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Prusogliptin Tablets is a supported variety of the National Major Science and Technology Project for Major New Drug Creation, with independent intellectual property rights, and it is a novel highly selective oral dipeptidyl peptidase-IV (DPP-4) inhibitor.
AuthenticGuaranteeFast DeliveryPrivacy Two pivotal Phase 3 clinical trials have demonstrated that Prusogliptin Tablets achieves a higher blood glucose target attainment rate for monotherapy or combination therapy, has no common adverse reactions associated with DPP-4 inhibitors such as nasopharyngitis and upper respiratory tract infections, and features a superior safety profile, making it particularly suitable for elderly patients with type 2 diabetes complicated by multiple comorbidities and polypharmacy.
Prusogliptin Tablets are indicated for improving blood glucose control in adults with type 2 diabetes mellitus.
Prusogliptin Tablets can be used as monotherapy in combination with diet control and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.
When blood glucose control remains inadequate with metformin hydrochloride alone, this product can be used in combination with metformin hydrochloride to improve blood glucose control in adults with type 2 diabetes mellitus on the basis of diet and exercise.
Prusogliptin Tablets are not indicated for patients with type 1 diabetes mellitus or diabetic ketoacidosis.
The recommended dosage of Prusogliptin Tablets, whether for monotherapy or combination therapy with metformin, is 100mg once daily. This product may be taken with or without food.
Patients with Renal Impairment
It is recommended to assess renal function prior to the initiation of this product, with periodic assessments thereafter.
No dosage adjustment is required for patients with mild renal impairment (eGFR ≥ 60mL/min/1.73m²and < 90mL/min/1.73m²) or moderate renal impairment (eGFR ≥ 30mL/min/1.73m²and < 60mL/min/1.73m²).
Use of this product is not recommended for patients with severe renal impairment (eGFR ≥ 15mL/min/1.73m²and < 30mL/min/1.73m²) and non-dialyzed renal failure (eGFR < 15mL/min/1.73m²).
There are currently no available clinical study data on the use of this product in patients with dialyzed renal failure.
Patients with Hepatic Impairment
No dosage adjustment is required for patients with mild hepatic impairment.
Use of this product is not recommended for patients with moderate hepatic impairment.
There are currently no available clinical study data on the use of this product in patients with severe hepatic impairment.
This product is contraindicated in patients with hypersensitivity to the active ingredient of Prusogliptin Tablets or any excipients in this product.
Adverse Reactions with an Incidence of ≥1% and Higher Than That of Placebo is Abnormal Liver Function.
Adverse reactions with an incidence of 0.5%-1% reported in subjects treated with this product for 24 weeks include hyperlipidemia, hyperuricemia, hypoglycemia, abdominal pain, nausea, elevated serum uric acid, rash and dizziness.
Pregnancy
Adequate and well-controlled clinical studies of this product have not been conducted in pregnant women. Use of this product is not recommended during pregnancy.
Lactation
There are no available data on whether this product and its metabolites are excreted in human breast milk. Use of this product is not recommended during lactation.
The safety and efficacy of this product in patients under 18 years of age have not been established.
Adjustment of the dosing regimen of this product based on age is not recommended.
In two Phase 3 clinical trials of this product, a total of 602 patients received treatment with this product at a dose of 100 mg QD, among whom 247 (41.0%) were 60 years of age or older. No differences in overall safety and efficacy were observed between geriatric patients (≥60 years of age) and non-geriatric patients (<60 years of age). However, it cannot be ruled out that some geriatric patients may have increased sensitivity to this product.
For more detailed drug information, please consult the official package leaflet.
If any issues arise, please contact us immediately.
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