[Fiasp®] approved by FDA in Sep. 2017

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Fiasp® was approved by FDA in Sep. 2017
announced by Novo Nordisk on september 29, 2017

Brand Name

Fiasp® in US
NovoRapid® in EU, South Korea

the Novo Nordisk Patient Assistance Program by calling toll free at 866-310-7549

Ingredient

Insulin aspart
Vitamin B3 (niacinamide) : for rapid absorption
L-Arginine : for stability.

INDICATIONS AND USAGE

FIASP is a rapid-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus
for subcutaneous or intravenous use

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.
• 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.
• Subcutaneous injection :
  -- Inject at the start of a meal or within 20 minutes after starting a meal into the abdomen, upper arm, or thigh.
  -- Rotate injection sites within the same region.
  -- 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.

DOSAGE FORMS AND STRENGTHS

Injection: 100 units/mL (U-100):

• 10 mL multiple-dose vial
• 3 mL single-patient-use FIASP FlexTouch® pen

CONTRAINDICATIONS

• During episodes of hypoglycemia
• Hypersensitivity to insulin aspart or one of the excipients in FIASP

WARNINGS AND PRECAUTIONS

• Never share a FIASP FlexTouch pen between patients, even if the needle is changed .
• Hyper- or hypoglycemia with changes in insulin regimen: Carry out under close medical supervision and increase frequency of blood glucose monitoring .
• 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
• Hypoglycemia due to medication errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection
• Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated
• Hypersensitivity reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue FIASP, monitor and treat if indicated
• 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

ADVERSE REACTIONS

hypoglycemia, allergic reactions, hypersensitivity, injection site reactions, lipodystrophy, and weight gain

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.
• Drugs that Blunt Hypoglycemia Signs and Symptoms (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Increased frequency of glucose monitoring may be required.

Storage Conditions for Vial and FIASP FlexTouch

Product	Not in-use (unopened)		In-use (opened)
	Room Temperature (below 30°C)	Refrigerated (2°C to 8°C)	Room Temperature (below 30°C)	Refrigerated (2°C to 8°C)
10 ml vial	28 days	until expiration date	28 days	28 days
3 ml pen	28 days	until expiration date	28 days	28 days

• Storage of FIASP in Intravenous Infusion Fluids: Infusion bags prepared as indicated under Dosage and Administration are stable at room temperature for 24 hours.

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PATIENT COUNSELING INFORMATION

• Advise the patient to read the FDA-Approved Patient Labeling (Patient Information and Instructions for Use).
• Never Share a FIASP FlexTouch Pen Device Between Patients
• Advise patients that they should never share a FIASP FlexTouch pen device with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens. Advise patients using FIASP vials not to share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
• Hypoglycemia
  Inform patients that hypoglycemia is the most common adverse reaction with insulin. Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of FIASP therapy. Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals. Instruct patients on the management of hypoglycemia.
• Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery.
• Hypersensitivity Reactions
  Advise patients that hypersensitivity reactions have occurred with FIASP. Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions.
• Hypoglycemia due to Medication Errors
  Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products.
• Women of Reproductive Potential
  Advise patients to inform their health care professional if they are pregnant or are contemplating pregnancy.
• Administration
  FIASP must only be used if the solution is clear and colorless with no particles visible.
  Patients must be advised that FIASP must NOT be diluted or mixed with any other insulin or solution.
  Instruct patients on basal-bolus treatment who forget a mealtime dose to monitor their blood glucose level to decide if an insulin dose is needed, and to resume their usual dosing schedule at the next meal.

Approved: September 2017
Manufacturer : Novo Nordisk
www.novonordisk-us.com or call 1-800-727-6500
Twitter: @novonordiskus

ref.

• http://www.novo-pi.com/fiasp.pdf
• http://press.novonordisk-us.com/2017-09-29-Novo-Nordisk-Receives-FDA-Approval-for-Fiasp-R-a-New-Fast-Acting-Mealtime-Insulin
• http://hugin.info/2013/R/2138112/818474.pdf
• http://www.pharmacytimes.com/product-news/fda-approves-new-fastacting-mealtime-insulin