TRADJENTA PI PDF

Current estimates indicate that diabetes affects approximately 26 million people in the U. Almost 19 million people have diabetes, and the disease remains undiagnosed in an estimated 7 million people. Diabetes is associated with significant morbidity, including kidney failure, non-traumatic lower-limb amputations, neuropathies, hypertension, periodontal disease, and blindness. In addition, diabetes is a major risk factor for heart disease and stroke and is the seventh leading cause of death in the U.

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Generic Name: linagliptin Dosage Form: tablet, film coated. Medically reviewed by Drugs. Last updated on Apr 1, Tradjenta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies Tradjenta should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. 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.

Tradjenta linagliptin 5 mg tablets are light red, round, biconvex, bevel-edged, film-coated tablets with "D5" debossed on one side and the Boehringer Ingelheim logo debossed on the other side. 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.

There have been postmarketing reports of acute pancreatitis, including fatal pancreatitis, in patients treated with Tradjenta. Take careful notice of potential signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue Tradjenta and initiate appropriate management.

It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Tradjenta. An association between DPP-4 inhibitor treatment and heart failure has been observed in cardiovascular outcomes trials for two other members of the DPP-4 inhibitor class.

These trials evaluated patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease. Consider the risks and benefits of Tradjenta prior to initiating treatment in patients at risk for heart failure, such as those with a prior history of heart failure and a history of renal impairment, and observe these patients for signs and symptoms of heart failure during therapy.

Advise patients of the characteristic symptoms of heart failure and to immediately report such symptoms. If heart failure develops, evaluate and manage according to current standards of care and consider discontinuation of Tradjenta.

Insulin secretagogues and insulin are known to cause hypoglycemia. The use of Tradjenta in combination with an insulin secretagogue e. The use of Tradjenta in combination with insulin in subjects with severe renal impairment was associated with a higher rate of hypoglycemia [see Adverse Reactions 6. Therefore, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia when used in combination with Tradjenta.

There have been postmarketing reports of serious hypersensitivity reactions in patients treated with Tradjenta. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions. Onset of these reactions occurred predominantly within the first 3 months after initiation of treatment with Tradjenta, with some reports occurring after the first dose.

If a serious hypersensitivity reaction is suspected, discontinue Tradjenta, assess for other potential causes for the event, and institute alternative treatment for diabetes. Angioedema has also been reported with other dipeptidyl peptidase-4 DPP-4 inhibitors. Use caution in a patient with a history of angioedema to another DPP-4 inhibitor because it is unknown whether such patients will be predisposed to angioedema with Tradjenta. There have been postmarketing reports of severe and disabling arthralgia in patients taking DPP-4 inhibitors.

The time to onset of symptoms following initiation of drug therapy varied from one day to years. Patients experienced relief of symptoms upon discontinuation of the medication.

A subset of patients experienced a recurrence of symptoms when restarting the same drug or a different DPP-4 inhibitor. Consider DPP-4 inhibitors as a possible cause for severe joint pain and discontinue drug if appropriate. Postmarketing cases of bullous pemphigoid requiring hospitalization have been reported with DPP-4 inhibitor use. In reported cases, patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of the DPP-4 inhibitor.

Tell patients to report development of blisters or erosions while receiving Tradjenta. If bullous pemphigoid is suspected, Tradjenta should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment. The following serious adverse reactions are described below or elsewhere in the prescribing information:. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety evaluation of Tradjenta 5 mg once daily in patients with type 2 diabetes is based on 14 placebo-controlled trials, 1 active-controlled study, and one study in patients with severe renal impairment.

In the 14 placebo-controlled studies, a total of patients were randomized and treated with Tradjenta 5 mg daily and with placebo. The mean exposure in patients treated with Tradjenta across studies was The maximum follow-up was 78 weeks. The use of Tradjenta in combination with other antihyperglycemic agents was studied in six placebo-controlled trials: two with metformin 12 and 24 weeks' treatment duration ; one with a sulfonylurea 18 weeks' treatment duration ; one with metformin and sulfonylurea 24 weeks' treatment duration ; one with pioglitazone 24 weeks' treatment duration ; and one with insulin primary endpoint at 24 weeks.

The overall incidence of adverse events with Tradjenta were similar to placebo. Rates for other adverse reactions for Tradjenta 5 mg vs placebo when Tradjenta was used in combination with specific anti-diabetic agents were: urinary tract infection 3.

