Pulmonary Hypertension Treatments
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Generic Name
Aspart
Brand Names
FiAsp, Garzulys, Merilog, NovoLog, Orenitram, Remodulin, Treprostinil, Tyvaso, Tyvaso DPI, Yutrepia
FDA approval date: August 27, 2001
Classification: Prostacycline Vasodilator
Form: Injection, Inhalant, Tablet, Kit, Capsule
What is FiAsp (Aspart)?
FIASP is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. FIASP is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus .
Approved To Treat
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Brand Information
Fiasp (insulin aspart injection)
1INDICATIONS AND USAGE
FIASP is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
2DOSAGE FORMS AND STRENGTHS
Injection: 100 units of insulin aspart per mL (U-100) is available as a clear and colorless solution in:
- 10 mL multiple-dose vial
- 3 mL single-patient-use FIASP FlexTouch pen
- 3 mL single-patient-use PenFill cartridges for use in a PenFill cartridge delivery device
- 1.6 mL single-patient-use PumpCart cartridges for use in a compatible insulin pump.
3CONTRAINDICATIONS
FIASP is contraindicated:
- During episodes of hypoglycemia
- In patients with known hypersensitivity to insulin aspart or any of the excipients in FIASP
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in labeling:
- Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen
- Hypoglycemia
- Hypokalemia
- Hypersensitivity and allergic reactions
4.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates actually observed in clinical practice.
The data in Table 1 reflect the exposure of 763 adult patients with type 1 diabetes mellitus to FIASP in one clinical trial with a mean exposure duration of 25 weeks
The data in Table 2 reflect the exposure of 341 adult patients with type 2 diabetes mellitus to FIASP in one clinical trial with a mean exposure duration of 24 weeks
The data in Table 3 reflect the exposure of 519 pediatric patients with type 1 diabetes mellitus to FIASP in one clinical trial with a mean exposure duration of 26 weeks
Common adverse reactions, excluding hypoglycemia, were defined as events occurring in ≥5% and occurring at the same rate or greater for FIASP-treated patients than comparator-treated patients.
Table 1. Adverse Reactions (%*) in Adult Patients with Type 1 Diabetes Mellitus
*Incidence ≥ 5% and occurring at the same rate or greater with FIASP than comparator
Table 2. Adverse Reactions (%*) in Adult Patients with Type 2 Diabetes Mellitus
*Incidence ≥ 5% and occurring at the same rate or greater with FIASP than comparator
Table 3: Adverse Reactions (%*) in Pediatric Patients with Type 1 Diabetes Mellitus
*Incidence ≥ 5% and occurring at the same rate or greater with FIASP than comparator
Hypoglycemia
Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including FIASP. The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for FIASP with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that occur in clinical practice.
Incidence rates for severe hypoglycemia in adults with type 1 and type 2 diabetes mellitus and pediatric patients with type 1 diabetes mellitus treated with FIASP in clinical trials are shown in Table 4
Table 4. Proportion (%) of Patients with Type 1 Diabetes and Type 2 Diabetes Mellitus Experiencing at Least One Episode of Severe Hypoglycemia in Adult and Pediatric Clinical Trials
- *Severe hypoglycemia: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions
Blood glucose confirmed hypoglycemia was defined as a self-measured glucose calibrated to plasma of less than 56 mg/dL.
In Study D, adult patients with type 1 diabetes mellitus treated with FIASP in a pump reported a higher rate of blood glucose confirmed hypoglycemic episodes within the first hour after a meal compared to patients treated with NovoLog
In Study E, pediatric patients with type 1 diabetes mellitus treated with mealtime and postmeal FIASP reported a higher rate of blood glucose confirmed hypoglycemic episodes compared to patients treated with NovoLog; the imbalance was greater during the nocturnal period
Allergic Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including FIASP, and may be life threatening. In the clinical program, generalized hypersensitivity reactions (manifested by generalized skin rash and facial edema) were reported in 0.4% of adult patients treated with FIASP. Allergic skin manifestations reported with FIASP in 1.7% of adult patients from the clinical program include eczema, rash, rash pruritic, urticaria and dermatitis. In Study D, allergic reactions were reported in 4.2% of adult patients with type 1 diabetes mellitus treated with FIASP. In Study E, allergic reactions were reported in 4% of pediatric patients with type 1 diabetes mellitus treated with FIASP.
