Trijardy XR

What is Trijardy XR?

Trijardy XR is a prescription medicine that contains 3 diabetes medicines, empagliflozin (Jardiance), linagliptin (Tradjenta), and metformin hydrochloride. Trijardy XR can be used:

• along with diet and exercise to lower blood sugar in adults with type 2 diabetes,
• in adults with type 2 diabetes who have known cardiovascular disease when empagliflozin (Jardiance), one of the medicines in Trijardy XR, is needed to reduce the risk of cardiovascular death.
• Trijardy XR is not for people with type 1 diabetes.
• Trijardy XR is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
• If you have had pancreatitis in the past, it is not known if you have a higher chance of getting pancreatitis while you take Trijardy XR.
• It is not known if Trijardy XR is safe and effective in children under 18 years of age.

What is the most important information I should know about Trijardy XR?

Trijardy XR can cause serious side effects, including:

1. Lactic Acidosis. Metformin hydrochloride, one of the medicines in Trijardy XR, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) 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 (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 Trijardy 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). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough 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.
• are 65 years of age or older.

Tell your doctor if you have any of the problems in the list above. Tell your doctor that you are taking Trijardy XR before you have surgery or x-ray tests. Your doctor may need to stop your Trijardy XR for a while if you have surgery or certain x-ray tests. Trijardy XR can have other serious side effects. See "What are the possible side effects of Trijardy XR?”

2. Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.

Before you start taking Trijardy XR, tell your doctor if you have ever had:

• inflammation of your pancreas (pancreatitis)
• a history of alcoholism
• stones in your gallbladder (gallstones)
• high blood 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 to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

3. Heart failure. 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
• unusual tiredness

These may be symptoms of heart failure.

Who should not take Trijardy XR?

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 (JARDIANCE), linagliptin (TRADJENTA), metformin, or any of the ingredients in Trijardy XR. See the end of this Medication Guide for a complete list of ingredients in Trijardy XR.
  Symptoms of a serious allergic reaction to Trijardy XR may include:
  • skin rash, itching, flaking or peeling
  • raised red patches on your skin (hives)
  • swelling of your face, lips, tongue and throat that may cause difficulty in breathing or swallowing
  • difficulty with swallowing or breathing

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.

What should I tell my healthcare provider before taking Trijardy XR?

Before taking Trijardy XR, tell your doctor about all of your medical conditions, including if you:

• have moderate to severe 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 Trijardy XR again. See "What is the most important information I should know about Trijardy XR?"
• have type 1 diabetes. Trijardy XR should not be used to treat 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. If you become pregnant while taking Trijardy XR, tell your doctor as soon as possible. Talk with your doctor about the best way to control your blood sugar while you are pregnant.
• are breastfeeding or plan to breastfeed. Trijardy XR may pass into your breast milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you are taking Trijardy XR. Do not breastfeed while taking Trijardy XR.
• are a woman 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 woman (ovulation).This can increase your chance of getting pregnant. Tell your doctor right away if you become pregnant while taking Trijardy XR.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Trijardy XR may affect the way other medicines work, and other medicines may affect how Trijardy XR works.

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

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Trijardy XR?

• Take Trijardy XR exactly as your doctor tells you to take it.
• Take Trijardy XR by mouth 1 time each day with a meal in the morning. Taking Trijardy XR with a meal may lower your chance of having an upset stomach.
• Swallow Trijardy XR tablets whole. Do not break, cut, crush, dissolve, or chew Trijardy XR. If you cannot swallow Trijardy XR tablets whole, tell your doctor.
• You may see something that looks like the Trijardy XR tablet in your stool (bowel movement). If you see tablets in your stool, talk to your doctor. Do not stop taking Trijardy XR without talking to your doctor.
• Your doctor may change your dose if needed.
• If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses of Trijardy XR at the same time.
• Your doctor may tell you to take Trijardy XR along with other diabetes medicines. Low blood sugar can happen more often when Trijardy XR is taken with certain other diabetes medicines. See "What are the possible side effects of Trijardy XR?"
• If you take too much Trijardy XR, call your doctor or local poison control center or go to the nearest hospital emergency room right away.
• Check your blood sugar as your doctor tells you to.
• Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with Trijardy XR.
• When taking Trijardy XR, you may have sugar in your urine, which will show up on a urine test.
• Your doctor may do certain blood tests before you start taking Trijardy XR and during treatment.

What should I avoid while taking Trijardy XR?

