Novolog Information
Novolog (Insulin) Dosage And Administration
Novolog (Insulin) is an insulin analog with an earlier onset of action than regular human insulin. The dosage of Novolog (Insulin) must be individualized. Novolog (Insulin) given by subcutaneous injection should generally be used in regimens with an intermediate or long-acting insulin []. The total daily insulin requirement may vary and is usually between 0.5 to 1.0 units/kg/day. When used in a meal-related subcutaneous injection treatment regimen, 50 to 70% of total insulin requirements may be provided by Novolog (Insulin) and the remainder provided by an intermediate-acting or long-acting insulin. Because of Novolog (Insulin) ’s comparatively rapid onset and short duration of glucose lowering activity, some patients may require more basal insulin and more total insulin to prevent pre-meal hyperglycemia when using Novolog (Insulin) than when using human regular insulin.
Do not use Novolog (Insulin) that is viscous (thickened) or cloudy; use only if it is clear and colorless. Novolog (Insulin) should not be used after the printed expiration date.
Novolog (Insulin) should be administered by subcutaneous injection in the abdominal region, buttocks, thigh, or upper arm. Because Novolog (Insulin) has a more rapid onset and a shorter duration of activity than human regular insulin, it should be injected immediately (within 5-10 minutes) before a meal. Injection sites should be rotated within the same region to reduce the risk of lipodystrophy. As with all insulins, the duration of action of Novolog (Insulin) will vary according to the dose, injection site, blood flow, temperature, and level of physical activity.
Novolog (Insulin) may be diluted with Insulin Diluting Medium for Novolog (Insulin) for subcutaneous injection. Diluting one part Novolog (Insulin) to nine parts diluent will yield a concentration one-tenth that of Novolog (Insulin) (equivalent to U-10). Diluting one part Novolog (Insulin) to one part diluent will yield a concentration one-half that of Novolog (Insulin) (equivalent to U-50).
Novolog (Insulin) can also be infused subcutaneously by an external insulin pump []. Diluted insulin should not be used in external insulin pumps. Because Novolog (Insulin) has a more rapid onset and a shorter duration of activity than human regular insulin, pre-meal boluses of Novolog (Insulin) should be infused immediately (within 5-10 minutes) before a meal. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen. Although there is significant interpatient variability, approximately 50% of the total dose is usually given as meal-related boluses of Novolog (Insulin) and the remainder is given as a basal infusion.
The following insulin pumps† have been used in Novolog (Insulin) clinical or studies conducted by Novo Nordisk, the manufacturer of Novolog (Insulin) :
Before using a different insulin pump with Novolog (Insulin) , read the pump label to make sure the pump has been evaluated with Novolog (Insulin) .
Novolog (Insulin) can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia []. For intravenous use, Novolog (Insulin) should be used at concentrations from 0.05 U/mL to 1.0 U/mL insulin aspart in infusion systems using polypropylene infusion bags. Novolog (Insulin) has been shown to be stable in infusion fluids such as 0.9% sodium chloride.
Inspect Novolog (Insulin) for particulate matter and discoloration prior to parenteral administration.
Novolog (Insulin) Dosage Forms And Strengths
Novolog (Insulin) is available in the following package sizes: each presentation contains 100 units of insulin aspart per mL (U-100).
Novolog (Insulin) Contraindications
Novolog (Insulin) is contraindicated
Novolog (Insulin) Warnings And Precautions
Novolog (Insulin) has a more rapid onset of action and a shorter duration of activity than regular human insulin. An injection of Novolog (Insulin) should immediately be followed by a meal within 5-10 minutes. Because of Novolog (Insulin) ’s short duration of action, a longer acting insulin should also be used in patients with type 1 diabetes and may also be needed in patients with type 2 diabetes. Glucose monitoring is recommended for all patients with diabetes and is particularly important for patients using external pump infusion therapy.
Any change of insulin dose should be made cautiously and only under medical supervision. Changing from one insulin product to another or changing the insulin strength may result in the need for a change in dosage. As with all insulin preparations, the time course of Novolog (Insulin) action may vary in different individuals or at different times in the same individual and is dependent on many conditions, including the site of injection, local blood supply, temperature, and physical activity. Patients who change their level of physical activity or meal plan may require adjustment of insulin dosages. Insulin requirements may be altered during illness, emotional disturbances, or other stresses.