Lipodystrophy
Administration of insulin, including FIASP, has resulted in lipohypertrophy (enlargement or thickening of tissue) and lipoatrophy (depression in the skin). In the clinical program, lipodystrophy was reported in 0.4% of adult patients and 2.1% of pediatric patients treated with FIASP
Injection/Infusion Site Reactions
As with other insulin therapy, patients may experience rash, redness, inflammation, pain, bruising or itching at the site of FIASP injection or infusion. These reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation of FIASP. In the clinical program, injection site reactions occurred in 1.6% of adult patients treated with FIASP. In Study A, adult patients with type 1 diabetes mellitus treated with FIASP reported 2.2% injection site reactions. In Study D, infusion site reactions were reported in 10.2% of adult patients with type 1 diabetes mellitus treated with FIASP. In Study E, injection site reactions were reported in 4.2% of pediatric patients with type 1 diabetes mellitus treated with FIASP.
Weight Gain
Weight gain can occur with insulin therapy, including FIASP, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria. In Study A, adult patients with type 1 diabetes mellitus treated with FIASP gained an average of 0.7 kg and in Study B, adult patients with type 2 diabetes mellitus treated with FIASP gained an average of 2.7 kg.
Peripheral Edema
Insulin, including FIASP, may cause sodium retention and edema, particularly if previous poor metabolic control is improved by intensified insulin therapy. In the clinical program, peripheral edema occurred in 0.8% of adult patients treated with FIASP.
4.2Postmarketing Experience
The following additional adverse reactions have been identified during post-approval use of insulin aspart. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
5DRUG INTERACTIONS
Table 5 includes clinically significant drug interactions with FIASP.
Table 5. Clinically Significant Drug Interactions with FIASP
6OVERDOSAGE
Excess insulin administration may cause hypoglycemia and hypokalemia
7DESCRIPTION
Insulin aspart is a rapid-acting insulin analog for subcutaneous or intravenous administration. 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
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); dibasic sodium phosphate, USP (0.42 mg); glycerin, 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. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH to 7.1.
8PATIENT 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, PenFill Cartridge or PenFill Cartridge Device Between Patients
Advise patients that they should never share a FIASP FlexTouch pen device, PenFill cartridge or PenFill cartridge devices 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
Hyperglycemia or 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.
Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision
Hypersensitivity Reactions
Advise patients that hypersensitivity reactions have occurred with FIASP. Inform patients on the symptoms of hypersensitivity reactions
Hypoglycemia due to Medication Errors
Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products.
Patients Using Continuous Subcutaneous Insulin Pumps
- Train patients in intensive insulin therapy with multiple injections and in the function of their pump and pump accessories.
- Instruct patients to follow healthcare provider recommendations when setting basal and meal time infusion rate.
- Refer to the continuous subcutaneous infusion pump user manual to see if FIASP can be used with the pump. See recommended reservoir and infusion sets in the insulin pump user manual.
- Instruct patients to change FIASP in the pump reservoir at least every 6 days, or replace the PumpCart cartridge at least every 4 days or according to the pump user manual, whichever is shorter; infusion sets and infusion set insertion sites should be changed in accordance with the manufacturers’ user manual. By following this schedule, patients avoid insulin degradation, infusion set occlusion, and loss of the insulin preservative.
- Instruct patients to discard insulin exposed to temperatures higher than 37°C (98.6°F).
