Henagliflozin(脯氨酸恒格列净片)

Introduction of Henagliflozin

Empagliflozin Proline Tablets offers a high-quality domestic innovative oral antidiabetic option for patients with Type 2 diabetes mellitus in China, and is not indicated for patients with Type 1 diabetes mellitus (T1DM) or diabetic ketoacidosis (DKA).

Indications

Empagliflozin Proline Tablets are indicated for the improvement of glycemic control in adult patients with Type 2 diabetes mellitus (T2DM).

Monotherapy

This product may be used as monotherapy, in combination with diet and exercise, to improve glycemic control in adult patients with Type 2 diabetes mellitus.

Combination with Metformin Hydrochloride

When glycemic control is inadequate with Metformin Hydrochloride monotherapy, this product may be used in combination with Metformin Hydrochloride, together with diet and exercise, to improve glycemic control in adult patients with Type 2 diabetes mellitus.

Combination with Metformin Hydrochloride and Repaglinide Phosphate

When glycemic control is inadequate with Metformin Hydrochloride monotherapy, this product may be used in combination with Metformin Hydrochloride and Repaglinide Phosphate, together with diet and exercise, to improve glycemic control in adult patients with Type 2 diabetes mellitus.

Usage Restrictions

This product is not indicated for the treatment of Type 1 diabetes mellitus (T1DM) or diabetic ketoacidosis (DKA).

Overview

Dosage and Administration

Recommended Dose

The recommended starting dose is 5 mg once daily, preferably taken in the morning, without regard to food intake. For patients requiring enhanced glycemic control who tolerate 5 mg once daily, the dose of this product may be increased to 10 mg once daily.

For volume-depleted patients, it is recommended to correct this condition before initiating treatment with this product.

Renal Impairment

It is recommended to assess renal function before initiating this product and conduct regular assessments thereafter.

No dose adjustment is required for patients with an estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m² or higher.

No clinical studies have been conducted in patients with an eGFR below 30 mL/min/1.73 m², and the use of this product is not recommended in such patients.

Hepatic Impairment

It is recommended to assess hepatic function before initiating this product and conduct regular assessments thereafter.

No dose adjustment is required for patients with mild hepatic impairment (Child-Pugh Class A).

For patients with moderate to severe hepatic impairment (Child-Pugh Class B and C), exposure to this product is increased; the recommended dose of this product should be reduced to 5 mg once daily, and dose escalation should be performed with caution.

Contraindications

It is contraindicated in patients with hypersensitivity to the active ingredients or any excipients of Empagliflozin Proline Tablets.

It is contraindicated in patients with severe renal impairment, end-stage renal disease (ESRD) or those requiring dialysis.

Adverse Reactions

Diabetes-related Abnormalities (the most common adverse reactions)

Diabetic Ketosis (ketone body accumulation caused by hyperglycemia);

Elevated Blood Ketone Bodies (abnormal findings on blood tests);

Positive Blood Ketone Bodies (abnormal findings on urine tests).

Parathyroid Index Abnormalities

Abnormal findings may be observed on blood tests, including:

Elevated Parathyroid Hormone (detected by blood tests);

Abnormal Parathyroid Hormone (values outside the normal range);

Specific data show that after 24 weeks of administration, the mean changes in parathyroid hormone in the control group, 5 mg group and 10 mg group were 6.5%, 18.7% and 12.1% respectivelyⁿᵃ.

Urine Index Abnormalities

Elevated Urinary Albumin/Creatinine Ratio (abnormal protein content on urine tests);

Abnormal Fluctuations in the Above Ratio (unstable results in repeated tests).

Urinary Tract Disorders

Urinary Tract Infections (symptoms such as burning pain and urgent micturition during urination);

Asymptomatic Bacteriuria (bacteria detected in urine without accompanying discomfort);

Urinary Tract Inflammation (urination discomfort accompanied by abnormal laboratory indicators).

Risk of Volume Depletion

This drug may cause bodily fluid loss by increasing urination, leading to reactions such as hypotension. Clinical data show that no relevant symptoms were observed in the control group, while hypotension occurred in 0.5% (2 cases) of patients in both the 5 mg group and the 10 mg group. For patients who are inherently prone to dehydration, enhanced monitoring is required during the medication period.

Use in Special Populations

Pregnancy and Lactation

Pregnancy

No adequate and well-controlled clinical studies have been conducted in pregnant women with this product. Use of this product is not recommended during pregnancy.

Lactation

No data are available on whether this product and its metabolites are excreted in human milk. Use of this product is not recommended during lactation.

Pediatric Use

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

Geriatric Use

Dose adjustment of this product based on age is not recommended. In the 2 Phase Ⅱ and 3 Phase Ⅲ clinical trials of this product, subjects aged over 65 years accounted for 16.7%. No overall differences in safety and efficacy were observed between elderly and younger subjects. However, increased sensitivity to this product in some elderly patients cannot be ruled out.

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

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