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NOVOLOG
(insulin aspart) Injection
NOVOLOG (insulin aspart injection) is a rapid-acting human insulin analog used to lower blood glucose. NOVOLOG 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 (baker's yeast). Insulin aspart has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8.
Figure 1: Structural formula of insulin aspart
 |
NOVOLOG is a sterile, aqueous, clear, and colorless solution, that contains insulin aspart 100 Units/mL, glycerin 16 mg/mL, phenol 1.50 mg/mL, metacresol 1.72 mg/mL, zinc 19.6 mcg/mL, disodium hydrogen phosphate dihydrate 1.25 mg/mL, sodium chloride 0.58 mg/mL and water for injection. NOVOLOG has a pH of 7.2-7.6. Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH.
NOVOLOG is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
| NOVOLOG subcutaneous injection route | NOVOLOG may be mixed with NPH insulin preparations ONLY.
|
| NOVOLOG continuous subcutaneous infusion route (Insulin Pump) | Do NOT mix NOVOLOG with any other insulin. |
NOVOLOG 100 units per mL (U-100) is available as a clear and colorless solution for injection in:
NOVOLOG 100 units of insulin aspart per mL (U-100) is available as a clear and colorless solution for injection in:
10 mL vials NDC 0169-7501-11
3 mL PenFill cartridges* NDC 0169-3303-12
3 mL NOVOLOG FlexPen NDC 0169-6339-10
3 mL NOVOLOG FlexTouch NDC 0169-6338-10
*NOVOLOG PenFill cartridges are designed for use with Novo Nordisk insulin delivery devices with NovoFine disposable needles. FlexPen and FlexTouch can be used with NovoFine or NovoTwist disposable needles. NOVOLOG FlexPen, NOVOLOG FlexTouch, PenFill cartridge, and PenFill cartridge insulin delivery devices manufactured by Novo Nordisk must never be shared between patients, even if the needle is changed.
Unused NOVOLOG should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not freeze NOVOLOG and do not use NOVOLOG if it has been frozen. Do not expose NOVOLOG to excessive heat or light.
NOVOLOG should not be drawn into a syringe and stored for later use.
Always remove and discard the needle after each injection from the NOVOLOG FlexPen or NOVOLOG FlexTouch and store without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing.
The storage conditions are summarized in the following table:
Table 9: Storage conditions for vial, PenFill
cartridges, NOVOLOG FlexPen, and NOVOLOG FlexTouch
| NOVOLOG presentation | Not in-use (unopened) Room Temperature (below 30°C [86°F]) | Not in-use (unopened) Refrigerated | In-use(opened) Room Temperature (below 30°C [86°F]) |
| 10 mL vial | 28 days | Until expiration date | 28 days (refrigerated/room temperature) |
| 3 mL PenFill cartridges | 28 days | Until expiration date | 28 days (Do not refrigerate) |
| 3 mL NOVOLOG FlexPen | 28 days | Until expiration date | 28 days (Do not refrigerate) |
| 3 mL NOVOLOG FlexTouch | 28 days | Until expiration date | 28 days (Do not refrigerate) |
NOVOLOG in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.
NOVOLOG diluted with Insulin Diluting Medium for NOVOLOG to a concentration equivalent to U-10 or equivalent to U-50 prepared as indicated under Dosage and Administration (2.2) may remain in patient use at temperatures below 30°C (86°F) for 28 days.
Infusion bags prepared as indicated under DOSAGE AND ADMINISTRATION are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion
Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark. For information about NOVOLOG contact: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, New Jersey 08536. Revised: Dec 2016
The following adverse reactions are also discussed elsewhere:
Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice. The safety of NOVOLOG was evaluated in two treat-to-target trials of 6 months duration, conducted in subjects with type 1 diabetes or type 2 diabetes [see Clinical Studies].
The data in Table 1 reflect the exposure of 596 patients with type 1 diabetes to NOVOLOG in one clincal trial with a mean exposure duration to NOVOLOG of 24 weeks. The mean age was 38.9 years. Fifty-one percent were male, 94% were Caucasian, 2% were Black and 4% were other races. The mean body mass index (BMI) was 25.6 kg/m². The mean duration of diabetes was 15.7 years and the mean HbA1c at baseline was 7.9%.
The data in Table 2 reflect the exposure of 91 patients with type 2 diabetes to NOVOLOG in one clincal trial with a mean exposure duration to NOVOLOG of 24 weeks. The mean age was 56.6 years. Sixty-three percent were male, 76% were Caucasian, 9% were Black and 15% were other races. The mean BMI was 29.7 kg/m². The mean duration of diabetes was 12.7 years and the mean HbA1c at baseline was 8.1%.
Common adverse reactions were defined as events occurring in ≥ 5%, excluding hypoglycemia, of the population studied. Common adverse events occurring at the same rate or greater for NOVOLOG-treated subjects than on comparator-treated subjects during clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus (other than hypoglycemia) are listed in Table 1 and Table 2, respectively.
