What are SYNJARDY and SYNJARDY XR?
SYNJARDY and SYNJARDY XR are prescription medicines that contain 2 diabetes medicines, empagliflozin (JARDIANCE) and metformin. SYNJARDY and SYNJARDY XR can be used along with diet and exercise to improve blood sugar in adults with type 2 diabetes, and can be used in adults with type 2 diabetes who have known cardiovascular (CV) disease when both empagliflozin and metformin are appropriate and empagliflozin is needed to reduce the risk of CV death. The effectiveness of SYNJARDY and SYNJARDY XR at reducing the risk of cardiovascular death has not been studied.
SYNJARDY and SYNJARDY XR are not for people with type 1 diabetes, or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
IMPORTANT SAFETY INFORMATION
Serious side effects can happen in people taking SYNJARDY or SYNJARDY XR, including:
Lactic acidosis (a build-up of lactic acid in the blood). Metformin, 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.
Call your doctor right away if you get any of the following symptoms of lactic acidosis: cold in your hands or feet; feel dizzy or lightheaded; slow or irregular heartbeat; feel very weak or tired; have unusual muscle pain; have trouble breathing; feel sleepy or drowsy; have stomach pains, nausea, or vomiting.
You have a higher chance of getting lactic acidosis with SYNJARDY or SYNJARDY XR if you: have moderate to severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye; have liver problems; drink alcohol very often, or drink a lot of alcohol in the short term (“binge” drinking); get dehydrated (lose a large amount of body fluids); have surgery; have a heart attack, severe infection, or stroke.
Do not take SYNJARDY or SYNJARDY XR if you:
- have moderate to severe kidney problems 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, or any of the ingredients in SYNJARDY or SYNJARDY XR.
SYNJARDY or SYNJARDY XR may cause serious side effects, including:
Dehydration. SYNJARDY or SYNJARDY XR can cause some people to have dehydration (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up. You may be at higher risk of dehydration if you have low blood pressure, kidney problems, are 65 years of age or older, are on a low salt diet, or take medicines to lower your blood pressure, including water pills (diuretics).
Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a serious condition, which may need to be treated in the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs in people with type 1 diabetes and can also occur in people with type 2 diabetes taking SYNJARDY or SYNJARDY XR, even if blood sugar is less than 250 mg/dL. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with SYNJARDY or SYNJARDY XR. Stop taking SYNJARDY or SYNJARDY XR and call your doctor right away if you get any of the following symptoms, and, if possible, check for ketones in your urine:
- stomach-area (abdominal) pain
- trouble breathing
Kidney problems. Sudden kidney injury has happened to people taking SYNJARDY or SYNJARDY XR. Talk to your doctor right away if you reduce the amount you eat or drink, or if you lose liquids; for example, from vomiting, diarrhea, or being in the sun too long.
Serious urinary tract infections. Serious urinary tract infections can occur in people taking SYNJARDY or SYNJARDY XR, and may lead to hospitalization. Tell your doctor 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). 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. 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 women and men who take SYNJARDY or SYNJARDY XR, and may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have 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).
Vaginal yeast infection. Women who take SYNJARDY or SYNJARDY XR may get vaginal yeast infections. Talk to your doctor if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching.
Yeast infection of the penis. Men who take SYNJARDY or SYNJARDY XR may get a yeast infection of the skin around the penis, especially uncircumcised males and those with chronic infections. Talk to your doctor if you experience redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from the penis, and/or pain in the skin around penis.
Allergic (hypersensitivity) reactions: Symptoms of serious allergic reactions to SYNJARDY or SYNJARDY XR may include swelling of your face, lips, throat, and other areas of your skin, difficulty with swallowing or breathing, and raised, red areas on your skin (hives). If you have any of these symptoms, stop taking SYNJARDY or SYNJARDY XR and contact your doctor or go to the nearest emergency room right away.
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 doctor may do blood tests to check your vitamin B12 levels.
Increased fats in your blood (cholesterol).
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 doctor or pharmacist.
Before taking SYNJARDY or SYNJARDY XR, tell your doctor about all of your medical conditions, including if you:
- have moderate to severe kidney problems. Your doctor may do blood tests to check your kidneys before and during treatment with SYNJARDY or SYNJARDY XR
- have liver problems
- have a history of urinary tract infection or problems with urination
- have heart problems, including congestive heart failure
- are going to have surgery. Your doctor may stop your SYNJARDY or SYNJARDY XR before you have surgery. Talk to your doctor if you are having surgery about when to stop taking SYNJARDY or SYNJARDY XR and when to start it again
- are eating less or there is a change in your diet
- 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)
- 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 doctor about when you should stop SYNJARDY or SYNJARDY XR and when you should start SYNJARDY or SYNJARDY XR again
- have type 1 diabetes. SYNJARDY or SYNJARDY XR should not be used in people with type 1 diabetes
- are pregnant or plan to become pregnant. SYNJARDY or SYNJARDY XR may harm your unborn baby. Tell your doctor right away if you become pregnant while taking SYNJARDY or SYNJARDY XR
- are a premenopausal woman (before the “change of life”), who does not have periods regularly or at all. Talk to your doctor about birth control choices while taking SYNJARDY or SYNJARDY XR as it may increase your chances of becoming pregnant
- are breastfeeding or plan to breastfeed. SYNJARDY or SYNJARDY XR may pass into your breast milk and may harm your baby. Do not breastfeed while taking SYNJARDY or SYNJARDY XR
Tell your doctor 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.
Please see Prescribing Information and Medication Guide for SYNJARDY XR.