Empagliflozin, linagliptin, and metformin

Generic name: empagliflozin, linagliptin, and metformin [ EM-pa-gli-FLOE-zin, LIN-a-GLIP-tin, and-met-FOR-min ]
Brand name: Trijardy XR
Dosage form: oral tablet, extended release (10 mg-5 mg-1000 mg; 12.5 mg-2.5 mg-1000 mg; 25 mg-5 mg-1000 mg; 5 mg-2.5 mg-1000 mg)
Drug class: Antidiabetic combinations

Medically reviewed by Drugs.com on Oct 7, 2021. Written by Cerner Multum.

What is empagliflozin, linagliptin, and metformin (Trijardy XR)?

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

Trijardy XR is also used to lower 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 purposes not listed in this medication guide.

Warnings

Stop taking empagliflozin, linagliptin, and metformin and call your doctor at once if you have signs of a serious side effect, such as severe stomach pain (may spread to your back), vomiting, tiredness, or trouble breathing.

Tell your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

Get 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 don''t feel well.

Before taking this medicine

You should not use this medicine 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.

How should I take Trijardy XR?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally 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 the 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.

empagliflozin, linagliptin, and metformin 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.

What happens if I miss a dose?

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

What happens if I overdose?

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 if you feel very weak.

What should I avoid while taking Trijardy XR?

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

Trijardy XR side effects

Get emergency medical help if you have signs of an allergic reaction: hives, itching, flaking or peeling skin; trouble swallowing, difficult 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.

Empagliflozin, linagliptin, and metformin dosing information

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/day

Comments:
-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.

What other drugs will affect Trijardy XR?

Other drugs may increase or decrease the effects of empagliflozin, linagliptin, and metformin on lowering your blood sugar. Tell your doctor about all your current medicines and any you start or stop using, especially:

• insulin, or other oral diabetes medicine;

• rifampin (to treat tuberculosis); or

• a diuretic or "water pill."

This list is not complete. 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 listed here.

Where can I get more information?

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2023 Cerner Multum, Inc. Version: 2.01.

Generic name: pegcetacoplan
Dosage form: injection, for subcutaneous use
Drug class: Selective immunosuppressants

Medically reviewed by Judith Stewart, BPharm. Last updated on Sep 1, 2021.

What is Empaveli?

Empaveli is a prescription medicine used to treat adults with a disease called paroxysmal nocturnal hemoglobinuria (PNH).

It is not known if Empaveli is safe and effective in children.

Important information

Empaveli is a medicine that can affect your immune system. Empaveli can lower the ability of your immune system to fight infections.

• Empaveli may increase your chance of getting serious and life-threatening meningococcal infections.
• Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early.
• Empaveli may also increase the risk of getting serious infections. People who take Empaveli may have an increased risk of getting infections caused by Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Serious infections may quickly become life threatening and cause death if not recognized and treated early.
• You must be vaccinated against these bacteria at least 2 weeks before your first dose if you have not already had these vaccines.
• If your healthcare provider decides that urgent treatment with Empaveli is needed, you should receive the required vaccinations as soon as possible.
• If you have not been vaccinated and Empaveli therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
• If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting treatment. Your healthcare provider will decide if you need additional vaccinations.
• Vaccines reduce the risk of serious infections, but do not prevent all serious infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious infection:
  • fever with or without shivers or the chills
  • fever and a rash
  • shortness of breath
  • extreme pain or discomfort
  • headache with nausea or vomiting
  • high heart rate
  • headache and a fever
  • headache with a stiff neck or stiff back
  • confusion
  • muscle aches with flu-like symptoms
  • eyes sensitive to light
  • clammy skin

Your healthcare provider will give you a Patient Safety Card about the risk of serious infections. Carry it with you at all times during treatment and for 2 months after your last dose. Your risk of serious infections may continue for several weeks after your last dose. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.

