Trijardy XR

• Risk factors: Age 65 or older | Kidney or liver problems | Dehydration | Low oxygen | Imaging using contrast dye | Fasting from food or fluids | Taking other medications that can cause lactic acidosis

Trijardy XR contains metformin. In rare cases, metformin can cause lactic acidosis. This happens when too much lactic acid builds up in your blood and can be life-threatening. If severe, it can lead to serious problems, like very low body temperature, low blood pressure, or a slow heart rate.

Watch for early signs of lactic acidosis. These include feeling unwell, feeling tired or weak, muscle pain, fast breathing, sleepiness, or confusion. Get emergency medical help if you suddenly have these symptoms.

• Risk factors: Sick with a fever | Eating much less than usual | Ketogenic (keto) diet | Dehydration | Problems with the pancreas | Alcohol use | Insulin dose reduction or missed insulin doses | Surgery

Some people taking Trijardy XR have had ketoacidosis. It's a serious condition when your body makes too many acids called ketones. This can make your blood too acidic, which can be very dangerous. Your risk might be higher if you get sick, eat much less than usual, or recently had surgery.

Watch for signs of ketoacidosis while taking Trijardy XR. Symptoms can include thirst, shortness of breath, dry mouth, and urinating more often. Other signs are fruity breath, stomach pain, nausea, vomiting, or feeling very tired. If this happens, check your ketone levels if possible and get medical help right away.

• Risk factors: History of pancreatitis | History of alcoholism | Kidney problems | Gallstones | High triglyceride (a type of fat) levels

Trijardy XR contains linagliptin. It's rare, but some people who took linagliptin have developed inflammation in their pancreas. This is called pancreatitis. It's not clear if having pancreatitis in the past can raise your risk that it can happen again during treatment. To be safe, tell your prescriber if you've had pancreatitis before.

Stop taking Trijardy XR and get medical help right away if you have severe stomach pain that doesn't go away, especially if it spreads to your back. You might also have nausea or vomiting. These can be signs of pancreatitis.

• Risk factors: Older adults | Kidney problems | Taking certain water pills called loop diuretics

Empagliflozin, which is in Trijardy XR, can cause your body to lose too much fluid. This can lead to dehydration or very low blood pressure in some people. Low fluid levels can also lower blood flow to the kidneys and might cause kidney injury.

You might be at risk if you're 65 years or older or if you already have kidney problems. The risk can also be higher if you take certain water pills, like furosemide (Lasix).

If you're at risk, your prescriber will check your kidneys with blood tests before you start Trijardy XR. They might also check during treatment to make sure the medication is still safe for you.

Tell your care team if you feel dizzy, lightheaded, or confused while taking Trijardy XR. These can be signs of dehydration or low blood pressure. Also let them know if you're urinating less than usual or have darker urine. These could also be signs of dehydration or a kidney problem.

• Risk factors: History of urinary tract infections (UTIs) | History of genital yeast infections

Trijardy XR can raise your risk of genital infections, like yeast infections. It can also raise your risk of urinary tract infections (UTIs). Some can end up affecting the kidneys. In rare cases, these infections can become very serious and might need hospital treatment. Your risk of genital infections and UTIs can be higher if you have these infections often.

Get urgent care right away if you have a fever, it burns when you urinate, you need to urinate often, or you see blood in your urine. These can be signs of a UTI. Also get medical care if you notice an odor from your genitals or have pain, redness, swelling, or itching around your genitals. These can be signs of a genital yeast infection. It's important to get it checked out so you can get treated for any infections quickly.

Taking Trijardy XR with insulin or sulfonylureas, like glipizide, can put you at risk of low blood sugar. Very low blood sugar can be dangerous and even life-threatening.

Be sure you can recognize symptoms of low blood sugar. This can include feeling shaky, anxious, confused, sleepy, weak, or very hungry. You might also have a fast heartbeat, be sweaty, or have chills.

If you have these symptoms, check your blood sugar and treat any low blood sugar right away. Talk to your prescriber or pharmacist about your risk for low blood sugar.

• Risk factors: History of amputations | Peripheral artery disease (narrowed blood vessels) | Diabetic foot ulcers

Trijardy XR has empagliflozin in it. During studies, some people who took empagliflozin needed foot or leg amputations. The risk was higher for those with blood circulation problems or diabetes. In studies, the most common reasons for amputations were peripheral artery disease and diabetic foot ulcers.

Tell a healthcare professional right away if you have any new pain, tenderness, sores, ulcers, or infections on your legs or feet. Your care team can talk to you about ways to manage these problems or treat them before they get worse. If you have diabetes, make sure to have regular foot exams with your diabetes care team.

• Risk factors: Low vitamin B12 intake or absorption | Low calcium intake or absorption

Trijardy XR contains metformin, which can sometimes lower your vitamin B12 levels. Low vitamin B12 levels might lead to anemia.

Your prescriber might check your vitamin B12 levels and blood cell counts while you're taking Trijardy XR. If your vitamin B12 is low, they might recommend a vitamin B12 supplement or switch you to a different medication. This usually helps your vitamin B12 return to normal.

In rare cases, Trijardy XR can cause serious allergic reactions. This can include severe swelling and anaphylaxis. These reactions often happen within the first 3 months of treatment. Watch for a rash; trouble breathing; or swelling of your face, lips, tongue, or throat. If a serious allergic reaction happens, get medical help right away.

Tell your prescriber if you've ever had an allergic reaction to another DPP-4 inhibitor (also called a "gliptin"), such as Januvia (sitagliptin). Trijardy XR contains a similar medication, so you might have a similar reaction.

Trijardy XR contains linagliptin. In rare cases, some people taking linagliptin have developed a skin problem called bullous pemphigoid. It can cause itchy, skin, blistering rash, or sores. These usually go away once you stop taking the medication and get treatment. Other times, linagliptin has caused severe skin reactions that might peel.

If you notice a rash with blisters, itchy skin, or peeling skin, get medical help right away. You might need to stop taking Trijardy XR , see a dermatologist, and get medical care.

Some people who took linagliptin, which is in Trijardy XR, have developed severe joint pain. This can happen anytime from a day to many years after starting the medication. For most people, the pain got better after they stopped the medication. Let your prescriber know if you feel any unusual or severe discomfort in your joints while taking Trijardy XR.

• Risk factors: Heart failure | Heart problems | Kidney problems

Trijardy XR contains linagliptin. It's not known if linagliptin has a risk of heart failure. But some similar medications have been linked to heart failure in people with Type 2 diabetes and heart disease.

Before starting Trijardy XR, let your prescriber know if you have a history of heart failure or kidney problems. They can help weigh the risk of heart failure and benefits of the medication.

Tell your care team right away if you have any signs of heart failure. This can include trouble breathing, unusual tiredness, swelling in your legs or feet, or sudden weight gain. Depending on your symptoms, your prescriber might tell you to stop Glyxambi Trijardy XR and get medical care.