Tenelia Special Precautions

Careful Administration: TENELIA should be administered with care in the following patients: Patients with severe hepatic impairment [There has been no clinical experience establishing its safety in such patients (see Pharmacology: Pharmacokinetics under Actions)].
Patients with cardiac failure (NYHA class III or IV) [There has been no clinical experience establishing its safety in such patients].
Patients receiving sulfonylurea or insulin [The risk of hypoglycaemia may be increased (see Important Precautions as follows, Interactions and Adverse Reactions)].
The following patients or conditions [Hypoglycaemia may occur]: Pituitary insufficiency or adrenal insufficiency; Malnutrition, starvation, irregular diet, insufficient food intake or hyposthenia; Extreme muscle exercise; Patients with excessive alcohol intake.
Patients with a history of abdominal operation or a history of intestinal obstruction [Intestinal obstruction may occur (see Adverse Reactions)].
Patients prone to QT interval prolongation (patients with current or a history of arrhythmia such as severe bradycardia, patients with cardiac disease such as congestive cardiac failure, patients with hypokalaemia, etc.) [QT interval prolongation may occur (see Overdosage and Pharmacology: Pharmacokinetics under Actions)].
Important Precautions: Prior to the use of this product, patients should be instructed to recognize hypoglycemic symptoms and their management. In particular, when used in combination with sulfonylurea or insulin, this product may increase the risk of hypoglycaemia. In order to decrease the risk of hypoglycaemia associated with coadministration with sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should be considered when this product is coadministered with these drugs (see Careful Administration as previously mentioned, Interactions and Adverse Reactions).
Use of this product should be considered only in patients with established diagnosis of diabetes mellitus. It should be noted that there are other diseases than diabetes mellitus that have symptoms similar to those of diabetes mellitus (renal glycosuria, abnormal thyroid function, etc.), such as impaired glucose tolerance and positive urine sugar.
Use of this product should be considered only when there is inadequate response to diet and exercise therapy, which are fundamental for treatment of diabetes mellitus, after adequate trial of the therapies.
During treatment with this product, blood glucose should be regularly monitored, and the effect of the drug should be checked. If the response to this product is inadequate after 3 months of treatment, a change to other treatment should be considered.
During continued treatment with this product, it may become unnecessary to administer the product or it may become necessary to reduce a dose of the product. In addition, there may be no or inadequate response to the product due to patient's failure to take care of themselves or a complication of infection, etc. Therefore, attention should be paid to the amount of food intake, blood glucose level and presence/absence of infection to judge continuation of treatment, doses and selection of drugs.
Adverse drug reactions such as prolonged QT may occur. Treatment with this product should preferably be avoided in patients with current or a history of QT interval prolongation (congenital long QT syndrome, etc.) or with a history of Torsades de pointes (see Overdosage and Pharmacology: Pharmacokinetics under Actions).
Both GLP-1 receptor agonists and this product have an antihyperglycaemic action mediated by GLP-1 receptor. No results of clinical trials studying a combined therapy with both drugs are available and the efficacy and safety of the coadministration have not been proved.
Acute pancreatitis may occur. Patients should be instructed to consult with a physician immediately if initial symptoms including persistent and intense abdominal pain and/or vomiting occur (see Adverse Reactions).
Precaution concerning Use: Precautions regarding dispensing: For drugs that are dispensed in a press-through package (PTP), instruct the patient to remove the drug from the PTP sheet prior to use. [It was reported that, if the PTP sheet is swallowed, the sharp corners of the sheet may puncture the esophageal mucosa, resulting in severe complications such as mediastinitis.]
Other Precautions: QT interval prolongation has been reported after administration of this product at a dose of 160 mg once daily (see Overdosage and Pharmacology: Pharmacokinetics under Actions). [The usual approved dosage of this product is 20 mg of teneligliptin once daily, and the maximum dosage is 40 mg once daily (see Dosage & Administration).]
Effects on ability to drive and use machines: Since hypoglycemic symptoms may occur, attention should be paid to patients engaged in work at altitude or driving a car, etc.
Use in Children: The safety of this product in low-birth-weight infants, neonates, nursing infants, infants, or children has not been established (no clinical experience).
Use in the Elderly: Since elderly patients often have reduced physiological function, this product should be administered carefully with close monitoring of the patient's condition.