Efsubaglutide Alfa(依苏帕格鲁肽α注射液)

Introduction of Efsubaglutide Alfa

As one of the representatives of China's domestically developed original GLP-1 receptor agonists, the commercial launch of Efsubaglutide Alfa not only offers a new therapeutic option for patients with type 2 diabetes mellitus, but also marks a significant breakthrough in China’s field of innovative biopharmaceuticals for metabolic diseases.

Indications

This product is indicated for blood glucose control in adult patients with type 2 diabetes mellitus:

Monotherapy

For patients whose blood glucose is not adequately controlled with diet and exercise alone.

Combination Therapy

For patients whose blood glucose is still not adequately controlled despite metformin treatment combined with diet and exercise.

Overview

Dosage and Administration

Dosage

Monotherapy: The recommended initial dose is 1 mg of this product administered once weekly. If further improvement in blood glucose control is required, the dose may be increased to 3 mg of this product once weekly.

Combination Therapy: When adding this product to metformin treatment, the current dose of metformin may be continued, and 3 mg of this product may be administered once weekly at the same time.

Administration

Efsubaglutide Alfa Injection is administered by subcutaneous injection in the abdomen. When injecting in the same general area, it is recommended to select a different injection site each week.

It can be administered at any time of the day, regardless of meals.

Missed Dose

The interval between two doses shall not be less than 3 days (72 hours).

If a dose is missed during the current week:

If the time until the next scheduled weekly dose is more than 3 days (72 hours), administer the missed dose as soon as possible within the current week.

If the time until the next scheduled weekly dose is less than 3 days (72 hours), skip the dose for the current week and resume the next scheduled weekly dose.

If necessary, the day of weekly administration may be changed, provided that the interval from the last dose is more than 3 days (72 hours).

Contraindications

Persons allergic to Efsubaglutide Alfa or any excipients of this product are contraindicated.

Efsubaglutide Alfa is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC), as well as in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2).

Adverse Reactions

When Efsubaglutide Alfa is used as monotherapy or in combination with metformin, adverse reactions with an incidence rate ≥5% are mainly concentrated in gastrointestinal-related symptoms and elevated lipase, with the following overall characteristics:

Core Adverse Reaction Types: Gastrointestinal reactions such as diarrhea, abdominal distension, nausea, vomiting, and decreased appetite are predominant, and elevated lipase can also be observed.

Dose-Related Effect: The incidence of adverse reactions is associated with the drug dose, with the incidence generally being higher in the 3 mg dose group than in the 1 mg dose group.

Consistency Across Treatment Regimens: When used in combination with metformin, the characteristics of adverse reactions of Efsubaglutide Alfa are generally consistent with the trends observed with monotherapy.

Use in Special Populations

Use in Pregnant and Lactating Women

Pregnancy

No data are available on the use of this product in pregnant women. Preclinical animal studies have shown that this product has reproductive toxicity. This product is contraindicated in pregnant women.

Lactation

It is not known whether this product is excreted in human milk. The risk of this product to neonates/infants cannot be excluded. This product must not be used during lactation.

Fertility

The effect of this product on human fertility is unclear.

Pediatric Use

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

Geriatric Use

Clinical study data including patients aged 19 to 74 years show that no dose adjustment is required based on age for this product.

No data are available on the safety and efficacy of this product in patients over 75 years of age.

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

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