TRIJARDY XR- empagliflozin, linagliptin, metformin hydrochloride tablet, extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

EMPAGLIFLOZIN (UNII: HDC1R2M35U) (EMPAGLIFLOZIN - UNII:HDC1R2M35U), LINAGLIPTIN (UNII: 3X29ZEJ4R2) (LINAGLIPTIN - UNII:3X29ZEJ4R2), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Prieinama:

Boehringer Ingelheim Pharmaceuticals, Inc.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

TRIJARDY XR is a combination of empagliflozin, linagliptin, and metformin hydrochloride (HCl) indicated 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 death in adults with type 2 diabetes mellitus and established cardiovascular disease [see Clinical Studies (14.2)] . Limitations of Use TRIJARDY XR is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.2)] . TRIJARDY XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using TRIJARDY XR [see Warnings and Precautions (5.3)]. TRIJARDY XR is contraindicated in patients with: - severe renal impairment (eGFR less than 30 mL/min/1.73 m2 ), end-stage renal disease,

Produkto santrauka:

TRIJARDY XR tablets are available as follows: Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from exposure to high humidity.

Autorizacija statusas:

New Drug Application

Pakuotės lapelis

Boehringer Ingelheim Pharmaceuticals, Inc.
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MEDICATION GUIDE
TRIJARDY® XR (TRY-JAR-DEE XR)
(EMPAGLIFLOZIN, LINAGLIPTIN, AND METFORMIN HYDROCHLORIDE
EXTENDED-RELEASE TABLETS)
FOR ORAL USE
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: October 2023
What is the most important information I should know about TRIJARDY
XR?
TRIJARDY XR can cause serious side effects, including:
1.
Lactic Acidosis. Metformin hydrochloride (HCl), one of the medicines
in TRIJARDY XR, can
cause a rare but serious condition called lactic acidosis (a build-up
of lactic acid in the blood) that
can cause death. Lactic acidosis is a medical emergency and must be
treated in a hospital.
Stop taking TRIJARDY XR and call your healthcare provider 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 (not normal) muscle pain
•
have trouble breathing
•
have unexplained stomach or intestinal
problems with nausea and vomiting, or
diarrhea
•
have unusual sleepiness or sleep longer
than usual
•
feel cold, especially in your arms and
legs
•
feel dizzy or lightheaded
•
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 a lot of alcohol (very often or short-term "binge" drinking).
•
get dehydrated (lose a large amount of body fluids). This can happen
if you are sick with a
fever, vomiting, or diarrhea. Dehydration can also happen when you
sweat a lot with activity or
exercise and do not drink enough fluids.
•
have certain x-ray tests with injectable dyes or contrast agents.
•
have surgery or other procedure for which you need to restrict the
amount of food and liquid
you eat and drink.
•
have congestive heart failure.
•
have a heart attack, severe infection, or stroke.
•
are 65 years of age or older.
Tell your healthcare provider if you

Prekės savybės

TRIJARDY XR- EMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDE
TABLET,
EXTENDED RELEASE
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRIJARDY XR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRIJARDY XR.
TRIJARDY XR (EMPAGLIFLOZIN, LINAGLIPTIN, AND METFORMIN HYDROCHLORIDE
EXTENDED-RELEASE
TABLETS), FOR ORAL USE
INITIAL U.S. APPROVAL: 2020
WARNING: LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
POSTMARKETING CASES OF METFORMIN-ASSOCIATED LACTIC ACIDOSIS HAVE
RESULTED IN DEATH,
HYPOTHERMIA, HYPOTENSION, AND RESISTANT BRADYARRHYTHMIAS. SYMPTOMS
INCLUDED
MALAISE, MYALGIAS, RESPIRATORY DISTRESS, SOMNOLENCE, AND ABDOMINAL
PAIN.
LABORATORY ABNORMALITIES INCLUDED ELEVATED BLOOD LACTATE LEVELS, ANION
GAP ACIDOSIS,
INCREASED LACTATE/PYRUVATE RATIO; AND METFORMIN PLASMA LEVELS
GENERALLY >5 MCG/ML.
(5.1)
RISK FACTORS INCLUDE RENAL IMPAIRMENT, CONCOMITANT USE OF CERTAIN
DRUGS, AGE ≥65
YEARS OLD, RADIOLOGICAL STUDIES WITH CONTRAST, SURGERY AND OTHER
PROCEDURES, HYPOXIC
STATES, EXCESSIVE ALCOHOL INTAKE, AND HEPATIC IMPAIRMENT. STEPS TO
REDUCE THE RISK
OF AND MANAGE METFORMIN-ASSOCIATED LACTIC ACIDOSIS IN THESE HIGH RISK
GROUPS ARE
PROVIDED IN THE FULL PRESCRIBING INFORMATION. (5.1)
IF LACTIC ACIDOSIS IS SUSPECTED, DISCONTINUE TRIJARDY XR AND INSTITUTE
GENERAL
SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS
RECOMMENDED.
(5.1)
RECENT MAJOR CHANGES
Indications and Usage (1)
10/2023
Dosage and Administration (2.5, 2.6)
10/2023
Warnings and Precautions (5.2, 5.9)
10/2023
INDICATIONS AND USAGE
TRIJARDY XR is a combination of empagliflozin, a sodium-glucose
co-transporter 2 (SGLT2) inhibitor,
linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin
hydrochloride (HCl), a biguanide,
indicated 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