What is the most important information I should
know about GLYXAMBI?
Serious side effects can happen to
people taking GLYXAMBI,
including:
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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 doctor if you have ever had:
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- inflammation of your pancreas (pancreatitis)
- a history of alcoholism
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- stones in your gallbladder (gallstones)
- high blood triglyceride levels
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Stop taking GLYXAMBI
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.
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Heart failure. Heart failure means your heart
does not pump blood well enough.
Before you start
taking GLYXAMBI, 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.
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Dehydration. GLYXAMBI 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:
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- have low blood pressure
- are on low sodium (salt) diet
- are 65 years of age or older
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- take medicines to lower your blood pressure, including diuretics
(water pills)
- have kidney problems
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Vaginal yeast infection. Women who take GLYXAMBI
may get vaginal yeast infections. Symptoms of a vaginal yeast infection
include:
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- vaginal odor
- vaginal itching
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- white or yellowish vaginal discharge (discharge may be lumpy
or look like cottage cheese)
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Yeast infection of the penis (balanitis or balanoposthitis). Men who take GLYXAMBI may get a yeast infection of the skin around
the penis. 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 yeast infection of the penis include:
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- redness, itching, or swelling of the penis
- foul smelling discharge from the penis
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- rash of the penis
- pain in the skin around penis
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Talk to your doctor
about what to do if you get symptoms of a yeast infection of the vagina
or penis. Your doctor may tell you to use an over-the-counter antifungal
medicine. Talk to your doctor right away if you use an over-the-counter
antifungal medicine and your symptoms do not go away. |
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 in adults
with type 2 diabetes,
- in adults with type 2 diabetes who have known cardiovascular
disease when both empagliflozin (JARDIANCE) and linagliptin (TRADJENTA)
is appropriate and empagliflozin (JARDIANCE) is needed to reduce the
risk of cardiovascular death.
- GLYXAMBI is not for people with type 1 diabetes.
- GLYXAMBI 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
GLYXAMBI.
It is not known if GLYXAMBI is safe and effective in children
under 18 years of age.
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Who should
not take GLYXAMBI?
Do not take GLYXAMBI if you:
- have severe kidney problems or are on dialysis
- 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 tell your doctor
or go to the nearest hospital emergency room right away.
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What should
I tell my doctor before taking GLYXAMBI?
Before you take
GLYXAMBI, tell your doctor about all of your medical conditions, including
if you:
- have kidney problems
- have liver problems
- 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
- are eating less due to illness, surgery, or 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 pregnant or plan to become pregnant. GLYXAMBI may harm
your unborn baby. If you become pregnant while taking GLYXAMBI, 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. GLYXAMBI 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 GLYXAMBI. Do
not breastfeed while taking GLYXAMBI.
Tell your doctor 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.
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.
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How should
I take GLYXAMBI?
- Take GLYXAMBI exactly as your doctor tells you to take it.
- Take GLYXAMBI 1 time each day in the morning, with or without
food.
- 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 GLYXAMBI at the same time.
- Your doctor 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 take too much GLYXAMBI, call your doctor or local
poison control center or go to the nearest hospital emergency room
right away.
- 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 that you need may change. Tell your doctor right
away if you have any of these conditions and follow your doctor's
instructions.
- Check your blood sugar as your doctor tells you to.
- Stay on your prescribed diet and exercise program while
taking GLYXAMBI.
- Talk to your doctor about how to prevent, recognize and
manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia),
and complications of diabetes.
- Your doctor will check your diabetes with regular blood
tests, including your blood sugar levels and your hemoglobin A1C.
- When taking GLYXAMBI, you may have sugar in your urine,
which will show up on a urine test.
- Your doctor will do blood tests to check how well your kidneys
are working before and during your treatment with GLYXAMBI.
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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?"
-
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 GLYXAMBI. Ketoacidosis is a serious condition,
which may need to be treated in a hospital. Ketoacidosis may lead
to death.
Ketoacidosis can happen with GLYXAMBI even if your
blood sugar is less than 250 mg/dL. Stop taking GLYXAMBI and call
your doctor right away if you get any of the following symptoms:
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- nausea
- vomiting
- stomach-area (abdominal) pain
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- tiredness
- trouble breathing
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| If you get any of these
symptoms during treatment with GLYXAMBI, if possible, check for ketones
in your urine, even if your blood sugar is less than 250 mg/dL
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Kidney problems. Sudden kidney injury has happened
to people taking GLYXAMBI. 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
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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 GLYXAMBI.
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.
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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:
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- headache
- drowsiness
- weakness
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- irritability
- hunger
- fast heartbeat
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- confusion
- shaking or feeling jittery
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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 GLYXAMBI. 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:
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- redness of skin (erythema)
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Allergic (hypersensitivity) reactions. Serious
allergic reactions have happened in people who are taking GLYXAMBI.
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 these symptoms, stop taking GLYXAMBI and tell your
doctor or go to the nearest hospital emergency room right away.
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Increased fats in your blood (cholesterol)
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Joint pain. Some people who take medicines
called DPP-4 inhibitors, one of the medicines in GLYXAMBI, may develop
joint pain that can be severe. Call your doctor if you have severe
joint pain.
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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 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 GLYXAMBI.
The most common side effects of GLYXAMBI include: |
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- stuffy or runny nose and sore throat
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- upper respiratory tract infection
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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 GLYXAMBI. 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.
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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.
This Medication Guide summarizes the most important information
about GLYXAMBI. If you would like more information, talk with your
doctor. You can ask your pharmacist or doctor for information about
GLYXAMBI that is written for health professionals.
For
more information about GLYXAMBI including current prescribing information
and Medication Guide, go to www.glyxambi.com, or scan the code below,
or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257
or (TTY) 1-800-459-9906.
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What are
the ingredients in GLYXAMBI?
Active ingredients: empagliflozin and linagliptin
Inactive ingredients: mannitol, pregelatinized starch, corn starch, copovidone, crospovidone,
talc and magnesium stearate. The film coating contains the following
inactive ingredients: hypromellose, mannitol, talc, titanium dioxide,
polyethylene glycol.
10 mg/5 mg tablets also contain yellow
ferric oxide.
25 mg/5 mg tablets also contain red ferric
oxide.
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Distributed by: Boehringer Ingelheim Pharmaceuticals,
Inc. Ridgefield, CT 06877 USA
Marketed by: Boehringer Ingelheim Pharmaceuticals,
Inc. Ridgefield, CT 06877 USA and Eli Lilly and Company, Indianapolis,
IN 46285 USA
Licensed from: Boehringer Ingelheim International
GmbH, Ingelheim, Germany
Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the
Glyxambi®, Jardiance®, Tradjenta®, EMPA-REG OUTCOME®, and CARMELINA®
trademarks under license.
The other trademarks referenced are owned by third parties not affiliated
with Boehringer Ingelheim Pharmaceuticals, Inc.
Copyright © 2019 Boehringer Ingelheim International
GmbH
ALL RIGHTS RESERVED
IT5885NG102019
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