INSULIN LISPRO- insulin lispro injection, solution
INSULIN LISPRO KWIKPEN
- insulin lispro injection, solution
INSULIN LISPRO JUNIOR KWIKPEN
- insulin lispro injection, solution
Eli Lilly and Company
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use INSULIN LISPRO safely and effectively. See full prescribing information for INSULIN LISPRO.
INSULIN LISPRO injection, for subcutaneous or intravenous use Initial U.S. Approval: 1996 This product is HUMALOG® (insulin lispro). INDICATIONS AND USAGEInsulin Lispro is a rapid acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. (1) DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSInjection: 100 units/mL (U-100) is available as: (3)
CONTRAINDICATIONSWARNINGS AND PRECAUTIONS
ADVERSE REACTIONSAdverse reactions associated with Insulin Lispro include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 9/2023 |
Insulin Lispro is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
Subcutaneous Injection
Subcutaneous Injection: Diluted Insulin Lispro
Continuous Subcutaneous Infusion (Insulin Pump)
Intravenous Administration
Dosage modification may be needed when Insulin Lispro is used concomitantly with certain drugs [see Drug Interactions (7)].
The table below includes administration instructions regarding mixing Insulin Lispro with other insulins.
Insulin Lispro subcutaneous injection route |
|
Insulin Lispro continuous subcutaneous infusion route (Insulin Pump) | Do NOT mix Insulin Lispro with any other insulin. |
Injection: 100 units/mL (U-100) clear and colorless solution available as:
Insulin Lispro prefilled pens must never be shared between patients, even if the needle is changed. Patients using Insulin Lispro vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
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 antidiabetic products may be needed.
Hypoglycemia is the most common adverse reaction associated with insulins, including Insulin Lispro. Severe hypoglycemia can cause seizures, 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 (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 Insulin Lispro may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature [see Clinical Pharmacology (12.2)]. 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 (7)]. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use in Specific Populations (8.6, 8.7)].
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. 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 insulin products have been reported. To avoid medication errors between Insulin Lispro and other insulins, instruct patients to always check the insulin label before each injection.
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including Insulin Lispro. If hypersensitivity reactions occur, discontinue Insulin Lispro; treat per standard of care and monitor until symptoms and signs resolve [see Adverse Reactions (6.1)]. Insulin Lispro is contraindicated in patients who have had hypersensitivity reactions to Insulin Lispro or any of the excipients in Insulin Lispro [see Contraindications (4)].
All insulins, including Insulin Lispro, 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 concentrations).
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 Insulin Lispro, 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 Insulin Lispro 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 (16.2) and Patient Counseling Information (17)].
The following adverse reactions are 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 with those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.
Common adverse reactions, excluding hypoglycemia, were defined as events that occurred in ≥5% of patients treated with Insulin Lispro or regular human insulin. The frequencies of adverse reactions during Insulin Lispro clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.
Insulin Lispro (%) (n=81) | Regular human insulin (%) (n=86) |
|
Flu syndrome | 34.6 | 32.6 |
Pharyngitis | 33.3 | 33.7 |
Rhinitis | 24.7 | 29.1 |
Headache | 29.6 | 22.1 |
Pain | 19.8 | 16.3 |
Cough increased | 17.3 | 17.4 |
Infection | 13.6 | 20.9 |
Nausea | 6.2 | 15.1 |
Accidental injury | 8.6 | 11.6 |
Surgical procedure | 6.2 | 14.0 |
Fever | 6.2 | 11.6 |
Abdominal pain | 7.4 | 8.1 |
Asthenia | 7.4 | 8.1 |
Bronchitis | 7.4 | 7.0 |
Diarrhea | 8.6 | 5.8 |
Dysmenorrhea | 6.2 | 7.0 |
Myalgia | 7.4 | 5.8 |
Urinary tract infection | 6.2 | 4.7 |
Insulin Lispro (%) (n=714) | Regular human insulin (%) (n=709) |
|
Headache | 11.6 | 9.3 |
Pain | 10.8 | 10.0 |
Infection | 10.1 | 7.6 |
Pharyngitis | 6.6 | 8.2 |
Rhinitis | 8.1 | 6.6 |
Flu syndrome | 6.2 | 8.2 |
Surgical procedure | 7.4 | 6.8 |
Insulin initiation and intensification of glucose control
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.
Hypoglycemia
Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Insulin Lispro.
Lipodystrophy
Long-term use of insulin, including Insulin Lispro, 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 [see Dosage and Administration (2.2)].
Weight gain
Weight gain can occur with insulins, including Insulin Lispro, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
Peripheral Edema
Insulins, including Insulin Lispro, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Adverse Reactions with Continuous Subcutaneous Insulin Infusion (CSII)
In a 12-week, randomized, crossover study in adult patients with type 1 diabetes (n=39), the rates of catheter occlusions and infusion site reactions were similar for Insulin Lispro and regular human insulin treated patients (see Table 3).
