TRADJENTA- linagliptin tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

linagliptin (UNII: 3X29ZEJ4R2) (linagliptin - UNII:3X29ZEJ4R2)

Tilgjengelig fra:

Cardinal Health 107, LLC

INN (International Name):

linagliptin

Sammensetning:

linagliptin 5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use TRADJENTA should not be used in patients with type 1 diabetes as it would not be effective. TRADJENTA 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 TRADJENTA [see Warnings and Precautions (5.1)]. TRADJENTA is contraindicated in patients with hypersensitivity to linagliptin or any of the excipients in TRADJENTA, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred [see Warnings and Precautions (5.3) and Adverse Reactions (6)]. Risk Summary The limited data with TRADJENTA use in pregnant women are not sufficient to inform of drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poor

Produkt oppsummering:

TRADJENTA tablets are available as light red, round, biconvex, bevel-edged, film-coated tablets containing 5 mg of linagliptin. TRADJENTA tablets are debossed with "D5" on one side and the Boehringer Ingelheim logo on the other side. They are supplied as follows: 5 mg, available in bottles of approximately 2640 tablets, NDC 55154-0410-8 If repackaging is required, dispense in a tight container as defined in USP. 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].

Autorisasjon status:

New Drug Application

Informasjon til brukeren

Cardinal Health 107, LLC
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: April 2022
MEDICATION GUIDE
TRADJENTA® (TRAD gen ta)
(linagliptin tablets)
for oral use
What is the most important information I should know about TRADJENTA?
TRADJENTA can cause serious side effects, including:
•
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 TRADJENTA, 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 TRADJENTA 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.
What is TRADJENTA?
•
TRADJENTA is a prescription medicine used along with diet and exercise
to lower blood sugar in
adults with type 2 diabetes.
•
TRADJENTA is not for people with type 1 diabetes.
•
If you have had pancreatitis in the past, it is not known if you have
a higher chance of getting
pancreatitis while you take TRADJENTA.
•
It is not known if TRADJENTA is safe and effective in children.
Who should not take TRADJENTA?
Do not take TRADJENTA if you:
•
are allergic to linagliptin or any of the ingredients in TRADJENTA.
See the end of this Medication
Guide for a complete list of ingredients in TRADJENTA.
Symptoms of a serious allergic reaction to TRADJENTA 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 TRADJENTA and call your
healthcare provi

Preparatomtale

TRADJENTA- LINAGLIPTIN TABLET, FILM COATED
CARDINAL HEALTH 107, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRADJENTA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRADJENTA.
TRADJENTA® (LINAGLIPTIN TABLETS), FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
RECENT MAJOR CHANGES
Indications and Usage (1)
4/2022
INDICATIONS AND USAGE
TRADJENTA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as
an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus (1)
Limitations of Use
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg (3)
CONTRAINDICATIONS
Hypersensitivity to linagliptin or any of the excipients in TRADJENTA
(4, 5.3)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
Adverse reactions reported in ≥5% of patients treated with TRADJENTA
and more commonly than in
patients treated with placebo included nasopharyngitis (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BOEHRINGER INGELHEIM
PHARMACEUTICALS,
INC. AT 1-800-542-6257, OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Strong P-glycoprotein/CYP3A4 inducer: The efficacy of TRADJENTA may be
reduced when administered in
combination (e.g., with rifampin). Use of alternative treatments is
strongly recommended. (7.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 10/2022
Should not be used in patients with type 1 diabetes (1)
Has not been studied in patients with a history of pancreatitis (1)
The recommended dose of TRADJENTA is 5 mg once daily (2.1)
TRADJENTA can be taken with or without food (2.1)
_Pancreatitis:_ There have been reports of acute pancreatitis,
including fatal pancreatitis. If pancreatitis
is suspected, promptly discontinue TRADJENTA. (5.1)
_Hypoglycemia:_ Consider lowering the dose of insulin secretagogue or
insulin to reduce the risk of
hypoglycemia when initiating TRADJENTA (5.2)
_Hypersensitivity reactions:_ Serious