INDICATIONS AND USAGE（适应症）

TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.

DOSAGE（服用剂量）

Starting Dose in Insulin Naïve Patients

Type 1 Diabetes Mellitus:

The recommended starting dose of TRESIBA in insulin naïve patients with type 1 diabetes is approximately one-third to one-half of the total daily insulin dose. The remainder of the total daily insulin dose should be administered as a short-acting insulin and divided between each daily meal. As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose in insulin naïve patients with type 1 diabetes.

Type 2 Diabetes Mellitus:

The recommended starting dose of TRESIBA in insulin naïve patients with type 2 diabetes mellitus is 10 units once daily.

Starting Dose in Patients Already on Insulin Therapy

Adults withType 1 or Type 2 Diabetes Mellitus:

Start TRESIBA at the same unit dose as the total daily long or intermediate-acting insulin unit dose.

Pediatric Patients 1 Year of Age and Older with Type 1 or Type 2 Diabetes Mellitus:

Start TRESIBA at 80% of the total daily long or intermediate-acting insulin unit dose to minimize the risk of hypoglycemia.

ADVERSE REACTIONS（不良反应）

TRESIBA may cause serious side effects that can lead to death, including:

Low blood sugar (hypoglycemia).

Low potassium in your blood (hypokalemia).

Heart failure

Common side effects of TRESIBA may include: serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain.

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/84197351-cb71-4282-8217-13103404a2b4/spl-doc?hl=Tresiba

Tresibainformation