Patient information: uses, side effects, how to take - Glyxambi

What is the most important information I should know about GLYXAMBI?

GLYXAMBI can cause serious side effects, including:

Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 and other ketoacidosis. GLYXAMBI can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who: are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood.
Stop taking GLYXAMBI and call your healthcare provider or get medical help right away if you get any of the following. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL:

nausea
vomiting
stomach-area (abdominal) pain

tiredness
trouble breathing
ketones in your urine or blood

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 GLYXAMBI, tell your healthcare provider 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 GLYXAMBI and call your healthcare provider 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.

Dehydration. GLYXAMBI 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 (orthostatic hypotension). There have been reports of sudden worsening of kidney function in people who are taking GLYXAMBI. You may be at higher risk of dehydration if you:
- take medicines to lower your blood pressure, including diuretics (water pills)
- are on a low sodium (salt) diet
- have kidney problems
- are 65 years of age or older
Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you are sick or you cannot eat, or start to lose liquids from your body, for example from vomiting, diarrhea or being in the sun too long.

What is GLYXAMBI?

GLYXAMBI is a prescription medicine that contains 2 diabetes medicines, empagliflozin (JARDIANCE) and linagliptin (TRADJENTA). GLYXAMBI can be used:

along with diet and exercise to lower blood sugar (glucose) 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 GLYXAMBI, is needed to reduce the risk of cardiovascular death.

GLYXAMBI is not for use to lower blood sugar (glucose) in people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in 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 GLYXAMBI.
GLYXAMBI is not for use to lower blood sugar (glucose) in people with type 2 diabetes who have severe kidney problems, because it may not work.
It is not known if GLYXAMBI is safe and effective in children.

Who should not take GLYXAMBI?

Do not take GLYXAMBI if you:

are allergic to linagliptin (TRADJENTA), empagliflozin (JARDIANCE) or any of the ingredients in GLYXAMBI. See the end of this Medication Guide for a complete list of ingredients in GLYXAMBI.
Symptoms of a serious allergic reaction to GLYXAMBI 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 GLYXAMBI and call your healthcare provider right away or go to the nearest hospital emergency room.

What should I tell my healthcare provider before taking GLYXAMBI?

Before taking GLYXAMBI, tell your healthcare provider about all of your medical conditions, including if you:

have type 1 diabetes or have had diabetic ketoacidosis.
have a decrease in your insulin dose.
have a serious infection.
have a history of infection of the vagina or penis.
have a history of amputation.
have kidney problems.
have liver problems.
have a history of urinary tract infections or problems with urination.
are on a low sodium (salt) diet. Your healthcare provider may change your diet or your dose.
are going to have surgery. Your healthcare provider may stop your GLYXAMBI before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking GLYXAMBI and when to start it again.
are eating less, or there is a change in your diet.
are dehydrated.
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).
have ever had an allergic reaction to GLYXAMBI.
are pregnant or plan to become pregnant. GLYXAMBI may harm your unborn baby. If you become pregnant while taking GLYXAMBI, tell your healthcare provider as soon as possible. Talk with your healthcare provider about the best way to control your blood sugar while you are pregnant.
are breastfeeding or plan to breastfeed. GLYXAMBI may pass into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you are taking GLYXAMBI. Do not breastfeed while taking GLYXAMBI.

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

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

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

How should I take GLYXAMBI?

Take GLYXAMBI exactly as your healthcare provider tells you to take it.
Take GLYXAMBI by mouth 1 time each day in the morning, with or without food.
Your healthcare provider will tell you how much GLYXAMBI to take and when to take it. Your healthcare provider may change your dose if needed.
Your healthcare provider may tell you to take GLYXAMBI along with other diabetes medicines. Low blood sugar can happen more often when GLYXAMBI is taken with certain other diabetes medicines. See "What are the possible side effects of GLYXAMBI?"
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take two doses of GLYXAMBI at the same time. Talk with your healthcare provider if you have questions about a missed dose.
If you take too much GLYXAMBI, call your healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away.
When taking GLYXAMBI, you may have sugar in your urine, which will show up on a urine test.
When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your healthcare provider right away if you have any of these conditions and follow your healthcare provider's instructions.
Your healthcare provider may do certain blood tests before you start GLYXAMBI and during treatment as needed.

What are the possible side effects of GLYXAMBI?