Insulin Lispro (n=38) | Regular human insulin (n=39) |
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Catheter occlusions/month | 0.09 | 0.10 |
Infusion site reactions | 2.6% (1/38) | 2.6% (1/39) |
In a randomized, 16-week, open-label, parallel design study of pediatric patients with type 1 diabetes, adverse reactions related to infusion-site reactions were similar for Insulin Lispro and insulin aspart (21% of 100 patients versus 17% of 198 patients, respectively). In both groups, the most frequently reported infusion site reactions were infusion site erythema and infusion site reaction.
Allergic Reactions
Local Allergy — As with any insulin, patients taking Insulin Lispro may experience redness, swelling, or itching at the site of the injection. These minor reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation of Insulin Lispro.
Systemic Allergy — Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with any insulin, including Insulin Lispro. Generalized allergy to insulin may cause whole body rash (including pruritus), dyspnea, wheezing, hypotension, tachycardia, or diaphoresis.
In controlled clinical trials, pruritus (with or without rash) was seen in 17 patients receiving regular human insulin (n=2969) and 30 patients receiving Insulin Lispro (n=2944).
Localized reactions and generalized myalgias have been reported with injected metacresol, which is an excipient in Insulin Lispro [see Contraindications (4)].
Antibody Production
In large clinical trials with patients with type 1 (n=509) and type 2 (n=262) diabetes mellitus, anti-insulin antibody (insulin lispro-specific antibodies, insulin-specific antibodies, cross-reactive antibodies) formation was evaluated in patients receiving both regular human insulin and Insulin Lispro (including patients previously treated with human insulin and naive patients). As expected, the largest increase in the antibody levels occurred in patients new to insulin therapy. The antibody levels peaked by 12 months and declined over the remaining years of the study. These antibodies do not appear to cause deterioration in glycemic control or necessitate an increase in insulin dose. There was no statistically significant relationship between the change in the total daily insulin dose and the change in percent antibody binding for any of the antibody types.
The following additional adverse reactions have been identified during post-approval use of Insulin Lispro. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Medication errors in which other insulins have been accidentally substituted for Insulin Lispro have been identified during post-approval use.
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.
The table below includes clinically significant drug interactions with Insulin Lispro.
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 Insulin Lispro is co-administered with these drugs. |
Drugs That May Decrease the Blood Glucose Lowering Effect of Insulin Lispro | |
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 Insulin Lispro is co-administered with these drugs. |
Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Insulin Lispro | |
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 Insulin Lispro 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 Insulin Lispro is co-administered with these drugs. |
Risk Summary
Published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of 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).
Pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis. No adverse effects on embryo/fetal viability or morphology were observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day. No adverse effects on embryo/fetal development were observed in offspring of rabbits exposed to insulin lispro at doses up to approximately 0.2 times the human subcutaneous dose of 1 unit/kg/day (see Data).
The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with a HbA1c >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
Published data from retrospective studies and meta-analyses do not report an association with insulin lispro and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin lispro is used during pregnancy. However, these studies cannot definitely establish or exclude the absence of any risk because of methodological limitations including small sample size, selection bias, confounding by unmeasured factors, and some lacking comparator groups.
Animal Data
In a combined fertility and embryo-fetal development study, female rats were given subcutaneous insulin lispro injections of 1, 5, and 20 units/kg/day (0.2, 0.8, and 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) from 2 weeks prior to cohabitation through Gestation Day 19. There were no adverse effects on female fertility, implantation, or fetal viability and morphology. However, fetal growth retardation was produced at the 20 units/kg/day-dose as indicated by decreased fetal weight and an increased incidence of fetal runts/litter.
In an embryo-fetal development study in pregnant rabbits, insulin lispro doses of 0.1, 0.25, and 0.75 unit/kg/day (0.03, 0.08, and 0.2 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) were injected subcutaneously on Gestation days 7 through 19. There were no adverse effects on fetal viability, weight, and morphology at any dose.
Risk Summary
Available data from published literature suggests that exogenous human insulin products, including insulin lispro, are transferred into human milk. There are no adverse reactions reported in breastfed infants in the literature. There are no data on the effects of exogenous human insulin products, including insulin lispro, on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for insulin, any potential adverse effects on the breastfed child from Insulin Lispro or from the underlying maternal condition.
The safety and effectiveness of Insulin Lispro to improve glycemic control have been established in pediatric patients with diabetes mellitus. Use of Insulin Lispro for this indication is supported by evidence from adequate and well-controlled studies in 831 pediatric patients with type 1 diabetes mellitus aged 3 years and older and from studies in adults with diabetes mellitus [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].
Of the total number of patients (n=2,834) in eight clinical studies of Insulin Lispro, twelve percent (n=338) were 65 years of age or over. The majority of these patients had type 2 diabetes. HbA1c values and hypoglycemia rates did not differ by age. Pharmacokinetic/pharmacodynamic studies to assess the effect of age on the onset of Insulin Lispro action have not been performed.
Patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent Insulin Lispro dose adjustment and more frequent blood glucose monitoring [see Clinical Pharmacology (12.3)].
Patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent Insulin Lispro dose adjustment and more frequent blood glucose monitoring [see Clinical Pharmacology (12.3)].
Excess insulin administration may cause hypoglycemia and 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 a glucagon product for emergency use 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.
Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5.808 kDa, both identical to that of human insulin.
Insulin lispro has the following primary structure:
Insulin Lispro injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use.
Each mL of Insulin Lispro contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.0 mg), glycerin (16 mg), metacresol (3.15 mg), trace amounts of phenol, zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP.
Insulin Lispro has a pH of 7.0 to 7.8.
Hydrochloric acid 10% and/or sodium hydroxide 10% is added to adjust the pH.
Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin lispro. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.
Insulin Lispro has been shown to be equipotent to human insulin on a molar basis. One unit of Insulin Lispro has the same glucose-lowering effect as one unit of regular human insulin. Studies in normal volunteers and patients with diabetes demonstrated that Insulin Lispro has a more rapid onset of action and a shorter duration of activity than regular human insulin when given subcutaneously.
The time course of action of insulin and insulin analogs, such as Insulin Lispro, may vary considerably in different individuals or within the same individual. The parameters of Insulin Lispro activity (time of onset, peak time, and duration) as designated in Figure 1 should be considered only as general guidelines. The rate of insulin absorption, and consequently the onset of activity are known to be affected by the site of injection, exercise, and other variables [see Warnings and Precautions (5.2)].
Figure 1: Blood Glucose Levels After Subcutaneous Injection of Regular Human Insulin or Insulin Lispro (0.2 unit/kg) Immediately Before a High Carbohydrate Meal in 10 Patients with Type 1 Diabetesa.
a Baseline insulin concentration was maintained by infusion of 0.2 mU/min/kg human insulin.
Intravenous Administration — The glucose lowering effect of intravenously administered Insulin Lispro was tested in 21 patients with type 1 diabetes. For the study, the patients' usual doses of insulin were held and blood glucose concentrations were allowed to reach a stable range of 200 to 260 mg/dL during a one to three hours run-in phase. The run-in phase was followed by a 6-hour assessment phase. During the assessment phase, patients received intravenous Insulin Lispro at an initial infusion rate of 0.5 units/hour. The infusion rate of Insulin Lispro could be adjusted at regular timed intervals to achieve and maintain blood glucose concentrations between 100 to 160 mg/dL.
The mean blood glucose levels during the assessment phase for patients on Insulin Lispro therapy are summarized below in Table 4. All patients achieved the targeted glucose range at some point during the 6-hour assessment phase. At the endpoint, blood glucose was within the target range (100 to 160 mg/dL) for 17 of 20 patients treated with Insulin Lispro. The average time (±SE) required to attain near normoglycemia was 129 ± 14 minutes for Insulin Lispro.
a Results shown as mean ± SD |
|
Time from Start of Infusion (minutes) | Mean Blood Glucose (mg/dL) Intravenous |
0 | 224 ± 16 |
30 | 205 ± 21 |
60 | 195 ± 20 |
120 | 165 ± 26 |
180 | 140 ± 26 |
240 | 123 ± 20 |
300 | 120 ± 27 |
360 | 122 ± 25 |
Absorption and Bioavailability — Studies in healthy volunteers and patients with diabetes demonstrated that Insulin Lispro is absorbed more quickly than regular human insulin. In healthy volunteers given subcutaneous doses of Insulin Lispro ranging from 0.1 to 0.4 unit/kg, peak serum levels were seen 30 to 90 minutes after dosing. When healthy volunteers received equivalent doses of regular human insulin, peak insulin levels occurred between 50 to 120 minutes after dosing. Similar results were seen in patients with type 1 diabetes (see Figure 2).
Figure 2: Serum Insulin Lispro and Insulin Levels After Subcutaneous Injection of Regular Human Insulin or Insulin Lispro (0.2 unit/kg) Immediately Before a High Carbohydrate Meal in 10 Patients with Type 1 Diabetesa.
a Baseline insulin concentration was maintained by infusion of 0.2 mU/min/kg human insulin.
Insulin Lispro was absorbed at a consistently faster rate than regular human insulin in healthy male volunteers given 0.2 unit/kg at abdominal, deltoid, or femoral subcutaneous sites. After Insulin Lispro was administered in the abdomen, serum drug levels were higher and the duration of action was slightly shorter than after deltoid or thigh administration. Bioavailability of Insulin Lispro is similar to that of regular human insulin. The absolute bioavailability after subcutaneous injection ranges from 55% to 77% with doses between 0.1 to 0.2 unit/kg, inclusive.
