Enter drug's generic or brand name below. Results will appear here. Note: all drug related information obtained on this page is provided by RX List.
Using the RX LIST database:
(1) Enter the drug name in the search box below and hit ENTER
(2) The rx list web site will open here with the drug search completed. Next, scroll down the page to locate the link to the drug you are searching for and then click on the link.
What is Lyumjev and how is it used?
What are the possible side effects of Lyumjev?
Lyumjev may cause serious side effects that can lead to death, including:
Get emergency medical help if you have:
The most common side effects of Lyumjev include:
These are not all the possible side effects of Lyumjev. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc 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 5808 daltons, both identical to that of human insulin.
Insulin lispro-aabc has the following primary structure:
 |
Lyumjev (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of Lyumjev U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP.
Each mL of Lyumjev U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. Lyumjev has a pH of 7.0 to 7.8.
LYUMJEV™ is indicated to improve glycemic control in adults with diabetes mellitus.
Injection: 100 units per mL (U-100) clear and colorless solution available as:
Injection: 200 units per mL (U-200) clear and colorless solution available as:
LYUMJEV (insulin lispro-aabc) injection is a clear and colorless solution available as shown in Table 8.
Table 8: How Supplied
| LYUMJEV | NDC Number | Concentration | Total Units in Presentation | Dose Increment | Package Size |
| U-100 multiple-dose 10 mL vial | 0002-7728-01 | 100 units/mL | 1,000 units | n/a | 1 vial |
| U-100 single-patient-use 3 mL cartridgea | 0002-7726-05 | 100 units/mL | 300 units | n/a | 5 cartridges |
| U-100 single-patient-use 3 mL KwikPen | 0002-8207-05 | 100 units/mL | 300 units | 1 unit | 5 pens |
| U-100 single-patient-use 3 mL Junior KwikPen | 0002-8351-05 | 100 units/mL | 300 units | 0.5 unit | 5 pens |
| U-100 single-patient-use 3 mL Tempo Penb | 0002-8235-05 | 100 units/mL | 300 units | 1 unit | 5 pens |
| U-200 single-patient-use 3 mL KwikPen | 0002-8228-27 | 200 units/mL | 600 units | 1 unit | 2 pens |
| a 3 mL cartridge is for use in Eli Lilly and Company's HumaPen® Luxura® HD insulin delivery device. Patients need to check their device manual to determine if the LYUMJEV cartridge is compatible for use in other devices. b Tempo Pen contains a component that allows for data connectivity when used with a compatible transmitter. | |||||
Dispense in the original sealed carton with the enclosed Instructions for Use.
Refrigerate unopened LYUMJEV vials, pens, and cartridges between 36°F to 46°F (2°C to 8°C) until time of use and keep in the original carton to protect from light. Do not freeze or use LYUMJEV if it has been frozen. Do not expose to direct heat. Discard opened or unopened LYUMJEV vials, pens, and cartridges stored at room temperature below 86°F (30°C) after 28 days.
The storage conditions for vials, pens, and cartridges are summarized in Table 9.
Table 9: Storage Conditions for Vials, Pens, and Cartridges
| LYUMJEV Presentation | Not In-use (Unopened) | In-use (Opened) | ||
| Room Temperature (below 86°F [30°C]) | Refrigerated (36°F to 46°F [2°C to 8°C]) | Room Temperature (below 86°F [30°C]) | Refrigerated (36°F to 46°F [2°C to 8°C]) | |
| 10 mL viala,b | 28 days | Until expiration date | 28 days | 28 days |
| 3 mL cartridgeb | 28 days | Until expiration date | 28 days | Do not refrigerate |
| 3 mL LYUMJEV KwikPen (U-100 and U-200)b | 28 days | Until expiration date | 28 days | Do not refrigerate |
| 3 mL LYUMJEV Junior KwikPenb | 28 days | Until expiration date | 28 days | Do not refrigerate |
| 3 mL LYUMJEV Tempo Penb | 28 days | Until expiration date | 28 days | Do not refrigerate |
| a In-use (opened) vials, whether or not refrigerated, must be used within 28 days. b When stored at room temperature, LYUMJEV can only be used for a total of 28 days including both not in-use (unopened) and in-use (opened) storage time. | ||||
Diluted LYUMJEV may be stored for up to 4 days when refrigerated at 36°F to 46°F (2°C to 8°C) and up to 12 hours at room temperature at 68°F to 77°F (20°C to 25°C) [see DOSAGE AND ADMINISTRATION].
