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Novolin R Human Insulin 100 [iU]/mL Injection, Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Insulin class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Human insulin is used to control blood sugar in people who have type 1 diabetes (condition in which the body does not make insulin and therefore cannot control the amount of sugar in the blood) or in people who have type 2 diabetes (condition in which the blood sugar is too high because the body does not produce or use insulin normally) that cannot be controlled with oral medications alone. Human insulin is in a class of medications called hormones. Human insulin is used to take the place of insulin that is normally produced by the body. It works by helping move sugar from the blood into other...
Read the full MedlinePlus article ↗- Novolin is a human insulin — it's identical to the insulin your body naturally makes. It's prescribed to help control your blood sugar when your body doesn't produce enough insulin...
- What exactly is Novolin and why was I prescribed it?
- Yes, timing with meals matters. For subcutaneous use, you inject Novolin about 30 minutes before you start eating. You can inject into your abdomen, thigh, buttock, or upper arm —...
- How do I take this injection, and does it matter when I eat?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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16 mg / 1 mL
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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3 mg / 1 mL
UNII GGO4Y809LO
Metacresol is a preservative derived from coal tar or petroleum. It prevents bacterial and fungal growth in liquid medicines, helping keep the product safe and stable during storage.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
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21 ug / 1 mL
UNII J41CSQ7QDS
A mineral element that strengthens tablet structure and acts as a processing aid. Zinc helps bind ingredients together and may improve the medicine's stability during manufacturing and storage.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $4.625 | $46.25 / 10 ml |
| Medicaid paysCMS SDUD · 12 mo | $5.97 | $59.73 / 10 ml |
| Medicare drug plans payPart D · Q2 2026 | $4.62 | $46.16 / 10 ml |
| Medicare Part B allowsASP · J1815 | No ASP payment limit on file for J1815 this quarter. | |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Humulin R 100 [iU]/mL 00002-8215-01 | Eli | 1 vial | $4.264 | — | Availability likely | save 8% |
| Novolin R 100 [iU]/mLthis 00169-1833-11 | Novo | 1 vial | $4.625 | — | Availability likely | — |
| Novolin R 100 [iU]/mL 00169-3003-15 | Novo | 5 syringes | $5.816 | — | Availability likely | +26% |
| Novolin N 100 [iU]/mL 00169-3004-15 | Novo | 5 syringes | $5.823 | — | Availability likely | +26% |
| Novolin 70/30 100 [iU]/mL 00169-3007-15 | Novo | 5 syringes | $5.826 | — | Availability likely | +26% |
| Humulin R 100 [iU]/mL 00002-0213-01 | Eli | 1 vial | — | — | FDA listed | — |
| Humulin R 100 [iU]/mL 50090-0353-00 | A-S | 1 vial | — | — | FDA listed | — |
| Novolin N 100 [iU]/mL 00169-1834-02 | Novo | 1 vial | — | — | FDA listed | — |
| Novolin 70/30 100 [iU]/mL 00169-1837-02 | Novo | 1 vial | — | — | FDA listed | — |
| Novolin 70/30 100 [iU]/mL 50090-0403-00 | A-S | 1 vial | — | — | FDA listed | — |
| Novolin N 100 [iU]/mL 50090-6565-00 | A-S | 5 syringes | — | — | Discontinued | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00169-1833-02 | 1 VIAL in 1 CARTON (0169-1833-02) / 10 mL in 1 VIAL | — | — | 1991-06-25 | Active |
| 00169-1833-11 You're viewing this | 1 VIAL in 1 CARTON (0169-1833-11) / 10 mL in 1 VIAL | $4.62 / mL | $46.25 | 1991-06-25 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 86% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00169-1833-11?
What NDC number is used to bill for this package of Novolin R Human Insulin 100 [iU]/mL Injection, Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE NOVOLIN R is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. NOVOLIN R is a short-acting human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus ( 1 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • See Full Prescribing Information for important administration instructions. ( 2.1 ) • Subcutaneous injection: inject subcutaneously 30 minutes before a meal into the abdominal area, buttocks, thigh or the upper arm. Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
( 2.2 ) • Intravenous use: administer intravenously ONLY under medical supervision at concentrations from 0.05 unit/mL to 1 unit/mL in infusion systems using polypropylene infusion bags. ( 2.2 ) • Individualize dose based on route of administration, metabolic needs, blood glucose monitoring results and glycemic control goal. ( 2.3 ) • NOVOLIN R given by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin.
( 2.3 ) • Can be mixed with NOVOLIN N. ( 2.5 )
2.1Important Administration Instructions Always check insulin labels before administration [see Warnings and Precautions ( 5.4 )]. • Inspect NOVOLIN R visually before use. It should appear clear and colorless. Do not use NOVOLIN R if particulate matter or coloration is seen. • Use of NOVOLIN R in insulin pumps is not recommended because of the risk of precipitation.