Table 1: Adverse reactions occurring in ≥ 5% of
Type 1 Diabetes Mellitus Adult Patients treated with NOVOLOG and at the same
rate or greater on NOVOLOG than on comparator
| NOVOLOG + NPH (%) (n= 596) |
Regular Human Insulin + NPH (%) (n= 286) |
|
| Headache | 12 | 10 |
| Injury accidental | 11 | 10 |
| Nausea | 7 | 5 |
| Diarrhea | 5 | 3 |
Table 2: Adverse reactions occurring in ≥ 5% of
Type 2 Diabetes Mellitus Adult Patients treated with NOVOLOG and at the same
rate or greater on NOVOLOG than on comparator
| NOVOLOG + NPH (%) (n= 91) |
Human Regular Insulin + NPH (%) (n= 91) |
|
| Hyporeflexia | 11 | 7 |
| Onychomycosis | 10 | 5 |
| Sensory disturbance | 9 | 7 |
| Urinary tract infection | 8 | 7 |
| Chest pain | 5 | 3 |
| Headache | 5 | 3 |
| Skin disorder | 5 | 2 |
| Abdominal pain | 5 | 1 |
| Sinusitis | 5 | 1 |
Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including NOVOLOG [see WARNINGS AND PRECAUTIONS]. 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 NOVOLOG with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that will occur in clinical practice.
Severe hypoglycemia was defined as hypoglycemia associated with central nervous system symptoms and requiring the intervention of another person or hospitalization.
The incidence of severe hypoglycemia in adult and pediatric patients receiving subcutaneous NOVOLOG with type 1 diabetes mellitus was 17% at 24 weeks and 6% at 24 weeks, respectively [see Clinical Studies].
The incidence of severe hypoglycemia in adult patients receiving subcutaneous NOVOLOG with type 2 diabetes mellitus was 10% at 24 weeks.
The incidence of severe hypoglycemia in adult and pediatric patients with type 1 diabetes mellitus, receiving NOVOLOG via continuous subcutaneous insulin infusion by external pump was 2% at 16 weeks and 10% at 16 weeks respectively.
No severe hypoglycemic episodes were reported in adult patients with type 2 diabetes mellitus receiving NOVOLOG via continuous subcutanuous insulin infusion by external pump at 16 weeks.
Some patients taking insulin therapy, including NOVOLOG have experienced erythema, local edema, and pruritus at the site of injection. These conditions were usually self-limiting. Severe cases of generalized allergy (anaphylaxis) have been reported [see WARNINGS AND PRECAUTIONS].
Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.
Administration of insulin, including NOVOLOG, subcutaneously and via subcutaneous insulin infusion by external pump, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients [see DOSAGE AND ADMINISTRATION].
Insulin products, including NOVOLOG, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Weight gain has occurred with some insulin therapies including NOVOLOG and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to NOVOLOG in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
In a 6-month study with a 6 month extension in adult subjects with type 1 diabetes, 99.8% of patients who received NOVOLOG were positive for anti-insulin antibodies (AIA) at least once during the study, including 97.2% that were positive at baseline. A total of 92.1% of patients who received NOVOLOG were positive for anti-drug antibodies (ADA) at least once during the study, including 64.6% that were positive at baseline.
In a phase 3 type 1 diabetes clinical trial of NOVOLOG, initial increase in titers of antibodies to insulin, followed by a decrease to baseline values, was observed in regular human insulin and insulin aspart treatment groups with similar incidences. These antibodies did not cause deterioration in glycemic control or necessitate increases in insulin dose.
The following adverse reactions have been identified during post-approval use of NOVOLOG. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Medication errors have been reported in which other insulins have been accidentally substituted for NOVOLOG [see WARNINGS AND PRECAUTIONS].
| 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, propoxyphene, salicylates, somatostatin analog (e.g., octreotide) ,and sulfonamide antibiotics. |
| Intervention: | Dose adjustment and increased frequency of glucose monitoring may be required when NOVOLOG is coadministered with these drugs. |
| Drugs That May Decrease the Blood Glucose Lowering Effect of NOVOLOG | |
| 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 adjustment and increased frequency of glucose monitoring may be required when NOVOLOG is coadministered with these drugs. |
| Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of NOVOLOG | |
| Drugs: | Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. |
| Intervention: | Dose adjustment and increased frequency of glucose monitoring may be required when NOVOLOG is coadministered 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 NOVOLOG is co-administered with these drugs. |
Included as part of the PRECAUTIONS section.
NOVOLOG FlexPen, NOVOLOG FlexTouch, PenFill cartridge, and PenFill cartridge devices should never be shared between patients, even if the needle if changed. Patients using NOVOLOG vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia [See Hypoglycemia] or hyperglycemia. These changes should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.
Hypoglycemia is the most common adverse effect of all insulin therapies, including NOVOLOG. Severe hypoglycemia can cause seizures, may lead to unconsciousness may be life threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g. driving or operating other machinery).
Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see DRUG INTERACTIONS], or in patients who experience recurrent hypoglycemia.
