Retagliptin(磷酸瑞格列汀片)

Introduction of Retagliptin

Retagliptin Phosphate Tablets, an original Class 1 innovative hypoglycemic drug of the dipeptidyl peptidase-4 (DPP-4) inhibitor class, is independently developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd. It is the first domestic original research drug of this class and was approved for marketing by the National Medical Products Administration (NMPA) in June 2023.

Indications

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

Monotherapy: As monotherapy, this product can be combined 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 inadequate with metformin hydrochloride alone, this product may be used in combination with metformin hydrochloride, together with diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus.

Overview

Dosage and Administration

Recommended Dosage

Retagliptin may be administered without regard to meals.

Monotherapy: The recommended dosage is 100 mg once daily or 50 mg twice daily.

Combination therapy with metformin: The recommended dosage is 50 mg twice daily.

Special Populations

Patients with Renal Impairment

Assessment of renal function is recommended prior to the initiation of retagliptin therapy, and regular re-assessment should be performed thereafter.

For patients with mild renal impairment [creatinine clearance (Ccr) 60–89ml/min], no dosage adjustment is required.

For patients with moderate renal impairment [creatinine clearance (Ccr) 30–59ml/min], the dosage should be adjusted to 50mg once daily.

For patients with severe renal impairment [creatinine clearance (Ccr) ≤ 29ml/min], the use of retagliptin is not recommended. If administration is deemed necessary, close monitoring of renal function status is required.

Patients with Hepatic Impairment

No studies have been conducted in patients with hepatic impairment to date, and no clinical data are available for this population.

Contraindications

Hypersensitivity to the active ingredient of retagliptin tablets or any of their excipients is a contraindication for use.

Adverse Reactions

Mild Reactions: Headache, nasopharyngitis, upper respiratory tract infection and other symptoms may occur, which are usually self-relieving.

Gastrointestinal Discomfort: Nausea and diarrhea are occasionally reported. Administration with meals is recommended to alleviate such symptoms.

Rare Risks: Pancreatitis or hypersensitivity reactions (e.g., skin rash, edema) may occur in a very small number of patients. Immediate drug withdrawal and medical attention are required.

Use in Special Populations

Use in Pregnancy and Lactation

Pregnancy

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

Lactation

There are no data available regarding the excretion of this product or its metabolites in human milk. The use of this product during lactation is not recommended.

Pediatric Use

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

Geriatric Use

Dosage adjustment based on age is not recommended. In the two Phase III clinical trials of this product, no overall differences in safety and effectiveness were observed between elderly subjects and younger subjects. However, increased sensitivity to this product in some elderly patients cannot be excluded.

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

Recommended articles

Contact Information

If any issues arise, please contact us immediately.

Email:haiousales@gmail.com

WhatsApp