- Instruct patients to inform physician and select a new site for infusion if infusion site becomes erythematous, pruritic, or thickened.
- Instruct patients on the risk of rapid hyperglycemia and ketosis due to pump malfunction, infusion set occlusion, leakage, disconnection or kinking, and degraded insulin. Instruct patients on the risk of hypoglycemia from pump malfunction. If these problems cannot be promptly corrected, instruct patients to resume therapy with subcutaneous insulin injection and contact their physician
Version: 8
Novo Nordisk
PATENT Information: http://novonordisk-us.com/products/product-patents.html
© 2023
Manufactured by:
Novo Nordisk Inc.
For information about FIASP contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, New Jersey 08536
1-800-727-6500
www.novonordisk-us.com
9Patient Information
FIASP
(insulin aspart)
(insulin aspart)
Injection, for subcutaneous or intravenous use
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.
What is FIASP?
- FIASP is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.
Who should not take FIASP?
Do not take FIASP if you:
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.
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.
- 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:
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:
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:
- 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:
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.
What are the ingredients in FIASP?
Active Ingredient: insulin aspart
Inactive Ingredients: arginine, dibasic sodium phosphate, glycerin, metacresol, niacinamide, phenol, zinc and water for injection.
Manufactured by:
Novo Nordisk Inc.
Novo Nordisk Inc.
U.S. License Number 1261
For more information, go to www.novonordisk-us.com or call 1-800-727-6500.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 06/2023
9.1INSTRUCTIONS FOR USE
FIASP (fee’ asp)
(insulin aspart) injection
10 mL multiple-dose vial (100 units/mL, U-100)
Read this Instructions for Use before you start taking FIASP and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. The vial is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product and insulin syringe.
Do not reuse or share syringes or needles with other people. You may give other people a serious infection or get a serious infection from them.
Supplies you will need to give your FIASP injection:
- a 10 mL FIASP vial
- a U-100 insulin syringe and needle
- 2 alcohol swabs
- 1 sharps container for throwing away used needles and syringes. See “Disposing of your used needles and syringes” at the end of these instructions.
Preparing your FIASP dose:
- Do not roll or shake the FIASP vial. Shaking the FIASP vial right before the dose is drawn into the syringe may cause bubbles or foam. This can cause you to draw up the wrong dose of insulin.
- The tamper-resistant cap should not be loose or damaged before the first use.
- Wash your hands with soap and water.
- Before you start to prepare your injection, check the FIASP label to make sure that you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
- Check that the FIASP vial is not cracked or damaged.
- FIASP should look clear and colorless.
- Do not use FIASP past the expiration date printed on the label.
Giving your FIASP injection:
- Inject your FIASP exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
- You should take your dose of FIASP at the start of a meal or within 20 minutes after starting a meal.
- FIASP can be injected under the skin (subcutaneously) of your stomach area, upper legs, or upper arms, infused in an insulin pump into an area of your body recommended in the instructions that come with your insulin pump, or given through a needle in your arm (intravenously) by your healthcare provider.
- If you use FIASP in an insulin pump, you should change the infusion sets and the infusion set insertion site according to the pump manufacturers’ user manual. The insulin in the reservoir should be changed at least every 6 days even if you have not used all of the insulin.
- If you use FIASP in an insulin pump, see your insulin pump manual for instructions or talk to your healthcare provider. Your healthcare provider should provide recommendations for appropriate basal and meal time infusion rates.
- Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
- Do not dilute or mix FIASP with any other type of insulin products or solutions.
After your injection:
- Do not recap the needle. Recapping the needle can lead to needle stick injury.
Disposing of your used needles and syringes:
Put your used insulin needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic;
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out;
- upright and stable during use;
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. Do not reuse or share needles or syringes with another person. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at:
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
How should I store FIASP?
- Do not freeze FIASP. Do not use FIASP if it has been frozen.
- Keep FIASP away from excessive heat or light.