Eli Lilly and Company, Indianapolis, IN 46285, USA US License No. 1891. Revised: Jun 2020
The following adverse reactions are also discussed elsewhere:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates actually observed in clinical practice.
The data in Table 1 reflect the exposure of 780 patients with type 1 diabetes to LYUMJEV with a mean exposure duration of 26 weeks [see Clinical Studies]. The mean age was 44 years, the mean duration of diabetes was 19 years, 55% were male, 77% were White, 2% were Black or African American, and 9% were Hispanic. The mean BMI was 26.6 kg/m² and the mean HbA1c at baseline was 7.3%.
The data in Table 2 reflect the exposure of 336 patients with type 2 diabetes to LYUMJEV with a mean exposure duration of 26 weeks [see Clinical Studies]. The mean age was 60 years, the mean duration of diabetes was 16 years, 55% were male, 69% were White, 4% were Black or African American, and 24% were Hispanic. The mean BMI was 32.1 kg/m² and the mean HbA1c at baseline was 7.3%.
Common adverse reactions, excluding hypoglycemia, were defined as events occurring in ≥5% and occurring at the same rate or greater for LYUMJEV-treated patients than HUMALOG®-treated patients.
Table 1: Adverse Reactions Occurring in ≥5% of LYUMJEV-Treated Patients with Type 1 Diabetes
| Mealtime LYUMJEV + basal insulin (N=451) % | Postmeal LYUMJEV + basal insulin (N=329) % | |
| Nasopharyngitis | 14.2 | 14.6 |
Table 2: Adverse Reactions Occurring in ≥5% of LYUMJEV-Treated Patients with Type 2 Diabetes
| Mealtime LYUMJEV + basal insulin (N=336) % | |
| Nasopharyngitis | 12.5 |
| Upper Respiratory Tract Infection | 7.4 |
Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including LYUMJEV. The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for LYUMJEV with the incidence of hypoglycemia for other products may be misleading and also may not be representative of hypoglycemia rates that occur in clinical practice.
Incidence rates for severe hypoglycemia in adults with type 1 and type 2 diabetes mellitus treated with LYUMJEV in clinical trials are shown in Table 3 [see Clinical Studies].
Table 3: Proportion of Patients with Type 1 Diabetes and Type 2 Diabetes Experiencing at Least One Episode ofSevere Hypoglycemia in Adult Clinical Trials
| PRONTO-T1D (Type 1) | PRONTO-T2D (Type 2) | ||
| Mealtime LYUMJEV + basal insulin (N=451) % | Postmeal LYUMJEV + basal insulin (N=329) % | Mealtime LYUMJEV + basal insulin (N=336) % | |
| Severe hypoglycemiaa | 5.5 | 4.6 | 0.9 |
| a Severe hypoglycemia: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions | |||
Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including LYUMJEV, and may be life threatening. Generalized hypersensitivity reactions such as skin rashes and hypersensitivity were reported in patients treated with LYUMJEV: eczema (0.4%), rash (0.4%), dermatitis (0.3%), hypersensitivity (0.2%), and pruritus (0.2%).
Administration of insulin, including LYUMJEV, has resulted in lipohypertrophy (enlargement or thickening of tissue) and lipoatrophy (depression in the skin). Lipodystrophy was reported in 0.2% of patients treated with LYUMJEV [see DOSAGE AND ADMINISTRATION].
As with other insulin therapy, patients may experience rash, redness, inflammation, bruising, or itching at the site of LYUMJEV injection. Injection site reactions occurred in 2.7% of patients treated with LYUMJEV. These reactions were usually mild, with <0.1% of patients discontinuing from trials due to this event.
Weight gain can occur with insulin therapy, including LYUMJEV, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria. Patients with type 1 diabetes treated with LYUMJEV gained an average of 0.6 kg and patients with type 2 diabetes treated with LYUMJEV gained an average of 1.5 kg.
Insulin, including LYUMJEV, may cause sodium retention and edema, particularly if previous poor metabolic control is improved by intensified insulin therapy. Peripheral edema occurred in 0.2% of patients treated with LYUMJEV.
As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to LYUMJEV in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
In a 26-week study in type 1 diabetes patients, 49% were anti-drug (insulin lispro-aabc) antibody (ADA)-positive at baseline, 91% of which were cross-reactive with native insulin. A total of 33% of LYUMJEV-treated patients had treatment-emergent ADA post-baseline (i.e., either new ADA or a 57% increase in assay signal over baseline), 75% of which were cross-reactive with native insulin.
