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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 Junior KwikPen, Humalog 200 units/mL KwikPen, Humalog Mix75/25, and Humalog Mix50/50?

  • Do not share your Humalog, Humalog Junior, Humalog Mix75/25, or Humalog Mix50/50 KwikPens, 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 www.fda.gov/medwatch or call 1-800-FDA-1088.

Humalog, Humalog Mix75/25, and Humalog Mix50/50 are available by prescription only.

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.

HUMALOG BOI CON ISI 03AUG2017

Humalog®, Humalog® KwikPen® and Humalog® Junior 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™® 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 Junior 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.

HUMALOG BOI HCP ISI 03AUG2017

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

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image of Humalog Mix75/25 KwikPen and Humalog Mix50/50 KwikPen - About Humalog Mixes

Humalog® Mixes

Basal and prandial insulin together
in a convenient mix.

Humalog<sup>®</sup> Mix50/50 KwikPen<sup>®</sup> Logo Humalog<sup>®</sup> Mix75/25 KwikPen<sup>®</sup> Logo

Consider Humalog® Mix75/25 for your patients with type 2 diabetes who:

  • Need greater glycemic control than oral medications alone are providing1
  • Are willing to add insulin injections, but want to minimize the number needed
  • Want to use a single product that will improve both mealtime and fasting control1-3

Humalog Mix75/25

  • A convenient premixed option combining 75% longer-acting insulin and 25% rapid-acting insulin
  • Is dosed 15 minutes prior to a meal
  • Improves both fasting3 and mealtime4 control in a single product
  • Available in Humalog® Mix75/25 KwikPen®

Efficacy of Humalog Mix75/25

Humalog Mix75/25 provided improved glucose control

Two studies in adult patients with type 2 diabetes

When added to metformin, Humalog Mix75/25 improved A1C1

  • Two open-label, randomized, crossover trials compared the glycemic response of Humalog Mix75/25 BID + metformin with that of glargine QD + metformin1,2

Humalog Mix75/25 improved fasting blood glucose (FBG) and postprandial glucose (PPG) control3

  • A randomized, double-blind study with 3-way crossover compared Human Insulin 70/30, Humalog Mix75/25, and Humalog® Mix50/50 after a standardized breakfast meal3

PAIR-IN: Design and methods1

  • Humalog Mix75/25 BID plus metformin versus glargine QD plus metformin
  • Open-label, randomized, crossover trial, 16 weeks on each treatment
  • 105 insulin-naive patients with type 2 diabetes
  • Mean age 55 years
    • All randomized patients included in safety analysis
    • 67 patients included in efficacy analysis (29 patients excluded because they may have received expired study drug)
  • Baseline A1C: 8.7%

Primary endpoint

  • Change in A1C over 16 weeks

Note: PAIR-IN average (standard deviation) daily dose of insulin was 0.62 (0.37) U/kg for Humalog Mix75/25 vs 0.57 (0.37) U/kg for glargine (P<.001).

PAIR-PI: Design and methods

  • Humalog Mix75/25 BID plus metformin versus glargine QD plus metformin
  • Inadequately controlled patients with type 2 diabetes on once- or twice-daily insulin alone or in combination with oral agents
  • 97 patients
  • Open-label, randomized, crossover trial

Note: PAIR-PI average (standard deviation) daily dose of insulin was 0.42 (0.20) U/kg for Humalog Mix75/25 vs 0.36 (0.18) U/kg for glargine (P<.001).

PAIR-IN: A1C change from baseline
PAIR-PI: A1C change from baseline
PAIR-IN: Percent of patients to A1C goal of <7%
PAIR-PI: Percent of patients to A1C goal of <7%
PAIR-IN: FBG control
PAIR-PI: FBG control

PAIR-IN: Hypoglycemia1

Overall hypoglycemia rates for the groups were as follows:

  • Humalog Mix75/25 + MET group: 0.68 episodes/patient per 30 days
  • Glargine + MET group: 0.39 episodes/patient per 30 days

Nocturnal hypoglycemia rates for the groups were as follows:

  • Humalog Mix75/25 + MET group: 0.14 episodes/patient per 30 days
  • Glargine + MET group: 0.24 episodes/patient per 30 days

PAIR-PI: Hypoglycemia2

Overall hypoglycemia rates for the groups were as follows:

  • Humalog Mix75/25 + MET group: 0.61 episodes/patient per 30 days
  • Glargine + MET group: 0.44 episodes/patient per 30 days

Nocturnal hypoglycemia rates for the groups were as follows:

  • Humalog Mix75/25 + MET group: 0.14 episodes/patient per 30 days
  • Glargine + MET group: 0.34 episodes/patient per 30 days
PAIR-IN: Overall hypoglycemia
PAIR-PI: Overall hypoglycemia
PAIR-IN: Nocturnal hypoglycemia
PAIR-PI: Nocturnal hypoglycemia

PAIR-IN

  • Humalog Mix75/25 BID plus metformin versus glargine QD plus metformin
  • Insulin-naive patients with type 2 diabetes
  • 105 patients
  • 67 patients included in efficacy analysis (29 patients excluded, since they may have received expired study drug)
  • Baseline A1C: 8.7%

Note: PAIR-IN average (standard deviation) daily dose of insulin was 0.62 (0.37) U/kg for Humalog Mix75/25 vs 0.57 (0.37) U/kg for glargine (P<.001).

