adults. With limited treatment options available, a new therapy is critical for people living with CKD to help slow disease progression –  which is why the recent FDA approval of a new therapy to treat CKD in patients at risk of progression with and without type 2 diabetes is monumental for this patient population.

CKD is a progressive condition and patients with CKD have an increased risk of having heart disease. However, most patients don’t know they have CKD, in large part because it is a “silent” disease, with most patients feeling no symptoms until the disease has progressed. In fact, while approximately 15% of U.S. adults are living with CKD, 9 in 10 are unaware they have it.

Now, a new treatment option, FARXIGA® (dapagliflozin), has been proven to help slow the progression of CKD – a huge scientific innovation for CKD patients at risk of progression with and without T2D. This approval is the most significant advancement in the treatment of CKD in over 20 years.

Because CKD may be overlooked until symptoms appear at advanced stages, it is especially important to be aware of risk factors and the serious complications that can occur.

CKD tends to get worse over time, so the earlier treatment starts, the better the patient outcomes are.

As always, talk to your health care provider about your treatment options and if FARXIGA® (dapagliflozin) is right for you.

For more information, visit farxiga.com

Important Safety Information for FARXIGA® (dapagliflozin) 5 mg and 10 mg tablets

Do not take FARXIGA if you:

• are allergic to dapagliflozin or any of the ingredients in FARXIGA. Symptoms of a serious allergic reaction may include skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue and throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking FARXIGA and contact your health care provider or go to the nearest hospital emergency room right away
• are on dialysis

What are the possible side effects of FARXIGA?

FARXIGA may cause serious side effects including:

• Ketoacidosis occurred in people with type 1 and type 2 diabetes during treatment with FARXIGA. Ketoacidosis is a serious condition which may require hospitalization and may lead to death. Symptoms may include nausea, tiredness, vomiting, trouble breathing and abdominal pain. If you get any of these symptoms, stop taking FARXIGA and call your health care provider right away. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL
• Dehydration, which may cause you to feel dizzy, faint, lightheaded or weak, especially when you stand up. There have been reports of sudden kidney injury in people with type 2 diabetes who are taking FARXIGA. You may be at a higher risk of dehydration if you take medicines to lower your blood pressure, including water pills; are age 65 or older; are on a low salt diet or have kidney problems.
• Serious urinary tract infections: Some that lead to hospitalization occurred in people taking FARXIGA. Tell your health care provider if you have any signs or symptoms of UTI including a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine with or without fever, back pain, nausea or vomiting
• Low blood sugar can occur if you take FARXIGA with another medicine that can cause low blood sugar, such as sulfonylureas or insulin. Symptoms of low blood sugar include shaking, sweating, fast heartbeat, dizziness, hunger, headache and irritability.
• Bacterial infections under the skin of the genitals and areas around them. Rare but serious infections that cause severe tissue damage under the skin of the genitals and areas around them have happened with FARXIGA. This infection has happened in women and men and may lead to hospitalization, surgeries and death.  Seek medical attention immediately if you have fever or you are feeling very weak, tired or uncomfortable and you also develop any pain or tenderness, swelling or redness of the skin in the genitals and areas around them

The most common side effects of FARXIGA include yeast infections of the vagina or penis and changes in urination, including urgent need to urinate more often, in larger amounts or at night.

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