TIONS
• Drugs that Increase Hypoglycemia Risk or Increase or DecreaseBlood Glucose Lowering Effect: Adjustment of dosage may beneeded; closely monitor blood glucose.
• Drugs that Blunt Hypoglycemia Signs and Symptoms (e.g.,beta-blockers, clonidine, guanethidine, and reserpine): Increasedfrequency of glucose monitoring may be required.
See 17 for PATIENT COUNSELING INFORMATION and
FDA-approved patient labeling.
Revised: 09/2018
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
2.2 General Dosing Instructions
2.3 Converting to FIASP® from Other Insulins in Patients
with Either Type 1 or Type 2 Diabetes
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Never Share a FIASP® FlexTouch® Pen, PenFill®
Cartridge or PenFill® Cartridge Device Between
Patients
5.2 Hyperglycemia or Hypoglycemia with Changes in
Insulin Regimen
5.3 Hypoglycemia
5.4 Hypoglycemia Due to Medication Errors
5.5 Hypokalemia
5.6 Hypersensitivity and Allergic Reactions
5.7 Fluid Retention and Heart Failure with Concomitant
Use of PPAR-Gamma Agonists
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 Overview of Clinical Studies
14.2 Type 1 Diabetes - Adults
14.3 Type 2 Diabetes - Adults
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 prescribinginformation are not listed
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
FIASP® is indicated to improve glycemic control in adults withdiabetes mellitus.
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
• Always check insulin label before administration [see Warningsand Precautions (5.4)].
• Inspect visually for particulate matter and discoloration. Only use
FIASP® if the solution appears clear and colorless.
• Train patients on proper use and injection technique beforeinitiating FIASP®.
• Use FIASP® FlexTouch® pen with caution in patients with visualimpairment that may rely on audible clicks to dial their dose.
• DO NOT administer FIASP® intramuscularly.
• DO NOT dilute or mix FIASP® with any other insulin products orsolutions, except infusion fluids.
2.2 General Dosing Instructions
• Individualize the dosage of FIASP® based on the patient’smetabolic needs, blood glucose monitoring results, and glycemic
control goal.
• Dose adjustments may be needed when switching fromanother insulin, with changes in physical activity, changesin concomitant medications, changes in meal patterns (i.e.,macronutrient content or timing of food intake), changes in renalor hep |
