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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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Helpful Links

Type 1 resources

A type 1 diagnosis can feel scary and overwhelming. If you or someone close to you was recently diagnosed with type 1, you might be asking yourself: Could we have prevented this? Did we do something wrong? How will we live our lives with these changes?

Pause. Take a deep breath. And remember that you are not alone.

Type 1 diabetes is not your fault. It’s not something you caused or could have prevented, but it is something you can manage. Don’t forget that families just like yours have been in your shoes and walked this path before. Like you, they faced the whirlwind of diagnosis, worried about what it meant, and then forged ahead—one step at a time. Remind yourself that kids with type 1 diabetes can still be kids. Your family can still enjoy life to the fullest.

Just focus on what you need to know right now, and you can get through this.

Be patient with yourself. Start with the basics and the rest will come with time. The type 1 community is a strong network where we can all learn from one another’s experiences.

We collaborate with the American Diabetes Association, JDRF, Children with Diabetes, the College Diabetes Network, and top athletes with type 1 diabetes to support your family all along your diabetes journey—from diabetes camps to college scholarships, and much more.

American Diabetes Association JDRF Children with Diabetes College Diabetes Network

The usage of the American Diabetes Association, JDRF, Children with Diabetes, and the College Diabetes Network logos do not imply endorsement of Lilly Diabetes products.

Support for your family

Everyday Wisdom Kit is a free, interactive toolkit for your family from Lilly Diabetes and the American Diabetes Association.

JDRF Bag of Hope is a backpack filled with useful resources for children diagnosed with T1D and their caregivers.

Lilly Camp Care Package Initiative provides insulin, supplies, backpacks, and motivational speakers to diabetes camps across the country.

The Lilly Diabetes Journey Awards honor people who have successfully managed their diabetes with insulin for 10, 25, 50, and 75 years.

Everyday inspiration

T1EverydayMagic brings everyday magic to families like yours through books, online resources, and inspiring stories through a collaboration between Lilly Diabetes and Disney.

Kris Freeman Lilly Camp Care Package offers opportunities to meet Olympic cross-country skier Kris Freeman and learn how he partners with Lilly Diabetes to inspire kids to dream big at diabetes camps across the country.

Kris Freeman’s official blog is where you can follow Kris Freeman as he trains for his next big competition and shares his stories.

Ryan Reed, NASCAR® driver, didn’t let type 1 diabetes hold him back even after being told he’d never race again. Instead, he partnered with Lilly and the American Diabetes Association.

Ryan Reed Drive to Stop DiabetesSM brings awareness and diabetes education to thousands of spectators at NASCAR races nationwide.

Crystal Bowersox never let type 1 diabetes keep her from pursuing her dream. She plays an active role in advocating for diabetes awareness and education, including visits to diabetes summer camps on behalf of Lilly Diabetes.

College scholarships and on-campus support

Diabetes Scholars Foundation is supported by Lilly Diabetes and helps exceptional high school seniors with type 1 diabetes make their college dreams come true.

College Diabetes Network (CDN) offers on-campus support and a hub of online resources for young adults with diabetes with support from Lilly.

Type 2 resources

Diabetes has its ups and downs, but if you work together with your doctor, it can be managed successfully. Here’s a list of helpful resources you can use every day to learn about diabetes basics, useful programs, and much more.

Diabetes basics

American Diabetes Association provides information on everything from the basics of living with diabetes to exercise, food and fitness, and ways to help fund research and education. For Spanish, go to American Diabetes Association (En Español).

WebMD Diabetes Health Center offers useful tips for managing your diabetes, including diet and exercise information.

Lilly Cares can provide help through Lilly’s Patient Assistance Programs if you’re having difficulty paying for your medication.

Food & nutrition

Food Network has a wide variety of diabetes-friendly recipes for dinner, desserts, snacks, and more.

USDA (Choose My Plate) offers Healthy Eating Solutions for Everyday Life as well as useful online tools.

Mayo Clinic (Meal Plan Recipes) provides diabetes meal plan recipes and the option to subscribe to a free newsletter with updates on health topics you may find interesting.

Lifestyle tips

American Diabetes Association offers tips on everything from how to pack for vacation to how to prepare for an emergency when away from home.

dLife is a great all-around source for people living with type 1 or type 2 diabetes, including Blogabetes®, a forum for “informative diabetes conversation.”

CNN Health (exercises for type 2 diabetes) and American Diabetes Association Fitness have suggestions about the best type of exercise for people living with type 2 diabetes.

Paying for Humalog

Your co-pay or out-of-pocket costs for Humalog will depend on your insurance plan. Keep in mind that the cost of Humalog is determined by several groups/organizations, including wholesalers and pharmacies. If you have any questions, please contact The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).

Contact Lilly

If you have a medical emergency, you should immediately call 911 (or your local emergency services number). If you are seeking medical advice, you should direct those questions to your doctor. Your own doctor is the best source of information regarding your health.

If you cannot find the answers you need through this website, you can contact The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979), Monday through Friday from 9 AM to 8 PM ET. The toll-free number is a service provided by Eli Lilly and Company and is not intended to replace the advice of your doctor.

You clicked on a page that’s meant for healthcare providers.

This section includes technical information. If you’re a US healthcare provider, click “Continue.” Otherwise, click “Return” to keep reading the main site.

You are now leaving the Humalog.com website

The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC, does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC, is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.

Click "Continue" to proceed or "Cancel" to return to Humalog.com