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Insulin Aspart Injection

FDA Drug Information • Also known as: Fiasp

Brand Names
Fiasp
Drug Class
Insulin Analog [EPC]
Route
SUBCUTANEOUS
Dosage Form
INJECTION, SOLUTION
Product Type
HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION 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 Saccharomyces cerevisiae . Insulin aspart has the empirical formula C 256 H 381 N 65 0 79 S 6 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); 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. Figure 1

What Is Insulin Aspart Injection Used For?

1 INDICATIONS AND USAGE 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 ( 1 ).

    • Dosage and Administration

    2 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 ( 2.3 ).
  • 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 ( 2.3 ).
  • 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 to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. o Should generally be used in regimens with an intermediate- or long-acting insulin.
  • Continuous Subcutaneous Infusion (Insulin Pump) ( 2.2 ): o Refer to the insulin infusion pump user manual to see if FIASP can be used. Use in accordance with the insulin pumps’ instructions for use. o Administer by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
  • 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 ). 2.1 Important Preparation and Administration Instructions
  • Always check insulin label before administration [see Warnings and Precautions ( 5.4 ) ] .
  • Inspect FIASP visually before use. It should appear clear and colorless. Do not use FIASP if particulate matter or coloration is seen.
  • Use FIASP FlexTouch pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
  • Use PenFill cartridges with caution in patients with visual impairment.
  • Do not mix FIASP with any other insulin. 2.2 Route of Administration Instructions Subcutaneous Injection:
  • Inject FIASP at the start of a meal or within 20 minutes after starting a meal subcutaneously into the abdomen, upper arm, or thigh.
  • Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Adverse Reactions ( 6.1 , 6.2 )].
  • FIASP given by subcutaneous injection should generally be used in regimens with intermediate or long-acting insulin.
  • 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.
  • The FIASP FlexTouch pen dials in 1 unit increments. Continuous Subcutaneous Infusion (Insulin Pump):
  • Refer to the continuous subcutaneous insulin infusion pump user manual to see if FIASP or FIASP PumpCart...

    • Side Effects (Adverse Reactions)

    6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling:

  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen [see Warnings and Precautions ( 5.2 )]
  • Hypoglycemia [see Warnings and Precautions ( 5.3 )]
  • Hypokalemia [see Warnings and Precautions ( 5.5 )]
  • Hypersensitivity and allergic reactions [see Warnings and Precautions ( 5.6 )] Adverse reactions observed with FIASP include: hypoglycemia, allergic reactions, hypersensitivity, injection/infusion 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. 6.1 Clinical 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 [see Clinical Studies ( 14.2 )] . The mean age was 44.4 years and the mean duration of diabetes was 19.9 years. 59% were male, 93% were White, and 2% were Black or African American; and 7% were Hispanic or Latino. The mean BMI was 26.7 kg/m 2 and the mean HbA 1c at baseline was 7.6%. 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 [see Clinical Studies ( 14 )] . The mean age was 59.6 years and the mean duration of diabetes was 13.2 years. 47% were male, 80% were White, and 6% were Black or African American; and 8% were Hispanic or Latino. The mean BMI was 31.5 kg/m 2 and the mean HbA 1c at baseline was 8.0%. 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 [see Clinical Studies ( 14.3 )] . The mean age was 11.7 years and the mean duration of diabetes mellitus was 4.4 years. 54% were male, 81% were White, 16% were Asian and 2% were Black or African American. The mean BMI was 19.7 kg/m 2 and the mean HbA 1c at baseline was 7.6%. 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 Mealtime FIASP + Insulin detemir (N=386) Postmeal FIASP + Insulin detemir (N=377) Nasopharyngitis 20.2 23.9 Upper respiratory tract infection 9.1 7.4 Nausea 4.9 5.0 Diarrhea 5.4 3.2 Back pain 5.2 4.0 *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 FIASP + Insulin glargine (N=341) Urinary tract infection 5.9 *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 Mealtime FIASP + Insulin degludec (N=261) Postmeal FIASP + Insulin degludec (N=258) Viral upper respiratory tract infection Upper respiratory tract infection Influenza Rhinitis Headache Pyrexia Vomiting 23.0 8.4 7.7 3.8 6.1 8.4 3.4 20.5 12.4 5.8 6.2 10.1 6.2 8.1 *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...

