Loading…
TRAJENTA is a brand name for Linagliptin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ...........................................................................3 CONTRAINDICATIONS .................................................................................................3 WARNINGS AND PRECAUTIONS ...............................................................................4…
Verbatim from this product's HC label. Tap a section to expand.
and ADVERSE REACTIONS). For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section. Patients with diabetic ketoacidosis or with type 1 diabetes mellitus. WARNINGS AND PRECAUTIONS General TRAJENTA is contraindicated in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Cardiovascular An association between dipeptidyl peptidase-4 (DPP-4) inhibitor treatment and heart failure has been observed in cardiovascular outcomes trials for two other members of the DPP-4 inhibitor class. Before initiating TRAJENTA, consider factors that may predispose patients to a risk of heart failure, such as a history of prior heart failure and a history of renal impairment.
Monitor for signs and symptoms of heart failure after initiating therapy and discontinue TRAJENTA if this complication occurs.
Endocrine and Metabolism Hypoglycemia:
Caution is advised when linagliptin is used in combination with a sulfonylurea or insulin. , sulfonylurea) was associated with a higher rate of hypoglycemia compared with placebo in clinical trials. Sulphonylureas and insulin are known to cause hypoglycemia.
Therefore, to reduce the risk of hypoglycemia associated with these indications, a lower dose of sulfonylurea or insulin may be considered (see ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION). When TRAJENTA was used in combination with a sulfonylurea plus metformin, the incidence of hypoglycemia was increased over the placebo in combination with a sulfonylurea plus metformin (see ADVERSE REACTIONS).
Loss of Control of Blood Glucose:
When a patient stabilized on TRAJENTA is exposed to stress such as fever, trauma, infection, or surgery, a loss of control of blood glucose may occur. At such times, it may be necessary to temporarily discontinue TRAJENTA and administer insulin.
Use with P-gp/Cytochrome P450 (CYP) 3A4 Inducers:
Glycemic control should be carefully assessed when TRAJENTA is used concomitantly with a potent P-gp inducer or a potent CYP3A4 inducer. , rifampicin) may decrease exposure to linagliptin, which may reduce the glycemic lowering effect of TRAJENTA (see WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests and DRUG INTERACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Linagliptin in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
TRAJENTA® Product Monograph Page 5 of 46 Hepatic/Biliary/Pancreatic Hepatic:
Use in patients with severe hepatic impairment is not recommended (see DOSAGE AND ADMINISTRATION and ACTION AND CLINICAL PHARMACOLOGY). The number of patients with hepatic impairment was limited in clinical trials.
Pancreatitis:
There have been reports of acute and chronic pancreatitis in patients taking TRAJENTA during the clinical trials. 1%) adjudication-confirmed fatal cases due to acute pancreatitis in patients treated with TRAJENTA (see ADVERSE REACTIONS) compared to none in the placebo group.
There have also been post- marketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients receiving DPP-4 inhibitors. After initiation of TRAJENTA, patients should be observed carefully for signs and symptoms of pancreatitis.
If pancreatitis is suspected, TRAJENTA should promptly be discontinued and appropriate management should be initiated. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using TRAJENTA.
Risk factors for pancreatitis include a history of: pancreatitis, gallstones, alcoholism, or hypertriglyceridemia.
Immune Hypersensitivity Reactions:
Serious hypersensitivity reactions, including anaphylaxis, angioedema, bronchial reactivity, rash, urticaria, and exfoliative skin conditions were observed with TRAJENTA in clinical trials and/or post-marketing reports. With other members of this class, there have been post- marketing reports of exfoliative skin conditions, including Stevens-Johnson syndrome.
Onset of these reactions occurred within the first 3 months after initiation of treatment, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue TRAJENTA, assess for other potential causes for the event, and institute alternative treatment for diabetes (see CONTRAINDICATIONS and ADVERSE REACTIONS).
Immunocompromised Patients:
A dose-related mean decrease in absolute lymphocyte count was observed with other members of this class. When clinically indicated, such as in settings of unusual or prolonged infection, lymphocyte count should be measured. g. human immunodeficiency virus) is unknown.
Immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodeficiency syndrome have not been studied in the TRAJENTA clinical program. Therefore, the efficacy and safety profile of TRAJENTA in these patients has not been established.
Monitoring and Laboratory Tests Blood Glucose and HbA1c:
Response to TRAJENTA treatment should be monitored by periodic measurements of blood glucose and HbA1c levels. When TRAJENTA is co-administered with strong inducers of P-gp or CYP3A4, blood glucose should be monitored more closely. In cases of insufficient glycemic control, a change of the P-gp/CYP3A4 inducer to a non P-gp/CYP3A4 inducing compound or a change of TRAJENTA to another oral antidiabetic agent should be considered (see DRUG INTERACTIONS).
TRAJENTA® Product Monograph Page 6 of 46 Hepatic Function:
Hepatic function should be assessed before starting treatment and periodically thereafter. Peri-Operative Considerations See WARNINGS AND PRECAUTIONS, Endocrine and Metabolism section. Renal Clinical study experience with TRAJENTA in patients with end-stage renal disease (ESRD) and those on dialysis is […]