In a 26-week study in type 2 diabetes patients, 35% were ADA-positive at baseline, 81% of which were cross-reactive with native insulin. A total of 31% of LYUMJEV-treated patients had treatment-emergent ADA post-baseline (i.e., either new ADA or a 57% increase in assay signal over baseline), 68% of which were cross-reactive with native insulin.
Presence of antibody did not correlate with reduced efficacy, as measured by HbA1c, or specific adverse reactions.
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.
Localized cutaneous amyloidosis at the injection site has occurred with insulin use. 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.
Table 4 includes clinically significant drug interactions with LYUMJEV.
Table 4: Clinically Significant Drug Interactions with LYUMJEV
| 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 analogs (e.g., octreotide), and sulfonamide antibiotics. |
| Intervention: | Dose reductions and increased frequency of glucose monitoring may be required when LYUMJEV is co-administered with these drugs. |
| Drugs That May Decrease the Blood Glucose Lowering Effect of LYUMJEV | |
| 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 increases and increased frequency of glucose monitoring may be required when LYUMJEV is co-administered with these drugs. |
| Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of LYUMJEV | |
| 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 LYUMJEV 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 LYUMJEV is coadministered with these drugs. |
Included as part of the PRECAUTIONS section.
LYUMJEV prefilled pens or cartridges should never be shared between patients, even if the needle is changed. Patients using LYUMJEV 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, insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Hypoglycemia] 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].
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.
Hypoglycemia is the most common adverse reaction associated with insulins, including LYUMJEV [see ADVERSE REACTIONS]. Severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life-threatening, or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). LYUMJEV, or any insulin, should not be used during episodes of hypoglycemia [see CONTRAINDICATIONS].
Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see DRUG INTERACTIONS], or in patients who experience recurrent hypoglycemia.
The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation. As with all insulin preparations, the glucose lowering effect time course of LYUMJEV 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]. Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to co-administered medication [see DRUG INTERACTIONS]. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use In Specific Populations].
Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of 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 glucose monitoring is recommended.
Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between LYUMJEV and other insulins, instruct patients to always check the insulin label before each injection.
Do not transfer LYUMJEV U-200 from the LYUMJEV KwikPen to a syringe. The markings on the insulin syringe will not measure the dose correctly and can result in overdosage and severe hypoglycemia [see DOSAGE AND ADMINISTRATION and Hypoglycemia].
All insulin products, including LYUMJEV, 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).
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including LYUMJEV [see ADVERSE REACTIONS]. If hypersensitivity reactions occur, discontinue LYUMJEV; treat per standard of care and monitor until symptoms and signs resolve. LYUMJEV is contraindicated in patients who have had hypersensitivity reactions to insulin lispro-aabc or any of its excipients [see CONTRAINDICATIONS].
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 LYUMJEV, 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.
Advise the patient to read the FDA-Approved Patient Labeling (PATIENT INFORMATION and Instructions for Use).
Advise patients that they must never share a LYUMJEV prefilled pen or cartridge with another person, even if the needle is changed. Advise patients using LYUMJEV vials not to share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens [see WARNINGS AND PRECAUTIONS].
Inform patients that hypoglycemia is the most common adverse reaction with insulin. Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of LYUMJEV 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].
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].
Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products. Inform patients that LYUMJEV U-200 contains 2 times as much insulin per mL as LYUMJEV U-100. The LYUMJEV U-200 KwikPen dose window shows the number of units of LYUMJEV U-200 to be injected so no dose conversion is required [see DOSAGE AND ADMINISTRATION]. Instruct patients to not transfer LYUMJEV U-200 from the LYUMJEV U-200 KwikPen to a syringe [see WARNINGS AND PRECAUTIONS].
Advise patients that hypersensitivity reactions have occurred with LYUMJEV. Inform patients on the symptoms of hypersensitivity reactions [see WARNINGS AND PRECAUTIONS].
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.
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% to 10% in women with pre-gestational diabetes with a HbA1c>7 and has been reported to be as high as 20% to 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% to 4% and 15% to 20%, respectively.
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.
Human Data
Published data from retrospective studies and meta-analyses do not report an association with insulin lispro and major birth defects, 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
Animal reproduction studies have not been performed with LYUMJEV. However, subcutaneous reproduction and teratology studies have been conducted with insulin lispro. 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.
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 LYUMJEV or from the underlying maternal condition.
The safety and effectiveness of LYUMJEV in pediatric patients have not been established.
