TRADJENTA- linagliptin tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

LINAGLIPTIN (UNII: 3X29ZEJ4R2) (LINAGLIPTIN - UNII:3X29ZEJ4R2)

Commercializzato da:

A-S Medication Solutions

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 is not recommended in patients with type 1 diabetes mellitus 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 poorly controlled diabetes in pregnancy [see Clinical Considerations]. In animal reproduction studies, no adverse developmental effects were observed when linagliptin was administered to pregnant rats during the period of organogenesis at doses similar to the maximum recommended clinical dose, based on exposure [see Data] . The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20% to 25% in women with HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Animal Data No adverse developmental outcome was observed when linagliptin was administered to pregnant Wistar Han rats and Himalayan rabbits during the period of organogenesis at doses up to 240 mg/kg/day and 150 mg/kg/day, respectively. These doses represent approximately 943-times (rats) and 1,943-times (rabbits) the 5 mg maximum clinical dose, based on exposure. No adverse functional, behavioral, or reproductive outcome was observed in offspring following administration of linagliptin to Wistar Han rats from gestation day 6 to lactation day 21 at a dose 49-times the maximum recommended human dose, based on exposure. Linagliptin crosses the placenta into the fetus following oral dosing in pregnant rats and rabbits. Risk Summary There is no information regarding the presence of linagliptin in human milk, the effects on the breastfed infant, or the effects on milk production. However, linagliptin is present in rat milk. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TRADJENTA and any potential adverse effects on the breastfed child from TRADJENTA or from the underlying maternal condition. The safety and effectiveness of TRADJENTA have not been established in pediatric patients. Effectiveness of TRADJENTA was not demonstrated in a 26-week randomized, double-blind, placebo-controlled trial (NCT03429543) in 157 pediatric patients aged 10 to 17 years with inadequately controlled type 2 diabetes mellitus. In linagliptin studies, 1,085 linagliptin-treated patients were 65 years of age and older and 131 patients were 75 years of age and older. In these linagliptin studies, no overall differences in safety or effectiveness of linagliptin were observed between geriatric patients and younger adult patients. No dosage adjustment is recommended for patients with renal impairment [see Clinical Pharmacology (12.3)]. In the TRADJENTA treatment arm of the CARMELINA trial [see Clinical Studies (14)] , 2,200 (63%) patients had renal impairment (eGFR <60 mL/min/1.73 m2 ). Approximately 20% of the population had eGFR ≥45 to <60 mL/min/1.73 m2 , 28% of the population had eGFR ≥30 to <45 mL/min/1.73 m2 and 15% had eGFR <30 mL/min/1.73 m2 . The overall incidence of adverse reactions were generally similar between the TRADJENTA and placebo treatment arms. No dose adjustment is recommended for patients with hepatic impairment [see Clinical Pharmacology (12.3)] .

Dettagli prodotto:

Product: 50090-4383 NDC: 50090-4383-0 90 TABLET, FILM COATED in a BOTTLE

Stato dell'autorizzazione:

New Drug Application

Foglio illustrativo

A-S Medication Solutions
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This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: June 2023
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 mellitus.
•
TRADJENTA is not for people with type 1 diabetes mellitus.
•
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

Scheda tecnica

TRADJENTA- LINAGLIPTIN TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
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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
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
Not recommended in patients with type 1 diabetes mellitus as it would
not be effective (1)
Has not been studied in patients with a history of pancreatitis (1)
DOSAGE AND ADMINISTRATION
The recommended dosage of TRADJENTA is 5 mg orally once daily (2.1)
TRADJENTA can be taken with or without food (2.1)
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
_Pancreatitis:_ There have been reports of acute pancreatitis,
including fatal pancreatitis. If pancreatitis is
suspected, promptly discontinue TRADJENTA. (5.1)
_Hypoglycemia:_ Consider lowering the dosage of insulin secretagogue
or insulin to reduce the risk of
hypoglycemia when initiating TRADJENTA (5.2)
_Hypersensitivity reactions:_ Serious hypersensitivity reactions
(e.g., anaphylaxis, angioedema, and
exfoliative skin conditions) have occurred with TRADJENTA. If
hypersensitivity reactions occur,
discontinue TRADJENTA, treat promptly, and monitor until signs and
symptoms resolve. (5.3)
_Arthralgia:_ Severe and disabling arthralgia has been reported in
patients taking TRADJENTA. Consider as
a possible cause for severe joint pain and discontinue drug if
appropriate. (5.4)
_Bullous pemphigoid:_ There have been reports of bullous pemphigoid
requiring hospitalization. Tell
patients to report development of blisters or erosions. If bullous
pemphigoid is suspected, discontinue
TRADJENTA. (5.5)
_Heart failure:_ Hea