The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulin preparations, the glucose lowering effect time course of NOVOLOG may vary in different individuals or at different times in the same individual and depends on may conditions, including the area of injection as well as the injection site blood supply and temperature [see CLINICAL PHARMACOLOGY]. Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to co-administered medication [see DRUG INTERACTIONS]. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use in Specific Populations].
Risk Mitigation Strategies for Hypoglycemia Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia, increased frequency of blood glucose monitoring is recommended. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.
Accidental mix-ups between NOVOLOG and other insulin products have been reported. To avoid medication errors between NOVOLOG and other insulins, instruct patients to always check the insulin label before each injection.
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including NOVOLOG. If hypersensitivity reactions occur, discontinue NOVOLOG; treat per standard of care and monitor until symptoms and signs resolve [see ADVERSE REACTIONS]. NOVOLOG is contraindicated in patients who have had hypersensitivity reactions to insulin aspart or one of the excipients [see CONTRAINDICATIONS].
All insulin products, including NOVOLOG, can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentration).
Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR) gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including NOVOLOG, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.
Malfunction of the insulin pump or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Interim subcutaneous injections with NOVOLOG may be required. Patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure [see HOW SUPPLIED/Storage and Handling and PATIENT INFORMATION].
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use)
Advise patients that they must never share NOVOLOG FlexPen, NOVOLOG Flex Touch, PenFill cartrige or PenFill cartridge devices with another person even if the needle is changed, because doing so carries a risk for trasmission of blood-borne pathogens. Advise patients using NOVOLOG vials not to share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens [see WARNINGS AND PRECAUTIONS].
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 NOVOLOG 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 [see WARNINGS AND PRECAUTIONS].
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
Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products[see WARNINGS AND PRECAUTIONS].
Advise patients that hypersensitivity reactions have occurred with NOVOLOG. Inform patients of the symptoms of hypersensitivity reactions [see WARNINGS AND PRECAUTIONS].
Advise patients to inform their health care professional if they are pregnant or are contemplating pregnancy.
NOVOLOG must only be used if the solution is clear and colorless with no particles visible. Instruct patients that when injecting NOVOLOG, they must press and hold down the dose button until the dose counter shows 0 and then keep the needle in the skin and count slowly to 6 as the prescribed dose is not completely delivered until 6 seconds later. If the needle is removed earlier, the full dose may not be delivered (a possible under-dose may occur by as much as 20%). Inform the patient to increase the frequency of checking their blood glucose and that possible additional insulin administration may be necessary.
If 0 does not appear in the dose counter after continuously pressing the dose button, the patient may have used a blocked needle. In this case they would not have received any insulin - even though the dose counter has moved from the original dose that was set. Instruct the patient to change the needle as described in Section 5 of the Instructions for Use and repeat all steps in the IFU starting with Section 1: Prepare your pen with a new needle. Make sure the patient selects the full dose needed.
The following insulin pumps† have been used in NOVOLOG clinical or in vitro studies conducted by Novo Nordisk, the manufacturer of NOVOLOG:
Before using another insulin pump with NOVOLOG, read the pump label to make sure the pump has been evaluated with NOVOLOG.
Standard 2-year carcinogenicity studies in animals have not been performed to evaluate the carcinogenic potential of NOVOLOG. In 52-week studies, Sprague-Dawley rats were dosed subcutaneously with NOVOLOG at 10, 50, and 200 units/kg/day (approximately 2, 8, and 32 times the human subcutaneous dose of 1.0 units/kg/day, based on units/body surface area, respectively). At a dose of 200 units/kg/day, NOVOLOG increased the incidence of mammary gland tumors in females when compared to untreated controls. The relevance of these findings to humans is unknown.
NOVOLOG was not genotoxic in the following tests: Ames test, mouse lymphoma cell forward gene mutation test, human peripheral blood lymphocyte chromosome aberration test, in vivo micronucleus test in mice, and in ex vivo UDS test in rat liver hepatocytes.
In fertility studies in male and female rats, at subcutaneous doses up to 200 units/kg/day (approximately 32 times the human subcutaneous dose, based on units/body surface area), no direct adverse effects on male and female fertility, or general reproductive performance of animals was observed.
Pregnancy Category B. All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. Insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential in these patients. Therefore, female patients should be advised to tell their physician if they intend to become, or if they become pregnant while taking NOVOLOG.
An open-label, randomized study compared the safety and efficacy of NOVOLOG (n=157) versus regular human insulin (n=165) in 322 pregnant women with type 1 diabetes. Two-thirds of the enrolled patients were already pregnant when they entered the study. Because only one-third of the patients enrolled before conception, the study was not large enough to evaluate the risk of congenital malformations. Both groups achieved a mean HbA1c of ~ 6% during pregnancy, and there was no significant difference in the incidence of maternal hypoglycemia.
