1 HIGHLIGHTS OF PRESCRIBING INFORMATION Dosage adjustments may be needed with changes in physical heart failure; consider dosage reduction or discontinuation if These highlights do not include all the information activity, changes in meal patterns ( , macronutrient content heart failure occurs ( ). needed to use NOVOLOG safely and effectively. See or timing of food intake), changes in renal or hepatic function Hyperglycemia and Ketoacidosis Due to Insulin Pump Device full prescribing information for NOVOLOG . or during acute illness ( ) Malfunction: Monitor glucose and administer NOVOLOG by NOVOLOG (insulin aspart injection) solution for subcutaneous injection if pump malfunction occurs ( ).
2 DOSAGE FORMS AND STRENGTHS . subcutaneous or intravenous use Each presentation contains 100 Units of insulin aspart per mL ADVERSE REACTIONS . Initial Approval: 2000 (U-100) Adverse reactions observed with NOVOLOG include 10 mL vials (3) hypoglycemia, allergic reactions, local injection site reactions, INDICATIONS AND USAGE lipodystrophy, rash, and pruritus (6). 3 mL PenFill cartridges for the 3 mL PenFill cartridge device NOVOLOG is rapid acting human insulin analog indicated to (3) To report SUSPECTED ADVERSE REACTIONS, contact improve glycemic control in adults and children with diabetes Novo Nordisk Inc. at 1-800-727-6500 or FDA at 1-800- 3 mL NOVOLOG FlexPen (3). mellitus (1). FDA-1088 or 3 mL NOVOLOG FlexTouch (3).
3 DOSAGE AND ADMINISTRATION DRUG INTERACTIONS . CONTRAINDICATIONS . See Full Prescribing Information for important administration Drugs that may increase the risk of hypoglycemia: antidiabetic and dosage instructions ( , , , , ). During episodes of hypoglycemia (4). agents, ACE inhibitors, angiotensin II receptor blocking Subcutaneous injection ( ): Hypersensitivity to NOVOLOG or one of its excipients. agents, disopyramide, fibrates, fluoxetine, monoamine o Inject subcutaneously within 5-10 minutes before a meal WARNINGS AND PRECAUTIONS oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, into the abdominal area, thigh, buttocks or upper arm. Never share a NOVOLOG FlexPen or a NOVOLOG salicylates, somatostatin analog ( , octreotide),and o Rotate injection sites within the same region from one FlexTouch , PenFill cartridge or PenFill cartridge device sulfonamide antibiotics (7).
4 Injection to the next. between patients, even if the needle is changed ( ). Drugs that may decrease the blood glucose lowering effect: o Should generally be used in regimens with an Hyper- or hypoglycemia with changes in insulin regimen: atypical antipsychotics, corticosteroids, danazol, diuretics, intermediate- or long-acting insulin. Carry out under close medical supervision and increase estrogens, glucagon, isoniazid, niacin, oral contraceptives, Continuous Subcutaneous Infusion (Insulin Pump) ( ): frequency of blood glucose monitoring ( ). phenothiazines, progestogens ( , in oral contraceptives), o Change the NOVOLOG in the reservoir at least every 6 Hypoglycemia: May be life-threatening.
5 Increase frequency protease inhibitors, somatropin, sympathomimetic agents of glucose monitoring with changes to: insulin dosage, ( , albuterol, epinephrine, terbutaline), and thyroid days co-administered glucose lowering medications, meal pattern, hormones (7). o Change the infusion set, and the infusion set insertion site physical activity; and in patients with renal or hepatic Drugs that may increase or decrease the blood glucose at least every 3 days. impairments and hypoglycemia unawareness ( ). lowering effect: Alcohol, beta-blockers, clonidine, lithium o Do not mix with other insulins or diluents in the pump Medication Errors: Accidental mix-ups between insulin salts, and pentamidine (7).
