Empagliflozin, linagliptin, and metformin

Empagliflozin, linagliptin, and metformin (Trijardy XR) is a combination medicine used with diet and exercise to help control blood sugar in adults with type 2 diabetes mellitus.

Trijardy XR is also used to reduce the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.

Trijardy XR is not for treating type 1 diabetes.

Empagliflozin, linagliptin, and metformin may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may sometimes change your dose. Use the medicine exactly as directed.

Trijardy XR is usually taken in the morning with a meal.

Swallow the tablet whole and do not crush, chew, break, or dissolve it. Tell your doctor if you have trouble swallowing the tablet.

Part of a tablet shell may appear in your stool, but this will not make the medicine less effective.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones in your urine. Empagliflozin can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have high ketones in your urine.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia) such as increased thirst or urination. Ask your doctor before changing your medication dosage.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Trijardy XR.

Your doctor may have you take extra vitamin B12 while you are taking Trijardy XR. Take only the amount of vitamin B12 your doctor has prescribed.

Store at room temperature away from moisture and heat.

Stop taking this medicine and call your doctor immediately if you have signs of a serious side effect, such as severe stomach pain (which may spread to your back), vomiting, tiredness, or trouble breathing.

Inform your doctor if you are experiencing vomiting or diarrhea, or if you are eating or drinking less than usual.

Seek emergency medical help if you have symptoms of lactic acidosis, such as unusual muscle pain, trouble breathing, irregular heartbeats, or if you feel very weak.

This medicine can cause serious infections around the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness, or swelling of the genital or rectal area, fever, or if you feel unwell.

You should not use empagliflozin, linagliptin, and metformin if you are allergic to empagliflozin, linagliptin, or metformin, or if you have:

• severe kidney disease (or if you are on dialysis);
• a history of severe allergic or skin reaction after taking linagliptin; or
• metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment).

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking this medicine. Be sure your caregivers know ahead of time that you are using Trijardy XR.

Tell your doctor if you have ever had:

• liver or kidney disease;
• a bladder infection or urination problems;
• a pancreas disorder;
• congestive heart failure, a heart attack or stroke;
• gallstones;
• a genital infection (penis or vagina);
• alcoholism, or if you currently drink large amounts of alcohol;
• high cholesterol or triglycerides;
• if you are on a low salt diet; or
• if you are 65 or older.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Ask your doctor about your risk.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

You should not use Trijardy XR during the second or third trimester of pregnancy.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

Do not breastfeed.

Not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction: hives, itching, flaking or peeling skin; trouble swallowing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have signs of a serious genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.

Stop taking empagliflozin, linagliptin, and metformin and call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• severe or ongoing pain in your joints;
• lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired;
• serious skin reaction--itching, blisters, breakdown of the outer layer of skin;
• ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting;
• dehydration--dizziness, confusion, feeling very thirsty, less urination;
• signs of a bladder infection--pain or burning when you urinate, blood in your urine, pain in pelvis or back; or
• symptoms of heart failure--shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Common side effects of empagliflozin, linagliptin, and metformin may include:

• stomach pain, diarrhea, constipation;
• a bladder infection;
• headache; or
• cold symptoms such as runny or stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Diabetes Type 2:

Individualize initial dose based on the patient's current regimen: -For patients on metformin, with or without linagliptin: Initiate with a similar metformin dose plus empagliflozin 10 mg and linagliptin 5 mg orally once a day-For patients on metformin and any regimen containing empagliflozin, with or without linagliptin: Initiate with a similar dose of metformin, the same empagliflozin dose, and linagliptin 5 mg orally once a day Monitor effectiveness and tolerability and adjust dose as appropriate not to exceed maximum doses -Maximum doses: Empagliflozin 25 mg/day; Linagliptin 5 mg/day; Metformin 2000 mg/dayComments:-When used in combination with insulin or an insulin secretagogue, a lower dose of insulin or insulin secretagogue should be considered to reduce the risk of hypoglycemia.-Correct volume depletion prior to beginning therapy.-This drug is not recommended in patients with type 1 diabetes mellitus; it may increase the risk of ketoacidosis in these patients. -This drug has not been studied in patients with a history of pancreatitis and therefore it is unknown if patients with a history of pancreatitis are at an increased risk for developing pancreatitis while using this drug. Uses: -As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. -Empagliflozin is indicated to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease.

Take the medicine as soon as you can, but if it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose may cause lactic acidosis. Symptoms may include unusual muscle pain, trouble breathing, irregular heartbeats, or feeling very weak.

Avoid drinking alcohol. It may increase your risk of lactic acidosis.

Other drugs may change how well empagliflozin, linagliptin, and metformin work to lower your blood sugar. Tell your doctor about all the medicines you are currently taking and any that you start or stop, especially:

• insulin, or other oral diabetes medicine;
• rifampin (to treat tuberculosis); or
• a diuretic or "water pill."

This list does not include everything. Other drugs may affect empagliflozin, linagliptin, and metformin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are included here.