Subcutaneous reproduction and teratology studies have been performed with NOVOLOG and regular human insulin in rats and rabbits. In these studies, NOVOLOG was given to female rats before mating, during mating, and throughout pregnancy, and to rabbits during organogenesis. The effects of NOVOLOG did not differ from those observed with subcutaneous regular human insulin. NOVOLOGcaused pre-and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 units/kg/day (approximately 32 times the human subcutaneous dose of 1.0 units/kg/day, based on units/body surface area) and in rabbits at a dose of 10 units/kg/day (approximately three times the human subcutaneous dose of 1.0 units/kg/day, based on units/body surface area). No significant effects were observed in rats at a dose of 50 units/kg/day and in rabbits at a dose of 3 units/kg/day. These doses are approximately 8 times the human subcutaneous dose of 1.0 units/kg/day for rats and equal to the human subcutaneous dose of 1.0 units/kg/day for rabbits, based on units/body surface area.
Endogenous insulin is present in human milk; it is unknown whether insulin aspart is excreted in human milk. Because many drugs, including human insulin, are excreted in human milk, caution should be exercised when NOVOLOG is administered to a nursing woman. Use of NOVOLOG is compatible with breastfeeding, but women with diabetes who are lactating may require adjustments of their insulin doses.
NOVOLOG is approved for use in children for subcutaneous daily injections and for subcutaneous continuous infusion by external insulin pump [See Clinical Studies]. NOVOLOG has not been studied in pediatric patients younger than 2 years of age. NOVOLOG has not been studied in pediatric patients with type 2 diabetes.
Of the total number of patients (n= 1,375) treated with NOVOLOG in 3 controlled clinical studies, 2.6% (n=36) were 65 years of age or over. One-half of these patients had type 1 diabetes (18/1285) and the other half had type 2 diabetes (18/90). The HbA1c response to NOVOLOG, as compared to regular human insulin, did not differ by age.
Patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent NOVOLOG dose adjustment and more frequent blood glucose monitoring [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
Patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent NOVOLOG dose adjustment and more frequent blood glucose monitoring [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
Excess insulin administration may cause hypoglycemia and hypokalemia [see WARNINGS AND PRECAUTIONS]. 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 intramuscular/subcutaneous glucagon 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.
NOVOLOG is contraindicated:
The primary activity of insulin, including NOVOLOG is the regulation of glucose metabolism. Insulin, and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.
The pharmacodynamic profile of NOVOLOG given subcutaneously in 22 patients with type 1 diabetes is shown in Figure 2. The maximum glucose-lowering effect of NOVOLOG occurred between 1 and 3 hours after subcutaneous injection (0.15 units/kg). The duration of action for NOVOLOG is 3 to 5 hours. The time course of action of insulin and insulin analogs such as NOVOLOG may vary considerably in different individuals or within the same individual. The parameters of NOVOLOG activity (time of onset, peak time and duration) as designated in Figure 2 should be considered only as general guidelines. The rate of insulin absorption and onset of activity is affected by the site of injection, exercise, and other variables [see WARNINGS AND PRECAUTIONS].
Figure 2: Serial mean serum glucose collected up to 6
hours following a single 0.15 units/kg pre-meal dose of NOVOLOG (solid curve)
or regular human insulin (hatched curve) injected immediately before a meal in
22 patients with type 1 diabetes.
 |
A double-blind, randomized, two-way crossover study in 16 patients with type 1 diabetes demonstrated that intravenous infusion of NOVOLOG resulted in a blood glucose profile that was similar to that after intravenous infusion with regular human insulin. NOVOLOG or human insulin was infused until the patient's blood glucose decreased to 36 mg/dL, or until the patient demonstrated signs of hypoglycemia (rise in heart rate and onset of sweating), defined as the time of autonomic reaction (R) (see Figure 3).
Figure 3: Mean blood glucose profiles following
intravenous infusion of NOVOLOG (hatched curve) and regular human insulin
(solid curve) in 16 patients with type 1 diabetes. R represents the time of
autonomic reaction.
 |
Absorption and Bioavailability
In studies in healthy volunteers (total n=107) and patients with type 1 diabetes (total n=40), the median time to maximum concentration of NOVOLOG in these trials was 40 to 50 minutes versus 80 to 120 minutes, for regular human insulin respectively.
The relative bioavailability of NOVOLOG (0.15 units/kg) compared to regular human insulin indicates that the two insulins are absorbed to a similar extent.
In a clinical trial in patients with type 1 diabetes, NOVOLOG and regular human insulin, both administered subcutaneously at a dose of 0.15 units/kg body weight, reached mean maximum concentrations of 82 and 36 mU/L, respectively.
Insulin aspart has a low binding affinity to plasma proteins ( < 10%), similar to that seen with regular human insulin.
Figure 4. Serial mean serum free insulin concentration
collected up to 6 hours following a single 0.15 units/kg pre-meal dose of
NOVOLOG (solid curve) or regular human insulin (hatched curve) injected
immediately before a meal in 22 patients with type 1 diabetes.
 |
In a randomized, double-blind, crossover study 17 healthy Caucasian male subjects between 18 and 40 years of age received an intravenous infusion of either NOVOLOG or regular human insulin at 1.5 mU/kg/min for 120 minutes. The mean insulin clearance was similar for the two groups with mean values of 1.2 L/h/kg for the NOVOLOG group and 1.2 L/h/kg for the regular human insulin group.