All unopened vials:
- Store unopened FIASP vials in the refrigerator at 36
- If unopened vials have been stored in the refrigerator, vials may be used until the expiration date printed on the label.
- If unopened vials have been stored at room temperature, vials should be thrown away after 28 days.
After vials have been opened:
- Opened FIASP vials can be stored in the refrigerator at 36
- Throw away all opened FIASP vials after 28 days (including 6 days pump in-use time), even if they still have insulin left in them.
General information about the safe and effective use of FIASP
- Always use a new syringe and needle for each injection to help ensure sterility and prevent blocked needles.
- Do not reuse or share syringes or needles with other people. You may give other people a serious infection or get a serious infection from them.
- Keep FIASP vials, syringes, and needles out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-800-727-6500
U.S. License No. 1261
FIASP
PATENT Information:
© 2023 Novo Nordisk
For information about FIASP
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, New Jersey 08536
1-800-727-6500
Revised: 06/2023
9.2INSTRUCTIONS FOR USE
FIASPFlexTouch
(insulin aspart)
injection, for subcutaneous use
3 mL single-patient-use pen: 100 units/mL (U-100)
- Do not share your FIASP FlexTouch Pen with other people, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them.
- FIASP FlexTouch Pen (“Pen”) is a prefilled disposable, single-patient-use pen containing 300 units of U-100 FIASP (insulin aspart) injection. You can inject from 1 to 80 units in a single injection. The units can be increased by 1 unit at a time.
- People who are blind or have vision problems should not use the Pen without help from a person trained to use the Pen.
- Do not use a syringe to remove FIASP from the FlexTouch Pen.
Supplies you will need to give your FIASP injection:
- FIASP FlexTouch Pen
- a new NovoFine, NovoFine Plus or NovoTwist needle
- alcohol swab
- a sharps container for throwing away used Pens and needles.
Preparing your FIASP FlexTouch Pen:
- Wash your hands with soap and water.
- Before you start to prepare your injection, check the FIASP FlexTouch Pen label to make sure you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin.
- FIASP should look clear and colorless.
- Do not use FIASP past the expiration date printed on the label or 28 days after you start using the Pen.
- Always use a new needle for each injection to help ensure sterility and prevent blocked needles. Do not reuse or share needles with another person. You may give other people a serious infection, or get a serious infection from them.
Priming your FIASP FlexTouch Pen:
Selecting your dose:
Giving your injection:
- Inject your FIASP exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
- You should take your dose of FIASP at the start of a meal or within 20 minutes after starting a meal.
- FIASP can be injected under the skin (subcutaneously) of your stomach area (abdomen), upper legs (thighs) or upper arms.
- Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
After your injection:
- Put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
- upright and stable during use
- leak-resistant
- properly labeled to warn of hazardous waste inside the container
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. Do not reuse or share needles or syringes with another person. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at:
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
How should I store my FIASP FlexTouch Pen?
Before use:
- Store unused FIASP FlexTouch Pens in the refrigerator at 36°F to 46°F (2°C to 8°C) or at room temperature below 86
- Do not freeze FIASP. Do not use FIASP if it has been frozen.
- Unused Pens may be used until the expiration date printed on the label, if kept in the refrigerator.
- If FIASP FlexTouch Pens are stored at room temperature prior to first use, it should be used or thrown away within 28 days.
Pen in use:
- Store the Pen you are currently using without the needle attached at room temperature below 86°F (30°C) or in the refrigerator at 36°F to 46°F (2°C to 8°C) for up to 28 days.
- Keep FIASP away from excessive heat or light.
- The FIASP FlexTouch Pen you are using is to be thrown away after 28 days, even if it still has insulin left in it and the expiration date has not passed.
General Information about the safe and effective use of FIASP:
- Keep FIASP FlexTouch Pens and needles out of the reach of children.
- Always use a new needle for each injection.
