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Novolog® (Insulin Aspart)

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Novolog® (Insulin Aspart) HIGHLIGHTS OF PRESCRIBING INFORMATION • Individualize and adjust the dosage of NOVOLOG® based heart failure; consider dosage reduction or discontinuation if These highlights do not include all the information on route of administration, the individual’s metabolic needs, heart failure occurs (5.7). needed to use NOVOLOG® safely and effectively. blood glucose monitoring results and glycemic control goal • Hyperglycemia and Ketoacidosis Due to Insulin Pump Device See full prescribing information for NOVOLOG®. (2.4). Malfunction: Monitor glucose and administer NOVOLOG® by NOVOLOG® (insulin aspart) injection, for subcutaneous • Dosage adjustments may be needed with changes in physical subcutaneous injection if pump malfunction occurs (5.8). or intravenous use activity, changes in meal patterns (i.e., macronutrient content ——— ADVERSE REACTIONS ——— Initial U.S. Approval: 2000 or timing of food intake), changes in renal or hepatic function Adverse reactions observed with NOVOLOG® include or during acute illness (2.4). hypoglycemia, allergic reactions, local injection site reactions, ——— RECENT MAJOR CHANGES ——— ——— DOSAGE FORMS AND STRENGTHS ——— lipodystrophy, rash, and pruritus (6). Indications and Usage (1) ----------------------------------------- 03/2021 Injection: 100 units/mL (U-100) of insulin aspart available as: To report SUSPECTED ADVERSE REACTIONS, contact Warnings and Precautions (5.3, 5.4, 5.5, 5.6) -------------------- 03/2021 • 10 mL multiple-dose vial (3) Novo Nordisk Inc. at 1-800-727-6500 or FDA at 1-800- ® FDA-1088 or www.fda.gov/medwatch. ——— INDICATIONS AND USAGE ——— • 3 mL single-patient-use PenFill cartridges for the ® • NOVOLOG® is rapid acting human insulin analog indicated to 3 mL PenFill cartridge device (3) ——— DRUG INTERACTIONS ——— improve glycemic control in adults and pediatric patients with • 3 mL single-patient-use NOVOLOG® FlexPen® (3) • Drugs that may increase the risk of hypoglycemia: antidiabetic diabetes mellitus (1). • 3 mL single-patient-use NOVOLOG® FlexTouch® (3) agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine ——— DOSAGE AND ADMINISTRATION ——— ——— CONTRAINDICATIONS ——— oxidase inhibitors, pentoxifylline, pramlintide, salicylates, • See Full Prescribing Information for important administration • During episodes of hypoglycemia (4). somatostatin analog (e.g., octreotide), and sulfonamide and dosage instructions (2.1,2.2,2.3,2.4,2.5). • Hypersensitivity to NOVOLOG® or one of its excipients. antibiotics (7). • Subcutaneous injection (2.2): ——— WARNINGS AND PRECAUTIONS ——— • Drugs that may decrease the blood glucose lowering effect: • Inject subcutaneously within 5-10 minutes before a meal • Never share a NOVOLOG® FlexPen® or a NOVOLOG® atypical antipsychotics, corticosteroids, danazol, diuretics, into the abdominal area, thigh, buttocks or upper arm. FlexTouch®, PenFill® cartridge or PenFill® cartridge device estrogens, glucagon, isoniazid, niacin, oral contraceptives, • Rotate injection sites within the same region from one between patients, even if the needle is changed (5.1). phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents injection to the next to reduce risk of lipodystrophy and • Hyperglycemia or hypoglycemia with changes in insulin (e.g., albuterol, epinephrine, terbutaline), and thyroid localized cutaneous amyloidosis. regimen: Make changes to a patient’s insulin regimen (e.g., hormones (7). • Should generally be used in regimens with an insulin strength, manufacturer, type, injection site or method intermediate- or long-acting insulin. of administration) under close medical supervision with • Drugs that may increase or decrease the blood glucose • Continuous Subcutaneous Infusion (Insulin Pump) (2.2): increased frequency of blood glucose monitoring (5.2). lowering effect: alcohol, beta-blockers, clonidine, lithium salts, and pentamidine (7). • Administer by continuous subcutaneous infusion using an • Hypoglycemia: May be life-threatening. Increase frequency insulin pump in a region recommended in the instructions of glucose monitoring with changes to: insulin dosage, • Drugs that may blunt the signs and symptoms of from the pump manufacturer. co-administered glucose lowering medications, meal hypoglycemia: beta-blockers, clonidine, guanethidine, and • Rotate the injection sites within the same region from one pattern, physical activity; and in patients with renal or hepatic reserpine (7). injection to the next to reduce the risk of lipodystrophy and impairments and hypoglycemia unawareness (5.3). See 17 for PATIENT COUNSELING INFORMATION and localized cutaneous amyloidosis. • Medication Errors: Accidental mix-ups between insulin FDA approved patient