After subcutaneous administration in normal male volunteers (n=24), NOVOLOG was eliminated with an average apparent half-life of 81 minutes.
Pediatrics: The pharmacokinetic and pharmacodynamic properties of NOVOLOG and regular human insulin were evaluated in a single dose study in 18 children (6-12 years, n=9) and adolescents (13-17 years [Tanner grade > 2], n=9) with type 1 diabetes. The relative differences in pharmacokinetics and pharmacodynamics in children and adolescents with type 1 diabetes between NOVOLOG and regular human insulin were similar to those in healthy adult subjects and adults with type 1 diabetes.
Geriatrics: The pharmacokinetic and pharmacodynamic properties of NOVOLOG and regular human insulin were investigated in a single dose study in 18 subjects with type 2 diabetes who were ≥ 65 years of age. The relative differences in pharmacokinetics and pharmacodynamics in geriatric patients with type 2 diabetes between NOVOLOG and regular human insulin were similar to those in younger adults.
Gender: In healthy volunteers given a single subcutaneous dose of NOVOLOG 0.06 units/kg, no difference in insulin aspart levels was seen between men and women based on comparison of AUC (0-10h) or Cmax.
Obesity: A single subcutaneous dose of 0.1 units/kg NOVOLOG was administered in a study of 23 patients with type 1 diabetes and a wide range of body mass index (BMI, 22-39 kg/m²). The pharmacokinetic parameters, AUC and Cmax, of NOVOLOG were generally unaffected by BMI in the different groups - BMI 19-23 kg/m² (N=4); BMI 23-27 kg/m² (N=7); BMI 27-32 kg/m² (N=6) and BMI > 32 kg/m² (N=6). Clearance of NOVOLOG was reduced by 28% in patients with BMI > 32 kg/m² compared to patients with BMI < 23 kg/m² .
Renal Impairment: - A single subcutaneous dose of 0.08 units/kg NOVOLOG was administered in a study to subjects with either normal renal function (N=6) creatinine clearance (CLcr) ( > 80 ml/min) or mild (N=7; CLcr = 50-80 ml/min), moderate (N=3; CLcr = 30-50 ml/min) or severe (but not requiring hemodialysis) (N=2; CLcr = < 30 ml/min) renal impairment. In this study, there was no apparent effect of creatinine clearance values on AUC and Cmax of NOVOLOG.
Hepatic Impairment: - A single subcutaneous dose of 0.06 units/kg NOVOLOG was administered in an open-label, single-dose study of 24 subjects (N=6/group) with different degree of hepatic impairment (mild, moderate and severe) having Child-Pugh Scores ranging from 0 (healthy volunteers) to 12 (severe hepatic impairment). In this study, there was no correlation between the degree of hepatic impairment and any NOVOLOG pharmacokinetic parameter.
In standard biological assays in mice and rabbits, one unit of NOVOLOG has the same glucose-lowering effect as one unit of regular human insulin.
The safety and effectiveness of subcutaneous NOVOLOG was compared to regular human insulin in 596 type 1 diabetes adult, 187 pediatric type 1 diabetes, and 91 adult type 2 diabetes patients using NPH as basal insulin (see Tables 3,4,5). The reduction in glycated hemoglobin (HbA1c) was similar to regular human insulin.
The safety and effectiveness of NOVOLOG administered by continuous subcutaneous insulin infusion (CSII) by external pump was compared to buffered regular human insulin (administered by CSII), to lispro (administered by CSII) and compared to NOVOLOG injections and NPH injection. Overall, the reduction in HbA1c was similar to the comparator.
Two 24 week, open-label, active-controlled studies were conducted to compare the safety and efficacy of NOVOLOG to regular human insulin injection in adult patients with type 1 diabetes. Because the two study designs and results were similar, data are shown for only one study (see Table 3).
The mean age of the trial population was 38.9 years and mean duration of diabetes was 15.7 years. Fifty-one percent were male. Ninety-four percent were Caucasian, 2% were Black and 4% were Other. The mean BMI was approximately 25.6 kg/m² .
NOVOLOG was administered by subcutaneous injection immediately prior to meals and regular human insulin was administered by subcutaneous injection 30 minutes before meals. NPH insulin was administered as the basal insulin in either single or divided daily doses. Changes in HbA1c were comparable for the two treatment regimens in this study (Table 3).
Table 3: Type 1 Diabetes Mellitus - Adult (NOVOLOG
plus NPH insulin vs. regular human insulin plus NPH insulin)
| NOVOLOG + NPH (N=596) |
Regular Human Insulin+ NPH (N=286) |
|
| Baseline HbA1c (%)* | 7.9 ±1.1 | 8.0 ± 1.2 |
| Change from Baseline HbA1c (%) | -0.1 ± 0.8 | 0.0 ± 0.8 |
| Treatment Difference in HbA1c, Mean (95% confidence interval) | -0.2 (-0.3, -0.1) | |
| *Values are Mean ± SD | ||
The efficacy of NOVOLOG to improve glycemic control in pediatric patients with type 1 diabetes mellitus is based on an adequate and well-controlled trial of regular human insulin in pediatric patients with type 1 diabetes mellitus (Table 4). This 24-week, parallel-group study of children and adolescents with type 1 diabetes (n = 283), aged 6 to 18 years, compared two subcutaneous multiple-dose treatment regimens: NOVOLOG (n=187) or regular human insulin (n=96). NPH insulin was administered as the basal insulin. Similar effects on HbA1c were observed in both treatment groups (Table 4).