- Do not share FIASP FlexTouch Pens or needles with other people. You may give other people a serious infection, or get a serious infection from them.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-800-727-6500
U.S. License No. 1261
Revised: 06/2023
For more information go to
© 2023 Novo Nordisk
9.3INSTRUCTIONS FOR USE
FIASP® [fee’asp] PenFill
(insulin aspart)
injection, for subcutaneous use
3 mL cartridge: 100 units/mL (U-100)
- Do not share your PenFill cartridge or PenFill cartridge compatible insulin delivery device 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.
- Your healthcare provider should show you or your caregiver how to inject FIASP the right way before you inject it for the first time.
- FIASP PenFillcartridge 100 units/mL is a prefilled single-patient-use cartridge containing 300 units of U-100 FIASP (insulin aspart) injection.
- After you insert the PenFill cartridge in your device, you can use it for multiple injections. Read the
- This PenFill cartridge is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product and your insulin delivery device.
- If using a
- If the FIASP PenFill cartridge has already been
Supplies you will need to give your FIASP injection:
- FIASP PenFill cartridge
- Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery device
- 1 new NovoFine
- Alcohol swab
- Adhesive bandage
- Cotton gauze
- A sharps container for throwing away used PenFill cartridges and needles.
(Figure A)
How to use the FIASP PenFill cartridge
- Wash your hands with soap and water.
- Before you start to prepare your injection,
- The tamper-resistant foil should be in place before the first use. If the foil has been broken or removed before your first use of the cartridge,
- Carefully look at the cartridge and the insulin inside it. Check that the FIASP cartridge:
- FIASP should look clear and colorless.
(Figure B)
Step 1:
- Insert a 3 mL cartridge with the threaded end first into your Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery device (See Figure C).
- If you drop your device, check the insulin cartridge for damage such as cracks or leaking. If your cartridge is damaged, throw it away and use a new one.
(Figure C)
Prepare your device with a new needle
Step 2:
- Take a new needle, and tear off the paper tab. Always use a new needle for each injection to make sure the needle is free of germs (sterile) and to prevent blocked needles. Do not attach a new needle to your device until you are ready to give your injection. Do not reuse or share your needles with other people. You may give others a serious infection, or get a serious infection from them.
- Be careful not to bend or damage the needle before you use it.
- Push the needle straight onto the device. Turn the needle clockwise until it is on tight (See Figure D).
(Figure D)
Step 3:
- Pull off the outer needle cap (See Figure E). Do not throw it away. You will need it after the injection to safely remove the needle.
(Figure E)
Step 4:
- Pull off the inner needle cap and throw it away (See Figure F). Do not try to put the inner needle cap back on the needle.
(Figure F)
A drop of insulin may appear at the needle tip. This is normal, but you must still check the insulin flow.
Check the insulin flow
Step 5:
- Small amounts of air may collect in the cartridge during normal use. You must do an airshot before each injection to avoid injecting air and to make sure you receive the prescribed dose of your medicine.
- Do the airshot as described in the instruction manual that comes with your device.
- Keep testing your Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery device until you see insulin at the needle tip. If you still do not see a drop of insulin after 6 times, change the needle and repeat this step. This makes sure that any air bubbles are removed and that insulin is getting through the needle (See Figure G).
(Figure G)
Select your dose
Step 6:
- Check to make sure that the dose counter is set to 0.
- Turn the dose selector clockwise to select the dose you need to inject (See Figure H). The pointer should line up with your dose. When turning the dose selector, be careful not to press the dose button as insulin will come out. You will hear a click for every single unit dialed. Do not set the dose by counting the number of clicks you hear because you may get an incorrect dose.
- Refer to your insulin delivery device manual if necessary.
(Figure H)
Inject your dose
Step 7:
- Do the injection exactly as shown to you by your healthcare provider. Your healthcare provider should tell you if you need to pinch the skin before injecting.