labeling. • Change the NOVOLOG® in the reservoir at least every 6 products can occur. Instruct patients to check insulin labels days. before injection (5.4). Revised: 03/2021 • Change the infusion set and the infusion set insertion site • Hypersensitivity reactions: Severe, life-threatening, at least every 3 days. generalized allergy, including anaphylaxis, may occur. • Do not mix with other insulins or diluents in the pump. Discontinue NOVOLOG®, treat, and monitor, if indicated (5.5). • Intravenous Administration (2.2): • Hypokalemia: May be life-threatening. Monitor potassium • Dilute NOVOLOG® to concentrations from 0.05 unit/ levels in patients at risk of hypokalemia and treat if indicated mL to 1 unit/mL insulin aspart in infusion systems using (5.6). polypropylene infusion bags. • Fluid retention and heart failure with concomitant use of • NOVOLOG® is stable in infusion fluids such as 0.9% thiazolidinediones (TZDs): Observe for signs and symptoms of Sodium Chloride Injection, USP. FULL PRESCRIBING INFORMATION: CONTENTS* 6 ADVERSE REACTIONS 14 CLINICAL STUDIES 1 INDICATIONS AND USAGE 6.1 Clinical Trial Experience 14.1 Overview of Clinical Studies 6.2 Immunogenicity 14.2 Clinical Studies in Adult and Pediatric Patients with 2 DOSAGE AND ADMINISTRATION Type 1 Diabetes and Subcutaneous Daily Injections 2.1 Important Administration Instructions 6.3 Post Marketing Experience 7 DRUG INTERACTIONS 14.3 Clinical Studies in Adults with Type 2 Diabetes and 2.2 Route of Administration Subcutaneous Daily Injections 2.3 Dosage Information 8 USE IN SPECIFIC POPULATIONS 14.4 Clinical Studies in Adults and Pediatrics with Type 2.4 Dosage Adjustment Due to Drug Interactions 8.1 Pregnancy 1 Diabetes Using Continuous Subcutaneous Insulin 2.5 Instructions for Mixing with Other Insulins 8.2 Lactation Infusion (CSII) by External Pump 3 DOSAGE FORMS AND STRENGTHS 8.4 Pediatric Use 14.5 Clinical Studies in Adults with Type 2 Diabetes Using Continuous Subcutaneous Insulin Infusion 4 CONTRAINDICATIONS 8.5 Geriatric Use 8.6 Renal Impairment (CSII) by External Pump 5 WARNINGS AND PRECAUTIONS 8.7 Hepatic Impairment 16 HOW SUPPLIED/STORAGE AND HANDLING ® ® ® 5.1 Never Share a NOVOLOG FlexPen , NOVOLOG ® ® ® 10 OVERDOSAGE 16.1 How Supplied FlexTouch , PenFill Cartridge, or PenFill 16.2 Recommended Storage Cartridge Device between Patients 11 DESCRIPTION 17 PATIENT COUNSELING INFORMATION 5.2 Hyperglycemia or Hypoglycemia with Changes in 12 CLINICAL PHARMACOLOGY Insulin Regimen 12.1 Mechanism of Action * Sections or subsections omitted from the full prescribing 5.3 Hypoglycemia 12.2 Pharmacodynamics information are not listed. 5.4 Hypoglycemia Due to Medication Errors 12.3 Pharmacokinetics 5.5 Hypersensitivity Reactions 5.6 Hypokalemia 13 NONCLINICAL TOXICOLOGY 5.7 Fluid Retention and Heart Failure with Concomitant 13.1 Carcinogenesis, Mutagenesis, Impairment of Use of PPAR-gamma Agonists Fertility 5.8 Hyperglycemia and Ketoacidosis Due to Insulin 13.2 Animal Toxicology and/or Pharmacology Pump Device Malfunction 1 NovoLog® (insulin aspart) injection 2 FULL PRESCRIBING INFORMATION 2.5 Instructions for Mixing with Other Insulins 5.5 Hypersensitivity Reactions 1 INDICATIONS AND USAGE NOVOLOG® NOVOLOG® may be mixed with NPH insulin Severe, life-threatening, generalized allergy, including anaphylaxis, can NOVOLOG® is indicated to improve glycemic control in adults and subcutaneous injection preparations ONLY. occur with insulins, including NOVOLOG®. If hypersensitivity reactions pediatric patients with diabetes mellitus. route • If NOVOLOG® is mixed with NPH occur, discontinue NOVOLOG®; treat per standard of care and monitor insulin, draw NOVOLOG® into the ® 2 DOSAGE AND ADMINISTRATION until symptoms and signs resolve [see Adverse Reactions (6)]. NOVOLOG syringe first and inject immediately is contraindicated in patients who have had hypersensitivity reactions to 2.1 Important Administration Instructions after mixing. insulin aspart or one of the excipients [see Contraindications (4)]. • Always check insulin labels before administration [see Warnings and NOVOLOG® continuous Do NOT mix NOVOLOG® with any other Precautions (5.4)]. subcutaneous infusion insulin. 5.6 Hypokalemia ® ® • Inspect NOVOLOG visually before use. It should appear clear and route (Insulin Pump) All insulins, including NOVOLOG , can cause a shift in potassium from ® colorless. Do not use NOVOLOG if particulate matter or coloration is 3 DOSAGE FORMS AND STRENGTHS the extracellular to intracellular space, possibly leading to hypokalemia. seen. Untreated hypokalemia may cause respiratory paralysis, ventricular ® ® ® ® Injection: 100 units/mL (U-100) is a clear and colorless solution available • Use NOVOLOG FlexPen and NOVOLOG FlexTouch with caution in as: arrhythmia, and death.
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