In clinical trials, 187 of 1116 (16.8%) LYUMJEV-treated patients with type 1 or type 2 diabetes were ≥65 years of age and 18 of 1116 (1.6%) were ≥75 years of age. No overall differences in safety or effectiveness were observed between these elderly patients and younger adult patients.
Patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent LYUMJEV dose adjustment and more frequent glucose monitoring [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
Patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent LYUMJEV dose adjustment and more frequent glucose monitoring [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
Excess insulin administration may cause hypoglycemia and hypokalemia [see WARNINGS AND PRECAUTIONS]. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise, may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with 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.
LYUMJEV is contraindicated:
The primary activity of LYUMJEV is the regulation of glucose metabolism. Insulins, including insulin lispro-aabc, exert their specific action through binding to insulin receptors. Receptor-bound insulin lowers 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.
The time course of insulin action (i.e., glucose lowering) may vary considerably in different individuals or within the same individual. The average pharmacodynamic profile [i.e., glucose lowering effect measured as glucose infusion rate (GIR) in a euglycemic clamp study] for subcutaneous administration of 7, 15, and 30 units of LYUMJEV in 42 healthy subjects is shown in Figure 1 and key characteristics of the timing of the effect are described in Table 5 below.
Figure 1: Mean Insulin Effect Over Time After Subcutaneous Administration of 7, 15, and 30 units of LYUMJEV inHealthy Subjects.
 |
Table 5: Timing of Insulin Effect (i.e., Mean Pharmacodynamic Effect) After Subcutaneous Administration of 7, 15,and 30 Units of LYUMJEV in Healthy Subjects (N=42) and Corresponding to the Data Shown in Figure 1
| Parameter for Insulin Effect | LYUMJEV 7 units | LYUMJEV 15 units | LYUMJEV 30 units |
| Time to first measurable effect | ~17 minutes | ~17 minutes | ~15 minutes |
| Time to peak effect | ~120 minutes | ~138 minutes | ~174 minutes |
| Time for effect to return to baseline | ~4.6 hours | ~6.2 hours | ~7.3 hours |
On average, the pharmacodynamic effects of LYUMJEV, measured as area under the glucose infusion rate-time curve (AUCGIR), was 1080 mg/kg, 1860 mg/kg, and 3030 mg/kg following administration of 7, 15, and 30 units of LYUMJEV in healthy subjects.
Similar pharmacodynamic profiles were observed in separate studies conducted in 40 patients with type 1 diabetes and 38 patients with type 2 diabetes given LYUMJEV subcutaneously as a single 15 unit dose. The onset and total glucose lowering were similar when LYUMJEV was administered in the abdomen, deltoid, or thigh. The day-to-day variability [percent coefficient of variation (CV%)] within subjects in the glucose-lowering-effect of LYUMJEV was 24% for the early glucose lowering (AUCGIR, 0-1h), 27% for the total glucose lowering (AUCGIR, 0-10h), and 19% for maximum glucose lowering effect (GIRmax).
When given at the start of a meal or 20 minutes after the start of the meal, LYUMJEV reduced postprandial glucose during a standardized test meal over the complete 5-hour period [change from premeal AUC(0-5h)] in patients with type 1 or type 2 diabetes.
The maximum and total glucose lowering were comparable for a single 15 unit dose of LYUMJEV 200 units/mL or LYUMJEV 100 units/mL when administered subcutaneously to healthy subjects. The insulin time action profile with LYUMJEV 200 units/mL was the same as observed with LYUMJEV 100 units/mL.
Absorption of insulin lispro-aabc was evaluated in healthy subjects (see Figure 2) and patients with diabetes following subcutaneous injection of LYUMJEV.
In healthy subjects, the day-to-day variability [CV%] within subjects of LYUMJEV was 10% for total exposure (AUC, 0-10h) and 16% for maximum insulin lispro-aabc concentration (Cmax).
Figure 2: Mean Serum Insulin Lispro-aabc After Subcutaneous Injection of LYUMJEV (15 unit dose) in HealthySubjects
 |
The absolute bioavailability of insulin lispro-aabc after subcutaneous administration of LYUMJEV in the abdomen, deltoid, and thigh was approximately 65%. The rate of absorption of insulin lispro-aabc is maintained regardless of injection site.
Maximum concentration and time to maximum concentration were comparable for the abdomen and upper arm regions; time to maximum concentration was longer and maximum concentration was lower for the thigh. Total insulin lispro-aabc exposure and maximum insulin lispro-aabc concentration increased proportionally with increasing subcutaneous doses of LYUMJEV within the therapeutic dose range.