    • Drug Interactions

    7 DRUG INTERACTIONS Table 5 includes clinically significant drug interactions with FIASP. Table 5. Clinically Significant Drug Interactions with FIASP Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. Intervention: Dose reductions and increased frequency of glucose monitoring may be required when FIASP is co-administered with these drugs. Drugs That May Decrease the Blood Glucose Lowering Effect of FIASP Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dose increases and increased frequency of glucose monitoring may be required when FIASP is co-administered with these drugs. Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of FIASP Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when FIASP is co-administered with these drugs. Drugs That May Blunt Signs and Symptoms of Hypoglycemia Drugs: Beta-blockers, clonidine, guanethidine, and reserpine. Intervention: Increased frequency of glucose monitoring may be required when FIASP is co-administered with these drugs.

  • 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 ).

    • Contraindications

    4 CONTRAINDICATIONS FIASP is contraindicated:

  • During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] .
  • In patients with known hypersensitivity to insulin aspart or any of the excipients in FIASP [see Warnings and Precautions ( 5.6 )] .
  • During episodes of hypoglycemia ( 4 ).
  • Hypersensitivity to insulin aspart or any of the excipients in FIASP ( 4 ).

    • Pregnancy and Breastfeeding

    8.1 Pregnancy Risk Summary There are no available data with FIASP in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects or adverse maternal or fetal outcomes [see Data] . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations] . In animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8- times and equal to the human subcutaneous dose of 1.0 unit/kg/day, respectively. Pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. These effects were similar to those observed in rats administered regular human insulin [see Data] . The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA 1c >7% and has been reported to be as high as 20-25% in women with a HbA 1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Human Data Published data from 5 randomized controlled trials of 441 pregnant...

    Overdosage

    10 OVERDOSAGE Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3 , 5.5 )] . Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise, may be needed. More severe episodes with coma, seizure or neurologic impairment may be treated with an intramuscular/subcutaneous glucagon product for emergency use or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

    How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied FIASP (insulin aspart) injection 100 units of insulin aspart per mL (U-100) is available as a clear and colorless solution in the following presentations and packaging configurations: Carton of one 10 mL multiple-dose vials NDC 0169-3201-11 Carton of five 3 mL single-patient-use FIASP FlexTouch pens NDC 0169-3204-15 Carton of five 3 mL single-patient-use PenFill cartridges * NDC 0169-3205-15 Carton of five 1.6 mL single-patient-use PumpCart cartridges** NDC 0169-3206-15 The FIASP FlexTouch pen dials in 1 unit increments. * FIASP PenFill cartridges are designed for use with Novo Nordisk insulin delivery devices. ** FIASP PumpCart cartridges are designed for use in compatible pumps only. 16.2 Recommended Storage Dispense in the original sealed carton with the enclosed Instructions for Use. 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, PenFill Cartridges and PumpCart cartridges in the carton so they will stay clean and protected from light. The storage conditions for vials, FIASP FlexTouch pens, 3 mL PenFill cartridges and 1.6 mL PumpCart cartridges are summarized in Table 12: Table 12. Storage Conditions for Vial, FIASP FlexTouch, PenFill Cartridges and PumpCart Cartridges FIASP presentation Not in-use (unopened) In-use (opened) Room Temperature (up to 30°C [86°F]) Refrigerated (2°C to 8°C [36°F to 46°F]) Room Temperature (up to 30°C [86°F]) Refrigerated (2°C to 8°C [36°F to 46°F]) 10 mL multiple-dose vial 28 days...

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.