2.2Route of Administration Subcutaneous Administration • Inject NOVOLIN R subcutaneously approximately 30 minutes prior to the start of a meal into the abdominal area, buttocks, thigh, or the upper arm. • Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6 )]. Intravenous Administration • Administer NOVOLIN R intravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels to reduce the risk of hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3 , 5.6 ) and How Supplied/Storage and Handling ( 16.2 )] . • Dilute NOVOLIN R to concentrations from 0.05 unit/mL to 1 unit/mL insulin in infusion systems using polypropylene infusion bags.
NOVOLIN R is stable in infusion fluids such as 0.9% sodium chloride, 5% dextrose, or 10% dextrose with 40 mmol/L potassium chloride. Intravenous infusion bags are stable at room temperature for 24 hours.
2.3Dosage Information • Individualize and adjust the dosage of NOVOLIN R based on route of administration, the individual's metabolic needs, blood glucose monitoring results and glycemic control goal. • NOVOLIN R given by subcutaneous injection should generally be used in regimens that include an intermediate or long-acting insulin . • During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2)] . • Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness [see Warnings and Precautions ( 5.2 , 5.3 ) and Use in Specific Populations ( 8.6 , 8.7 )]. • Dosage adjustment may be needed when switching from another insulin to NOVOLIN R [see Warnings and Precautions ( 5.2 )].
2.4Dosage Adjustment due to Drug Interactions • Dosage adjustment may be needed when NOVOLIN R is co-administered with certain drugs [see Drug Interactions ( 7 )] .
2.5Instructions for Mixing with Other Insulins for Subcutaneous Injection • NOVOLIN R can be mixed with NOVOLIN N. • When mixing, the NOVOLIN R should be drawn into the syringe first and the mixture should be injected immediately after mixing.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 100 units/mL (U-100), a clear and colorless solution available as: • 10 mL multiple-dose vial • 3 mL single-patient-use NOVOLIN R FlexPen prefilled pen Injection: 100 units/mL (U-100) is available as: • 10 mL multiple-dose vial ( 3 ) • 3 mL single-patient-use NOVOLIN R FlexPen prefilled pen ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS NOVOLIN R is contraindicated: • During episodes of hypoglycemia • In patients with hypersensitivity to NOVOLIN R or any of its excipients • During episodes of hypoglycemia ( 4 ) • Hypersensitivity to NOVOLIN R or any of its excipients ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Never share a NOVOLIN R FlexPen or syringe between patients, even if the needle is changed. ( 5.1 ) • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. ( 5.2 ) • Hypoglycemia: May be life-threatening.
Increase frequency of blood glucose monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; in patients with renal or hepatic impairment or with hypoglycemia unawareness. ( 5.3 ) • Hypoglycemia Due to Medication Errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection.
( 5.4 ) • Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue NOVOLIN R, monitor, and treat if indicated. ( 5.5 ) • Hypokalemia: May be life-threatening.
Monitor potassium levels in patients at risk for hypokalemia and treat if indicated. ( 5.6 ) • Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs. ( 5.7 )
5.1Never Share a NOVOLIN R FlexPen or Syringe between Patients NOVOLIN R FlexPen must never be shared between patients, even if the needle is changed. Patients using NOVOLIN R vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
5.2Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions ( 5.3 )] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions ( 6 )] .
Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.
5.3Hypoglycemia Hypoglycemia is the most common adverse reaction of all insulins, including NOVOLIN R. 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 the patient 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 patient and change over time in the same patient. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic neuropathy, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions ( 7 )] , or in patients who experience recurrent hypoglycemia. Risk Factors for 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 insulins, the glucose lowering effect time course of NOVOLIN R may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: • Hypoglycemia [see Warnings and Precautions ( 5.3 )] • Medication Errors [see Warnings and Precautions ( 5.4 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] • Hypokalemia [see Warnings and Precautions ( 5.6 )] Adverse Reactions from Clinical Studies or Postmarketing Reports The following additional adverse reactions have been identified during clinical studies or from postmarketing reports with use of NOVOLIN R.
Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. Adverse reactions associated with insulin initiation and glucose control intensification 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. Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy.
Hypersensitivity reactions Severe, life-threatening, generalized allergy, including anaphylaxis. Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in NOVOLIN R. Hypokalemia NOVOLIN R can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia.
Injection site reactions NOVOLIN R can cause local injection site reactions including redness, swelling, or itching at the site of injection. These reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation. Localized reactions and generalized myalgias have been reported with the use of metacresol, which is an excipient in NOVOLIN R.