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.
Hypoglycemia is the most common adverse effect of all insulin therapies, including Novolog (Insulin) . Severe hypoglycemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or death. Severe hypoglycemia requiring the assistance of another person and/or parenteral glucose infusion or glucagon administration has been observed in clinical trials with insulin, including trials with Novolog (Insulin) .
The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulations []. Other factors such as changes in food intake (e.g., amount of food or timing of meals), injection site, exercise, and concomitant medications may also alter the risk of hypoglycemia []. As with all insulins, use caution in patients with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia (e.g., patients who are fasting or have erratic food intake). The patient’s ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery.
Rapid changes in serum glucose levels may induce symptoms of hypoglycemia in persons with diabetes, regardless of the glucose value. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as longstanding diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control []. These situations may result in severe hypoglycemia (and, possibly, loss of consciousness) prior to the patient’s awareness of hypoglycemia. Intravenously administered insulin has a more rapid onset of action than subcutaneously administered insulin, requiring more close monitoring for hypoglycemia.
Local Reactions
Systemic Reactions
When used in an external subcutaneous insulin infusion pump, Novolog (Insulin) should not be mixed with any other insulin or diluent.
Pump or infusion set malfunctions or insulin degradation can lead to a rapid onset of hyperglycemia and ketosis because of the small subcutaneous depot of insulin. This is especially pertinent for rapid-acting insulin analogs that are more rapidly absorbed through skin and have a shorter duration of action. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Interim therapy with subcutaneous injection may be required [].
Novolog (Insulin) should not be exposed to temperatures greater than 37°C (98.6°F). [].
Novolog (Insulin) Adverse Reactions
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.
Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Novolog (Insulin) [].
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.
Long-term use of insulin, including Novolog (Insulin) , can cause lipodystrophy at the site of repeated insulin injections or infusion. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. Rotate insulin injection or infusion sites within the same region to reduce the risk of lipodystrophy.
Weight gain can occur with some insulin therapies, including Novolog (Insulin) , and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
The frequencies of adverse drug reactions during Novolog (Insulin) clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.
The following additional adverse reactions have been identified during postapproval use of Novolog (Insulin) . Because these adverse reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency. Medication errors in which other insulins have been accidentally substituted for Novolog (Insulin) have been identified during postapproval use [].
Novolog (Insulin) Drug Interactions
A number of substances affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring.
Novolog (Insulin) Use In Specific Populations
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 (Insulin) .
An open-label, randomized study compared the safety and efficacy of Novolog (Insulin) (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 HbA 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 (Insulin) and regular human insulin in rats and rabbits. In these studies, Novolog (Insulin) was given to female rats before mating, during mating, and throughout pregnancy, and to rabbits during organogenesis. The effects of Novolog (Insulin) did not differ from those observed with subcutaneous regular human insulin. Novolog (Insulin) , like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 U/kg/day (approximately 32 times the human subcutaneous dose of 1.0 U/kg/day, based on U/body surface area) and in rabbits at a dose of 10 U/kg/day (approximately three times the human subcutaneous dose of 1.0 U/kg/day, based on U/body surface area). The effects are probably secondary to maternal hypoglycemia at high doses. No significant effects were observed in rats at a dose of 50 U/kg/day and in rabbits at a dose of 3 U/kg/day. These doses are approximately 8 times the human subcutaneous dose of 1.0 U/kg/day for rats and equal to the human subcutaneous dose of 1.0 U/kg/day for rabbits, based on U/body surface area.
Novolog (Insulin) Overdosage
Excess insulin administration may cause hypoglycemia and, particularly when given intravenously, hypokalemia. 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 (Insulin) Description
Novolog (Insulin) (insulin aspart [rDNA origin] injection) is a rapid-acting human insulin analog used to lower blood glucose. Novolog (Insulin) 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 (baker's yeast). Insulin aspart has the empirical formula CHN0S and a molecular weight of 5825.8.
Novolog (Insulin) 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 (Insulin) has a pH of 7.2-7.6. Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH.