Distribution — When administered intravenously as bolus injections of 0.1 and 0.2 U/kg dose in two separate groups of healthy subjects, the mean volume of distribution of Insulin Lispro appeared to decrease with increase in dose (1.55 and 0.72 L/kg, respectively) in contrast to that of regular human insulin for which, the volume of distribution was comparable across the two dose groups (1.37 and 1.12 L/kg for 0.1 and 0.2 U/kg dose, respectively).
Metabolism — Human metabolism studies have not been conducted. However, animal studies indicate that the metabolism of Insulin Lispro is identical to that of regular human insulin.
Elimination — After subcutaneous administration of Insulin Lispro, the t1/2 is shorter than that of regular human insulin (1 versus 1.5 hours, respectively). When administered intravenously, Insulin Lispro and regular human insulin demonstrated similar dose-dependent clearance, with a mean clearance of 21.0 mL/min/kg and 21.4 mL/min/kg, respectively (0.1 unit/kg dose), and 9.6 mL/min/kg and 9.4 mL/min/kg, respectively (0.2 unit/kg dose). Accordingly, Insulin Lispro demonstrated a mean t1/2 of 0.85 hours (51 minutes) and 0.92 hours (55 minutes), respectively for 0.1 unit/kg and 0.2 unit/kg doses, and regular human insulin mean t1/2 was 0.79 hours (47 minutes) and 1.28 hours (77 minutes), respectively for 0.1 unit/kg and 0.2 unit/kg doses.
Specific Populations
The effects of age, gender, race, obesity, pregnancy, or smoking on the pharmacokinetics of Insulin Lispro have not been studied.
Renal Impairment — Type 2 diabetic patients with varying degree of renal impairment showed no difference in pharmacokinetics of regular insulin and Insulin Lispro. However, the sensitivity of the patients to insulin did change, with an increased response to insulin as the renal function declined. Some studies with human insulin have shown increased circulating levels of insulin in patients with renal impairment [see Use in Specific Populations (8.6)].
Hepatic Impairment — Type 2 diabetic patients with impaired hepatic function showed no effect on the pharmacokinetics of Insulin Lispro as compared to patients with no hepatic dysfunction. However, some studies with human insulin have shown increased circulating levels of insulin in patients with liver failure [see Use in Specific Populations (8.7)].
Standard 2-year carcinogenicity studies in animals have not been performed. In Fischer 344 rats, a 12-month repeat-dose toxicity study was conducted with insulin lispro at subcutaneous doses of 20 and 200 units/kg/day (approximately 3 and 32 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area). Insulin lispro did not produce important target organ toxicity including mammary tumors at any dose.
Insulin lispro was not mutagenic in the following genetic toxicity assays: bacterial mutation, unscheduled DNA synthesis, mouse lymphoma, chromosomal aberration and micronucleus assays.
Male fertility was not compromised when male rats given subcutaneous insulin lispro injections of 5 and 20 units/kg/day (0.8 and 3 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area) for 6 months were mated with untreated female rats. In a combined fertility, perinatal, and postnatal study in male and female rats given 1, 5, and 20 units/kg/day subcutaneously (0.2, 0.8, and 3 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area), mating and fertility were not adversely affected in either gender at any dose.
The safety and efficacy of Insulin Lispro were studied in pediatric and adult patients with type 1 diabetes (n=789) and adult patients with type 2 diabetes (n=722).
A 12-month, randomized, parallel, open-label, active-controlled study was conducted in patients with type 1 diabetes to assess the safety and efficacy of Insulin Lispro (n=81) compared with Humulin® R [insulin human injection (100 units/mL)] (n=86). Insulin Lispro was administered by subcutaneous injection immediately prior to meals and Humulin R was administered 30 to 45 minutes before meals. Humulin® U [ULTRALENTE® human insulin (rDNA origin) extended zinc suspension] was administered once or twice daily as the basal insulin. There was a 2- to 4-week run-in period with Humulin R and Humulin U before randomization. Most patients were Caucasian (97%). Forty-seven percent of the patients were male. The mean age was 31 years (range 12 to 70 years). Glycemic control, the total daily doses of Insulin Lispro and Humulin R, and the incidence of severe hypoglycemia (as determined by the number of events that were not self-treated) were similar in the two treatment groups. There were no episodes of diabetic ketoacidosis in either treatment group.
