1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TRESIBA
®
safely and effectively. See full prescribing information for TRESIBA
®
.
TRESIBA
®
(insulin degludec injection), for subcutaneous use
Initial U.S. Approval: 2015
——— RECENT MAJOR CHANGES ———
Dosage and Administration (2.1)
11/2018
Warnings and Precautions (5.1)
11/2018
——— INDICATIONS AND USAGE ———
TRESIBA
®
is a long-acting human insulin analog indicated to improve glycemic control in
patients 1 year of age and older with diabetes mellitus (1).
Limitations of Use:
• Not recommended for treating diabetic ketoacidosis.
——— DOSAGE AND ADMINISTRATION ———
• See Full Prescribing Information for important administration instructions (2.1).
• Rotate injection sites to reduce the risk of lipodystrophy (2.1).
• For pediatric patients requiring less than 5 units of TRESIBA
®
each day, use a TRESIBA
®
U-100 vial (2.1).
• In adults, inject subcutaneously once daily at any time of day (2.2).
• In pediatric patients inject subcutaneously once daily at the same time every day (2.2).
• Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring
results and glycemic control goal (2.2).
• The recommended days between dose increases are 3 to 4 days (2.2).
• See Full Prescribing Information for recommended starting dose in insulin naïve patients and
patients already on insulin therapy (2.3, 2.4).
——— DOSAGE FORMS AND STRENGTHS ———
TRESIBA
®
injection is available in the following package sizes:
• 100 units/mL (U-100): 3 mL single-patient-use FlexTouch
®
(3).
• 200 units/mL (U-200): 3 mL single-patient-use FlexTouch
®
(3).
• 100 units/mL (U-100): 10 mL multiple-dose vial (3).
——— CONTRAINDICATIONS ———
• During episodes of hypoglycemia (4).
• Hypersensitivity to TRESIBA
®
or one of its excipients (4).
——— WARNINGS AND PRECAUTIONS ———
•
Never share
a TRESIBA
®
FlexTouch
®
pen between patients, even if the needle is changed (5.1).
•
Hyper- or hypoglycemia with changes in insulin regimen:
Carry out under close medical
supervision and increase frequency of blood glucose monitoring (5.2).
•
Hypoglycemia:
May be life-threatening. Increase monitoring with changes to: insulin dosage,
co-administered glucose lowering medications, meal pattern, physical activity; and in
patients with renal impairment or hepatic impairment or hypoglycemia unawareness (5.3,
5.4, 6.1).
•
Hypoglycemia due to medication errors:
Accidental mix-ups between insulin products can
occur. Instruct patients to check insulin labels before injection. DO NOT transfer TRESIBA
®
into a syringe for administration as overdosage and severe hypoglycemia can result (5.4).
•
Hypersensitivity reactions:
Severe, life-threatening, generalized allergy, including
anaphylaxis, can occur. Discontinue TRESIBA
®
, monitor and treat if indicated (5.5).
•
Hypokalemia:
May be life-threatening. Monitor potassium levels in patients at risk for
hypokalemia and treat if indicated (5.6).
•
Fluid retention and heart failure with concomitant use of Thiazolidinediones (TZDs):
Observe
for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart
failure occurs (5.7).
——— ADVERSE REACTIONS ———
Adverse reactions commonly associated with TRESIBA
®
are:
• hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash,
edema and weight gain (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk at
1-800-727-6500 or FDA at 1−800−FDA−1088 or www.fda.gov/medwatch.
——— DRUG INTERACTIONS ———
•
Drugs that may increase the risk of hypoglycemia:
antidiabetic agents, ACE inhibitors,
angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine
oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin
analog (e.g., octreotide), and sulfonamide antibiotics (7).
•
Drugs that may decrease the blood glucose lowering effect:
atypical antipsychotics,
corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral
contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease
inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline),
and thyroid hormones (7).
•
Drugs that may increase or decrease the blood glucose lowering effect:
Alcohol, beta-
blockers, clonidine, lithium salts, and pentamidine (7).
•
Drugs that may blunt the signs and symptoms of hypoglycemia:
beta-blockers, clonidine,
guanethidine, and reserpine (7).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient
labeling.
Revised: 11/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1
INDICATIONS AND USAGE
2
DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
2.2 General Dosing Instructions
2.3 Starting Dose in Insulin Naïve Patients
2.4 Starting Dose in Patients Already on Insulin Therapy
3
DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5
WARNINGS AND PRECAUTIONS
5.1 Never Share a TRESIBA
®
FlexTouch
®
Pen, Needle, or Syringe Between Patients
5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen
5.3 Hypoglycemia
5.4 Hypoglycemia Due to Medication Errors
5.5 Hypersensitivity and Allergic Reactions
5.6 Hypokalemia
5.7 Fluid Retention and Congestive Heart Failure with Concomitant Use of a PPAR
Gamma Agonist
6
ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Immunogenicity
7
DRUG INTERACTIONS
8
USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13
NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14
CLINICAL STUDIES
14.1 Type 1 Diabetes – Adult
14.2 Type 1 Diabetes – Pediatric Patients 1 Year of Age and Older
14.3 Type 2 Diabetes – Adult
14.4 Safety Outcomes Trial
16
HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Recommended Storage
17
PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed.
