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FOR ADULTS WITH TYPE 2 DIABETES,
ALONG WITH DIET AND EXERCISE

TO HELP LOWER
A1C ASK ABOUT
SYNJARDY

SYNJARDY COMBINES 2 PROVEN DIABETES
MEDICATIONS IN 1 PILL THAT CAN MEAN ONE
LESS PILL FOR MANAGING YOUR TYPE 2
DIABETES.

Type 2 diabetes patients

With SYNJARDY, you’ll get the power of two medications—JARDIANCE (empagliflozin) and metformin—in a single pill to help lower your A1C, along with diet and exercise. And in adults with type 2 diabetes who also have known heart disease, JARDIANCE, one of the medicines in SYNJARDY, can reduce the risk of cardiovascular death.

Metformin Empagliflozin Combination Icon

While JARDIANCE has been shown to reduce the risk of cardiovascular death, the effectiveness of SYNJARDY, the combination of JARDIANCE and metformin, on reducing the risk of cardiovascular death has not been studied.

Click below to see if SYNJARDY may be right for you.

Why SYNJARDY?

GET THE SAVINGS AND
SUPPORT YOU NEED

My SYNJARDY Support offers helpful emails and sends optional texts (including prescription reminders) throughout your treatment. Plus, the SYNJARDY savings program lets eligible patients pay as little as $10* a month for a 1- to 3-month prescription.

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A LOWER A1C COULD BE WITHIN YOUR REACH

In clinical studies of adults with type 2 diabetes, people taking a combination of empagliflozin and metformin, along with diet and exercise, were able to significantly lower their A1C.

SYNJARDY works in multiple ways to lower A1C and fasting blood sugar. If you take SYNJARDY and your blood sugar improves, that is excellent! But it’s important to continue taking SYNJARDY even after you've started seeing improvements in your A1C and blood sugar.

What is SYNJARDY or SYNJARDY XR?

SYNJARDY or SYNJARDY XR is a prescription medicine that contains 2 diabetes medicines, empagliflozin (JARDIANCE) and metformin HCl. SYNJARDY can be used along with diet and exercise to improve blood sugar in adults and children who are 10 years of age and older with type 2 diabetes. SYNJARDY XR can be used along with diet and exercise to improve blood sugar in adults with type 2 diabetes.

One of the medicines in SYNJARDY and SYNJARDY XR, empagliflozin (JARDIANCE), can also be used in adults with type 2 diabetes:

  • who have known cardiovascular disease to reduce the risk of cardiovascular death
  • who have heart failure (when the heart cannot pump enough blood to the rest of your body) to reduce the risk of cardiovascular death and hospitalization for heart failure

SYNJARDY or SYNJARDY XR is not for use to lower blood sugar in people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in the blood or urine).

SYNJARDY or SYNJARDY XR is only for use in people with type 2 diabetes, because they contain the prescription medicine metformin hydrochloride (HCl).

 

IMPORTANT SAFETY INFORMATION

SYNJARDY or SYNJARDY XR can cause serious side effects, including:

Lactic acidosis (a build‐up of lactic acid in the blood). Metformin HCl, one of the medicines in SYNJARDY and SYNJARDY XR, can cause lactic acidosis, a rare but serious condition that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Stop taking SYNJARDY or SYNJARDY XR and call your healthcare provider right away or go to the nearest hospital emergency room if you get any of the following symptoms of lactic acidosis: feel very weak and tired; have unusual (not normal) muscle pain; have trouble breathing; have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea; have unusual sleepiness or sleep longer than usual; feel cold, especially in your arms and legs; feel dizzy or lightheaded; have a slow or irregular heartbeat.

You have a higher chance of getting lactic acidosis with SYNJARDY or SYNJARDY XR if you: have moderate to severe kidney problems; have liver problems; drink a lot of alcohol (very often or short term “binge” drinking); get dehydrated (lose a large amount of body fluids); have certain x-ray tests with injectable dyes or contrast agents; have surgery or other procedure for which you need to restrict the amount of food and liquid you eat and drink; have congestive heart failure; have a heart attack, severe infection, or stroke, or are 65 years of age or older.

Do not take SYNJARDY or SYNJARDY XR if you:

  • Have severe kidney problems, end stage renal disease, or are on dialysis
  • have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine)
  • are allergic to empagliflozin (JARDIANCE), metformin HCL, or any of the ingredients in SYNJARDY or SYNJARDY XR. Symptoms of an allergic reaction may include: 
    rash 
    raised, red areas on your skin (hives) 
    swelling of your face, lips, mouth, and throat that may cause difficulty in breathing or swallowing

If you have any of these symptoms, stop taking SYNJARDY or SYNJARDY XR and call your healthcare provider right away or go to the nearest hospital emergency room.

