Novo Nordisk NovoLog Instructions For Use Manual

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information
needed to use NovoLog ® safely and effectively. See full
prescribing information for NovoLog
NovoLog (insulin aspart [rDNA origin] injection)
®
solution for subcutaneous use
Initial U.S. Approval: 2000
——— INDICATIONS AND USAGE ———
• NovoLog ® is an insulin analog indicated to improve glycemic
control in adults and children with diabetes mellitus (1.1).
——— DOSAGE AND ADMINISTRATION ———
• The dosage of NovoLog ® must be individualized.
• Subcutaneous injection: NovoLog ® should generally be given
immediately (within 5-10 minutes) prior to the start of a meal
(2.2).
• Use in pumps: Change the NovoLog
®
every 6 days, change the infusion set, and the infusion set
insertion site at least every 3 days. NovoLog
mixed with other insulins or with a diluent when it is used in
the pump (2.3).
• Intravenous use: NovoLog ® should be used at concentrations
from 0.05 U/mL to 1.0 U/mL insulin aspart in infusion systems
using polypropylene infusion bags. NovoLog
to be stable in infusion fluids such as 0.9% sodium chloride
(2.4).
——— DOSAGE FORMS AND STRENGTHS ———
Each presentation contains 100 Units of insulin aspart per mL
(U-100)
• 10 mL vials (3)
• 3 mL PenFill cartridges for the 3 mL PenFill
®
• 3 mL NovoLog FlexPen (3)
® ®
• 3 mL NovoLog ® FlexTouch ® (3)
——— CONTRAINDICATIONS ———
• Do not use during episodes of hypoglycemia (4).
• Do not use in patients with hypersensitivity to NovoLog
of its excipients.
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Treatment of Diabetes Mellitus
2 DOSAGE AND ADMINISTRATION
2.1 Dosing
2.2 Subcutaneous Injection
2.3 Continuous Subcutaneous Insulin Infusion (CSII) by External
Pump
2.4 Intravenous Use
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Administration
5.2 Hypoglycemia
5.3 Hypokalemia
5.4 Renal Impairment
5.5 Hepatic Impairment
5.6 Hypersensitivity and Allergic Reactions
5.7 Antibody Production
5.8 Mixing of Insulins
5.9 Continuous Subcutaneous Insulin Infusion by External Pump
5.10 Fluid retention and heart failure with concomitant use of
PPAR-gamma agonists
6

ADVERSE REACTIONS

——— WARNINGS AND PRECAUTIONS ———
• Hypoglycemia is the most common adverse effect of insulin
therapy. Glucose monitoring is recommended for all patients with
. diabetes. Any change of insulin dose should be made cautiously
®
and only under medical supervision (5.1, 5.2).
• Insulin, particularly when given intravenously or in settings of
poor glycemic control, can cause hypokalemia. Use caution in
patients predisposed to hypokalemia (5.3).
• Like all insulins, NovoLog
patients with renal impairment or hepatic impairment (5.4, 5.5).
• Severe, life-threatening, generalized allergy, including
anaphylaxis, may occur with insulin products, including
NovoLog
• Fluid retention and heart failure can occur with concomitant use
of thiazolidinediones (TZDs), which are PPAR-gamma agonists,
and insulin, including NovoLog
in the reservoir at least
Adverse reactions observed with NovoLog
allergic reactions, local injection site reactions, lipodystrophy, rash
® should not be
and pruritus (6).
To report SUSPECTED ADVERSE REACTIONS, contact
Novo Nordisk Inc. at 1-800-727-6500 or FDA at 1-800-
FDA-1088 or www.fda.gov/medwatch.
® has been shown
• The following may increase the blood-glucose-lowering effect
and susceptibility to hypoglycemia: oral antidiabetic products,
pramlintide, ACE inhibitors, disopyramide, fibrates, fluoxetine,
monoamine oxidase inhibitors, propoxyphene, salicylates,
somatostatin analogs, sulfonamide antibiotics (7).
• The following may reduce the blood-glucose-lowering effect:
corticosteroids, niacin, danazol, diuretics, sympathomimetic
cartridge device (3)
®
agents (e.g., epinephrine, salbutamol, terbutaline), isoniazid,
phenothiazine derivatives, somatropin, thyroid hormones,
estrogens, progestogens (e.g., in oral contraceptives), atypical
antipsychotics (7).
• Beta-blockers, clonidine, lithium salts, and alcohol may either
potentiate or weaken the blood-glucose-lowering effect of insulin
® or one
(7).
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1
8.3
8.4
8.5
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
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Subcutaneous Daily Injections
14.2 Continuous Subcutaneous Insulin Infusion (CSII) by External
14.3 Intravenous Administration of NovoLog
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Recommended Storage
requirements may be reduced in
®
(5.6).
®
® (5.10).
——— ADVERSE REACTIONS ———
include hypoglycemia,
®
——— DRUG INTERACTIONS ———
Pregnancy
Nursing Mothers
Pediatric Use
Geriatric Use
Pump
®
1
• Pentamidine may cause hypoglycemia, which may sometimes be
followed by hyperglycemia (7).
• The signs of hypoglycemia may be reduced or absent in patients
taking sympatholytic products such as beta-blockers, clonidine,
guanethidine, and reserpine (7).
——— USE IN SPECIFIC POPULATIONS ———
• Pediatric: Has not been studied in children with type 2 diabetes.
Has not been studied in children with type 1 diabetes <2 years of
age (8.4).
See 17 for PATIENT COUNSELING INFORMATION and
FDA approved patient labeling.
Revised: 4/2014
17 PATIENT COUNSELING INFORMATION
17.1 Physician Instructions
17.2 Patients Using Pumps
17.3 FDA Approved Patient Labeling
* Sections or subsections omitted from the full prescribing information are
not listed.