The results of a study in healthy subjects demonstrated that LYUMJEV 200 units/mL is bioequivalent to LYUMJEV 100 units/mL following administration of a single 15 unit dose for the area under the serum insulin lispro-aabc concentration-time curve from time zero to infinity and maximum insulin lispro-aabc concentration. The rate of insulin lispro-aabc absorption after administration of LYUMJEV 200 units/mL was similar as observed with LYUMJEV 100 units/mL.
Following a 15 unit intravenous bolus injection of LYUMJEV in healthy subjects, the geometric mean (CV%) volume of distribution of insulin lispro-aabc (Vd) was 34 L (30%).
Following a 15 unit intravenous bolus injection of LYUMJEV in healthy subjects, the geometric mean (CV%) clearance of insulin lispro-aabc was 32 L/hour (22%) and the median half-life of insulin lispro-aabc was 44 minutes.
Age (18 to 77 years), gender, and race did not affect the pharmacokinetics and pharmacodynamics of LYUMJEV.
Renal and hepatic impairment is not known to impact the pharmacokinetics of insulin lispro-aabc. Insulin requirements may be reduced in the presence of renal or hepatic impairment.
The safety and efficacy of LYUMJEV was evaluated in 2 randomized, active controlled trials of 26 weeks in adult patients with type 1 diabetes (N=780) or type 2 diabetes (N=336).
PRONTO-T1D (NCT03214367) was a 26 week, randomized (4:4:3), active controlled, treat-to-target, multinational trial that evaluated the efficacy of LYUMJEV in 1222 patients with type 1 diabetes. Patients were randomized to either blinded mealtime LYUMJEV (N=451), blinded mealtime HUMALOG (N=442), or open-label postmeal LYUMJEV (N=329), all in combination with either insulin glargine or insulin degludec. Mealtime LYUMJEV or HUMALOG was injected 0 to 2 minutes before the meal and postmeal LYUMJEV was injected 20 minutes after the start of the meal.
Patients had a mean age of 44 years; mean duration of diabetes of 19 years; 56% were male; race: 77% White, 19% Asian, and 2% Black or African American. Eight percent of the randomized patients were Hispanic. The mean BMI was 26.6 kg/m². At week 26, treatment with mealtime LYUMJEV provided a mean reduction in HbA1c that met the pre-specified non-inferiority margin (0.4%) (see Table 6). In addition, postmeal LYUMJEV met the prespecified non-inferiority margin (0.4%) compared to mealtime HUMALOG. Insulin doses were similar in all treatment groups at baseline and at 26 weeks.
Table 6: Results from Study PRONTO-T1D: 26 Week Trial of Mealtime LYUMJEV and Postmeal LYUMJEVcompared with Mealtime HUMALOG, all in Combination with Basal Insulin in Adults with Type 1 Diabetes
| Mealtime LYUMJEV + basal insulin | Mealtime HUMALOG + basal insulin | Postmeal LYUMJEV + basal insulin | |
| Number of randomized subjects (N) | 451 | 442 | 329 |
| HbA1c (%) (mean)a,b | |||
| Baseline | 7.3 | 7.3 | 7.4 |
| Adjusted mean change from baseline | -0.12 | -0.04 | 0.1 |
| Estimated treatment difference versus HUMALOG [95% CI] | -0.08 [-0.16, 0.00]c | 0.14 [0.05, 0.22] | |
| a Analysis population: all randomized subjects regardless of adherence to treatment or availability of post-baseline assessment. Missing data at Week 26 were imputed by return to baseline approach. At week 26, primary efficacy assessment was missing for 3.8%, 4.8%, and 5.2% of subjects, for mealtime LYUMJEV, mealtime HUMALOG, and postmeal LYUMJEV, respectively. b Least-squares (LS) mean from ANCOVA adjusted for baseline value and other stratification factors. cTested for non-inferiority. | |||
PRONTO-T2D (NCT03214380) was a 26-week, randomized (1:1), active controlled, treat-to-target, multinational trial that evaluated the efficacy of LYUMJEV in 673 patients with type 2 diabetes who at study entry were on up to three oral anti-diabetic medications (OAMs), basal insulin and at least one prandial insulin injection or premixed insulin with at least two injections daily. Patients were allowed to continue on metformin and/or a SGLT2 inhibitor and were randomized to either mealtime LYUMJEV (N=336) or to mealtime HUMALOG (N=337), both in combination with insulin glargine or insulin degludec in a basal-bolus regimen. Mealtime LYUMJEV or mealtime HUMALOG was injected 0-2 minutes before the meal.