Subcutaneous administration of NOVOLOG and regular human insulin have also been compared in children with type 1 diabetes (n=26) aged 2 to 6 years with similar effects on HbA1c.
Table 4: Pediatric Subcutaneous Administration of
NOVOLOG in Type 1 Diabetes (24 weeks; n=283)
| NOVOLOG + NPH (N=187) |
Regular Human Insulin+ NPH (N=96) |
|
| Baseline HbA1c (%)* | 8.3 ± 1.2 | 8.3 ± 1.3 |
| Change from Baseline HbA1c (%) | 0.1± 1.0 | 0.1± 1.1 |
| Treatment Difference in HbA1c, Mean (95% confidence interval) | -0.2 (-0.5, 0.1) | |
| *Values are Mean ± SD | ||
Clinical Studies In Adults With Type 2 Diabetes And Subcutaneous Daily Injections
One six-month, open-label, active-controlled study was conducted to compare the safety and efficacy of NOVOLOG to regular human insulin in patients with type 2 diabetes (Table 5).
The mean age of the trial population was 56.6 years and mean duration of diabetes was 12.7 years. Sixty-three percent were male. Seventy-six percent were Caucasian, 9% were Black and 15% were Other. The mean BMI was approximately 29.7 kg/m² .
NOVOLOG was administered by subcutaneous injection immediately prior to meals and regular human insulin was administered by subcutaneous injection 30 minutes before meals. NPH insulin was administered as the basal insulin in either single or divided daily doses. Changes in HbAlc were comparable for the two treatment regimens.
Table 5: Subcutaneous NOVOLOG Administration in Type 2
Diabetes (6 months; n=176)
| NOVOLOG + NPH (N=90) |
Regular Human Insulin + NPH (N=86) |
|
| Baseline HbA1c (%)* | 8.1 ± 1.2 | 7.8 ± 1.1 |
| Change from Baseline HbA1c (%) | -0.3 ± 1.0 | -0.1 ± 0.8 |
| Treatment Difference in HbA1c, Mean (95% confidence interval) | -0.1 (-0.4, 0.1) | |
| *Values are Mean ± SD | ||
Two open-label, parallel design studies (6 weeks [n=29] and 16 weeks [n=118]) compared NOVOLOG to buffered regular human insulin (Velosulin) in adults with type 1 diabetes receiving a subcutaneous infusion with an external insulin pump.
The mean age of the trial population was 42.3 years. Thirty-nine percent were male. Ninety-eight percent were Caucasian and 2% were Black.
The two treatment regimens had comparable changes in HbA1c.
Table 6: Adult Insulin Pump Study in Type 1 Diabetes (16
weeks; n=118)
| NOVOLOG (N=59) |
Buffered human insulin (N=59) |
|
| Baseline HbA1c (%)* | 7.3 ± 0.7 | 7.5 ± 0.8 |
| Change from Baseline HbA1c (%) | 0.0 ± 0.5 | 0.2 ± 0.6 |
| Treatment Difference in HbA1c, Mean (95% confidence interval) | 0.2 (-0.1, 0.4) | |
| *Values are Mean ± SD | ||
A randomized, 16-week, open-label, parallel design study of children and adolescents with type 1 diabetes (n=298) aged 4-18 years compared two subcutaneous infusion regimens administered via an external insulin pump: NOVOLOG (n=198) or insulin lispro (n=100). These two treatments resulted in comparable changes from baseline in HbA1c (see Table 7).
Table 7: Pediatric Insulin Pump Study in Type 1
Diabetes (16 weeks; n=298)
| NOVOLOG (N=198) | Lispro (N=100) | |
| Baseline HbA1c (%)* | 8.0 ± 0.9 | 8.2 ± 0.8 |
| Change from Baseline HbA1c (%) | -0.1 ± 0.8 | -0.1 ± 0.7 |
| Treatment Difference in HbA1c, Mean (95% confidence interval) | -0.1 (-0.3, 0.1) | |
| *Values are Mean ± SD | ||
An open-label, 16-week parallel design trial compared pre-prandial NOVOLOG injection in conjunction with NPH injections to NOVOLOG administered by continuous subcutaneous infusion in 127 adults with type 2 diabetes.
The mean age of the trial population was 55.1 years. Sixty-four percent were male. Eighty percent were Caucasian, 12% were Black and 8% were Other. The mean BMI was approximately 32.2 kg/m² .
The two treatment groups had similar reductions in HbA1c (Table 8).
