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TRESIBA
®
(insulin degludec injection)
2
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.
2
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):
o
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.
o
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)]
.
3
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)]
.
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
®
is contraindicated
in patients who have had hypersensitivity reactions to insulin degludec or one of the excipients
[see Contraindications (4)]
.
5.6 Hypokalemia
All insulin products, including TRESIBA
®
, cause a shift in potassium from the extracellular
to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause
respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at
risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients
taking medications sensitive to serum potassium concentrations).
5.7 Fluid Retention and Congestive Heart Failure with Concomitant Use of a
PPAR Gamma Agonist
Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-
gamma agonists can cause dose related fluid retention, particularly when used in combination
with insulin. Fluid retention may lead to or exacerbate congestive heart failure. Patients treated
with insulin, including TRESIBA
®
and a PPAR-gamma agonist should be observed for signs
and symptoms of congestive heart failure. If congestive heart failure develops, it should be
managed according to current standards of care and discontinuation or dose reduction of the
PPAR-gamma agonist must be considered.