Patients had a mean age of 61 years; mean duration of diabetes of 17 years; 53% were male; race: 69% White, 24% Asian, and 5% Black or African American. Twenty-three percent of the randomized patients were Hispanic. The mean BMI was 32.3 kg/m².
At week 26, treatment with mealtime LYUMJEV provided a mean reduction of HbA1c from baseline that met the prespecified non-inferiority margin (0.4%) compared to mealtime HUMALOG (see Table 7). Insulin doses were similar in both treatment groups at baseline and at 26 weeks.
Table 7: Results from Study PRONTO-T2D: 26 Week Trial of Mealtime LYUMJEV Compared with MealtimeHUMALOG, both in Combination with Basal Insulin in Adults with Type 2 Diabetes
| Mealtime LYUMJEV + basal insulin | Mealtime HUMALOG + basal insulin | |
| Number of randomized subjects (N) | 336 | 337 |
| HbA1c (%)a,b | ||
| Baseline mean | 7.3 | 7.3 |
| Adjusted mean change from baseline | -0.36 | -0.38 |
| Estimated treatment difference versus HUMALOG [95% CI]c | 0.03 [-0.08, 0.13] | |
| a Analysis population: all randomized subjects regardless of adherence to treatment or availability of post-baseline assessment. Missing data at Week 26 were imputed by return to baseline approach. At week 26, primary efficacy assessment was missing for 4.8% of subjects for mealtime LYUMJEV and for 4.5% mealtime HUMALOG. b Least-squares (LS) mean from ANCOVA adjusted for baseline value and other stratification factors. c Tested for non-inferiority. | ||
LYUMJEV™
(LOOM-jehv)
(insulin lispro-aabc) injection, for subcutaneous or intravenous use
Do not share your LYUMJEV 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 LYUMJEV?
Do not take LYUMJEV if you:
Before taking LYUMJEV, tell your healthcare provider about all of your medical conditions, including if you:
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 LYUMJEV, talk to your healthcare provider about low blood sugar and how to manage it.
How should I take LYUMJEV?
Keep LYUMJEV and all medicines out of the reach of children.
Your dose of LYUMJEV may need to change because of: a change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.
What should I avoid while taking LYUMJEV?
While taking LYUMJEV do not:
What are the possible side effects of LYUMJEV?
LYUMJEV may cause serious side effects that can lead to death, including:
Get emergency medical help if you have:
The most common side effects of LYUMJEV include:
These are not all the possible side effects of LYUMJEV. 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 LYUMJEV.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take LYUMJEV for a condition for which it was not prescribed. Do not give LYUMJEV to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about LYUMJEV that is written for health professionals.
What are the ingredients in LYUMJEV?
Active ingredient: insulin lispro-aabc
Inactive ingredients: glycerol, magnesium chloride hexahydrate, metacresol, sodium citrate dihydrate, treprostinil sodium, zinc oxide (zinc ion), and Water for Injection, USP
Instructions for Use
LYUMJEV™ KwikPen®
(LOOM-jehv)
(insulin lispro-aabc) injection, for subcutaneous use 3 mL single-patient-use pen 100 units/mL
 |
Read the Instructions for Use before you start taking LYUMJEV™ and each time you get another LYUMJEV 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 LYUMJEV KwikPen with other people, even if the needle has been changed. Do notreuse or share needles with other people. You may give other people a serious infection or get a serious infection from them.
LYUMJEV KwikPen (“Pen”) is a disposable single-patient-use prefilled pen containing 300 units of LYUMJEV.
People who are blind or have vision problems should not use the Pen without help from a person trained to use the Pen.
LYUMJEV KwikPen Parts
 |
Pen Needle Parts (Needles Not Included)
 |
Dose Knob
 |
How to recognize your LYUMJEV KwikPen
Supplies needed to give your injection
Preparing your Pen
Step 1:
 |
Step 2:
Step 3:
 |
Step 4:
 |
Step 5:
 |
Priming your Pen
Prime before each injection.
Step 6:
 |
Step 7:
 |
Step 8:
You should see insulin at the tip of the needle.
Small air bubbles are normal and will not affect your dose.
 |
Selecting your dose
Step 9:
 |
Giving your injection
Step 10:
 |
Step 11:
 |
Do not try to inject your insulin by turning the dose knob. You will not receive your insulin by turning the dose knob.
 |
Step 12:
 |
The plunger only moves a little with each injection, and you may not notice that it moves.