Lipodystrophy Administration of insulin subcutaneously, including NOVOLIN R, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see Dosage and Administration (2.2)] in some patients. Localized Cutaneous Amyloidosis Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
Medication Errors Medication errors in which other insulins have been accidentally substituted for NOVOLIN R have been identified during postapproval use. Peripheral edema Insulins, including NOVOLIN R, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Weight gain Weight gain can occur with insulins, including NOVOLIN R, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
Immunogenicity As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form. Increases in titers of anti-insulin antibodies that react with human insulin have been observed in patients treated with NOVOLIN R. Adverse reactions observed with NOVOLIN R include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, weight gain and edema ( 6 ) .
To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 1: Clinically Significant Drug Interactions with NOVOLIN R Drugs that May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when NOVOLIN R is co-administered with these drugs.
Drugs that May Decrease the Blood Glucose Lowering Effect of NOVOLIN R 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 NOVOLIN R is co-administered with these drugs.
Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of NOVOLIN R Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when NOVOLIN R is co-administered with these drugs.
Drugs that May Blunt Signs and Symptoms of Hypoglycemia Drugs: Beta-blockers, clonidine, guanethidine, and reserpine Intervention: Increased frequency of glucose monitoring may be required when NOVOLIN R is co-administered with these drugs. • Drugs that Affect Glucose Metabolism: Adjustment of insulin dosage may be needed. ( 7 ) • Antiadrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Signs and symptoms of hypoglycemia may be reduced or absent. ( 5.3 , 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data from published studies over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Animal reproduction studies were not performed.
The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA 1c >7 and has been reported to be as high as 20-25% in women with a HbA 1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. Data Human Data While available studies cannot definitively establish the absence of risk, published data from retrospective studies, open-label, randomized, parallel studies and meta-analyses have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes.
All available studies have methodological limitations including lack of blinding, unclear methods of randomization, and small sample size.
8.2Lactation Risk Summary Available data from published literature suggest that exogenous human insulin products, including NOVOLIN R, are transferred into human milk. There are no adverse reactions reported in the breastfed infants in the literature. There are no data on the effects of exogenous human insulin products, including NOVOLIN R, on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NOVOLIN R and any potential adverse effects on the breastfed infant from NOVOLIN R or from the underlying maternal condition.
8.4Pediatric Use NOVOLIN R is indicated to improve glycemic control in pediatric patients with diabetes mellitus. The dosage of NOVOLIN R must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose to reduce the risk of hypoglycemia [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.3 )] .
8.5Geriatric Use In clinical trials 18 of 1285 patients (1.4%) with type 1 diabetes and 151 of 635 patients (24%) with type 2 diabetes treated with NOVOLIN R were ≥65 years of age. Therefore, conclusions are limited regarding the efficacy and safety of NOVOLIN R in patients ≥65 years of age. The effect of age on the pharmacokinetics and pharmacodynamics of NOVOLIN R has not been studied.
Elderly patients using NOVOLIN R, may be at increased risk of hypoglycemia due to co-morbid disease [see Warnings and Precautions ( 5.3 )] .
8.6Renal Impairment The effect of renal impairment on the pharmacokinetics and pharmacodynamics of NOVOLIN R has not been studied. Patients with renal impairment are at increased risk of hypoglycemia and may require more frequent NOVOLIN R dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions ( 5.3 )] .
8.7Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of NOVOLIN R has not been studied. Patients with hepatic impairment are at increased risk of hypoglycemia and may require more frequent NOVOLIN R dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions ( 5.3 )] .
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from published studies over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Animal reproduction studies were not performed.
The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA 1c >7 and has been reported to be as high as 20-25% in women with a HbA 1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. Data Human Data While available studies cannot definitively establish the absence of risk, published data from retrospective studies, open-label, randomized, parallel studies and meta-analyses have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes.
All available studies have methodological limitations including lack of blinding, unclear methods of randomization, and small sample size.
🧒 Pediatric Use ▾
8.4Pediatric Use NOVOLIN R is indicated to improve glycemic control in pediatric patients with diabetes mellitus. The dosage of NOVOLIN R must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose to reduce the risk of hypoglycemia [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.3 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use In clinical trials 18 of 1285 patients (1.4%) with type 1 diabetes and 151 of 635 patients (24%) with type 2 diabetes treated with NOVOLIN R were ≥65 years of age. Therefore, conclusions are limited regarding the efficacy and safety of NOVOLIN R in patients ≥65 years of age. The effect of age on the pharmacokinetics and pharmacodynamics of NOVOLIN R has not been studied.
Elderly patients using NOVOLIN R, may be at increased risk of hypoglycemia due to co-morbid disease [see Warnings and Precautions ( 5.3 )] .
🆘 Overdosage ▾
10 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 can be treated with intramuscular or subcutaneous glucagon or intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately [see Warnings and Precautions ( 5.3 , 5.6 )].
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The primary activity of insulin, including NOVOLIN R is the regulation of glucose metabolism. Insulins 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.
