Cofrogliptin(考格列汀片)

Introduction of Cofrogliptin

Cofrogliptin Tablets were first launched in China in June 2024 as an exclusive product. As a dipeptidyl peptidase 4 (DPP-4) inhibitor, this product exerts a hypoglycemic effect by inhibiting DPP-4 activity to increase the plasma concentration of incretins, and regulating the secretion of insulin and glucagon in a glucose-dependent manner.

Indications

This product is indicated for improving glycemic control in adults with type 2 diabetes mellitus.

Monotherapy

As monotherapy, this product can be used in combination with diet control and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Combination therapy with metformin hydrochloride

When glycemic control is still inadequate with metformin hydrochloride alone, this product can be used in combination with metformin hydrochloride to improve glycemic control in adults with type 2 diabetes mellitus on the basis of diet and exercise.

Important usage restrictions

This product is not indicated for patients with type 1 diabetes mellitus or diabetic ketoacidosis.

Overview

Dosage and Administration

The recommended dosage of Cofrogliptin Tablets, either as monotherapy or in combination with metformin, is 10 mg, administered orally once every two weeks (14 days), regardless of food intake.

After the initial dose, a fixed dosing schedule must be established, i.e., the drug should be taken on the same day every two weeks. The dosing schedule can be recorded on the log card enclosed in the product packaging.

If a dose is missed, it may be supplemented at any time before the next scheduled dose, and then the original dosing schedule should be resumed.

If a dose is taken ahead of schedule, the current dosing cycle shall be suspended, and the medication should be continued only at the next scheduled time.

In case of multiple missed doses or improper use, patients should resume the original dosing schedule or establish a new one under the guidance of a physician.

Contraindications

Hypersensitivity to cofrogliptin or any of the excipients.

Adverse Reactions

Data from Phase I clinical trials indicate that most drug-related adverse reactions are mild and transient, which do not require special treatment or drug withdrawal.

Among patients receiving continuous medication for 24 weeks, the adverse reactions with an incidence rate exceeding 1% and higher than that in the placebo group include elevated lipase (a pancreas-related enzyme index), elevated amylase (a digestive enzyme index), abnormal liver function, urinary tract infection, hyperuricemia, and hypoglycemia (it should be specifically noted that no severe hypoglycemia cases occurred during the trial).

Use in Special Populations

Use in Pregnancy and Lactation

Pregnancy

Adequate and well-controlled clinical studies of Cofrogliptin Tablets have not been conducted in pregnant women. The use of this product during pregnancy is not recommended.

Lactation

There are no available data on whether this product and its metabolites are excreted in human milk. The use of this product during lactation is not recommended.

Pediatric Use

The safety and effectiveness of Cofrogliptin Tablets in patients under 18 years of age have not been established.

Geriatric Use

Dosage adjustment based on age is not recommended.

In two phase clinical trials of this product, a total of 314 patients received Cofrogliptin Tablets at a dose of 10 mg once every two weeks (Q2W), among whom 104 patients (33.1%) were aged 60 years or older. No overall differences in safety and effectiveness were observed between geriatric patients (≥60 years old) and non-geriatric patients (<60 years old). However, it cannot be ruled out that certain geriatric patients may have increased sensitivity to this product.

Situations Requiring Immediate Discontinuation of Medication

If any physical discomfort occurs after administration, patients should promptly inform the physician. The physician will decide whether medication discontinuation or other interventions are necessary based on the severity of the specific reaction.

For more detailed drug information, please consult the official package leaflet.

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