PAIR-PI

  • Humalog Mix75/25 BID plus metformin versus glargine QD plus metformin
  • Inadequately controlled patients with type 2 diabetes on once- or-twice-daily insulin alone or in combination with oral agents
  • 97 patients
  • Open-label, randomized, crossover trial

Note: PAIR-PI average (standard deviation) daily dose of insulin was 0.42 (0.2) U/kg for Humalog Mix75/25 vs 0.36 (0.18) U/kg for glargine (P<.001).

Humalog Mix75/25 improved fasting3 and postprandial4 glucose control

Design and methods

  • Comparison of insulin formulations: Human Insulin 70/30, Humalog Mix75/25, and Humalog Mix50/50 after a standardized breakfast meal
  • Study was randomized and double-blind, with 3-way crossover of the premixed insulins in patients with type 2 diabetes. A control group of subjects without diabetes underwent the standardized test meal with no insulin treatment
  • After the test breakfast, glucose was measured for 4 hours
  • 22 patients received a single dose of Human Insulin 70/30 before breakfast; 22 received Humalog Mix75/25; and 23 received Humalog Mix50/50. Ten subjects without diabetes received no insulin. One patient who received Human Insulin 70/30 before the test meal, followed by the usual dose of insulin lispro before lunch, reported symptoms of hypoglycemia that resolved with oral carbohydrate
Pre- and postprandial serum glucose concentrations

Note: Mean (SD) dose of insulin was 44.1 (18.2) U/day for Human Insulin 70/30; 44.1 (18.2) U/day for Humalog Mix75/25; and 43.8 (17.8) U/day for Humalog Mix50/50. Standard test breakfast: 500 kcal; 50% carbohydrate, 34% fat, 16% protein. Each regimen resulted in 2-hour postprandial glucose significantly different from all other regimens (pairwise comparison).

Consider Humalog® Mix50/50 for your patients with type 2 diabetes who:

  • Need additional rapid-acting insulin to address postprandial glucose spikes
  • Tend to eat carb-loaded meals and to overeat
  • Want to use a pen device instead of vial and syringe
  • Are concerned about the cost of an additional insulin
  • Need an insulin regimen that contains both a rapid-acting and longer-acting insulin

Humalog Mix50/50

  • 50% longer-acting insulin and 50% rapid-acting insulin
  • Is dosed 15 minutes prior to a meal
  • Improved mealtime control3,5,6
  • Provides patients the greatest amount of rapid-acting insulin of any commercially available premixed insulin
  • Available in Humalog® Mix50/50 KwikPen®

Efficacy of Humalog Mix50/50

Humalog Mix50/50 improved postprandial glucose control3,5,6

A randomized, double-blind study compared Human Insulin 70/30, Humalog Mix75/25, and Humalog Mix50/50 after a standardized breakfast meal in patients with type 2 diabetes.3 Humalog Mix50/50 improved postprandial glucose control.3,5,6

Design and methods3

  • Comparison of insulin formulations: Human Insulin 70/30, Humalog Mix75/25, and Humalog Mix50/50 after a standardized breakfast meal
  • Study was randomized and double-blind, with 3-way crossover of the premixed insulins in patients with type 2 diabetes. A control group of subjects without diabetes underwent the standardized test meal with no insulin treatment
  • All patients previously used insulin (excluding insulin glargine) for at least one month prior to the study
  • After the test breakfast, glucose was measured for 4 hours
  • 22 patients received a single dose of Human Insulin 70/30 before breakfast; 22 received Humalog Mix75/25; and 23 received Humalog Mix50/50. Ten subjects without diabetes received no insulin. One patient who received Human Insulin 70/30 before the test meal, followed by the usual dose of insulin lispro before lunch, reported symptoms of hypoglycemia that resolved with oral carbohydrate

Humalog Mix50/50 provided improved postprandial control for patients after a standardized breakfast meal3

Humalog Mix50/50 provided improved postprandial
control for patients after a standardized breakfast meal

*Each regimen resulted in 2-hour postprandial glucose significantly different from all other regimens (pairwise comparison).

Note: Mean (SD) dose of insulin was 44.1 (18.2) U/day for Human Insulin 70/30; 44.1 (18.2) U/day for Humalog Mix75/25; and 43.8 (17.8) U/day for Humalog Mix50/50. Standard test breakfast: 500 kcal; 50% carbohydrate, 34% fat, 16% protein.