12.2Pharmacodynamics NOVOLIN R is a short-acting insulin. The time course of insulin action (i.e., glucose lowering) may vary considerably in different individuals, within the same individual, and different doses. When injected subcutaneously, the glucose-lowering effect of NOVOLIN R begins approximately 30 minutes post-dose, is maximal between 1.5 and 3.5 hours post-dose and terminates approximately 8 hours post-dose.
The onset of action of NOVOLIN R, when administered intravenously, is more rapid in comparison to the subcutaneous administration. When injected subcutaneously, NOVOLIN R has a slower onset of action and longer duration of action compared to the rapid-acting insulin analogs.
12.3Pharmacokinetics After single subcutaneous administration of 0.1 unit/kg of NOVOLIN R to healthy subjects, peak insulin concentrations occurred between 1.5 to 2.5 hours post-dose. On average, insulin concentrations returned to baseline at around 5 hours post-dose. The effects of gender, age, obesity, renal and hepatic impairment on the pharmacodynamics and pharmacokinetics of NOVOLIN R have not been studied.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The primary activity of insulin, including NOVOLIN R is the regulation of glucose metabolism. Insulins 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied NOVOLIN R (insulin human) injection is 100 units/mL (U-100), a clear and colorless solution available as: 10 mL multiple-dose vial NDC 0169-1833-11 ReliOn ® brand NDC 0169-1833-02 3 mL single-patient-use FlexPen NDC 0169-3003-15 ReliOn ® brand NDC 0169-3003-25 The NOVOLIN R FlexPen dials in 1-unit increments.
16.2Storage and Handling Dispense in the original sealed carton with the enclosed Instructions for Use. • Do not freeze. • Do not use if it has been frozen. • Do not use after the expiration date. • Do not expose to excessive heat or light. NOVOLIN R FlexPen must never be shared between patients, even if the needle is changed. Always remove and discard the needle after each injection from the NOVOLIN R FlexPen and store without a needle attached.
Patients using NOVOLIN R vials must never share needles or syringes with another person. Always use a new disposable syringe or needle for each injection to prevent contamination. Table 2: Storage Conditions and Expiration Dates for NOVOLIN R Not In-use (Unopened) Refrigerated (36°F - 46°F [2°C - 8°C]) Not In-use (Unopened ) Room Temperature (see temperature below) In-use (Opened) Room Temperature (see temperature below) 10 mL multiple-dose vial Until expiration date 42 days up to 77°F (25°C) 42 days up to 77°F (25°C) (Do not refrigerate) 3 mL single-patient-use FlexPen Until expiration date 28 days up to 86°F (30°C) 28 days up to 86°F (30°C) (Do not refrigerate) Intravenous infusion bags prepared as indicated [see Dosage and Administration ( 2.2 )] are stable at room temperature for 24 hours.
📋 Description ▾
11 DESCRIPTION Insulin human is a short-acting human insulin produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism and has the empirical formula C 257 H 383 N 65 O 77 S 6 with a molecular weight of 5808 Da. Figure 1: Structural formula of NOVOLIN R NOVOLIN R (insulin human) injection is a sterile, clear and colorless solution for subcutaneous or intravenous use. Each mililiter of NOVOLIN R contains 100 units of insulin human, and glycerin (16 mg), metacresol (3 mg), zinc (approximately 21 mcg/mL) and Water for Injection.
Hydrochloric acid 2N and sodium hydroxide 2N may be added during manufacture to adjust pH. The pH is 7.0 to 7.8. Structural formula of Novolin R
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Never Share a NOVOLIN R FlexPen or Syringe between Patients Advise patients using NOVOLIN R vials or FlexPen not to share needles, syringes or FlexPen with another person. Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions ( 5.1 )] .
Hyperglycemia or Hypoglycemia 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 NOVOLIN R 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 ( 5.3 )] . 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.
Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions ( 5.2 ) . Hypoglycemia due to Medication Errors Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products [see Warnings and Precautions ( 5.4 )] . Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with NOVOLIN R.
Inform patients on the symptoms of hypersensitivity reactions and to seek medical attention if they occur [see Warnings and Precautions ( 5.5 )] . Novolin ® , FlexPen ® and Novo Nordisk ® are registered trademarks of Novo Nordisk A/S. ReliOn ® is a registered trademark of Walmart Inc. and is used under license by Novo Nordisk Inc.
Patent Information: http://novonordisk-us.com/products/product-patents.html © 2022 Novo Nordisk Manufactured by: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, New Jersey 08536 1-800-727-6500 U.S. License Number 1261 For information about NOVOLIN R contact: Novo Nordisk Inc.
800 Scudders Mill Road Plainsboro, New Jersey 08536 www.novonordisk-us.com 1-800-727-6500 (Se habla español)