Avoid drinking alcohol very often or drinking a lot of alcohol in a short period of time ("binge" drinking). It can increase your chances of getting serious side effects.

What are the possible side effects of Trijardy XR?

Trijardy XR may cause serious side effects, including:

• See "What is the most important information I should know about Trijardy XR?"
• Dehydration. Dehydration may increase your risk of low blood pressure. Trijardy 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 (orthostatic hypotension).
  You may be at higher risk of dehydration if you:
  • have low blood pressure
  • have kidney problems
  • are 65 years of age or older
  • are on low sodium (salt) diet
  • take medicines to lower your blood pressure, including diuretics (water pills)
  Talk to your doctor about what you can do to prevent dehydration including how much fluid you should drink on a daily basis.
• Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with empagliflozin, one of the medicines in Trijardy XR. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with Trijardy XR. Ketoacidosis is a serious condition, which needs to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with Trijardy XR even if your blood sugar is less than 250 mg/dL. 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:
  • nausea
  • vomiting
  • stomach-area (abdominal) pain
  • tiredness
  • trouble breathing
  If you get any of these symptoms during treatment with Trijardy XR, if possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
• Kidney problems. Sudden kidney injury has happened to people taking Trijardy XR. Talk to your doctor right away if you:
  • reduce the amount of food or liquid you drink for example, if you are sick or cannot eat or
  • start to lose liquids from your body for example, from vomiting, diarrhea or being in the sun too long
• Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking empagliflozin, one of the medicines in Trijardy XR. Tell your doctor if you have any signs or symptoms of a urinary tract infection such as 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. 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 while you take Trijardy XR. Signs and symptoms of low blood sugar may include:
  • headache
  • drowsiness
  • weakness
  • irritability
  • hunger
  • fast heartbeat
  • confusion
  • shaking or feeling jittery
  • dizziness
  • sweating
• A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men who take empagliflozin, one of the medicines in Trijardy XR. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have a fever or you 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
  • redness of skin (erythema)
• Vaginal yeast infection. Women who take Trijardy XR may get vaginal yeast infections. Symptoms of a vaginal yeast infection include vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching.
• Yeast infection of the penis (balanitis). Men who take Trijardy XR may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of a yeast infection of the penis include redness, itching, or swelling of the penis, rash of the penis, foul smelling discharge from the penis, or pain in the skin around the penis.
  Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis. Your doctor may suggest you use an over-the-counter antifungal medicine. Talk to your doctor right away if you use an over-the-counter antifungal medication and your symptoms do not go away.
• Allergic (hypersensitivity) reactions. Serious allergic reactions have happened in people who are taking Trijardy XR. Symptoms may include:
  • swelling of your face, lips, throat, and other areas on your skin
  • difficulty with swallowing or breathing
  • 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 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 called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor may tell you to stop taking Trijardy XR.

The most common side effects of Trijardy XR include:

• upper respiratory tract infection
• urinary tract infection
• stuffy or runny nose and sore throat
• diarrhea
• constipation
• headache
• inflammation of the stomach and intestine (gastroenteritis)

Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Trijardy XR. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Trijardy XR

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Trijardy XR for a condition for which it was not prescribed. Do not give Trijardy XR to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or doctor for information about Trijardy XR that is written for health professionals.

How should I store Trijardy XR?

• Store Trijardy XR at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Trijardy XR tablets dry.

Keep Trijardy XR and all medicines out of the reach of children.

What are the ingredients in Trijardy XR?

Active ingredients: empagliflozin, linagliptin, and metformin hydrochloride

Inactive ingredients: Tablet core contains: polyethylene oxide, hypromellose, and magnesium stearate. The Film Coatings and Printing Ink contain: hydroxypropyl cellulose, hypromellose, talc, titanium dioxide, arginine, polyethylene glycol, carnauba wax, purified water, shellac glaze, n-butyl alcohol, propylene glycol, ammonium hydroxide, isopropyl alcohol, ferrosoferric oxide and ferric oxide yellow (5 mg/2.5 mg/1000 mg and 25 mg/5 mg/1000 mg), ferric oxide yellow and ferric oxide red (10 mg/5 mg/1000 mg), and ferrosoferric oxide and ferric oxide red (12.5 mg/2.5 mg /1000 mg).

For more information about Trijardy XR, including current prescribing information and Medication Guide, go to www.trijardyxr.com, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or (TTY) 1-800-459-9906.