Novolog (Insulin) Clinical Pharmacology
Studies in normal volunteers and patients with diabetes demonstrated that subcutaneous administration of Novolog (Insulin) has a more rapid onset of action than regular human insulin.
In a study in patients with type 1 diabetes (n=22), the maximum glucose-lowering effect of Novolog (Insulin) occurred between 1 and 3 hours after subcutaneous injection (see Figure 2). The duration of action for Novolog (Insulin) is 3 to 5 hours. The time course of action of insulin and insulin analogs such as Novolog (Insulin) may vary considerably in different individuals or within the same individual. The parameters of Novolog (Insulin) 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 [].
A double-blind, randomized, two-way cross-over study in 16 patients with type 1 diabetes demonstrated that intravenous infusion of Novolog (Insulin) resulted in a blood glucose profile that was similar to that after intravenous infusion with regular human insulin. Novolog (Insulin) 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).
The single substitution of the amino acid proline with aspartic acid at position B28 in Novolog (Insulin) reduces the molecule's tendency to form hexamers as observed with regular human insulin. Novolog (Insulin) is, therefore, more rapidly absorbed after subcutaneous injection compared to regular human insulin.
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 (Insulin) 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 (Insulin) group and 1.2 l/h/kg for the regular human insulin group.
Bioavailability and Absorption
In studies in healthy volunteers (total n=107) and patients with type 1 diabetes (total n=40), Novolog (Insulin) consistently reached peak serum concentrations approximately twice as fast as regular human insulin. The median time to maximum concentration in these trials was 40 to 50 minutes for Novolog (Insulin) versus 80 to 120 minutes for regular human insulin. In a clinical trial in patients with type 1 diabetes, Novolog (Insulin) and regular human insulin, both administered subcutaneously at a dose of 0.15 U/kg body weight, reached mean maximum concentrations of 82 and 36 mU/Lrespectively. Pharmacokinetic/pharmacodynamic characteristics of insulin aspart have not been established in patients with type 2 diabetes.
The intra-individual variability in time to maximum serum insulin concentration for healthy male volunteers was significantly less for Novolog (Insulin) than for regular human insulin. The clinical significance of this observation has not been established.
In a clinical study in healthy non-obese subjects, the pharmacokinetic differences between Novolog (Insulin) and regular human insulin described above, were observed independent of the site of injection (abdomen, thigh, or upper arm).
Distribution and Elimination
Specific Populations
Gender
lc
Obesity
max
max
The effect of age, ethnic origin, pregnancy and smoking on the pharmacokinetics and pharmacodynamics of Novolog (Insulin) has not been studied.
Novolog (Insulin) Clinical Studies
Two six-month, open-label, active-controlled studies were conducted to compare the safety and efficacy of Novolog (Insulin) to Novolin R in adult patients with type 1 diabetes. Because the two study designs and results were similar, data are shown for only one study (see ). Novolog (Insulin) 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 HbA and the incidence rates of severe hypoglycemia (as determined from the number of events requiring intervention from a third party) were comparable for the two treatment regimens in this study () as well as in the other clinical studies that are cited in this section. Diabetic ketoacidosis was not reported in any of the adult studies in either treatment group.
A 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 (Insulin) (n = 187) or Novolin R (n = 96). NPH insulin was administered as the basal insulin. Novolog (Insulin) achieved glycemic control comparable to Novolin R, as measured by change in HbA () and both treatment groups had a comparable incidence of hypoglycemia. Subcutaneous administration of Novolog (Insulin) 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 HbA and hypoglycemia.
One six-month, open-label, active-controlled study was conducted to compare the safety and efficacy of Novolog (Insulin) to Novolin R in patients with type 2 diabetes (). Novolog (Insulin) 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 HbA and the rates of severe hypoglycemia (as determined from the number of events requiring intervention from a third party) were comparable for the two treatment regimens.
Two open-label, parallel design studies (6 weeks [n=29] and 16 weeks [n=118]) compared Novolog (Insulin) to buffered regular human insulin (Velosulin) in adults with type 1 diabetes receiving a subcutaneous infusion with an external insulin pump. The two treatment regimens had comparable changes in HbA and rates of severe hypoglycemia.
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 (Insulin) (n=198) or insulin lispro (n=100). These two treatments resulted in comparable changes from baseline in HbA and comparable rates of hypoglycemia after 16 weeks of treatment (see ).