a Values are Mean ± SD |
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b Severe hypoglycemia refers to hypoglycemia for which patients were not able to self-treat. |
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Treatment Duration Treatment in Combination with: | 12 months Humulin U |
|
Insulin Lispro | Humulin R | |
N | 81 | 86 |
Baseline HbA1c (%)a | 8.2 ± 1.4 | 8.3 ± 1.7 |
Change from baseline HbA1c (%)a | -0.1 ± 0.9 | 0.1 ± 1.1 |
Treatment Difference in HbA1c Mean (95% confidence interval) | 0.4 (0.0, 0.8) | |
Baseline short-acting insulin dose (units/kg/day) | 0.3 ± 0.1 | 0.3 ± 0.1 |
End-of-Study short-acting insulin dose (units/kg/day) | 0.3 ± 0.1 | 0.3 ± 0.1 |
Change from baseline short-acting insulin dose (units/kg/day) | 0.0 ± 0.1 | 0.0 ± 0.1 |
Baseline Body weight (kg) | 72 ± 12.7 | 71 ± 11.3 |
Weight change from baseline (kg) | 1.4 ± 3.6 | 1.0 ± 2.6 |
Patients with severe hypoglycemia (n, %)b | 14 (17%) | 18 (21%) |
An 8-month, crossover study of pediatric patients with type 1 diabetes (n=463), aged 9 to 19 years, compared two subcutaneous multiple-dose treatment regimens: Insulin Lispro or Humulin R, both administered with Humulin N (NPH human insulin) as the basal insulin. Insulin Lispro achieved glycemic control comparable to Humulin R, as measured by HbA1c (see Table 6), and both treatment groups had a comparable incidence of hypoglycemia. In a 9-month, crossover study of pediatric patients (n=60) with type 1 diabetes, aged 3 to 11 years, Insulin Lispro administered immediately before meals, Insulin Lispro administered immediately after meals and Humulin R administered 30 minutes before meals resulted in similar glycemic control, as measured by HbA1c, and incidence of hypoglycemia, regardless of treatment group.
a Values are Mean ± SD |
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b Severe hypoglycemia refers to hypoglycemia that required glucagon or glucose injection or resulted in coma. |
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End point | |||
Baseline | Insulin Lispro + NPH | Humulin R + NPH |
|
HbA1c (%)a | 8.6 ± 1.5 | 8.7 ± 1.5 | 8.7 ± 1.6 |
Change from baseline HbA1c (%)a | — | 0.1 ± 1.1 | 0.1 ± 1.3 |
Short-acting insulin dose (units/kg/day)a | 0.5 ± 0.2 | 0.5 ± 0.2 | 0.5 ± 0.2 |
Change from baseline short-acting insulin dose (units/kg/day)a | — | 0.01 ± 0.1 | -0.01 ± 0.1 |
Body weight (kg)a | 59.1 ± 13.1 | 61.1 ± 12.7 | 61.4 ± 12.9 |
Weight change from baseline (kg)a | — | 2.0 ± 3.1 | 2.3 ± 3.0 |
Patients with severe hypoglycemia (n, %)b | — | 5 (1.1%) | 5 (1.1%) |
Diabetic ketoacidosis (n, %) | — | 11 (2.4%) | 9 (1.9%) |
To evaluate the administration of Insulin Lispro via external insulin pumps, two open-label, crossover design studies were performed in patients with type 1 diabetes. One study involved 39 patients, ages 19 to 58 years, treated for 24 weeks with Insulin Lispro or regular human insulin. After 12 weeks of treatment, the mean HbA1c values decreased from 7.8% to 7.2% in the Insulin Lispro -treated patients and from 7.8% to 7.5% in the regular human insulin-treated patients. Another study involved 60 patients (mean age 39, range 15 to 58 years) treated for 24 weeks with either Insulin Lispro or buffered regular human insulin. After 12 weeks of treatment, the mean HbA1c values decreased from 7.7% to 7.4% in the Insulin Lispro-treated patients and remained unchanged from 7.7% in the buffered regular human insulin-treated patients. Rates of hypoglycemia were comparable between treatment groups in both studies.
A randomized, 16-week, open-label, parallel design, study of pediatric patients with type 1 diabetes (n=298) aged 4 to 18 years compared two subcutaneous infusion regimens administered via an external insulin pump: insulin aspart (n=198) or Insulin Lispro (n=100). These two treatments resulted in comparable changes from baseline in HbA1c and comparable rates of hypoglycemia after 16 weeks of treatment (see Table 7). Infusion site reactions were similar between groups.