- You should take your dose of FIASP at the start of a meal or within 20 minutes after starting a meal.
- FIASP can be injected under the skin (subcutaneously) of your stomach area (abdomen), upper legs (thighs), or upper arms (See Figure I).
(Figure I)
- Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not use the same injection site 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.
- Clean your injection site with an alcohol swab. Let your skin dry. Do not touch this area again before injecting.
- Insert the needle into your skin. Press and hold down the dose button until the dose counter shows “0”. Continue to keep the dose button pressed and keep the needle in your skin and slowly count to 6 (see Figure J).
- Remove the needle from your skin.
(Figure J)
You may see a drop of FIASP at the needle tip after injecting. This is normal and has no effect on the dose you just received. If blood appears after you take the needle out of your skin, press the injection site lightly with a cotton gauze and cover with an adhesive bandage, if necessary.
After your injection
Step 8:
- Lay your outer needle cap on a flat surface. Carefully, lead the needle tip into the outer needle cap without touching the needle (See Figure K) and push the outer needle cap completely on.
(Figure K)
- Hold the black cartridge holder on the insulin delivery device and unscrew the needle counterclockwise (See Figure L).
(Figure L)
- Throw away (dispose of) the needle in an FDA-cleared sharps container as your healthcare professional has instructed you.
- Put your empty FIASP PenFill cartridge and used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and PenFill cartridges in your household trash.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
- upright and stable during use
- leak-resistant
- properly labeled to warn of hazardous waste inside the container
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. Do not reuse or share your needles or syringes with other people. For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Step 9:
- Keep the 3 mL PenFill cartridge in the device.
- Put the pen cap on your device after each use to protect the insulin from light (See Figure M).
(Figure M)
How should I store my FIASP PenFill cartridge?
Before use:
- Store unused FIASP PenFill cartridges in the refrigerator at 36°F to 46°F (2°C to 8°C).
- Do not freeze FIASP. Do not use FIASP if it has been frozen.
- Unused PenFill cartridges may be used until the expiration date printed on the label, if kept in the refrigerator.
- If FIASP is stored mistakenly outside of refrigeration between 47°F (9°C) to 86°F (30°C) prior to first use, it should be used within 28 days or thrown away.
PenFill cartridges in use:
- Store the PenFill cartridge you are currently using in the insulin delivery device at room temperature below 86°F (30°C) for up to 28 days. Do not refrigerate.
- Keep FIASP away from heat or light.
- The FIASP PenFill cartridge you are using should be thrown away after 28 days, even if it still has insulin left in it.
General Information about the safe and effective use of FIASP.
- Keep FIASP PenFill cartridges and needles out of the reach of children.
- Do not share FIASP PenFill cartridges or needles with other people. You may give other people a serious infection, or get a serious infection from them.
- Always carry extra insulin of the same type(s) you use in case of loss or damage.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
© 2023 Novo Nordisk
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-800-727-6500
U.S. License No. 1261
Revised: 06/2023
9.4INSTRUCTIONS FOR USE
FIASP®[fee’asp] PumpCart
(insulin aspart)
injection, for subcutaneous use
1.6 mL cartridge: 100 units/mL (U-100)
- Please read the pump manual (user guide) that comes with your insulin pump.
- Only use FIASP PumpCart with a compatible insulin pump. Check the insulin pump manual for instructions to see if FIASP PumpCart can be used with the pump. Do not use with other devices that are not designed for use with FIASP PumpCart.
- FIASP PumpCart is ready for use directly in the pump. Using the wrong device may result in the wrong insulin dosing and lead to high blood sugar (hyperglycemia) or low blood sugar (hypoglycemia).
- Do not share your PumpCart cartridge with other people. You may give other people a serious infection or get a serious infection from them.
- Do not use the PumpCart cartridge if you are blind or visually impaired without the assistance of a person trained in the proper use of the PumpCart.
- Do not mix with any other insulins.