An open-label, 16-week parallel design trial compared pre-prandial Novolog (Insulin) injection in conjunction with NPH injections to Novolog (Insulin) administered by continuous subcutaneous infusion in 127 adults with type 2 diabetes. The two treatment groups had similar reductions in HbA and rates of severe hypoglycemia () [].
Novolog (Insulin) How Supplied/storage And Handling
Unused Novolog (Insulin) should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Novolog (Insulin) should not be drawn into a syringe and stored for later use.
Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.
Once a cartridge or a Novolog (Insulin) FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A Novolog (Insulin) FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the Novolog (Insulin) FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured Novolog (Insulin) FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused Novolog (Insulin) FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light.
Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or Novolog (Insulin) FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.
Novolog (Insulin) 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.
The storage conditions are summarized in the following table:
Novolog (Insulin) diluted with Insulin Diluting Medium for Novolog (Insulin) to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.
Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.
Novolog (Insulin) Patient Counseling Information
[See ]
Maintenance of normal or near-normal glucose control is a treatment goal in diabetes mellitus and has been associated with a reduction in diabetic complications. Patients should be informed about potential risks and benefits of Novolog (Insulin) therapy including the possible adverse reactions. Patients should also be offered continued education and advice on insulin therapies, injection technique, life-style management, regular glucose monitoring, periodic glycosylated hemoglobin testing, recognition and management of hypo- and hyperglycemia, adherence to meal planning, complications of insulin therapy, timing of dose, instruction in the use of injection or subcutaneous infusion devices, and proper storage of insulin. Patients should be informed that frequent, patient-performed blood glucose measurements are needed to achieve optimal glycemic control and avoid both hyper- and hypoglycemia.
The patient’s ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia should be advised to use caution when driving or operating machinery.
Accidental substitutions between Novolog (Insulin) and other insulin products have been reported. Patients should be instructed to always carefully check that they are administering the appropriate insulin to avoid medication errors between Novolog (Insulin) and any other insulin.
Patients using external pump infusion therapy should be trained in intensive insulin therapy with multiple injections and in the function of their pump and pump accessories.
The following insulin pumps† have been used in Novolog (Insulin) clinical or studies conducted by Novo Nordisk, the manufacturer of Novolog (Insulin) :
Before using another insulin pump with Novolog (Insulin) , read the pump label to make sure the pump has been evaluated with Novolog (Insulin) .
Novolog (Insulin) is recommended for use in any reservoir and infusion sets that are compatible with insulin and the specific pump. Please see recommended reservoir and infusion sets in the pump manual.
To avoid insulin degradation, infusion set occlusion, and loss of the preservative (metacresol), insulin in the reservoir should be replaced at least every 6 days; infusion sets and infusion set insertion sites should be changed at least every 3 days.
See separate leaflet.
Date of Issue: June 2011
Version: 19
Novo Nordisk, Novolog (Insulin) , NovoPen 3, PenFill, Novolin, FlexPen, PenMate, and NovoFine are registered trademarks of Novo Nordisk A/S.
Novolog (Insulin) is covered by US Patent Nos. 5,618,913, 5,866,538, and other patents pending.
FlexPen is covered by US Patent Nos. 6,582,404, 6,004,297, 6,235,004, and other patents pending.
PenFill is covered by US Patent No. 5,693,027.
†The brands listed are the registered trademarks of their respective owners and are not trademarks of Novo Nordisk A/S.
© 2002-2011 Novo Nordisk
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark
For information about Novolog (Insulin) contact:
Novo Nordisk Inc.
Princeton, New Jersey 08540
1-800-727-6500
www.novonordisk-us.com
Novolog (Insulin) Patient Information
(insulin aspart [rDNA origin] Injection)
Make sure you know the type and strength of insulin prescribed for you.
Read the Patient Information that comes with Novolog (Insulin) before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your diabetes or your treatment. Make sure you know how to manage your diabetes. Ask your healthcare provider if you have any questions about managing your diabetes.
Novolog (Insulin) is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.
Only use Novolog (Insulin) if it appears clear and colorless. There may be air bubbles. This is normal. If it looks cloudy, thickened, or colored, or if it contains solid particles do not use it and call Novo Nordisk at 1-800-727-6500.