Table 8: Pump Therapy in Type 2 Diabetes (16 weeks;
n=127)
| NOVOLOG pump (N=66) |
NOVOLOG + NPH (N=61) |
|
| Baseline HbA1c (%)* | 8.2 ± 1.4 | 8.0 ± 1.1 |
| Change from Baseline HbA1c (%) | -0.6 ± 1.1 | -0.5 ± 0.9 |
| Treatment Difference in HbA1c, Mean (95% confidence interval) | 0.1 (-0.3, 0.4) | |
| *Values are Mean ± SD | ||
NovoLog®
(NO-vo-log)
(insulin aspart) Injection
Do not share your NovoLog FlexPen, NovoLog FlexTouch, 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.
What is NovoLog?
Who should not take NovoLog?
Do not take NovoLog if you:
Before taking NovoLog, tell your healthcare provider about all your medical conditions including, if you are:
Before you start taking NovoLog, talk to your healthcare provider about low blood sugar and how to manage it.
How should I take NovoLog?
What should I avoid while taking NovoLog?
While taking NovoLog do not:
What are the possible side effects of NovoLog?
NovoLog 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:
Your insulin dose may need to change because of:
Other common side effects of NovoLog may include:
Get emergency medical help if you have:
These are not all the possible side effects of NovoLog. 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 NovoLog.
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 NovoLog that is written for health professionals. Do not use NovoLog for a condition for which it was not prescribed. Do not give NovoLog to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in NovoLog?
Active Ingredient: insulin aspart
Inactive Ingredients: glycerin, phenol, metacresol, zinc, disodium hydrogen phosphate dihydrate, sodium chloride and water for injection
Instructions for Use
NovoLog®
(NO-vo-log) FlexTouch® Pen (insulin aspart injection)
Supplies you will need to give your NovoLog injection:
Preparing your NovoLog FlexTouch Pen:
Figure A
 |
Step 1:
Figure B
 |
Step 2:
Figure C
 |
Step 3:
Figure D
 |
Step 4:
Figure E
 |
Step 5:
Figure F
 |
Step 6:
Figure G
 |
Priming your NovoLog FlexTouch Pen:
Step 7:
Figure H
 |
Step 8:
Figure I
 |
Step 9:
Figure J
 |
Selecting your dose:
Step 10:
Figure K
 |
Figure L
 |
Giving your injection:
Step 11:
Choose your injection site and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure M).
Figure M
 |
Step 12:
Figure N
 |
Step 13:
Figure O
 |
Figure P
 |
Step 14:
Figure Q
 |
Step 15:
Figure R
 |
Figure S
 |
Step 16:
Figure T
 |
After your injection:
How should I store my NovoLog FlexTouch Pen?
General Information about the safe and effective use of NovoLog.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Instructions For Use
NovoLog® FlexPen®
Introduction
Please read the following instructions carefully before using your NovoLog® FlexPen® .
Do not share your NovoLog FlexPen 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.
NovoLog FlexPen is a disposable dial-a-dose insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. NovoLog FlexPen is designed to be used with NovoFine®, NovoFine® Plus or NovoTwist® needles.
Getting ready
Make sure you have the following items:
 |
Preparing your NovoLog FlexPen
Wash your hands with soap and water. Before you start to prepare your injection, check the label to make sure that you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin. NovoLog should look clear.
A. Pull off the pen cap (see diagram A).
Wipe the rubber stopper with an alcohol swab.
Figure A
 |
B. Attaching the needle
Remove the protective tab from a disposable needle.
Screw the needle tightly onto your FlexPen. It is important that the needle is put on straight (see diagram B).
Figure B
 |
Never place a disposable needle on your NovoLog FlexPen until you are ready to take your injection.
C. Pull off the big outer needle cap (see diagram C).
Figure C
 |
D. Pull off the inner needle cap and dispose of it (see diagram D).
Figure D
 |
Giving the airshot before each injection
Before each injection small amounts of air may collect in the cartridge during normal use. To avoid injecting air and to ensure proper dosing:
E. Turn the dose selector to select 2 units (see diagram E).
Figure E
 |
F. Hold your NovoLog FlexPen with the needle pointing up. Tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (see diagram F).
Figure F
 |
G. Keep the needle pointing upwards, press the push-button all the way in (see diagram G). The dose selector returns to 0.
Figure G
 |
A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.
If you do not see a drop of insulin after 6 times, do not use the NovoLog FlexPen and contact Novo Nordisk at 1-800-727-6500.
A small air bubble may remain at the needle tip, but it will not be injected.
Selecting your dose
Check and make sure that the dose selector is set at 0.
H. Turn the dose selector to the number of units you need to inject. The pointer should line up with your dose.
The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer (see diagram H). When turning the dose selector, be careful not to press the push-button as insulin will come out.
Figure H
 |
You cannot select a dose larger than the number of units left in the cartridge.
You will hear a click for every single unit dialed. Do not set the dose by counting the number of clicks you hear.
Giving the injection
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.
Novolog can be injected under the skin (subcutaneously) or your stomach area, buttocks, upper legs (thighs), or upper arms.