GLYXAMBI may cause serious side effects, including:

See "What is the most important information I should know about GLYXAMBI?"
Genital and urinary tract infections. Empagliflozin, one of the medicines in GLYXAMBI, can cause serious infections in your genital area or urinary tract that could require hospitalization. A rare but serious bacterial infection called necrotizing fasciitis can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum). This infection may require hospitalization, multiple surgeries, and could 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)

Also tell your healthcare provider if you have any of these signs or symptoms of urinary tract infections or yeast infections:

Urinary tract infection:
- burning feeling when you urinate
- need to urinate often or right away
- pain in the lower part of your stomach (pelvis)
- blood in your urine
You may also have a fever, back pain, nausea, or vomiting.
Vaginal yeast infection:
- vaginal odor
- white or yellowish vaginal discharge (may be lumpy or look like cottage cheese)
- vaginal itching
Yeast infection of the skin around the penis (balanitis or balanoposthitis): If you are uncircumcised, swelling may make it difficult to pull back the skin around the tip of your penis. Other symptoms include:

redness, itching, or swelling of the penis
bad smelling discharge from the penis

rash on the penis
pain in the skin around the penis

Talk to your healthcare provider about what to do if you get symptoms of a yeast infection. They may suggest you use an over-the-counter antifungal medicine. Contact your healthcare provider right away if your symptoms do not improve after using an over-the-counter antifungal medicine.

Low blood sugar (hypoglycemia). If you take GLYXAMBI 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 GLYXAMBI. Signs and symptoms of low blood sugar may include:

headache
drowsiness
weakness

irritability
hunger
fast heartbeat

confusion
shaking or feeling jittery

dizziness
sweating

Amputations. SGLT2 inhibitors may increase your risk of lower limb amputations.
You may be at a higher risk of lower limb amputation if you:
- have a history of amputation
- have had blocked or narrowed blood vessels, usually in your leg
- have had diabetic foot infection, ulcers or sores
Call your healthcare provider right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Talk to your healthcare provider about proper foot care.
Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking GLYXAMBI and call your healthcare provider right away or go to the nearest hospital emergency room. See "Who should not take GLYXAMBI?".
Joint pain. Some people who take linagliptin, one of the medicines in GLYXAMBI, may develop joint pain that can be severe. Call your healthcare provider if you have severe joint pain.
Skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the medicines in GLYXAMBI, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your healthcare provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your healthcare provider may tell you to stop taking GLYXAMBI.
Heart failure. Heart failure means your heart does not pump blood well enough.
Before you start taking GLYXAMBI, tell your healthcare provider if you have ever had heart failure or have problems with your kidneys. Contact your healthcare provider 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.

The most common side effects of GLYXAMBI include:

urinary tract infection
upper respiratory tract infection

stuffy or runny nose and sore throat

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of GLYXAMBI. 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.

How should I store GLYXAMBI?

Store GLYXAMBI at room temperature between 68°F to 77°F (20°C to 25°C).
Keep GLYXAMBI and all medicines out of the reach of children.

General information about the safe and effective use of GLYXAMBI.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use GLYXAMBI for a condition for which it was not prescribed. Do not give GLYXAMBI 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 about GLYXAMBI that is written for health professionals.

What are the ingredients in GLYXAMBI?

Active ingredients: empagliflozin and linagliptin

Inactive ingredients: copovidone, corn starch, crospovidone, magnesium stearate, mannitol, pregelatinized starch, and talc. The film coating contains the following inactive ingredients: hypromellose, mannitol, polyethylene glycol, talc, and titanium dioxide.

10 mg/5 mg tablets also contain ferric oxide yellow.

25 mg/5 mg tablets also contain ferric oxide red.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA

Licensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany

GLYXAMBI is a registered trademark of and used under license from Boehringer Ingelheim International GmbH.

Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the Jardiance^®, Tradjenta^®, EMPA-REG OUTCOME^®, CARMELINA^®, and CAROLINA^®trademarks under license.

The other brands listed are trademarks of their respective owners and are not trademarks of Boehringer Ingelheim Pharmaceuticals, Inc.

COL8994JA062026

For more information about GLYXAMBI, including current prescribing information and Medication Guide, go to www.glyxambi.com, scan the code, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

Glyxambi: Uses, Side Effects and Dosage