Novolog (Insulin) comes in:
If your healthcare provider recommends diluting Novolog (Insulin) , follow your healthcare provider's instructions exactly so that you know:
Severe low blood sugar can cause unconsciousness (passing out), seizures, and death. Know your symptoms of low blood sugar. Follow your healthcare provider’s instructions for treating low blood sugar. Talk to your healthcare provider if low blood sugar is a problem for you.
These are not all of the possible side effects from Novolog (Insulin) . Ask your healthcare provider or pharmacist for more information.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Medicines are sometimes prescribed for conditions that are not mentioned in the patient leaflet. Do not use Novolog (Insulin) for a condition for which it was not prescribed. Do not give Novolog (Insulin) to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about Novolog (Insulin) . If you would like more information about Novolog (Insulin) or diabetes, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Novolog (Insulin) that is written for healthcare professionals. Call 1-800-727-6500 or visit www.novonordisk-us.com for more information.
Helpful information for people with diabetes is published by the American Diabetes Association, 1701 N Beauregard Street, Alexandria, VA 22311 and on www.diabetes.org.
All Novolog (Insulin) vials, PenFill cartridges and Novolog (Insulin) FlexPen are latex free.
Date of Issue: June 2011
Version: 11
Novolog (Insulin) is covered by US Patent Nos. 5,618,913, 5,866,538, and other patents pending.
FlexPen is covered by US Patent Nos. 6,582,404, 6,004,297, 6,235,004, and other patents pending.
PenFill is covered by US Patent No. 5,693,027.
© 2002-2011 Novo Nordisk
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark
For information about Novolog (Insulin) contact:
Novo Nordisk Inc.
100 College Road West
Princeton, New Jersey 08540
Before starting, gather all of the supplies that you will need to use for preparing and giving your insulin injection.
Never re-use syringes and needles.
Novolog (Insulin) should be mixed only when injections with syringes are used. Novolog (Insulin) can be mixed with NPH human insulin right before use. The Novolog (Insulin) should be drawn into the syringe before you draw up the NPH insulin.
Patients who develop local skin reactions may need to change infusion sites more often than every 3 days.
Use only insulin pumps that have been specially tested with Novolog (Insulin) . Follow your healthcare provider or pharmacist instructions for which insulin pumps may be used.
Check with your healthcare provider or pharmacist to see if your pump and infusion set can be used with Novolog (Insulin) .
1. Check to make sure that you have the right type of insulin.
2. Look at the vial and insulin. The insulin should be clear and colorless. The tamper-resistant cap should be in place before the first use. If the cap had been removed before your first use, or if the insulin is cloudy or colored, do not use it and call Novo Nordisk at 1-800-727-6500.
3. Wash your hands with soap and water.
4. Fill the reservoir-syringe with 2 days worth of Novolog (Insulin) plus about 25 extra units to prime the pump and the infusion tubing.
5. Remove air bubbles from the reservoir by following the pump manufacturers’ instructions.
6. Attach the infusion set to the reservoir. Make sure the connection is tight. Prime the infusion set until you see a drop of insulin coming out of the infusion needle-catheter. Follow the pump manufacturers’ instructions for priming and removing air bubbles.
7. Clean your insertion site with an alcohol swab and let the site dry before you insert the needle-catheter. Talk with your healthcare provider about how to rotate insertion sites and how to insert the needle-catheter into the skin.
8. Insert the needle-catheter into the skin, remove the needle and prime the catheter according to the pump manufacturers’ instructions. Do not insert the needle-catheter into skin that is reddened, itchy, bumpy, or thickened.
9. Program the pump for mealtime Novolog (Insulin) boluses and Novolog (Insulin) basal insulin infusion according to instructions from your healthcare provider and the manufacturer of your pump equipment.
10. Change the infusion site and infusion set at least every 3 days, and change the insulin in the reservoir at least every 6 days even if you have not used all of the insulin. This will help ensure that Novolog (Insulin) and the pump work well.
11. Change the infusion site, the infusion set, the insulin reservoir and the insulin if you experience a pump alarm, catheter blockage, high blood sugars, or if your pump insulin has been exposed to heat greater than 98.6F (37C).