Select Safety Information

  • Severe hypoglycemia may be life threatening and can cause seizures or death. Hypoglycemia is the most common adverse effect of Humalog, Humalog Mix75/25, and Humalog Mix50/50 therapy. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia.
  • Fluid retention and heart failure can occur with concomitant use of TZDs and Humalog, Humalog Mix75/25, and Humalog Mix50/50. Observe patients for signs and symptoms of heart failure and consider discontinuation to dose reduction of the PPAR-gamma agonist.

Dosing for Humalog mixes

Dosing for Humalog mixes

The following dosing options for patients with type 2 diabetes starting premixed insulin are based on Hirsch et al.7 Dosing guidelines should be individualized for each patient.

Recommended dose

  • Start 10 units predinner
  • Add subsequent prebreakfast dose based on patient's needs, or
  • Start 10 units prebreakfast and predinner

Titration

  • Prebreakfast dose: Adjust based on predinner/evening glucose values
  • Predinner dose: Adjust based on prebreakfast/morning glucose values
  • Do not increase dose if hypoglycemia (<70 mg/dL) or symptoms are present

Titration schedule for once-daily or twice-daily insulin regimens7

schedule image

Some Important Dosing Information

Dosage regimens of insulin will vary among patients and should be determined by the healthcare provider familiar with the patient's metabolic needs, eating habits, and other lifestyle variables. In addition, the dose must be individualized for each patient, based on blood glucose monitoring.

Transitioning patients from basal to premixed insulin

Transitioning your patients from basal insulin to premixed insulin

  • To reduce the potential for insulin stacking, start premixed insulin therapy after the typical dosing cycle of the last dose of basal insulin therapy
    • For example, for a patient on a basal insulin analog, do not start premixed insulin therapy until 18 to 24 hours after the last basal insulin dose7
  • Convert the total daily dose of basal insulin as a guide for the initial starting dose of premixed insulin7
    • For example, a patient taking 50 units of basal insulin would be moved to a 50-unit total daily dose of premixed insulin
  • Titrate dosage as appropriate based on clinical judgment

Dosage regimens of insulin will vary among patients and should be determined by the healthcare provider familiar with the patient’s metabolic needs, eating habits, and other lifestyle variables. In addition, the dose must be individualized for each patient, based on blood glucose monitoring. 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. Do not withdraw insulin from the pen using a syringe.

  • Use average blood glucose (BG) values across 3 to 7 days7
  • A dose change is applied to a mealtime dose preceding the time of the reading7,8
    • For example, if pre-evening glucose is high, then increase insulin dose before breakfast
    • BG reading times should be kept consistent relative to mealtimes due to the time-action profile of a premixed therapy

References

  1. Malone JK, Kerr LF, Campaigne BN, Sachson RA, Holcombe JH; Lispro Mixture-Glargine Study Group. Combined therapy with insulin lispro Mix75/25 plus metformin or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy [published correction appears in Clin Ther. 2005;27(7):1112]. Clin Ther. 2004;26(12):2034-2044.
  2. Malone JK, Bai S, Campaigne BN, Reviriego J, Augendre-Ferrante B. Twice-daily pre-mixed insulin rather than basal insulin therapy alone results in better overall glycaemic control in patients with Type 2 diabetes. Diabet Med. 2005;22(4):374-381.
  3. Schwartz S, Zagar AJ, Althouse SK, Pinaire JA, Holcombe JH. A single-center, randomized, double-blind, three-way crossover study examining postchallenge glucose responses to human insulin 70/30 and insulin lispro fixed mixtures 75/25 and 50/50 in patients with Type 2 diabetes mellitus. Clin Ther. 2006;28(10):1649-1657.
  4. Koivisto VA, Tuominen JA, Ebeling P. Lispro Mix25 insulin as premeal therapy in type 2 diabetic patients. Diabetes Care. 1999;22(3):459-462.
  5. Kazda C, Hülstrunk H, Helsberg K, Langer F, Forst T, Hanefeld M. Prandial insulin substitution with insulin lispro or insulin lispro mid mixture vs. basal therapy with insulin glargine: a randomized controlled trial in patients with type 2 diabetes beginning insulin therapy. J Diabetes Complications. 2006;20(3):145-152.
  6. Roach P, Trautmann M, Arora V, Sun B, Anderson JH Jr. Improved postprandial blood glucose control and reduced nocturnal hypoglycemia during treatment with two novel insulin lispro-protamine formulations, insulin lispro mix25 and insulin lispro mix50. Clin Ther. 1999;23:523-534.
  7. Hirsch IB, Bergenstal RM, Parkin CG, Wright E Jr, Buse JB. A real-world approach to insulin therapy in primary care practice. Clin Diabetes. 2005;23(2):78-86.
  8. Jain SM, Mao X, Escalante-Pulido M, Vorokhobina N, Lopez I, Ilag LL. Prandial-basal insulin regimens plus oral antihyperglycaemic agents to improve mealtime glycaemia: initiate and progressively advance insulin therapy in type 2 diabetes. Diabetes Obes Metab. 2010;12(11):967-975.

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