a Values are Mean ± SD |
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b Severe hypoglycemia refers to hypoglycemia associated with central nervous system symptoms and requiring the intervention of another person or hospitalization. |
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Insulin Lispro | Aspart | |
N | 100 | 198 |
Baseline HbA1c (%)a | 8.2 ± 0.8 | 8.0 ± 0.9 |
Change from Baseline HbA1c (%) | -0.1 ± 0.7 | -0.1 ± 0.8 |
Treatment Difference in HbA1c, Mean (95% confidence interval) | 0.1 (-0.3, 0.1) | |
Baseline insulin dose (units/kg/24 hours)a | 0.9 ± 0.3 | 0.9 ± 0.3 |
End-of-Study insulin dose (units/kg/24 hours)a | 0.9 ± 0.2 | 0.9 ± 0.2 |
Patients with severe hypoglycemia (n, %)b | 8 (8%) | 19 (10%) |
Diabetic ketoacidosis (n, %) | 0 (0) | 1 (0.5%) |
Baseline body weight (kg)a | 55.5 ± 19.0 | 54.1 ± 19.7 |
Weight Change from baseline (kg)a | 1.6 ± 2.1 | 1.8 ± 2.1 |
A 6-month randomized, crossover, open-label, active-controlled study was conducted in insulin-treated patients with type 2 diabetes (n=722) to assess the safety and efficacy of Insulin Lispro for 3 months followed by Humulin R for 3 months or the reverse sequence. Insulin Lispro was administered by subcutaneous injection immediately before meals and Humulin R was administered 30 to 45 minutes before meals. Humulin® N [NPH human insulin (rDNA origin) isophane suspension] or Humulin U was administered once or twice daily as the basal insulin. All patients participated in a 2- to 4-week run-in period with Humulin R and Humulin N or Humulin U. Most of the patients were Caucasian (88%), and the numbers of men and women in each group were approximately equal. The mean age was 58.6 years (range 23.8 to 85 years). The average body mass index (BMI) was 28.2 kg/m2. During the study, the majority of patients used Humulin N (84%) compared with Humulin U (16%) as their basal insulin. The reductions from baseline in HbA1c and the incidence of severe hypoglycemia (as determined by the number of events that were not self-treated) were similar between the two treatments from the combined groups (see Table 8).
a Values are Mean ± SD |
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b Severe hypoglycemia refers to hypoglycemia for which patients were not able to self-treat. |
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End point | |||
Baseline | Insulin Lispro + Basal | Humulin R + Basal |
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HbA1c (%)a | 8.9 ± 1.7 | 8.2 ± 1.3 | 8.2 ± 1.4 |
Change from baseline HbA1c (%)a | — | -0.7 ± 1.4 | -0.7 ± 1.3 |
Short-acting insulin dose (units/kg/day)a | 0.3 ± 0.2 | 0.3 ± 0.2 | 0.3 ± 0.2 |
Change from baseline short-acting insulin dose (units/kg/day)a | — | 0.0 ± 0.1 | 0.0 ± 0.1 |
Body weight (kg)a | 80 ± 15 | 81 ± 15 | 81 ± 15 |
Weight change from baseline | — | 0.8 ± 2.7 | 0.9 ± 2.6 |
Patients with severe hypoglycemia (n, %)b | — | 15 (2%) | 16 (2%) |
Insulin Lispro injection is a clear and colorless solution available as:
Insulin Lispro | Total Volume | Concentration | NDC Number | Package Size |
U-100 multiple-dose vial | 10 mL | 100 units/mL | 0002-7737-01 | 1 vial |
U-100 single-patient-use KwikPen | 3 mL | 100 units/mL | 0002-8222-59 | 5 pens |
U-100 single-patient-use Junior KwikPen | 3 mL | 100 units/mL | 0002-7752-05 | 5 pens |
The KwikPen dials in 1-unit increments. The Junior KwikPen dials in 0.5-unit increments.
Each Insulin Lispro prefilled pen is for single-patient-use only. Insulin Lispro prefilled pens must never be shared between patients, even if the needle is changed. Patients using Insulin Lispro vials must never share needles or syringes with another person.
Dispense in the original sealed carton with the enclosed Instructions for Use.
Protect from direct heat and light. Do not freeze and do not use if it has been frozen.
See table below for storage information:
* When stored at room temperature, Insulin Lispro can only be used for a total of 28 days, including both not in-use (unopened) and in-use (opened) storage time. |
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Not In-Use (Unopened) Room Temperature
(Up to 86°F [30°C]) | Not In-Use (Unopened) Refrigerated
(36° to 46°F [2° to 8°C]) |
In-Use (Opened) (see temperature below*) |
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10 mL multiple-dose vial | 28 days | Until expiration date | 28 days Refrigerated or room temperature. |
3 mL single-patient-use Insulin Lispro KwikPen | 28 days | Until expiration date | 28 days Room temperature only (Do not refrigerate) |
3 mL single-patient-use Insulin Lispro Junior KwikPen | 28 days | Until expiration date | 28 days Room temperature only (Do not refrigerate) |
Use in an External Insulin Pump — Change the Insulin Lispro in the reservoir at least every 7 days, or according to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 98.6°F (37°C).
Storage of Diluted Insulin Lispro for Subcutaneous Injection — Diluted Insulin Lispro for subcutaneous injection may be stored for 28 days when refrigerated at 41°F (5°C) and 14 days at room temperature up to 86°F (30°C) [see Dosage and Administration (2.2)]. Do not dilute Insulin Lispro used in an external insulin pump.
Storage of Intravenous Infusion Preparations with Insulin Lispro
Intravenous infusion bags prepared with Insulin Lispro maybe stored for 48 hours when refrigerated at 36° to 46°F (2° to 8°C). The prepared intravenous bags may then be used at room temperature for up to an additional 48 hours [see Dosage and Administration (2.2)].
