HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use FIASP
safely and effectively. See full prescribing information for FIASP.
FIASP
� (insulin aspart injection) for subcutaneous or intravenous use
Initial U.S. Approval: 2000
-------------------------INDICATIONS AND USAGE----------------------------�
� FIASP is a rapid-acting human insulin analog indicated to improve
glycemic control in adults with diabetes mellitus (1).
----------------------DOSAGE AND ADMINISTRATION---------------------�
� Individualize and adjust the dosage of FIASP based on route of
administration, individual's metabolic needs, blood glucose monitoring
results and glycemic control goal (2.2).
� Dosage adjustments may be needed when switching from another insulin,
with changes in physical activity, changes in concomitant medications,
changes in meal patterns, changes in renal or hepatic function or during
acute illness (2.2).
� Subcutaneous injection (2.2):
o Inject at the start of a meal or within 20 minutes after starting a meal
into the abdomen, upper arm, or thigh.
o Rotate injection sites within the same region.
o Should generally be used in regimens with an intermediate- or long-
acting insulin.
� Intravenous Infusion: Administer only under medical supervision after
diluting to concentrations from 0. 5 to 1 unit/mL insulin aspart in infusion
systems using polypropylene infusion bags (2.2).
---------------------DOSAGE FORMS AND STRENGTHS--------------------�
Injection: 100 units/mL (U-100):
� 10 mL multiple-dose vial (3)
� 3 mL single-patient-use FIASP FlexTouch
� pen (3)
-----------------------------CONTRAINDICATIONS-----------------------------�
� During episodes of hypoglycemia (4).
� Hypersensitivity to insulin aspart or one of the excipients in FIASP (4).
-----------------------WARNINGS AND PRECAUTIONS---------------------�
� Never share a FIASP 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 frequency of glucose
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).
� Hypoglycemia due to medication errors: Accidental mix-ups between
insulin products can occur. Instruct patients to check insulin labels before
injection (5.4).
� Hypokalemia: May be life-threatening. Monitor potassium levels in
patients at risk for hypokalemia and treat if indicated (5.5).
� Hypersensitivity reactions: Severe, life-threatening, generalized allergy,
including anaphylaxis, can occur. Discontinue FIASP, monitor 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 observed with FIASP include: hypoglycemia, allergic
reactions, hypersensitivity, injection site reactions, lipodystrophy, and weight
gain (6.1).
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.
---------------------------------DRUG INTERACTIONS---------------------------�
� Drugs that Increase Hypoglycemia Risk or Increase or Decrease Blood
Glucose Lowering Effect: Adjustment of dosage may be needed; closely
monitor blood glucose (7).
� Drugs that Blunt Hypoglycemia Signs and Symptoms (e.g., beta-blockers,
clonidine, guanethidine, and reserpine): Increased frequency of glucose
monitoring may be required (7).
See 17 for PATIENT COUNSELING INFORMATION and FDAapproved patient labeling.
New: 09/2017
Reference ID: 4160518