12. If you have high blood sugar (hyperglycemia) when you check your blood sugar, this may be the first sign of a problem with the pump, infusion set, or Novolog (Insulin) . If you have high blood sugar without a pump alarm, you must still check the pump because alarms may not detect all the changes to Novolog (Insulin) that could result in high blood sugar. You may need to start insulin injections with syringes if the cause of the problem cannot be found quickly or fixed. Long lengths of infusion-set tubing increase the risk for kinking and expose the insulin in the tubing to more changes in temperature.
To prevent the injection of air and to make sure insulin is delivered, you must do an airshot before each injection. Hold the device with the needle pointing up and gently tap the PenFill cartridge holder with your finger a few times to raise any air bubbles to the top of the cartridge. Do the airshot as described in the device instruction manual.
6. Dial the number of units on the insulin delivery device that you need to inject. Inject the right way as shown to you by your healthcare provider.
7. Insert the needle into the skin. Inject the dose by pressing the push button all the way in. 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. This will make sure that the full dose has been given. You may see a drop of Novolog (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.
8. Recapping can lead to a needle stick injury.
9. Remove the needle from the PenFill cartridge after each injection. Keep the 3 mL PenFill cartridge in the insulin delivery device. The needle should not be attached to the 3 mL PenFill cartridge during storage. This will prevent infection or leakage of insulin and will help ensure that you receive the right dose of Novolog (Insulin) .
10. Put the used needle and cartridge in a sharps container, or some type of hard plastic or metal container with a screw on top such as a detergent bottle or coffee can. Check with your healthcare provider about the right way to throw away used needles and cartridges. There may be local or state laws about how to throw away used needles and syringes. Do not throw used needles and cartridges in household trash or recycling bins.
11. Put the pen cap back on the Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery device.
Date of Issue: June 2011
Version: 8
Novolog (Insulin) is covered by US Patent Nos. 5,618,913, 5,866,538, and other patents pending.
PenFill is covered by US Patent No. 5,693,027.
© 2002-2011 Novo Nordisk
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark
For information about Novolog (Insulin) contact:
Novo Nordisk Inc.
100 College Road West
Princeton, New Jersey 08540
Please read the following instructions carefully before using your Novolog (Insulin) FlexPen.
Novolog (Insulin) FlexPen is a disposable dial-a-dose insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. Novolog (Insulin) FlexPen is designed to be used with NovoFine needles.
Make sure you have the following items:
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 (Insulin) should look clear.
Wipe the rubber stopper with an alcohol swab.
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).
Never place a disposable needle on your Novolog (Insulin) FlexPen until you are ready to take your 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:
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 (Insulin) 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.
Check and make sure that the dose selector is set at 0.
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.
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.
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.
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.
You may see a drop of Novolog (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.
The Novolog (Insulin) FlexPen prevents the cartridge from being completely emptied. It is designed to deliver 300 units.
The insulin should fill the lower part of the big outer needle cap (see diagram L). If the Novolog (Insulin) FlexPen has released too much or too little insulin, do the function check again. If the same problem happens again, do not use your Novolog (Insulin) FlexPen and contact Novo Nordisk at 1-800-727-6500.
Your FlexPen is designed to work accurately and safely. It must be handled 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.
Novolog (Insulin) Principal Display Panel - Ml Novolog Vial
NDC 0169-7501-11
List 750111
10 mL 100 units/mL
Rx only
U-100
Novolog (Insulin) Principal Display Panel - Ml Novolog Penfill
NDC 0169-3303-12 List 330312
Insulin aspart Injection (rDNA origin)
3 mL cartridges
100 units/mL (U-100)
5 cartridges per package
For use with Novo Nordisk 3 mL PenFill cartridge compatible delivery devices, with or without the addition of a NovoPen 3 PenMate, and NovoFine disposable needles.
Keep in a cold place.
Avoid freezing.
Protect from light.
Rx only
Novolog (Insulin) Principal Display Panel - Ml Novolog Flexpen
NDC 0169-6339-10 List 633910
Prefilled Syringe
Insulin aspart Injection (rDNA origin)
100 units/mL (U-100)
5 x 3 mL Prefilled Insulin Syringes