For each injection, change (rotate) your injection site within the area of skin that you use. Do not use the same injection site for each injection.
I. Insert the needle into your skin.
Inject the dose by pressing the push-button all the way in until the 0 lines up with the pointer (see diagram I). Be careful only to push the button when injecting.
Turning the dose selector will not inject insulin.
Figure I
 |
J. Keep the needle in the skin for at least 6 seconds, and keep the push-button pressed all the way in until the needle has been pulled out from the skin (see diagram J). This will make sure that the full dose has been given.
Figure J
 |
J. Keep the needle in the skin for at least 6 seconds, and keep the push-button pressed all the way in until the needle has been pulled out from the skin (see diagram J). This will make sure that the full dose has been given.
You may see a drop of insulin at the needle tip. 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 finger. Do not rub the area.
After the injection
Do not recap the needle. Recapping can lead to a needle stick injury. Remove the needle from the NovoLog FlexPen after each injection and dispose of it. This helps to prevent infection, leakage of insulin, and will help to make sure you inject the right dose of insulin. If you do not have a sharps container, carefully slip the needle into the outer needle cap. Safely remove the needle and throw it away as soon as you can.
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.
The NovoLog FlexPen prevents the cartridge from being completely emptied. It is designed to deliver 300 units.
K. Put the pen cap on the NovoLog FlexPen and store the NovoLog FlexPen without the needle attached (see diagram K). Storing without the needle attached helps prevent leaking, blocking of the needle, and air from entering the Pen.
Figure K
 |
How should I store NovoLog FlexPen?
Maintenance
For the safe and proper use of your FlexPen be sure to handle it with care. . Avoid dropping your FlexPen as it may damage it. If you are concerned that your FlexPen is damaged, use a new one. You can clean the outside of your FlexPen by wiping it with a damp cloth. Do not soak or wash your FlexPen as it may damage it. Do not refill your FlexPen.
This Instructions for Use has been approved by the U.S. Food and Drug Administration
Instructions for Use
NovoLog®
(NO-vo-log) PenFill® 3 mL cartridge 100 Units/mL (U-100) (insulin aspart
injection)
Supplies you will need to give your NovoLog injection:
Figure A
 |
How to use the NovoLog PenFill cartridge
Figure B
 |
Step 1:
Figure C
 |
Prepare your device with a new needle
Step 2:
Figure D
 |
Step 3:
Figure E
 |
Step 4:
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:
Figure G
 |
Select your dose
Step 6:
Figure H
 |
Inject your dose
Step 7:
Figure I
 |
Figure J
 |
You may see a drop of NovoLog 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.
Do not rub the area.
After your injection
Step 8:
Figure K
 |
Figure L
 |
Step 9:
Figure M
 |
How should I store my NovoLog PenFill cartridge?
Before use:
PenFill cartridges in use:
General Information about the safe and effective use of NovoLog.
This Instructions for Use has been approved by the U.S. Food and Drug Administration. © 2002-2016 Novo Nordisk
Instructions for Use
NovoLog®
(NO-vo-log) (insulin aspart injection) 10 mL vial (100 Units/mL, U-100)
Read this Instructions for Use before you start taking NovoLog® 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.
Supplies you will need to give your NovoLog® injection:
 |
Preparing your NovoLog® dose:
 |
Step 1: Pull off the tamper resistant cap (See Figure A).
Step 2: Wipe the rubber stopper with an alcohol swab (See Figure B).
Figure A and B
 |
Step 3: Hold the syringe with the needle pointing up. Pull down on the plunger until the black tip reaches the line for the number of units for your prescribed dose (See Figure C).
Figure C
 |
Step 4: Push the needle through the rubber stopper of the NovoLog® vial (See Figure D).
Figure D
 |
Step 5: Push the plunger all the way in. This puts air into the NovoLog® vial (See Figure E).
Figure E
 |
Step 6: Turn the NovoLog® vial and syringe upsidedown and slowly pull the plunger down until the black tip is a few units past the line for your dose (See Figure F).
Figure F
 |
Figure G
 |
Step 7: Slowly push the plunger up until the black tip reaches the line for your NovoLog® dose (See Figure H).
Figure H
 |
Step 8: Check the syringe to make sure you have the right dose of NovoLog® .
Step 9: Pull the syringe out of the vial's rubber stopper (See Figure I).
Figure I
 |
Giving your Injection:
Step 10: Choose your injection site and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure J).
Figure J
 |
Step 11: Insert the needle into your skin. Push down on the plunger to inject your dose (See Figure K).
Figure K
 |
Needle should remain in the skin for at least 6 seconds to make sure you have injected all the insulin.
Step 12: Pull the needle out of your skin. After that, you may see a drop of NovoLog® at the needle tip. This is normal and does not affect the dose you just received (See Figure L).
Figure L
 |
After your injection:
How should I store NovoLog®?
Do not freeze NovoLog®. Do not use NovoLog® if it has been frozen.
General information about the safe and effective use of NovoLog®
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