If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area.
After your injection
Step 13:
 |
Step 14:
 |
Step 15:
 |
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 LYUMJEV KwikPen, contact Lilly at 1-800-545-5979 or call your healthcare provider for help. For more information on LYUMJEV KwikPen and insulin, go to www.lyumjev.com.
 |
Scan this code to launch www.lyumjev.com This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Instructions for Use
LYUMJEV™ Tempo Pen™
(LOOM-jehv) (insulin lispro-aabc) injection, for subcutaneous use 3 mL single-patient-use pen 100 units/mL
 |
Read the Instructions for Use before you start taking LYUMJEV™ and each time you get another LYUMJEV Tempo Pen. 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 LYUMJEV Tempo Pen with other people, even if the needle has been changed. Do not reuse or share needles with other people. You may give other people a serious infection or get a serious infection from them.
LYUMJEV Tempo Pen (“Pen”) is a disposable single-patient-use prefilled pen containing 300 units of LYUMJEV.
People who are blind or have vision problems should not use the Pen without help from a person trained to use the Pen.
LYUMJEV Tempo Pen Parts
 |
Pen Needle Parts(Needles Not Included)
 |
Dose Knob
 |
How to recognize your LYUMJEV Tempo Pen
Supplies needed to give your injection
Preparing your Pen
Step 1:
 |
Step 2:
Step 3:
 |
Step 4:
 |
Step 5:
 |
Priming your Pen
Prime before each injection.
Step 6:
 |
Step 7:
 |
Step 8:
You should see insulin at the tip of the needle.
Small air bubbles are normal and will not affect your dose.
 |
Selecting your dose
Step 9:
 |
Giving your injection
Step 10:
 |
Step 11:
 |
Do not try to inject your insulin by turning the dose knob. You will not receive your insulin by turning the dose knob.
 |
Step 12:
 |
After your injection
Step 13:
 |
Step 14:
 |
Step 15:
 |
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 LYUMJEV Tempo Pen, contact Lilly at 1-800-545-5979 or call your healthcare provider for help. For more information on LYUMJEV Tempo Pen and insulin, go to www.lyumjev.com.
 |
Scan this code to launch www.lyumjev.com This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Instructions for Use
LYUMJEV™ Junior KwikPen®
(LOOM-jehv) (insulin lispro-aabc) injection, for subcutaneous use 3 mL single-patient-use pen 100 units/mL
 |
Read the Instructions for Use before you start taking LYUMJEV™ and each time you get another LYUMJEV 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 LYUMJEV Junior KwikPen with other people, even if the needle has been changed. Do not reuse or share needles with other people. You may give other people a serious infection or geta serious infection from them.
LYUMJEV Junior KwikPen (“Pen”) is a disposable single-patient-use prefilled pen containing 300 units of LYUMJEV.
People who are blind or have vision problems should not use the Pen without help from a person trained to use the Pen.
LYUMJEV Junior KwikPen Parts
 |
Pen Needle Parts (Needles Not Included)
 |
Dose Knob
 |
How to recognize your LYUMJEV Junior KwikPen
Supplies needed to give your injection
Preparing your Pen
Step 1:
 |
Step 2:
Step 3:
 |
Step 4:
 |
Step 5:
 |
Priming your Pen
Prime before each injection.
Step 6:
 |
Step 7:
 |
Step 8:
You should see insulin at the tip of the needle.
Small air bubbles are normal and will not affect your dose.
 |
Selecting your dose
Step 9:
 |
Giving your injection
Step 10:
 |
Step 11:
 |
Do not try to inject your insulin by turning the dose knob. You will not receive your insulin by turning the dose knob.
 |
Step 12:
The plunger only moves a little with each injection, and you may not notice that it moves.
If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area.
 |
After your injection
Step 13:
Carefully replace the outer needle shield.
 |
Step 14:
Do not store the Pen with the needle attached to prevent leaking, blocking the needle, and air from entering the Pen.
 |
Step 15:
 |
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 LYUMJEV Junior KwikPen, contact Lilly at 1-800-545-5979 or call your healthcare provider for help. For more information on LYUMJEV Junior KwikPen and insulin, go to www.lyumjev.com.
 |
Scan this code to launch www.lyumjev.com This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Instructions for Use
LYUMJEV™
(LOOM-jehv) (insulin lispro-aabc) injection for subcutaneous use (100 units/mL, 10 mL multiple-dose vial)
Read the Instructions for Use before you start taking LYUMJEV 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 syringes or needles with other people. You may give other people a serious infection or get a serious infection from them.
