Fiasp

What is Fiasp?

Fiasp is a prescription man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

Description

FIASP (insulin aspart injection) is a rapid-acting insulin analog for subcutaneous or intravenous administration used to lower blood glucose. Insulin aspart is homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae. Insulin aspart has the empirical formula C256H381N65079S6 and a molecular weight of 5825.8 daltons.

FIASP (insulin aspart injection) is an aqueous, sterile, clear and colorless solution. Each mL contains 100 units of insulin aspart and the inactive ingredients: arginine (as L-arginine hydrochloride), USP (3.48 mg); disodium phosphate dihydrate, USP (0.53 mg); glycerol, USP (3.3 mg); metacresol, USP (1.72 mg); niacinamide, USP (20.8 mg); phenol, USP (1.50 mg); zinc (as zinc acetate), USP (19.6 mcg) and water for injection, USP. FIASP has a pH of 7.1. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

Mechanism of Action

The primary activity of FIASP is the regulation of glucose metabolism. Insulins, including insulin aspart, the active ingredient in FIASP, exert their specific action through binding to insulin receptors. Receptor-bound insulin lowers blood glucose by facilitating cellular uptake of glucose into skeletal muscle and adipose tissue and by inhibiting the output of glucose from the liver. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis, and enhances protein synthesis.

What is the most important information I should know about Fiasp?

Do not share your Fiasp with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Who should not take Fiasp?

Do not take Fiasp if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to insulin aspart or any of the ingredients in Fiasp.

What should I tell my healthcare provider before taking Fiasp?

Before taking Fiasp, tell your healthcare provider about all your medical conditions including, if you:

• have kidney problems.
• have liver problems.
• are pregnant or plan to become pregnant. Talk with your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Fiasp passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while using Fiasp.
• are taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.

Before you start taking Fiasp, talk to your healthcare provider about low blood sugar and how to manage it.

How should I take Fiasp?

• Read the Instructions for Use that come with your Fiasp.
• Take Fiasp exactly as your healthcare provider tells you to.
• Fiasp starts acting fast. You should take your dose of Fiasp at the beginning of the meal or within 20 minutes after starting a meal.
• Know the type and strength of insulin you take. Do not change the type of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin.
• If you miss a dose of Fiasp, monitor your blood sugar levels to decide if an insulin dose is needed. Continue with your regular dosing schedule at the next meal.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.
• Do not reuse or share needles with other people. You may give other people a serious infection or get a serious infection from them.
• Fiasp can be injected under the skin(subcutaneously) of your stomach area, upper legs, or upper arms, or by continuous infusion under the skin (subcutaneously) through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump.
• Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting pits in skin or thickened skin (lipodystrophy) and skin with lumps (localized cutaneous amyloidosis) at the injection sites.
• Do not use the exact same spot for each injection.
• Do not inject where the skin has pits, is thickened, or has lumps.
• Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

What should I avoid while taking Fiasp?

While taking Fiasp do not:

• Drive or operate heavy machinery until you know how Fiasp affects you.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of Fiasp?

Fiasp may cause serious side effects that can lead to death, including:

• low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
  • dizziness or light-headedness
  • blurred vision
  • anxiety, irritability, or mood changes
  • sweating
  • slurred speech
  • hunger
  • confusion
  • shakiness
  • headache
  • fast heart beat
• low potassium in your blood (hypokalemia).
• serious allergic reactions (whole body reactions). Get emergency medical help right away, if you have any of these signs or symptoms of a severe allergic reaction:
  • a rash over your whole body, trouble breathing, a fast heartbeat, swelling of your face, tongue or throat, sweating, extreme drowsiness, dizziness, confusion.
• heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Fiasp may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Fiasp. Your healthcare provider should monitor you closely while you are taking TZDs with Fiasp. Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, swelling of your ankles or feet, sudden weight gain. Treatment with TZDs and Fiasp may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
• Your insulin dose may need to change because of:
  • change in level of physical activity or exercise
  • increased stress
  • change in diet
  • weight gain or loss
  • illness

Common side effects of Fiasp may include:

• skin problems such as eczema, rash, itching, redness and swelling of your skin (dermatitis)
• reactions at the injection site such as itching, rash
• skin thickening or pits at the injection site (lipodystrophy)
• weight gain

These are not all the possible side effects of Fiasp. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Fiasp

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about Fiasp that is written for health professionals. Do not use Fiasp for a condition for which it was not prescribed. Do not give FIASP to other people, even if they have the same symptoms that you have. It may harm them.

How should I store Fiasp?

Unused Fiasp vials should be stored between 2° to 8°C (36° to 46°F) in a refrigerator, but not in or near a freezing compartment. Fiasp should not be exposed to excessive heat or light and must never be frozen. Do not use Fiasp if it has been frozen. Fiasp should not be drawn into a syringe and stored for later use.

Keep the cap on the pen in order to protect from light. Remove the needle from the Fiasp FlexTouch pen after each injection and store without a needle attached. Use a new needle for each injection. Keep unused vials, Fiasp FlexTouch and PenFill Cartridges in the carton so they will stay clean and protected from light.

The storage conditions for vials, Fiasp FlexTouch pens, and 3 mL PenFill cartridges are summarized in the table.

Storage Conditions for Vial, Fiasp FlexTouch, and PenFill Cartridges

^{* For insulin pump use, the total in-use time is 28 days, including 6 days pump in-use time.}

Storage of Fiasp in Insulin Pump:

Fiasp in the pump reservoir should be replaced at least every 6 days, or according to the pump user manual, whichever is shorter, to avoid insulin degradation or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and infusion set insertion sites should be changed according to the manufacturers’ user manual.

What are the ingredients in Fiasp?

Active Ingredient: insulin aspart

Inactive Ingredients: glycerol, phenol, metacresol, zinc, disodium phosphate dihydrate, arginine hydrochloride, niacinamide and water for injections

Label

PRINCIPAL DISPLAY PANEL – FLEXTOUCH

PRINCIPAL DISPLAY PANEL – PENFILL

• NDC 0169-3205-15 List 320515
• FIASP® PenFill®
• (insulin aspart injection)
• For Subcutaneous Use
• 100 units/mL (U-100)
• For Subcutaneous Use
• For use with Novo Nordisk 3 mL PenFill® cartridge compatible delivery devices, NovoPen® Echo®, and NovoFine®/NovoFine® Plus or NovoTwist® disposable needles.
• Not in-use (unopened) cartridges: Refrigerate at 36°F to 46°F (2°C to 8°C) in the original carton. In-use (opened) cartridge: Keep at room temperature below 86°F (30°C). Once stored at room temperature, discard after 28 days. Do not freeze. Protect from light.
• Rx only
• 3 mL cartridges
• 5 cartridges per package