6 Intravenous Administration ( ): Drugs that may blunt the signs and symptoms of hypoglycemia: products can occur. Instruct patients to check insulin labels o Dilute NOVOLOG to concentrations from unit/ beta-blockers, clonidine, guanethidine, and reserpine (7). before injection ( ). mL to 1 unit/mL insulin aspart in infusion systems using Hypersensitivity reactions: Severe, life-threatening, generalized USE IN SPECIFIC POPULATIONS . polypropylene infusion bags. allergy, including anaphylaxis, may occur. Discontinue Pediatric: Has not been studied in children with type 2. o NOVOLOG is stable in infusion fluids such as NOVOLOG , treat, and monitor, if indicated ( ). diabetes. Has not been studied in children with type 1 diabetes sodium chloride.
7 Hypokalemia: May be life-threatening. Monitor potassium <2 years of age ( ). Individualize and adjust the dosage of NOVOLOG based levels in patients at risk of hypokalemia and treat if indicated on route of administration, the individual's metabolic needs, ( ). See 17 for PATIENT COUNSELING INFORMATION and blood glucose monitoring results and glycemic control goal FDA approved patient labeling. Fluid retention and heart failure with concomitant use of ( ). thiazolidinediones (TZDs): Observe for signs and symptoms of Revised: 3/2017. FULL PRESCRIBING INFORMATION: CONTENTS* 6 ADVERSE REACTIONS 14 CLINICAL STUDIES. 1 INDICATIONS AND USAGE Clinical Trial Experience Overview of Clinical Studies Immunogenicity Clinical Studies in Adult and Pediatric Patients with 2 DOSAGE AND ADMINISTRATION Type 1 Diabetes and Subcutaneous Daily Injections Post Marketing Experience Important Administration Instructions Clinical Studies in Adults with Type 2 Diabetes and Route of Administration 7 DRUG INTERACTIONS.
8 Subcutaneous Daily Injections Dosage Information 8 USE IN SPECIFIC POPULATIONS Clinical Studies in Adults and Pediatrics with Type Dosage Adjustment Due to Drug Interactions Pregnancy 1 Diabetes Using Continuous Subcutaneous Insulin Instructions for Mixing with Other Insulins Nursing Mothers Infusion (CSII) by External Pump 3 DOSAGE FORMS AND STRENGTHS Pediatric Use Clinical Studies in Adults with Type 2 Diabetes Geriatric Use Using Continuous Subcutaneous Insulin Infusion 4 CONTRAINDICATIONS (CSII) by External Pump Renal Impairment 5 WARNINGS AND PRECAUTIONS Hepatic Impairment 16 HOW SUPPLIED/STORAGE AND HANDLING. Never Share a NOVOLOG FlexPen , NOVOLOG How Supplied FlexTouch , PenFill Cartridge, or PenFill 10 OVERDOSAGE.
9 Recommended Storage Cartridge Device Between Patients 11 DESCRIPTION. Hyperglycemia or Hypoglycemia with Changes in 17 PATIENT COUNSELING INFORMATION. 12 CLINICAL PHARMACOLOGY. Insulin Regimen Mechanism of Action * S ections or subsections omitted from the full prescribing Hypoglycemia Pharmacodynamics information are not listed. Hypoglycemia Due to Medication Errors Pharmacokinetics Hypersensitivity and Allergic Reactions Hypokalemia 13 NONCLINICAL TOXICOLOGY. Fluid Retention and Heart Failure with Concomitant Carcinogenesis, Mutagenesis, Impairment of Use of PPAR-gamma Agonists Fertility Hyperglycemia and Ketoacidosis Due to Insulin Animal Toxicology and/or Pharmacology Pump Device Malfunction 1.
10 NOVOLOG (insulin aspart injection) 2. FULL PRESCRIBING INFORMATION 3 DOSAGE FORMS AND STRENGTHS Fluid Retention and Heart Failure with Concomitant Use 1 INDICATIONS AND USAGE NOVOLOG 100 units per mL (U-100) is available as a clear and colorless of PPAR-gamma Agonists NOVOLOG is a rapid acting human insulin analog indicated to improve solution for injection in: Thiazolidinediones (TZDs), which are peroxisome proliferator-activated glycemic control in adults and children with diabetes mellitus. 10 mL vials receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, 3 mL PenFill cartridges for the 3 mL PenFill cartridge delivery device particularly when used in combination with insulin.