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Never Share an Insulin Lispro Prefilled Pen or Syringe Between Patients
Advise patients that they must never share an Insulin Lispro prefilled pen with another person, even if the needle is changed. Advise patients using Insulin Lispro vials not to share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions (5.1)].
Hyperglycemia or Hypoglycemia
Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of Insulin Lispro 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.
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 [see Warnings and Precautions (5.3)].
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 container 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 Insulin Lispro. Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions (5.5)].
Instructions For Patients Using Continuous Subcutaneous Insulin Pumps
Manufactured by:
Eli Lilly and Company
Indianapolis, IN 46285, USA
US License Number 1891
Humalog® and KwikPen® are registered trademarks of Eli Lilly and Company.
Copyright © 1996, 2023, Eli Lilly and Company. All rights reserved.
LIS-0008-USPI-20230921
This Patient Information has been approved by the U.S. Food and Drug Administration |
Revised: July 2023 |
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PATIENT INFORMATION
Insulin Lispro [IHN-soo-lihn LIYS-proh] injection, for subcutaneous or intravenous use 100 units per mL This product is HUMALOG® (insulin lispro). |
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Do not share your Insulin Lispro prefilled pens or syringes 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 Insulin Lispro?
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Who should not take Insulin Lispro?
Do not take Insulin Lispro if you:
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What should I tell my healthcare provider before taking Insulin Lispro?
Before taking Insulin Lispro, tell your healthcare provider about all of your medical conditions, including if you:
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Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Before you start taking Insulin Lispro, talk to your healthcare provider about low blood sugar and how to manage it. |
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How should I take Insulin Lispro?
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Keep Insulin Lispro and all medicines out of the reach of children. | ||
Your dose of Insulin Lispro may need to change because of a:
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What should I avoid while taking Insulin Lispro?
While taking Insulin Lispro do not:
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What are the possible side effects of Insulin Lispro?
Insulin Lispro may cause serious side effects that can lead to death, including:
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Your healthcare provider may prescribe a glucagon product for emergency use so that someone else can give you glucagon if your blood sugar becomes too low (severe hypoglycemia) and you are unable to take sugar by mouth.
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Treatment with TZDs and Insulin Lispro may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure. Get emergency medical help if you have: |
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The most common side effects of Insulin Lispro include: | ||
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These are not all the possible side effects of Insulin Lispro. 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 Insulin Lispro.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take Insulin Lispro for a condition for which it was not prescribed. Do not give Insulin Lispro to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about Insulin Lispro. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Insulin Lispro that is written for health professionals. |
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What are the ingredients in Insulin Lispro?
Active ingredient: insulin lispro Inactive ingredients: dibasic sodium phosphate, glycerin, hydrochloric acid, metacresol, trace amounts of phenol, sodium hydroxide, zinc oxide (zinc ion), and Water for Injection, USP. Humalog® is a registered trademark of Eli Lilly and Company. Manufactured by: Eli Lilly and Company, Indianapolis, IN 46285, USA, US License Number 1891 Copyright © 1996, 2023, Eli Lilly and Company. All rights reserved. For more information, call 1-800-545-5979. |
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LIS-0007-PPI-20230721
INSTRUCTIONS FOR USE
Insulin Lispro [IHN-soo-lihn LIYS-proh]
injection, for subcutaneous use
10 mL multiple-dose vial (100 units per mL, U-100)
This product is HUMALOG® (insulin lispro).
Read this Instructions for Use before you start taking Insulin Lispro and each time you get a new vial. 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.
Do not share your needles or syringes 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.
Supplies needed to give your injection
Vial | Syringe |
Preparing your Insulin Lispro dose
If you use Insulin Lispro with NPH insulin:
Giving your Insulin Lispro with a syringe
Giving your Insulin Lispro using an insulin pump
Disposing of used needles and syringes
How should I store Insulin Lispro?
All unopened vials:
After vials have been opened:
Insulin Lispro in an insulin pump:
Keep Insulin Lispro vials, syringes, needles and all medicines out of the reach of children.
If you have any questions or problems with your Insulin Lispro, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider for help.
Manufactured by:
Eli Lilly and Company
Indianapolis, IN 46285, USA
US License Number 1891
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Humalog® is a registered trademark of Eli Lilly and Company.
Instructions for Use revised: July/2023
Copyright © 1996, 2023, Eli Lilly and Company. All rights reserved.
LISVL-0006-IFU-20230721
INSTRUCTIONS FOR USE
Insulin Lispro [IHN-soo-lihn LIYS-proh]
KwikPen®
injection, for subcutaneous use
3 mL single-patient-use pen (100 units per mL)
This product is HUMALOG® (insulin lispro).
Read the Instructions for Use before you start taking Insulin Lispro and each time you get another KwikPen®. 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.
Do not share your Insulin Lispro KwikPen 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.