Supplies needed to give your injection
 |
Preparing your LYUMJEV dose
Step 1: If you are using a new vial, pull off the plastic protective cap, but do not remove the rubber stopper.
 |
Step 2: Wipe the rubber stopper with an alcohol swab.
 |
Step 3: Remove the needle shield from the syringe by pulling the needle shield straight off. Hold the syringe with the needle pointing up. Pull down on the plunger until the plunger tip reaches the line for the number of units for your prescribed dose.
 |
Step 4: Push the needle through the rubber stopper of the vial.
 |
Step 5: Push the plunger all the way in. This puts air into the vial.
 |
Step 6: Turn the vial and syringe upside down and slowly pull the plunger down until the plunger tip is a few units past the line for your prescribed dose. If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top.
 |
Step 7: Slowly push the plunger up until the plunger tip reaches the line for your prescribed dose. Check the syringe to make sure that you have the right dose.
 |
Step 8: Pull the syringe out of the rubber stopper of the vial.
 |
Giving your LYUMJEV injection with a syringe
Step 9: Choose your injection site.
LYUMJEV is injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs or upper arms.
Wipe your skin with an alcohol swab, and let your skin dry before you inject your dose.
 |
Step 10: Insert the needle into your skin.
 |
Step 11: Push down on the plunger to inject your dose.
The needle should stay in your skin for at least 5 seconds after pushing down on the plunger to make sure you have injected all of your insulin dose.
 |
Step 12: Pull the needle out of your skin.
 |
Disposing of used syringes and needles
How should I store LYUMJEV?
All not in-use (unopened) vials:
After vials have been in-use (opened):
Keep LYUMJEV vials, syringes, needles and all medicines out of the sight and reach of children.
If you have any questions or problems with your LYUMJEV, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider for help. For more information on LYUMJEV and insulin, go to www.lyumjev.com.
 |
Scan this code to launch www.lyumjev.com This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Instructions for Use
LYUMJEV™ KwikPen®
(LOOM-jehv) (insulin lispro-aabc) injection , for subcutaneous use 3 mL single-patient-use pen 200 units/mL
 |
Read the Instructions for Use before you start taking LYUMJEV™ and each time you get another LYUMJEV 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 LYUMJEV KwikPen with other people, even if the needle has been changed. Do notreuse or share needles with other people. You may give other people a serious infection or get a serious infection from them.
LYUMJEV KwikPen (“Pen”) is a disposable single-patient-use prefilled pen containing 600 units of LYUMJEV.
LYUMJEV KwikPen is available in two strengths, 100 units/mL and 200 units/mL. Inject LYUMJEV 200 units/mL only with your Pen. Do not transfer insulin from your Pen to a syringe. Syringes will notmeasure 200 units/mL of insulin correctly. A severe overdose can result, causing very low blood sugarwhich may put your life in danger.
People who are blind or have vision problems should not use the Pen without help from a person trained to use the Pen.
LYUMJEV KwikPen Parts
 |
Pen Needle Parts  (Needles Not Included)
 |
Dose Knob
 |
How to recognize your LYUMJEV KwikPen
Pen color: Taupe
Dose Knob: Taupe, with raised ridges on side
Supplies needed to give your injection
Preparing your Pen
Step 1:
 |
Step 2:
Step 3:
 |
Step 4:
 |
Step 5:
 |
Priming your Pen
Prime before each injection.
Step 6:
 |
Step 7:
 |
Step 8:
You should see insulin at the tip of the needle.
Small air bubbles are normal and will not affect your dose.
 |
Selecting your dose
This Pen has been designed to deliver the dose that is shown in the dose window. Dial your usual dose as instructed by your healthcare provider.
Step 9:
 |
Giving your injection
Step 10:
 |
Step 11:
 |
Do not try to inject your insulin by turning the dose knob. You will not receive your insulin by turning the dose knob.
 |
Step 12:
If you normally need to give 2 injections for your full dose, be sure to give your second injection.
 |
The plunger only moves a little with each injection, and you may not notice that it moves.
If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area.
After your injection
Step 13:
 |
Step 14:
 |
Step 15:
 |
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 LYUMJEV KwikPen, contact Lilly at 1-800-545-5979 or call your healthcare provider for help. For more information on LYUMJEV KwikPen and insulin, go to www.lyumjev.com.
 |
Scan this code to launch www.lyumjev.com
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