Empaveli is only available through a program called the Empaveli REMS. Before you can take Empaveli, your healthcare provider must:

• enroll in the Empaveli REMS program.
• counsel you about the risk of serious infections caused by certain bacteria.
• give you information about the symptoms of serious infections.
• give you a Patient Safety Card about your risk of serious infections, as discussed above.
• make sure that you are vaccinated.

Who should not take Empaveli?

Do not take Empaveli if you:

• are allergic to pegcetacoplan or any of the other ingredients. See the end of this Medication Guide for a complete list of ingredients.
• have not been vaccinated against Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B, unless your healthcare provider decides that urgent treatment with Empaveli is needed. See Important information.
• have a serious Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type B infection.

Before taking Empaveli

Before you take Empaveli, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection or fever.
• are pregnant or plan to become pregnant. Empaveli may harm your unborn baby. Females who are able to become pregnant should have a pregnancy test before starting treatment.
  • Females who are able to become pregnant should use an effective method of birth control (contraception) during treatment, and for 40 days after the final dose.
• are breastfeeding or plan to breastfeed. It is not known if Empaveli passes into your breast milk. You should not breastfeed during treatment, and for 40 days after the final dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Empaveli and other medicines can affect each other, causing side effects.

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

How should I take Empaveli?

• See the detailed Instructions for Use that comes with your prescription for information about how to prepare and infuse your dose of Empaveli.
• Your healthcare provider should show you how to prepare and infuse Empaveli before you use it for the first time.
• Use this medicine exactly as your healthcare provider tells you. Your healthcare provider will tell you how much to infuse and how often. Do not infuse more or less than your healthcare provider tells you to.
• Empaveli is given by infusion under the skin (subcutaneously) into your stomach (abdomen), back of upper arms, hips, or thighs using an infusion pump.
• Empaveli is given by an infusion 2 times each week. If there is an increase in your LDH, an enzyme in your blood, your healthcare provider may tell you to take Empaveli every 3 days.
• If you are changing treatment from eculizumab to Empaveli, you should continue eculizumab for 4 weeks after your first dose of Empaveli. After 4 weeks, you should stop treatment with eculizumab.
• If you are changing treatment from ravulizumab to Empaveli, you should take your starting dose of Empaveli no more than 4 weeks after your last dose of ravulizumab.
• If you have PNH and you stop taking Empaveli, your healthcare provider will need to monitor you closely for at least 8 weeks after stopping Empaveli. Stopping treatment may cause a breakdown of red blood cells due to PNH.
  Symptoms or problems that can happen due to red blood cell breakdown include:
  • decreased hemoglobin level in your blood
  • blood in your urine
  • shortness of breath
  • trouble swallowing
  • tiredness
  • pain in the stomach (abdomen)
  • blood clots
  • erectile dysfunction (ED)

If you miss a dose, take the missed dose as soon as possible. Take your next dose at your regularly scheduled time.

Empaveli side effects

Empaveli can cause serious side effects including:

• See Important information
• Allergic reactions. Allergic reactions can happen during your Empaveli infusion. Stop your infusion and tell your healthcare provider or get emergency medical care right away if you get any of these symptoms during your infusion:
  • chest pain
  • trouble breathing or shortness of breath
  • swelling of your face, tongue, or throat
  • feel faint or pass out

The most common side effects in people with PNH treated with Empaveli include injection-site reactions, infections, diarrhea, pain in the stomach (abdomen), respiratory tract infection, viral infection, and tiredness.

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

What other drugs will affect Empaveli?

Other drugs may interact with pegcetacoplan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

How should I store Empaveli?

• Store vials in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
• Do not use past the expiration date stamped on the carton.

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Empaveli

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information that is written for health professionals.

What are the ingredients in Empaveli?

Active ingredient: pegcetacoplan
Inactive ingredients: sorbitol, glacial acetic acid, sodium acetate trihydrate, Water for Injection USP. Empaveli may also contain sodium hydroxide and/or additional glacial acetic acid for pH adjustment.

Popular FAQ

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer