IMPORTANT SAFETY INFORMATION
Serious side effects can happen in people taking TRIJARDY XR, including:
Lactic acidosis (a buildup of lactic acid in the blood). Metformin hydrochloride, one of the medicines in TRIJARDY 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 TRIJARDY XR and call your doctor 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 muscle pain, have trouble breathing, have stomach or intestinal problems with nausea and vomiting, or diarrhea, feel sleepy or sleep longer than usual, feel cold in your arms and legs, feel dizzy or lightheaded, or have a slow or irregular heartbeat.
You have a higher chance of getting lactic acidosis with TRIJARDY XR if you: have moderate to severe kidney problems; have liver problems; drink alcohol (very often or short term “binge” drinking); get dehydrated (lose a large amount of body fluids); have x-ray tests that use injectable dye; have surgery; have congestive heart failure; have a heart attack, severe infection, or stroke, or are 65 years of age or older.
Inflammation of the pancreas (pancreatitis) is another serious side effect that can happen to people taking TRIJARDY XR. Pancreatitis may be severe and lead to death. Before you start taking TRIJARDY XR tell your doctor if you have ever had pancreatitis, a history of alcoholism, gallstones, or high triglyceride levels.
Stop taking TRIJARDY XR and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
Heart failure means your heart does not pump blood well enough. Before you start taking TRIJARDY XR, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor right away if you have any of the following symptoms: increasing shortness of breath or trouble breathing, especially when you lie down; swelling or fluid retention, especially in the feet, ankles, or legs; an unusually fast increase in weight or unusual tiredness. These may be symptoms of heart failure.
Do not take TRIJARDY 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, linagliptin, metformin, or any of the ingredients in TRIJARDY XR.
TRIJARDY XR may cause serious side effects, including:
Dehydration. TRIJARDY 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. 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). Talk to your doctor about what you can do to prevent dehydration.
Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a serious condition which needs to be treated in the hospital. Ketoacidosis may lead to death. Ketoacidosis has happened in people with type 1 diabetes and in people with type 2 diabetes taking empagliflozin, one of the medicines in TRIJARDY XR. Ketoacidosis can happen with TRIJARDY 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 TRIJARDY XR. Stop taking TRIJARDY XR and call your doctor right away or go to the nearest hospital emergency room 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 TRIJARDY 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 TRIJARDY 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 TRIJARDY 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 empagliflozin, one of the medications in TRIJARDY 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 TRIJARDY 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 TRIJARDY 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 TRIJARDY 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), skin rash, itching, flaking, or peeling. If you have any of these symptoms, stop taking TRIJARDY XR and call your doctor right away or go to the nearest hospital 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 doctor may do blood tests to check your vitamin B12 levels.
Joint pain. Some people who take medicines called dipeptidyl peptidase-4 (DPP-4) inhibitors, one of the medicines in TRIJARDY XR, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.
Skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the medicines in TRIJARDY XR, may develop a skin reaction. Tell your doctor right away if you develop blisters.
The most common side effects of TRIJARDY XR include upper respiratory tract infection, urinary tract infections, stuffy or runny nose and sore throat, diarrhea, constipation, headache, inflammation of the stomach and intestine (gastroenteritis).
These are not all the possible side effects of TRIJARDY XR. For more information, ask your doctor or pharmacist.
Before taking TRIJARDY XR, tell your doctor about all of your medical conditions, including if you:
- have kidney problems
- have liver problems
- have heart problems, including congestive heart failure
- are 65 years of age or older
- have a history of infection of the vagina or penis
- have a history of urinary tract infection or problems with urination
- are going to have surgery. Your doctor may stop your TRIJARDY XR before you have surgery. Talk to your doctor if you are having surgery about when to stop taking TRIJARDY 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. TRIJARDY XR may need to be stopped for a short time. Talk to your doctor about when you should stop TRIJARDY XR and when you should start it again
- have type 1 diabetes. TRIJARDY XR should not be used in people with type 1 diabetes
- have low levels of vitamin B12 in your blood
- are pregnant or plan to become pregnant. TRIJARDY XR may harm your unborn baby. Tell your doctor right away if you become pregnant while taking TRIJARDY XR
- are breastfeeding or plan to breastfeed. TRIJARDY XR may pass into your breast milk and may harm your baby. Do not breastfeed while taking TRIJARDY XR
- are a person who has not gone through menopause (premenopausal), who does not have periods regularly or at all. TRIJARDY XR can cause the release of an egg from an ovary in a person. This can increase your chance of getting pregnant.
Tell your doctor about all the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements.
Especially tell your doctor if you take:
- insulin or other medicines that can lower your blood sugar
- diuretics (water pills)
- rifampin (Rifadin, Rimactane, Rifater, Rifamate), an antibiotic that is used to treat tuberculosis.
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 TRIJARDY XR.