- Do not refill FIASP PumpCart. When it is empty, throw away (dispose) the cartridge.
- Do not use FIASP PumpCart in an insulin pen.
Preparing and Using the FIASP PumpCart cartridge
- Take FIASP PumpCart out of its package.
- Check the label to make sure that it is FIASP PumpCart and confirm that you are using a compatible insulin pump.
- Check the expiry date (EXP) – which is on the label and the carton.
- See picture A.
- Check that the insulin in FIASP PumpCart is clear and colorless. If the insulin looks cloudy, do not use FIASP PumpCart. The cartridge may contain small bubbles.
- Wash your hands with soap and water prior to installing the cartridge in your insulin pump.
- Follow the instructions in the pump user manual to insert a new FIASP PumpCart cartridge in your pump and to remove the FIASP PumpCart cartridge from your pump.
- Replace the FIASP PumpCart cartridge at least every 4 days, or according to the pump user manual, whichever is shorter, even if you have not used all of the insulin.
- Change the infusion sets and the infusion set insertion site according to the insulin pump manufacturers’ user manual.
- Throw away FIASP PumpCart in the pump reservoir if it has been exposed to temperatures higher than 98.6°F (37°C).
- How should I dispose my FIASP PumpCart cartridge?
- Put your empty FIASP PumpCart in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) Fiasp PumpCart in your household trash.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at:
How should I store my FIASP PumpCart cartridge?
- Not in-use (unopened) cartridges: Refrigerate at 36°F to 46°F (2°C to 8°C) in the original carton until expiration or for up to 18 days below 86°F (30°C).
- In-use (opened) cartridge: Do not refrigerate. Keep below 98.6°F (37°C) for up to 4 days. The maximum time at room temperature is 18 days including 4 days in the pump.
- Do not freeze.
- Keep FIASP PumpCart cartridge away from heat or light.
General Information about the safe and effective use of FIASP PumpCart cartridge
- Keep FIASP PumpCart out of the reach of children.
- Always carry extra insulin of the same type you use in case of loss or damage
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
© 2023 Novo Nordisk
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, New Jersey 08536
US License Number 1261
Revised: 06/2023
10PRINCIPAL DISPLAY PANEL - VIAL
NDC 0169-3201-11 List 320111
FIASP®
(insulin apart) injection
100 units/mL (U-100)
For subcutaneous or intravenous use
- Rx only
11PRINCIPAL DISPLAY PANEL - FLEXTOUCH
NDC 0169-3204-15 List 320415
FIASP®FlexTouch®
(insulin aspart) injection
For Single-Patient Use Only
100 units/mL (U-100)
For subcutaneous use only
Rx Only
Recommended for use with NovoFine
NovoFine
Keep in a refrigerator at 36° to 46°F (2° to 8°C) until first use.
After first use store at 36° to 86°F (2° to 30°C) up to 28 days.
Do not freeze.
Protect from light.
Dispense in this sealed carton.
5×3 mL Prefilled Pens
12PRINCIPAL DISPLAY PANEL - PenFill
- NDC 0169-3205-15 List 320515
FIASP
(insulin aspart) injection
For Single-Patient Use Only
100 units/mL (U-100)
For Subcutaneous Use
For use with Novo Nordisk 3 mL PenFill
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
13Principal Display Panel - PumpCart
NDC 0169-3206-15 List 320615
- Fiasp® PumpCart®
(insulin aspart) injection
For Single-Patient Use Only
100 units/mL (U-100)
For use with a compatible insulin pump only
For Subcutaneous Use
Not in-use (unopened) cartridges: Refrigerate at 36°F to 46°F (2°C to 8°C) until expiration or for up to 18 days below 86°F (30°C) in the original carton.
In-use (opened) cartridges: Keep below 98.6°F (37°C) for up to 4 days.
Do not freeze. Protect from light.
Rx only
1.6 mL cartridges
5 cartridges per package
