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TRESIBA

(insulin degludec injection)

FULL PRESCRIBING INFORMATION
1

INDICATIONS AND USAGE

TRESIBA

is indicated to improve glycemic control in patients 1 year of age and older with

diabetes mellitus.
Limitations of Use
• Not recommended for the treatment of diabetic ketoacidosis.

DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

• Always check insulin labels before administration

[see Warnings and Precautions (5.4)]

• Inspect visually for particulate matter and discoloration. Only use TRESIBA

if the solution

appears clear and colorless.

• Inject TRESIBA

subcutaneously into the thigh, upper arm, or abdomen.

• Rotate injection sites within the same region from one injection to the next to reduce the risk

of lipodystrophy

[see Adverse Reactions (6.1)]

• For pediatric patients requiring less than 5 units of TRESIBA

each day, use the

TRESIBA

U-100 vial.

• Use TRESIBA

with caution in patients with visual impairment that may rely on audible

clicks to dial their dose.

• DO NOT administer TRESIBA

intravenously or in an insulin infusion pump.

• DO NOT dilute or mix TRESIBA

with any other insulin products or solutions.

• DO NOT transfer TRESIBA

from the TRESIBA

pen into a syringe for administration

[see

Warnings and Precautions (5.4)]

2.2 General Dosing Instructions

• TRESIBA

is available in 2 concentrations (U-100 and U-200):

TRESIBA

U-100 concentration is available in 2 presentations, FlexTouch

pen and vial

•

TRESIBA

U-100 single-patient-use FlexTouch

pen contains 300 units of

TRESIBA

U-100. It delivers doses in 1 unit increments and can deliver up to 80 units

in a single injection.

•

TRESIBA

U-100 multiple-dose vial contains 1000 units of TRESIBA

U-100. Use vial

only with a U-100 insulin syringe.

TRESIBA

U-200 concentration is only available in a FlexTouch

pen

•

TRESIBA

U-200 single-patient-use FlexTouch

pen contains 600 units of

TRESIBA

U-200. It delivers doses in 2 unit increments and can deliver up to 160 units

in a single injection.

• DO NOT perform dose conversion when using the TRESIBA

U-100 or U-200 pens. The dose

window shows the number of insulin units to be delivered and no conversion is needed.

• In adults, inject TRESIBA

subcutaneously once-daily at any time of day.

• In pediatric patients inject TRESIBA

subcutaneously once-daily at the same time every day.

• Individualize and titrate the dose of TRESIBA

based on the patient’s metabolic needs, blood

glucose monitoring results, and glycemic control goal.

• The recommended days between dose increases are 3 to 4 days.
• Dose adjustments may be needed with changes in physical activity, changes in meal patterns

(i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or

during acute illness to minimize the risk of hypoglycemia or hyperglycemia

[see Warnings

and Precautions (5.3)]

• For adult patients, instruct patients who miss a dose of TRESIBA

to inject their daily dose

during waking hours upon discovering the missed dose. Instruct patients to ensure that at

least 8 hours have elapsed between consecutive TRESIBA

injections.

• For pediatric patients, instruct patients who miss a dose of TRESIBA

to contact their

healthcare provider for guidance and to monitor blood glucose levels more frequently until

the next scheduled TRESIBA

dose.

2.3 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.

2.4 Starting Dose in Patients Already on Insulin Therapy

Adults with Type 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

[see Warnings and Precautions (5.2)]

DOSAGE FORMS AND STRENGTHS

Injection: TRESIBA

is available as a clear and colorless solution:

• 100 units/mL (U-100): 3 mL single-patient-use FlexTouch

disposable prefilled pen

• 100 units/mL (U-100): 10 mL multiple-dose vial
• 200 units/mL (U-200): 3 mL single-patient-use FlexTouch

disposable prefilled pen

4 CONTRAINDICATIONS

TRESIBA

is contraindicated:

• During episodes of hypoglycemia

[see Warnings and Precautions (5.3)]

• In patients with hypersensitivity to TRESIBA

or one of its excipients

[see Warnings and

Precautions (5.5)]

WARNINGS AND PRECAUTIONS

5.1 Never Share a TRESIBA

FlexTouch

Pen, Needle, or Syringe Between

Patients

TRESIBA

FlexTouch

disposable prefilled pens should never be shared between patients, even

if the needle is changed. Patients using TRESIBA

vials should never share needles or syringes

with another person. Sharing poses a risk for transmission of blood-borne pathogens.

5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

Changes in insulin, manufacturer, type, or method of administration may affect glycemic control

and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously

and only under medical supervision and the frequency of blood glucose monitoring should be

increased. For patients with type 2 diabetes, adjustments in concomitant anti-diabetic treatment

may be needed. When converting from other insulin therapies to TRESIBA

follow dosing

recommendations

[see Dosage and Administration (2.4)]

5.3 Hypoglycemia

Hypoglycemia is the most common adverse reaction of insulin, including TRESIBA

[see

Adverse Reactions (6.1)]

. Severe hypoglycemia can cause seizures, may be life-threatening or

cause death. Hypoglycemia can impair concentration ability and reaction time; this may place

an individual and others at risk in situations where these abilities are important (e.g., driving or

operating other machinery). TRESIBA

, or any insulin, should not be used during episodes of

hypoglycemia

[see Contraindications (4)]

Hypoglycemia can happen suddenly and symptoms may differ in each individual and change

over time in the same individual. Symptomatic awareness of hypoglycemia may be less

pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in

patients using medications that block the sympathetic nervous system (e.g., beta-blockers)

[see

Drug Interactions (7)]

, or in patients who experience recurrent hypoglycemia.

Risk Factors for Hypoglycemia
The risk of hypoglycemia generally increases with intensity of glycemic control. The risk of

hypoglycemia after an injection is related to the duration of action of the insulin

[see Clinical

Pharmacology (12.2)]

and, in general, is highest when the glucose lowering effect of the insulin is

maximal. As with all insulin preparations, the glucose lowering effect time course of TRESIBA

may vary among different individuals or at different times in the same individual and depends

on many conditions, including the area of injection as well as the injection site blood supply and

temperature.
Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g.,

macronutrient content or timing of meals), changes in level of physical activity, or changes to

co-administered medication

[see Drug Interactions (7)]

. Patients with renal or hepatic impairment

may be at higher risk of hypoglycemia

[see Use in Specific Populations (8.6, 8.7)]

Risk Mitigation Strategies for Hypoglycemia
Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-

monitoring of blood glucose plays an essential role in the prevention and management of

hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced

symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is

recommended.

5.4 Hypoglycemia Due to Medication Errors

Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting

insulins, have been reported. To avoid medication errors between TRESIBA

and other insulins,

instruct patients to always check the insulin label before each injection.
To avoid dosing errors and potential overdose, never use a syringe to remove TRESIBA

from the

TRESIBA

FlexTouch

disposable insulin prefilled pen

[see Dosage and Administration (2.1) and

Warnings and Precautions (5.3)]

5.5 Hypersensitivity and Allergic Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin

products, including TRESIBA

. If hypersensitivity reactions occur, discontinue TRESIBA

; treat

per standard of care and monitor until symptoms and signs resolve. TRESIBA