Anti-Adrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Signs and symptoms of hypoglycemia may be reduced or absent( 7).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 12/2015
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 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 8.3 Nursing Mothers 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 2 Diabetes – Adult 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. Close
1 INDICATIONS AND USAGE
TRESIBA is indicated to improve glycemic control in adults with diabetes mellitus.
Limitations of Use
TRESIBA is 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) ].
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Inspect visually for particulate matter and discoloration. Only use TRESIBA if the solution appears clear and colorless.
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Train patients on proper use and injection technique before initiating TRESIBA. Training reduces the risk of administration errors such as needle sticks and incomplete dosing.
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Inject TRESIBA subcutaneously into the thigh, upper arm, or abdomen.
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Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy [see Adverse Reactions (6.1)].
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DO NOT administer TRESIBA intravenously, intramuscularly or in an insulin infusion pump.
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DO NOT dilute or mix TRESIBA with any other insulin products or solutions.
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DO NOT transfer TRESIBA from the TRESIBA pen into a syringe for administration [see Warningsand Precautions (5.4)].
2.2 General Dosing Instructions•
Inject TRESIBA subcutaneously once-daily at any time of day.
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Individualize and titrate the dose of TRESIBA based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal.
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The recommended days between dose increases is 3 to 4 days.
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Dose adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronut
