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Indication for Humalog Brand of Insulins

Humalog® is used to treat people with diabetes for the control of blood sugar. Humalog® Mix75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection) and Humalog® Mix50/50 (50% insulin lispro protamine suspension and 50% insulin lispro injection) are used to treat adults with diabetes for the control of high blood sugar.

Do not take Humalog if your blood sugar is too low (hypoglycemia) or if you are allergic to insulin lispro or any of the ingredients in Humalog.

Important Safety Information for Humalog Brand of Insulins

What is the most important information I should know about Humalog, Humalog 200 units/mL KwikPen, Humalog Mix75/25, and Humalog Mix50/50?

  • Do not share your Humalog, Humalog Mix75/25, or Humalog Mix50/50 KwikPen, cartridges, reusable pen compatible with Lilly 3 mL cartridges, 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.
  • Humalog 200 units/mL KwikPen contains 2 times as much insulin (200 units/mL) in 1 mL as standard insulin (100 units/mL).
  • The Humalog contained in the Humalog U-200 KwikPen should ONLY be injected with the Humalog U-200 KwikPen. Do NOT withdraw Humalog U-200 from the pen using a syringe. It could result in an overdose causing severe low blood sugar which may put your life in danger.
  • Do not change the insulin you use without talking to your healthcare provider. Changes may make you more likely to experience low or high blood sugar. Changes should be made cautiously under the supervision of your healthcare provider.
  • Test your blood sugar levels as your healthcare provider instructs.
  • Your insulin dose may need to change because of illness, stress, other medicines you take, change in diet, or change in physical activity or exercise.
  • When used in a pump, do not mix or dilute Humalog U-100 with any other insulin or liquid. Do NOT use Humalog U-200, Humalog Mix75/25 or Humalog Mix50/50 in a pump.

Who should not take Humalog, Humalog Mix75/25, or Humalog Mix50/50?

  • Do not take these insulins if your blood sugar is too low (hypoglycemia) or if you are allergic to insulin lispro or any of the ingredients in these insulins.

Before using Humalog, Humalog Mix75/25, or Humalog Mix50/50, what should I tell my healthcare providers?

  • About all of your medical conditions, including liver, kidney, or heart failure or other heart problems.
  • If you are pregnant, planning to become pregnant, or are breastfeeding.
  • About all the medicines you take, including prescription (especially ones commonly called TZDs [thiazolidinediones]) and nonprescription medicines, vitamins, and herbal supplements.

How should I use Humalog, Humalog Mix75/25, or Humalog Mix50/50?

  • These insulins start working faster than other insulins that contain regular human insulin. You should take Humalog within fifteen minutes before eating or right after eating a meal. You should take Humalog Mix75/25 and Humalog Mix50/50 within fifteen minutes before eating.
  • Always make sure that you receive the correct type of insulin from the pharmacy.
  • Do not use Humalog if it is cloudy, colored, or has solid particles or clumps in it.
  • Do not use Humalog Mix75/25 or Humalog Mix50/50 if they have solid particles or clumps in them. Humalog Mix75/25 and Humalog Mix50/50 should be mixed carefully before each use and should be cloudy or milky after mixing.
  • Do not mix Humalog U-100 with insulin other than NPH when using a syringe. Do not mix or dilute Humalog U-100 when used in a pump.
  • Never mix Humalog Mix75/25 or Humalog Mix50/50 in the same syringe with other insulin products. Never use Humalog U-200, Humalog Mix75/25 or Humalog Mix50/50 in a pump.
  • Inject your insulin under your skin (subcutaneously). Never inject into a vein or muscle. Change (rotate) your injection site with each dose. Make sure you inject the correct insulin and dose.
  • Do not re-use needles. Always use a new needle for each injection. Re-use of needles can cause you to receive the wrong dose of Humalog and result in infection.
  • Do not drive or operate heavy machinery until you know how Humalog affects you. Do not use alcohol while using Humalog.

What are the possible side effects of Humalog, Humalog Mix75/25, or Humalog Mix50/50?

  • Severe low blood sugar can cause unconsciousness (passing out), seizures, and death. Low blood sugar is the most common side effect. There are many causes of low blood sugar, including taking too much insulin. It is important to treat it quickly. You can treat mild to moderate low blood sugar by drinking or eating a quick source of sugar right away. Symptoms may be different for each person. Be sure to talk to your healthcare provider about low blood sugar symptoms and treatment.
  • Severe life-threatening allergic reactions (whole-body reactions) can happen. Get medical help right away if you develop a rash over your whole body, have trouble breathing, have a fast heartbeat, or are sweating.
  • Humalog, Humalog Mix75/25, and Humalog Mix50/50 can cause life-threatening low potassium in your blood (hypokalemia), which can cause severe breathing problems, irregular heartbeat, and death.
  • Serious side effects can include swelling of your hands and feet and heart failure when taking certain pills called thiazolidinediones or “TZDs” with Humalog, Humalog Mix75/25, or Humalog Mix50/50. This may occur in some people even if they have not had heart problems before. Tell your healthcare provider if you have shortness of breath, swelling of your ankles or feet, or sudden weight gain, which may be symptoms of heart failure. Your healthcare provider may need to adjust or stop your treatment with TZDs, Humalog, Humalog Mix75/25, or Humalog Mix50/50.
  • Failure of your insulin pump or infusion set or degradation of the insulin in the pump can cause hyperglycemia and ketoacidosis. Always carry an alternate form of insulin administration in case of pump failure.
  • The most common side effects of Humalog include low blood sugar, allergic reactions, including reactions at your injection site, skin thickening or pits at the injection site (lipodystrophy), itching, and rash. These are not all of the possible side effects. Ask your healthcare provider for more information or for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch or call 1-800-FDA-1088.

For additional information talk to your healthcare providers and please click to access Humalog Full Prescribing Information, Humalog U-100 Patient Prescribing Information, Humalog U-200 KwikPen Patient Prescribing Information, Humalog Mix75/25 Full Prescribing Information and Patient Prescribing Information, and Humalog Mix50/50 Full Prescribing Information and Patient Prescribing Information.

Please see Instructions for Use included with your pen.

HI U200 BOI CON ISI 26MAY2015

Humalog® and Humalog® KwikPen® are registered trademarks of Eli Lilly and Company, its subsidiaries, or affiliates, and are available by prescription only.

Humalog® Mix75/25, Humalog® Mix50/50, Humalog® Mix75/25 KwikPen®, and Humalog® Mix50/50 KwikPen® are trademarks of Eli Lilly and Company and are available by prescription only.

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Indication for Humalog Brand of Insulins

Humalog® is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Humalog® Mix75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection) and Humalog® Mix50/50 (50% insulin lispro protamine suspension and 50% insulin lispro injection) are indicated in the treatment of adults with diabetes mellitus for the control of hyperglycemia.

Important Safety Information for Humalog Brand of Insulins

Contraindications

  • Humalog, Humalog Mix75/25, and Humalog Mix50/50 are contraindicated during episodes of hypoglycemia and in patients who are hypersensitive to Humalog or any of its excipients.

Warnings and Precautions

  • Never Share a Humalog KwikPen, Humalog Mix75/25 KwikPen, or Humalog Mix50/50 KwikPen, Cartridge, Reusable Pen Compatible with Lilly 3 mL Cartridges, or Syringe Between Patients: Humalog, Humalog Mix75/25, and Humalog Mix50/50 KwikPens, cartridges, and reusable pens compatible with Lilly 3 mL cartridges must never be shared between patients, even if the needle is changed. Patients using Humalog, Humalog Mix75/25, or Humalog Mix50/50 vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
  • Changes in Insulin Regimen: Changes may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously under close medical supervision and the frequency of blood glucose monitoring should be increased.
  • Hypoglycemia: Severe hypoglycemia may be life threatening and can cause seizures or death. Hypoglycemia is the most common adverse reaction of Humalog, Humalog Mix75/25, and Humalog Mix50/50. The patient’s ability to concentrate and react may be impaired as a result of hypoglycemia. Hypoglycemia can happen suddenly and symptoms may vary for each person and may change over time. Early warning symptoms of hypoglycemia may be different or less pronounced under conditions such as long-standing diabetes, diabetic nerve disease, use of medications such as beta-blockers, or in patients who experience recurrent hypoglycemia. These situations may result in severe hypoglycemia and possibly loss of consciousness prior to the patient’s awareness of hypoglycemia.
  • Timing of hypoglycemia usually reflects the time-action profile of administered insulins which may vary in different individuals or at different times in the same individual. Other factors such as changes in food intake, injection site, exercise, and concomitant medications may increase the risk of hypoglycemia.
  • Educate patients to recognize and manage hypoglycemia. In patients at higher risk for hypoglycemia and patients with reduced symptomatic awareness, increased frequency of blood glucose monitoring is recommended. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia.
  • Hypoglycemia Due to Medication Errors: Instruct patients to always check the insulin label before each injection to avoid medication errors.
  • Humalog U-200 should not be transferred from the Humalog KwikPen to a syringe as overdose and severe hypoglycemia can occur.
  • Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with Humalog, Humalog Mix75/25, and Humalog Mix50/50. If hypersensitivity reactions occur, discontinue the use of insulin and treat per standard of care until signs and symptoms resolve.
  • Hypokalemia: Hypokalemia may be life threatening. Insulins, including Humalog, Humalog Mix75/25, and Humalog Mix50/50, cause a shift in potassium from the extracellular to intracellular space possibly leading to hypokalemia, which, if untreated, may result in respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia (eg, patients using potassium-lowering medications or medications sensitive to serum potassium concentrations).
  • Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Thiazolidinediones (TZDs), which are PPAR-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin, including Humalog, Humalog Mix75/25, and Humalog Mix50/50. This may lead to or exacerbate heart failure. Observe patients for signs and symptoms of heart failure and consider discontinuation or dose reduction of the PPAR-gamma agonist.
  • Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Malfunction of the insulin pump device, infusion set, or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Patients using subcutaneous insulin infusion pumps must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

Drug Interactions

  • Some medications may alter glucose metabolism, insulin requirements, and the risk for hypoglycemia or hyperglycemia. Signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs. Particularly close monitoring may be required.

Adverse Reactions

  • Adverse reactions associated with Humalog include hypoglycemia, hypokalemia, allergic reactions, injection-site reactions, lipodystrophy, pruritus, rash, weight gain, and peripheral edema.

Use in Specific Populations

  • Humalog has not been studied in children with type 1 diabetes less than 3 years of age or in children with type 2 diabetes. Safety and effectiveness of Humalog Mix75/25 and Humalog Mix50/50 in patients less than 18 years of age have not been established.

Dosage and Administration

  • Humalog should be given within 15 minutes before or immediately after a meal.
  • Humalog Mix75/25 and Humalog Mix50/50 should be given within 15 minutes before a meal.
  • Humalog U-100 can be administered intravenously under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia. Do NOT administer Humalog Mix75/25, Humalog Mix50/50, or Humalog U-200 intravenously.
  • Humalog U-100 for subcutaneous injection should only be mixed with NPH insulin. If Humalog U-100 is mixed with NPH insulin, Humalog should be drawn into the syringe first. Injection should occur immediately after mixing. Do NOT mix Humalog Mix75/25, Humalog Mix50/50, or Humalog U-200 in a syringe with any other insulin.
  • Humalog U-100 should not be diluted or mixed when used in an external insulin pump. Change Humalog U-100 in the reservoir at least every 7 days. Change the infusion set and insertion site at least every 3 days. Do NOT use Humalog Mix75/25, Humalog Mix50/50, or Humalog U-200 in a subcutaneous insulin infusion pump.
  • Do NOT perform dose conversion when using either the Humalog U-100 or Humalog U-200 KwikPens. The dose window shows the number of insulin units to be delivered and no conversion is needed.

Please click to access Humalog Full Prescribing Information, Humalog Mix75/25 Full Prescribing Information, and Humalog Mix50/50 Full Prescribing Information.

Please see Instructions for Use included with the pen.

HI BOI U200 HCP ISI 26MAY2015

Humalog® and Humalog® KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates, and are available by prescription only.

Humalog® Mix75/25, Humalog® Mix50/50, Humalog® Mix75/25 KwikPen®, and Humalog® Mix50/50 KwikPen® are trademarks of Eli Lilly and Company and are available by prescription only.

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About Humalog U-100

Humalog® U-100 Insulin

Adding mealtime insulin to diabetes therapy.

Consider Humalog for your patients with type 2 diabetes who:

  • Need rapid-acting insulin, in addition to long-acting insulin, to manage postmeal glucose levels
  • Need to add mealtime insulin injections to current basal insulin injections
  • In your opinion are appropriate for this treatment plan
  • Are ready to start mealtime insulin
  • Want an insulin regimen that allows flexibility around meals

Humalog U-100

  • Improved postmealtime glucose in adult patients when added to a basal insulin1
  • Must be injected 15 minutes before or immediately after a meal
  • Available in Humalog® U-100 KwikPen® and vial

Dosage of Humalog must be individualized. Humalog given by subcutaneous injection should generally be used in regimens with intermediate- or long-acting insulins.

Efficacy for type 2

Type 2 diabetes

Humalog offers improved glycemic control

When added to a basal insulin in patients with type 2 diabetes, Humalog dosed 15 minutes before or immediately after meals:

  • Reduced postprandial glucose levels1
  • Lowered A1C

Compared to regular human insulin, Humalog U-100 lowered 2-hour postprandial glucose excursions

53%

*In a study of 722 patients with type 2 diabetes, the increase in serum glucose levels at 2 hours following the test meal was 53% lower for Humalog relative to regular human insulin (P<.001). Actual values for the rise in glucose were 25.4 ± 1.8 mg/dL for Humalog vs 54.0 ± 1.8 mg/dL for regular human insulin.

Select Safety Information

  • Changes in insulin regimen may affect glycemic control and predispose patients to hypoglycemia and hyperglycemia. Changes should be made cautiously and the frequency of blood glucose monitoring should be increased.

Humalog U-100 self-titration dosing for your type 2 patients

The AUTONOMY study: self-titration dosing for your patients2

In the AUTONOMY study, patients initiated therapy with one injection at breakfast2

  • Injections using the AUTONOMY algorithm were administered using Humalog® U-100 KwikPen3
  • Carbohydrate counting was not required to adjust titration2
  • Under healthcare provider direction, patients recorded their blood glucose (BG) readings, and then self-adjusted their prandial insulin based on their readings either every day or every three days2
Learn more about the AUTONOMY Dosing and Titration Study >

Starting dose2

  • The initial breakfast mealtime dose was equivalent to 10% of the total daily glargine dose

Patients assessed and adjusted their own mealtime insulin2

  • Following the Q1D algorithm, patients adjusted the breakfast dose daily based on the previous day’s prelunch BG reading
  • When prelunch BG readings were consistently in the 85-114 mg/dL range, no further breakfast dose adjustments were required
Adjust dose

Additional doses were added at the healthcare provider’s discretion2,4

  • Once the optimal breakfast injection dose was reached and prelunch blood glucose readings were within the 85-114 mg/dL range, the HCP determined whether or not a lunch dose was needed. If additional control was required (predinner blood glucose readings ≥115 mg/dL), patients made adjustments using the same algorithm that they used for the breakfast dose

For Patients Who Used the Q1D Algorithm at 24 Weeks2,5:

required injections per day
  • For each meal, the base unit lispro dose was equivalent to4:
    • 10% of the total daily glargine dose at lunch
    • 5% of the total daily glargine dose at dinner
  • Lunch and dinner doses were titrated daily using the Q1D algorithm until the respective BG targets were reached
  • Lunch dose adjustments were based on the previous day’s predinner BG reading
  • Dinner dose adjustments were based on the previous day’s bedtime BG reading
  • 61.2% of patients using the Humalog U-100 KwikPen required only 1 or 2 daily injections of mealtime insulin at study endpoint2,3,5
Adjust dose Adjust dose Learn more about the AUTONOMY Dosing and Titration Study >

Consider Humalog KwikPen for your patients with type 1 diabetes who:

  • Don’t want to attract attention to their disease
  • Want a choice in delivery options

Humalog U-100

  • Reduced postprandial glucose (PPG) levels when added to basal insulin6
  • Provides flexible dosing, within 15 minutes before or immediately after a meal
  • Available in a variety of delivery options, including vial, KwikPen, and infusion pump*

In-use Humalog KwikPen should be stored at room temperature, below 86°F (30°C), and must be used within 28 days or be discarded, even if it still contains Humalog.

*Humalog has not been studied in children with type 1 diabetes less than 3 years of age or in children with type 2 diabetes.

Humalog in an external insulin pump is approved for use in children with type 1 diabetes 4 years of age and older.

Learn about HumaPen® LUXURA® HD and other delivery options >

Help your newly diagnosed families managing type 1 diabetes on their journey

At their most vulnerable moments of diagnosis and insulin initiation, your families managing type 1 diabetes can rely on us for starter kits and online educational resources. They can find comfort and hope in the many initiatives developed collaboratively with Disney—from cookbooks to storybooks, and a special Disney character with type 1 diabetes named Coco. And we continue our commitment throughout their journey with ongoing efforts like our summer camps for kids, scholarships for college, and awards to celebrate significant milestones of living life with diabetes without limits. Click here for details.

Efficacy for type 1

Type 1 diabetes

Humalog offers improved glycemic control

In patients with type 1 diabetes, Humalog U-100:

  • Reduced PPG to a greater extent compared to regular insulin in pediatric patients; A1C did not differ between patients treated with regular insulin and those treated with Humalog7,8
  • Humalog U-100 provided improved glycemic control when used in an external insulin pump

Humalog U-100 reduced postprandial blood glucose compared to regular human insulin*6

In pediatric patients with type 1 diabetes, Humalog reduced PPG to a greater extent than regular insulin; A1C did not differ between patients treated with regular human insulin and those treated with Humalog.7,8

Study design7

  • 61 children (2.9 to 11.4 years), mean baseline A1C value 8.4% ± 1.0%
    • Diagnosed ≥12 months earlier
    • Receiving human basal insulin (NPH, lente, or ultralente) plus human regular insulin (≥2 months prior to randomization)
  • 3-way crossover study
    • 3 treatment regimens
      • A: Humalog immediately postmeal
      • B: Humalog 15 minutes premeal
      • C: Regular human insulin 30-45 minutes premeal
    • Prestudy basal insulin regimen continued during study
    • All patients received all 3 treatment regimens for 3 months per regimen in a crossover design
    • Mean total daily insulin dose for all treatments was 0.8 U/kg/day
    • No difference in A1C or rate of hypoglycemia among the 3 therapies
    • Humalog has not been studied in children with type 1 diabetes less than 3 years of age or in children with type 2 diabetes

*Insulin lispro administered 15 minutes before meals compared with regular human insulin administered 30-45 minutes before meals lowered postprandial glucose after breakfast (11.7 mmol/L vs 15.0 mmol/L; P<.001) and the evening meal (8.8 mmol/L vs 10.8 mmol/L; P=.006).7 Insulin lispro administered before meals compared with regular human insulin administered 30-45 minutes before meals resulted in lower postprandial glucose after breakfast (9.7 mmol/L vs 10.6 mmol/L; P<.001) and the evening meal (8.6 mmol/L and 9.3 mmol/L, P=.003) in adolescents with type 1 diabetes.8

Humalog U-100 provided improved glycemic control when used in an external insulin pump

Humalog effectively improved A1C and blood glucose stability in patients with type 1 diabetes using insulin pumps.9,10 Humalog in an external insulin pump is approved for use in children with type 1 diabetes 4 years of age and older.

Adult pump use

In a 24-week, open-label, randomized, crossover multicenter study (N=39), using Humalog effectively improved A1C and blood glucose stability in patients using insulin pumps when compared to regular human insulin.10 The use of Humalog significantly reduced A1C and postprandial glucose levels, without increasing hypoglycemic episodes.9

Pediatric pump use

In a 16-week, open-label, parallel-group, multicenter study of children and adolescents with type 1 diabetes (N=298) aged 4 to 18 years, Humalog demonstrated comparable changes from baseline in A1C and comparable rates of hypoglycemia as insulin aspart.10

Pediatric Insulin Pump Study in Type 1 Diabetes (16 weeks; n=298)

Humalog Aspart
N 100 198
Baseline A1C (%)* 8.2 ± 0.8 8.0 ± 0.9
Change from baseline A1C (%) -0.1 ± 0.7 -0.1 ± 0.8
Treatment difference in A1C,
mean (95% confidence interval)
0.1 (-0.3, 0.1)
Baseline insulin dose (units/kg/24 hours)* 0.9 ± 0.3 0.9 ± 0.3
End-of-study insulin dose (units/kg/24 hours) 0.9 ± 0.2 0.9 ± 0.2
Patients with severe hypoglycemia (n, %)† 8 (8%) 19 (10%)

*Values are mean ± SD.

†Severe hypoglycemia refers to hypoglycemia associated with central nervous system symptoms and requiring the intervention of another person or hospitalization.

A randomized, crossover, open-label study (N=39) compared insulin lispro (IL) with regular human insulin (U-100) in patients with type 1 diabetes mellitus (mean age 39). Both were administered in an insulin pump (MiniMed 506).9,11 Each treatment was given for 3 months and then switched to the other for 3 months. In the IL cohort, the A1C decreased from 7.74 ± 0.20% at baseline to 7.11 ± 0.15% at 12 weeks of period 1. The U-100 cohort showed a decrease in A1C from 7.97 ± 0.13 to 7.88 ± 0.16%; the difference between IL and U-100 was significant (P=.01). Mean daily and 2-hour postprandial blood glucose was also significantly lower in the IL than U-100 cohort (P<.0001). The rate of hypoglycemia determined in the last 30 days of the first treatment period was 7.03 versus 7.94 events/month with IL and U-100, respectively.9 In a second study, 113 subjects (mean age 37.1 years) with type 1 diabetes mellitus were treated with IL or U-100 administered by continuous subcutaneous insulin infusion. The study was a randomized, crossover design in which each treatment was administered for 4 months. The baseline A1C was 7.24% and decreased to 6.77 ± 0.88% and 6.90 ± 0.97% in the IL and U-100 cohorts, respectively (P<.02). The postprandial glucose was reduced after breakfast (run-in 8.5 to 7.0 and 8.6 mmol/L), lunch (8.4 to 7.6 and 8.7 mmol/L), and dinner (8.2 to 7.6 and 8.3 mmol/L) in IL and U-100 cohorts, respectively (all P<.001). The total number of hypoglycemia episodes per patient was not significantly different between treatments (12.4 versus 11.0 in the IL and U-100 cohorts, respectively).12

In a 16-week, parallel-group, open-label, multicenter study, children and adolescents with type 1 diabetes were randomly assigned to insulin aspart (n=198) or insulin lispro (n=100) administered by continuous subcutaneous insulin infusion.10 Approximately two-thirds of subjects in each treatment arm were aged 12-18 years. The A1C change from baseline to endpoint for insulin aspart and insulin lispro was 0.15% and 0.05%, respectively. Insulin aspart was noninferior to insulin lispro as the 95% CI for the difference in treatment did not exceed 0.4 (95% CI -0.27 to 0.07%). In general, the incidence and rate of hypoglycemia were similar between insulin aspart and insulin lispro. At least one major hypoglycemic event occurred in 9.6% of aspart.

Important information about using Humalog U-100 in an insulin pump

Humalog U-100 should not be diluted or mixed when used in an external insulin pump. Change Humalog U-100 in the reservoir at least every 7 days. Change the infusion set and insertion site at least every 3 days.

Insulin pump or infusion set malfunction or degradation of the insulin in the pump reservoir can rapidly result in hyperglycemia and ketoacidosis. Patients should be instructed to carry alternate insulin therapy in case of pump failure.

Humalog U-100 in an external insulin pump is approved for use in patients with type 1 diabetes 4 years of age and older.

Adverse reactions associated with Humalog in patients receiving continuous subcutaneous insulin infusion: in adult patients, catheter occlusions (0.09/month), infusion-site reactions (2.6%). In children and adolescents, infusion-site reactions (21%).

Why Humalog U-100 KwikPen might be right for your patients

Humalog KwikPen is a small, lightweight, prefilled insulin pen for patients with type 2 or type 1 diabetes who want a portable device. Humalog KwikPen can be stored outside the refrigerator after first use and taken just about anywhere. Patients can carry it in their purse, backpack, or pocket because it’s the size of a marker.

In-use Humalog KwikPen should be stored at room temperature, below 86°F (30°C). Humalog KwikPen must be used within 28 days or be discarded, even if it still contains Humalog.

Humalog U-100 KwikPen can be an easy-to-use, easy-to-inject prefilled pen option*13

  • Easy to set the dose*13
  • Easy to see the numbers*13
  • Easy to dial up and back down for dose selection
  • Easy to dispense maximum dose of 60 units*13
  • Allows patients or caregivers to discreetly deliver insulin

To help patients and their caregivers learn how to inject using Humalog KwikPen, please click to access the Humalog U-100 KwikPen Instructions for Use.

*Humalog KwikPen Design Validation User Study included adult male and female participants with type 1 and type 2 diabetes. Of the total 150 study participants, 56 were insulin-naïve, 42 were currently administering insulin with a vial and syringe, and 52 were experienced insulin pen users.

Pen needles for use with Humalog KwikPen

Humalog KwikPen is suitable for use with Becton Dickinson (BD) needles (sold separately and may require a separate prescription). BD offers a comprehensive line of advanced protection products. For more information about BD pen needles, visit the BD Diabetes website for healthcare professionals.

Pens and needles are for single-patient use only and should not be shared, even in healthcare facilities, as infection or disease can be spread from one person to another.

Discard needle before storing pen. A new needle should be used for each injection.

Do not withdraw insulin from the pen using a syringe.

What questions do patients most frequently ask about Humalog? Click here.

Nationwide, Humalog U-100 has better coverage* than NovoLog® and, for more insured patients, costs less†‡

Humalog U-100 is available at the lowest branded co-pay on more plans than NovoLog. The out-of-pocket costs for each patient will depend on their insurance plan, but Humalog has better coverage in the majority of cases.

Learn more about Humalog U-100 formulary coverage in your area >

For additional resources and support, click here.

*“Better coverage” means more insured patients nationwide can get Humalog U-100 KwikPen and vials at the lowest brand co-pay or better without restriction compared to NovoLog® FlexPen® and vials, respectively.

†“Costs less” means more Humalog patients are responsible for less of the cost of a drug, as measured by the amount of their co-pay/coinsurance associated with their benefit’s tier status, than NovoLog patients.

‡Applies to Humalog U-100 KwikPen and vials; comparison compiled from Commercial, Medicare, Medicaid FFS, and Managed Medicaid formulary data accurate as of 08/2016. The underlying total number of insured patients used to conclude “better coverage” and “costs less” was developed by Decision Resources Group (DRG) based on DRG’s National Managed Care Census, DRG’s Employer Vantage product, data from the Centers for Medicare & Medicaid Services, data from state Medicaid offices, and data from other publicly available sources, with assumptions to account for dependents included under reported enrolled patients. Enrollment figures may not be representative of an individual physician’s patient population.

Additional Formulary Information

  • Source: Managed Markets Insight & Technology (MMIT), LLC as of 08/2016, and is subject to change without notice by a health plan or state. Please contact the plan or state for the most current information
  • This information is not a guarantee of coverage or payment (partial or full). Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures
  • The formulary information does not include generic medications in this therapeutic class
  • Employers and employer groups may also offer additional benefit designs which may be different than described
  • Co-payment amounts are subject to change by plans without notice. Lower co-payment cost alone does not necessarily reflect a cost advantage in the outcome of the condition treated because there may be other variables that affect relative costs
  • The formulary information on this website is for select products that share an approved indication with Humalog U-100. Inclusion of a product does not establish clinical comparability of the products for any or all indications and should not be seen as making any claim regarding efficacy or safety

References

  1. Anderson JH Jr, Brunelle RL, Keohane P, et al; Multicenter Insulin Lispro Study Group. Mealtime treatment with insulin analog improves postprandial hyperglycemia and hypoglycemia in patients with non-insulin-dependent diabetes mellitus. Arch Intern Med. 1997;157(11):1249-1255.
  2. Edelman SV, Liu R, Johnson J, Glass LC. AUTONOMY: the first randomized trial comparing two patient-driven approaches to initiate and titrate prandial insulin lispro in type 2 diabetes. Diabetes Care. 2014;37:2132-2140.
  3. Data on file, Lilly Research Laboratories: HI20140219B.
  4. Data on file, Lilly Research Laboratories: HI20140206A.
  5. Data on file, Lilly Research Laboratories: HI20140225A.
  6. Anderson JH Jr, Brunelle RL, Koivisto VA, et al; Multicenter Insulin Lispro Study Group. Reduction of postprandial hyperglycemia and frequency of hypoglycemia in IDDM patients on insulin-analog treatment. Diabetes. 1997;46(2):265-270.
  7. Deeb LC, Holcombe JH, Brunelle R, et al. Insulin lispro lowers postprandial glucose in prepubertal children with diabetes. Pediatrics. 2001;108:1175-1179.
  8. Holcombe JH, Zalani S, Arora VK, Mast CJ; Lispro in Adolescents Study Group. Comparison of insulin lispro with regular human insulin for the treatment of type 1 diabetes in adolescents. Clin Ther. 2002;24:629-638.
  9. Melki V, Renard E, Lassmann-Vague V, et al. Improvement of HbA1c and blood glucose stability in IDDM patients treated with lispro insulin analog in external pumps. Diabetes Care. 1998;21(6):977-982.
  10. Weinzimer SA, Ternand C, Howard C, Chang CT, Becker DJ, Laffel LM; Insulin Aspart Pediatric Pump Study Group. A randomized trial comparing continuous subcutaneous insulin infusion of insulin aspart versus insulin lispro in children and adolescents with type 1 diabetes. Diabetes Care. 2008;31(2):210-215.
  11. Zinman B, Tildesley H, Chiasson JL, Tsui E, Strack T. Insulin lispro in CSII: results of a double-blind crossover study [published correction appears in Diabetes. 1997;46(7):1239]. Diabetes. 1997;46(3):440-443.
  12. Renner R, Pfützner A, Trautmann M, Harzer O, Sauter K, Landgraf R; German Humalog-CSII Study Group. Use of insulin lispro in continuous subcutaneous insulin infusion treatment. Results of a multicenter trial. Diabetes Care. 1999;22(5):784-788.
  13. Data on file, Lilly Research Laboratories: HUM20071024A.

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