Other adverse reactions reported in clinical studies with treatment of Tradjenta were hypersensitivity e. In the clinical trial program, pancreatitis was reported in Three additional cases of pancreatitis were reported following the last administered dose of linagliptin. Table 2 summarizes the incidence of hypoglycemia in placebo-controlled studies of Tradjenta. The incidence of hypoglycemia increased when Tradjenta was administered with sulfonylurea or insulin.

For the initial 12 weeks of the study, background antidiabetic therapy was kept stable and included insulin, sulfonylurea, glinides, and pioglitazone. For the remainder of the trial, dose adjustments in antidiabetic background therapy were allowed. In general, the incidence of adverse events including severe hypoglycemia was similar to those reported in other Tradjenta trials.

During the same time period, severe hypoglycemic events, defined as an event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions, were reported in 3 4.

Events that were considered life-threatening or required hospitalization were reported in 2 2. Renal function as measured by mean eGFR and creatinine clearance did not change over 52 weeks' treatment compared to placebo.

Changes in laboratory findings were similar in patients treated with Tradjenta 5 mg compared to patients treated with placebo. Lipase levels above 3 times upper limit of normal were seen in 8. Increase in Amylase: In a cardiovascular safety study comparing Tradjenta versus glimepiride in patients with type 2 diabetes mellitus, amylase levels above 3 times upper limit of normal were seen in 1. The clinical significance of elevations in lipase and amylase with Tradjenta is unknown in the absence of potential signs and symptoms of pancreatitis [see Warnings and Precautions 5.

No clinically meaningful changes in vital signs were observed in patients treated with Tradjenta. Additional adverse reactions have been identified during postapproval use of Tradjenta.

Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Rifampin decreased linagliptin exposure, suggesting that the efficacy of Tradjenta may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer.

Therefore, use of alternative treatments is strongly recommended when linagliptin is to be administered with a strong P-gp or CYP3A4 inducer [see Clinical Pharmacology Coadministration of Tradjenta with an insulin secretagogue e. 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 miscarriage for the indicated population is unknown. In the U. Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications.

Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. These doses represent approximately times rats and times rabbits the 5 mg 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 5 mg clinical dose, based on exposure.

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.

Safety and effectiveness of Tradjenta in pediatric patients under 18 years of age have not been established. In the 15 type 2 diabetes studies with linagliptin, linagliptin-treated patients were 65 years of age and older including linagliptin-treated patients 75 years of age and older.

Of these 15 studies, 12 were double-blind placebo-controlled. In these 12 studies, linagliptin-treated patients were 65 years of age and older including 82 linagliptin-treated patients 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 dose adjustment is recommended for patients with renal impairment [see Clinical Pharmacology 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 In the event of an overdose with Tradjenta, contact the Poison Control Center. Removal of linagliptin by hemodialysis or peritoneal dialysis is unlikely. Tradjenta linagliptin tablets contain, as the active ingredient, an orally-active inhibitor of the dipeptidyl peptidase-4 DPP-4 enzyme.

Linagliptin is described chemically as 1H-Purine-2,6-dione, 8-[ 3R aminopiperidinyl] 2-butynyl -3,7-dihydromethyl[ 4-methylquinazolinyl methyl]-. The empirical formula is C 25 H 28 N 8 O 2 and the molecular weight is The structural formula is:. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance.

It is very slightly soluble in water 0. Linagliptin is soluble in methanol ca. Each film-coated tablet of Tradjenta contains 5 mg of linagliptin free base and the following inactive ingredients: mannitol, pregelatinized starch, corn starch, copovidone, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, talc, polyethylene glycol, and red ferric oxide. Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation.

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Efficacy and Safety of Linagliptin (Tradjenta) in Adults With Type-2 Diabetes Mellitus

Ridgefield, Conn. These updates are part of ongoing efforts to update product labels to ensure physicians, pharmacists and patients have the information they need to use our medications appropriately. Information about pancreatitis was included in the adverse reactions sections of the original labels for these products; it is now displayed in additional sections of the PIs. As part of our ongoing commitment to patient safety, Boehringer Ingelheim and Lilly will issue a separate communication to prescribers of dipeptidyl peptidase 4 DPP-4 inhibitors and pharmacists to inform them about the label updates. The updates are the same for both products, and include the following changes to the respective PIs:. FDA to ensure our labels give physicians, pharmacists and people living with diabetes the information they need to make informed decisions about our treatments and how to properly use them.

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