Insulin Lispro KwikPen (“Pen”) is a disposable single-patient-use prefilled pen containing 300 units of insulin lispro. You can give yourself more than 1 dose from the Pen. Each turn (click) of the Dose Knob dials 1 unit of insulin. You can give from 1 to 60 units in a single injection. If your dose is more than 60 units, you will need to give yourself more than 1 injection. The Plunger only moves a little with each injection, and you may not notice that it moves. The Plunger will only reach the end of the cartridge when you have used all 300 units in the Pen.
People who are blind or have vision problems should not use the Pen without help from a person trained to use the Pen.
How to recognize your Insulin Lispro KwikPen
Supplies you will need to give your injection
Preparing your Pen
Priming your Pen
Prime before each injection.
Selecting your dose
Giving your injection
After your injection
Disposing of Pens and Needles
Storing your Pen
Unused Pens
In-use Pen
General information about the safe and effective use of your Pen
Troubleshooting
If you have any questions or problems with your Insulin Lispro KwikPen, contact Lilly at 1-800-LillyRx (1-800-545-5979) or call your healthcare provider for help.
Manufactured by:
Eli Lilly and Company
Indianapolis, IN 46285, USA
US License Number 1891
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: July/2023
Humalog® and KwikPen® are registered trademarks of Eli Lilly and Company.
Copyright © 2007, 2023, Eli Lilly and Company. All rights reserved.
Insulin Lispro KwikPen meets the current dose accuracy and functional requirements of ISO 11608-1. |
LISKP-0006-IFU-20230721
INSTRUCTIONS FOR USE
Insulin Lispro [IHN-soo-lihn LIYS-proh]
Junior KwikPen®
injection, for subcutaneous use
3 mL single-patient-use pen (100 units per mL)
This product is HUMALOG® (insulin lispro).
Read the Instructions for Use before you start taking Insulin Lispro and each time you get another Insulin Lispro Junior KwikPen®. 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.
Do not share your Insulin Lispro Junior KwikPen 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.
Insulin Lispro Junior KwikPen (“Pen”) is a disposable single-patient-use prefilled pen containing 300 units of Insulin Lispro.
People who are blind or have vision problems should not use the Pen without help from a person trained to use the Pen.
How to recognize your Insulin Lispro Junior KwikPen:
Supplies needed to give your injection:
Preparing your Pen
Priming your Pen
Prime before each injection.
Selecting your dose
Giving your injection
After your injection
Disposing of Pens and Needles
Storing your Pen
Unused Pens
In-use Pen
General information about the safe and effective use of your Pen
Troubleshooting
If you have any questions or problems with your Insulin Lispro Junior KwikPen, contact Lilly at 1-800-LillyRx (1-800-545-5979) or call your healthcare provider for help.
Manufactured by:
Eli Lilly and Company
Indianapolis, IN 46285, USA
US License Number 1891
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: July/2023
Humalog® and KwikPen® are registered trademarks of Eli Lilly and Company.
Copyright © 2017, 2023, Eli Lilly and Company. All rights reserved.
Insulin Lispro Junior KwikPen meets the current dose accuracy and functional requirements of ISO 11608-1. |
LIS-JRKP-0002-IFU-20230721
PACKAGE CARTON – Insulin Lispro Injection 10 mL vial
NDC 0002-7737-01
Insulin Lispro Injection
100 units per mL (U-100)
For subcutaneous or intrevenous use
10 mL multiple-dose vial
Use only with a U-100 syringe
This product is Humalog.
Rx only
Lilly
PACKAGE CARTON – Insulin Lispro Injection KwikPen
NDC 0002-8222-59
Insulin Lispro KwikPen® Injection
For Single Patient Use Only
HP-8222
Dispense in this sealed carton.
Needles not included
100 units per mL (U-100)
This device is recommended for use with Becton, Dickinson and Company's insulin pen needles
For subcutaneous use only.
prefilled insulin delivery device
Rx only
This product is Humalog.
5 x 3 mL Prefilled Pens
Read Insulin Delivery Device Instructions for Use
PACKAGE CARTON – Insulin Lispro Injection Junior KwikPen
Dispense in this sealed carton.
NDC 0002-7752-05
Insulin Lispro Injection
Junior KwikPen®
For Single Patient Use Only
100 units per mL (U-100)
The pen can deliver 0.5 (½) to 30 units in one injection.
5 x 3 mL prefilled pens
For subcutaneous use only.
prefilled insulin delivery device
Rx only
This product is Humalog.
Read Insulin Lispro Injection Junior KwikPen® Instructions for Use.
NEEDLES NOT INCLUDED
This device is recommended for use with Becton, Dickinson and Company's insulin pen needles.
Lilly
INSULIN LISPRO
insulin lispro injection, solution |
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INSULIN LISPRO
KWIKPEN
insulin lispro injection, solution |
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INSULIN LISPRO
JUNIOR KWIKPEN
insulin lispro injection, solution |
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Labeler - Eli Lilly and Company (006421325) |