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Text Content

 * Prescribing Information
 * Medication Guide
 * Important Safety Information
 * For Healthcare Professionals

Trijardy®XR
$10 co-pay offer

 * Home
 * Taking TRIJARDY XR
 * Managing Your Diabetes
 * Support & Savings


JOIN MY TRIJARDY XR SUPPORT

You’ll receive valuable information and resources to support you on your journey
with TRIJARDY XR. And by signing up for a TRIJARDY XR Savings Card, your co-pay
could be as little as $10* a month for a 1- to 3-month prescription.


LET’S GET STARTED

Check the boxes that apply to you to start enrollment.

I’d like to enroll in My TRIJARDY XR Support I’d like to sign up for or activate
an existing TRIJARDY XR Savings Card
Get started

*TRIJARDY XR Savings Card Terms & Conditions apply

NOTE: To enroll in My TRIJARDY XR Support, you must be 18 years or older and
live in the 50 United States, DC, or Puerto Rico.


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, and 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. It may increase their risk
of diabetic ketoacidosis (increased ketones in the blood or urine).

If you have had pancreatitis (inflammation of the pancreas) in the past, it is
not known if you have a higher chance of getting pancreatitis while you take
TRIJARDY XR.


IMPORTANT SAFETY INFORMATION

Serious side effects can happen in people taking TRIJARDY XR, including:

Lactic acidosis (a buildup of lactic acid in the blood). Metformin
hydrochloride, one of the medicines in TRIJARDY XR, can cause lactic acidosis, a
rare but serious condition 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 muscle pain, have trouble
breathing, have stomach or intestinal problems with nausea and vomiting, or
diarrhea, feel sleepy or sleep longer than usual, feel cold in your arms and
legs, feel dizzy or lightheaded, or 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 alcohol
(very often or short term “binge” drinking); get dehydrated (lose a large amount
of body fluids); have x-ray tests that use injectable dye; have surgery; have
congestive heart failure; have a heart attack, severe infection, or stroke, or
are 65 years of age or older.

Inflammation of the pancreas (pancreatitis) is another serious side effect that
can happen to people taking TRIJARDY XR. Pancreatitis may be severe and lead to
death. Before you start taking TRIJARDY XR tell your doctor if you have ever had
pancreatitis, a history of alcoholism, gallstones, or high 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 through to your back. The pain may happen with or
without vomiting. These may be symptoms of pancreatitis.

Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a
serious condition which needs to be treated in the hospital. Ketoacidosis may
lead to death. Ketoacidosis occurs in people with type 1 diabetes and can also
occur in people with type 2 diabetes taking TRIJARDY XR, even if blood sugar is
less than 250 mg/dL. Ketoacidosis has also happened in people with diabetes who
were sick or who had surgery during treatment with TRIJARDY XR.
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, and, if
possible, check for ketones in your urine:

 * nausea
 * vomiting
 * stomach-area (abdominal) pain
 * tiredness
 * trouble breathing

Dehydration. TRIJARDY XR 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. You may be at higher risk
of dehydration if you have kidney problems, are 65 years of age or older, are on
a low salt diet, or take medicines to lower your blood pressure, including water
pills (diuretics). Talk to your doctor about what you can do to prevent
dehydration.

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, linagliptin, metformin, or any of the
   ingredients in TRIJARDY XR

TRIJARDY XR may cause serious side effects, including:

Serious urinary tract infections. Serious urinary tract infections can occur in
people taking empagliflozin, one of the medicines in TRIJARDY XR and may lead to
hospitalization. Tell your doctor if you have symptoms of a urinary tract
infection, such as a burning feeling when passing urine, a need to urinate often
or right away, pain in the lower part of your stomach or 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. Symptoms of low blood sugar may include
headache, drowsiness, weakness, irritability, hunger, fast heartbeat, confusion,
shaking or feeling jittery, dizziness, or sweating.

Necrotizing fasciitis. A rare but serious bacterial infection that causes damage
to the tissue under the skin in the area between and around your anus and
genitals (perineum). This bacterial infection has happened in women and men who
take empagliflozin, one of the medications in TRIJARDY XR, and may lead to
hospitalization, multiple surgeries, and death. Seek medical attention
immediately if you have fever or 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, and redness of skin
(erythema).

Vaginal yeast infection. Talk to your doctor if you have vaginal odor, white or
yellowish vaginal discharge (discharge may be lumpy or look like cottage
cheese), and/or vaginal itching.

Yeast infection of the penis. Swelling of an uncircumcised penis may develop
that makes it difficult to pull back the skin around the tip of the penis. Talk
to your doctor if you have redness, itching or swelling of the penis, foul
smelling discharge from the penis, rash of the penis or pain in the skin around
the penis.

Allergic (hypersensitivity) reactions. Symptoms of serious allergic reactions to
TRIJARDY XR may include swelling of your face, lips, tongue, throat, and other
areas of 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 dipeptidyl peptidase-4 (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. Tell your doctor
right away if you develop blisters.

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 or unusual
tiredness. These may be symptoms of heart failure.

The most common side effects of TRIJARDY XR include upper respiratory tract
infection, urinary tract infections, stuffy or runny nose and sore throat,
diarrhea, constipation, headache, inflammation of the stomach and intestine
(gastroenteritis).

These are not all the possible side effects of TRIJARDY XR. For more
information, ask your doctor or pharmacist.