SYNJARDY or SYNJARDY XR may cause serious side effects, including:

Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 and other ketoacidosis. SYNJARDY or SYNJARDY XR can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who: are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood. Stop taking SYNJARDY or SYNJARDY XR and call your healthcare provider right away or go to the nearest hospital emergency room if you get any of the following symptoms. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL:

  • nausea
  • vomiting
  • stomach‐area (abdominal) pain
  • tiredness
  • trouble breathing
  • ketones in your urine or blood

Dehydration. SYNJARDY or SYNJARDY XR can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up. Sudden worsening of kidney function has happened in people who are taking SYNJARDY or SYNJARDY XR. You may be at higher risk of dehydration if you:

  • take medicines to lower your blood pressure, including water pills (diuretics)
  • are on a low salt diet
  • have kidney problems
  • are 65 years of age or older

Talk to your healthcare provider about what you can do to prevent dehydration, including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, if you are sick or cannot eat, or start to lose liquids from your body from vomiting, diarrhea or being in the sun too long.

Vaginal yeast infection. Talk to your healthcare provider if you have vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching.

Yeast infection of the skin around the penis. Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis. Talk to your healthcare provider if you have redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from the penis, and/or pain in the skin around the penis.

Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medication and your symptoms do not go away.

Serious urinary tract infections. Serious urinary tract infections can occur in people taking empagliflozin, one of the medicines in SYNJARDY and SYNJARDY XR, and may lead to hospitalization. Tell your healthcare provider if you have symptoms of a urinary tract infection, such as a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach or pelvis, or blood in the urine. Sometimes people also may have a fever, back pain, nausea, or vomiting.

Low blood sugar (hypoglycemia). In adults, if you take SYNJARDY or SYNJARDY XR with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. In children who are 10 years of age and older, the risk for low blood sugar is higher with SYNJARDY even if you do not use another medicine that can lower blood sugar. The dose of your sulfonylurea medicine or insulin may need to be lowered. Symptoms of low blood sugar may include headache, drowsiness, weakness, irritability, hunger, fast heartbeat, confusion, shaking or feeling jittery, dizziness, or sweating.

Necrotizing fasciitis. A rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around your anus and genitals (perineum). This bacterial infection has happened in people who take SYNJARDY or SYNJARDY XR, and may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have a fever or are feeling very weak, tired, or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, and redness of skin (erythema).

Amputations. SGLT2 inhibitors may increase your risk of lower limb amputations. You may be at higher risk of lower limb amputation if you:

  • have a history of amputation
  • have blocked or narrowed blood vessels, usually in your leg
  • have had diabetic foot infection, ulcers or sores

Call your healthcare provider right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Talk to your healthcare provider about proper foot care.

Serious allergic reactions: If you have any symptoms of a serious allergic reaction, stop taking SYNJARDY or SYNJARDY XR and call your healthcare provider right away or go to the nearest emergency room.

Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin B12 blood levels before. Your healthcare provider may do blood tests to check your vitamin B12 levels.

The most common side effects of SYNJARDY or SYNJARDY XR include urinary tract infections, female genital infections, diarrhea, nausea, vomiting, gas, stomach pain, indigestion, weakness, headache, and stuffy or runny nose and sore throat.

These are not all the possible side effects of SYNJARDY or SYNJARDY XR. For more information, ask your healthcare provider or pharmacist.

Before taking SYNJARDY or SYNJARDY XR, tell your healthcare provider about all of your medical conditions, including if you:

  • have type 1 diabetes or have had diabetic ketoacidosis
  • have a decrease in your insulin dose
  • have a serious infection
  • have a history of infection of the vagina or penis
  • have a history of amputation
  • have kidney problems
  • have liver problems
  • have heart problems, including congestive heart failure
  • are 65 years of age or older
  • have a history of urinary tract infections or problems with urination
  • are on a low sodium (salt) diet. Your health care provider may change your diet or dose
  • are going to have surgery. Your healthcare provider may stop SYNJARDY or SYNJARDY XR before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking SYNJARDY or SYNJARDY and when to start it again
  • are eating less or there is a change in your diet
  • are dehydrated
  • have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas
  • drink alcohol very often, or drink a lot of alcohol in the short term (“binge” drinking)
  • have ever had an allergic reaction to SYNJARDY or SYNJARDY XR
  • are going to get an injection of dye or contrast agents for an x-ray procedure. SYNJARDY or SYNJARDY XR may need to be stopped for a short time. Talk to your healthcare provider about when you should stop SYNJARDY or SYNJARDY XR and when you should start SYNJARDY or SYNJARDY XR again
  • have low levels of vitamin B12 in your blood
  • are pregnant or plan to become pregnant. SYNJARDY or SYNJARDY XR may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking SYNJARDY or SYNJARDY XR
  • are breastfeeding or plan to breastfeed. SYNJARDY or SYNJARDY XR may pass into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you are taking SYNJARDY or SYNJARDY XR. Do not breastfeed while taking SYNJARDY
  • are a person who has not gone through menopause (premenopausal), who does not have periods regularly or at all. SYNJARDY or SYNJARDY XR can cause the release of an egg from an ovary in a person (ovulation). This can increase your chance of getting pregnant

Tell your healthcare provider about all the medicines you take, including prescription or over‐the‐counter medicines, vitamins, or herbal supplements.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.

Please see Prescribing Information and Medication Guide for SYNJARDY and SYNJARDY XR.

CL-SY-100080 10.30.23