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

 * have 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 it
   again
 * have type 1 diabetes. TRIJARDY XR should not be used in 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. Tell your doctor right away if you become pregnant while taking
   TRIJARDY XR
 * are breastfeeding or plan to breastfeed. TRIJARDY XR may pass into your
   breast milk and may harm your baby. Do not breastfeed while taking
   TRIJARDY XR
 * are a person 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 person. This can increase your chance of getting pregnant.

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

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

You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

CL-TRI-100034 06.15.2021

Please see Prescribing Information and Medication Guide for 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, and 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. It may increase their risk
of diabetic ketoacidosis (increased ketones in the blood or urine).

If you have had pancreatitis (inflammation of the pancreas) in the past, it is
not known if you have a higher chance of getting pancreatitis while you take
TRIJARDY XR.


IMPORTANT SAFETY INFORMATION

Serious side effects can happen in people taking TRIJARDY XR, including:

Lactic acidosis (a buildup of lactic acid in the blood). Metformin
hydrochloride, one of the medicines in TRIJARDY XR, can cause lactic acidosis, a
rare but serious condition 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 muscle pain, have trouble
breathing, have stomach or intestinal problems with nausea and vomiting, or
diarrhea, feel sleepy or sleep longer than usual, feel cold in your arms and
legs, feel dizzy or lightheaded, or 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 alcohol
(very often or short term “binge” drinking); get dehydrated (lose a large amount
of body fluids); have x-ray tests that use injectable dye; have surgery; have
congestive heart failure; have a heart attack, severe infection, or stroke, or
are 65 years of age or older.

Inflammation of the pancreas (pancreatitis) is another serious side effect that
can happen to people taking TRIJARDY XR. Pancreatitis may be severe and lead to
death. Before you start taking TRIJARDY XR tell your doctor if you have ever had
pancreatitis, a history of alcoholism, gallstones, or high 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 through to your back. The pain may happen with or
without vomiting. These may be symptoms of pancreatitis.

Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a
serious condition which needs to be treated in the hospital. Ketoacidosis may
lead to death. Ketoacidosis occurs in people with type 1 diabetes and can also
occur in people with type 2 diabetes taking TRIJARDY XR, even if blood sugar is
less than 250 mg/dL. Ketoacidosis has also happened in people with diabetes who
were sick or who had surgery during treatment with TRIJARDY XR.
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, and, if
possible, check for ketones in your urine:

 * nausea
 * vomiting
 * stomach-area (abdominal) pain
 * tiredness
 * trouble breathing

Dehydration. TRIJARDY XR 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. You may be at higher risk
of dehydration if you have kidney problems, are 65 years of age or older, are on
a low salt diet, or take medicines to lower your blood pressure, including water
pills (diuretics). Talk to your doctor about what you can do to prevent
dehydration.

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, linagliptin, metformin, or any of the
   ingredients in TRIJARDY XR

TRIJARDY XR may cause serious side effects, including:

Serious urinary tract infections. Serious urinary tract infections can occur in
people taking empagliflozin, one of the medicines in TRIJARDY XR and may lead to
hospitalization. Tell your doctor if you have symptoms of a urinary tract
infection, such as a burning feeling when passing urine, a need to urinate often
or right away, pain in the lower part of your stomach or 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. Symptoms of low blood sugar may include
headache, drowsiness, weakness, irritability, hunger, fast heartbeat, confusion,
shaking or feeling jittery, dizziness, or sweating.

Necrotizing fasciitis. A rare but serious bacterial infection that causes damage
to the tissue under the skin in the area between and around your anus and
genitals (perineum). This bacterial infection has happened in women and men who
take empagliflozin, one of the medications in TRIJARDY XR, and may lead to
hospitalization, multiple surgeries, and death. Seek medical attention
immediately if you have fever or 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, and redness of skin
(erythema).

Vaginal yeast infection. Talk to your doctor if you have vaginal odor, white or
yellowish vaginal discharge (discharge may be lumpy or look like cottage
cheese), and/or vaginal itching.

Yeast infection of the penis. Swelling of an uncircumcised penis may develop
that makes it difficult to pull back the skin around the tip of the penis. Talk
to your doctor if you have redness, itching or swelling of the penis, foul
smelling discharge from the penis, rash of the penis or pain in the skin around
the penis.

Allergic (hypersensitivity) reactions. Symptoms of serious allergic reactions to
TRIJARDY XR may include swelling of your face, lips, tongue, throat, and other
areas of 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 dipeptidyl peptidase-4 (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. Tell your doctor
right away if you develop blisters.

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 or unusual
tiredness. These may be symptoms of heart failure.

The most common side effects of TRIJARDY XR include upper respiratory tract
infection, urinary tract infections, stuffy or runny nose and sore throat,
diarrhea, constipation, headache, inflammation of the stomach and intestine
(gastroenteritis).

These are not all the possible side effects of TRIJARDY XR. For more
information, ask your doctor or pharmacist.

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

 * have 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 it
   again
 * have type 1 diabetes. TRIJARDY XR should not be used in 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. Tell your doctor right away if you become pregnant while taking
   TRIJARDY XR
 * are breastfeeding or plan to breastfeed. TRIJARDY XR may pass into your
   breast milk and may harm your baby. Do not breastfeed while taking
   TRIJARDY XR
 * are a person 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 person. This can increase your chance of getting pregnant.

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

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

You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

CL-TRI-100034 06.15.2021

Please see Prescribing Information and Medication Guide for TRIJARDY XR.


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