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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 KwikPen beside a vial of Humalog - About Humalog U-100

Why Humalog® U-100?

You may have been taking a long-acting insulin for a while now. So why did your doctor prescribe another insulin? Well, it’s to help control the blood sugar spikes that happen naturally when you eat. Everyone gets them, but when you have diabetes you may need extra help controlling them. That’s where Humalog comes in.

Humalog is different than your long-acting insulin. Long-acting insulin helps control your blood sugar throughout the whole day.

Humalog is fast-acting insulin—it helps control the blood sugar spikes that happen naturally when you eat.

Humalog is available in the Humalog U-100 KwikPen, which is portable and easy to use. And, since it shouldn’t be refrigerated after the first use, you can take it just about anywhere.

Getting started on Humalog

Here are a few things to remember when you get started:

  • Humalog is taken 15 minutes before or immediately after a meal
  • Low blood sugar (hypoglycemia) is the most common side effect of Humalog and may be severe and cause unconsciousness, seizures, and death
  • You can treat low blood sugar promptly by eating or drinking something containing sugar (like jelly beans or fruit juice) to get your blood sugar back into a safe range
  • Make sure you understand how many units your doctor wants you to take and with what meals
close-up of dosing knob of Humalog U-100 KwikPen - Easy to deliver the dose, easy to set and see the dose, easy to dial up and back down for dose correction

Easy to deliver the dose

Easy to set and see the dose

Easy to dial up and back down for dose selection

Using Humalog® U-100 KwikPen®

Humalog KwikPen is a small, lightweight pen that’s prefilled with Humalog mealtime insulin. It’s portable, easy to use, and can help you inject your mealtime insulin simply and discreetly when you’re away from home.

After you use your pen for the first time, you don’t have to put it back in the refrigerator. Simply drop it into your purse or pocket until you need it again. Remember, always carry an extra pen with you.

LEARN HOW TO USE

How to use Humalog U-100 KwikPen

These are not the full instructions. Please see the Instructions for Use included with your pen for full instructions.

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OR CHOOSE A CHAPTER
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  • Introduction

  • Step 1: Preparing Your Humalog U-100 KwikPen

  • Step 2: Priming Your Humalog U-100 KwikPen

  • Step 3: Selecting Your Dose

  • Step 4: Giving Your Injection

  • Step 5: After Your Injection

  • Step 6: Disposing of Your Pens and Needles

  • Step 7: Storing the Pen

  • Step 8: General Information

  • Step 9: Important Safety Information

Full Prescribing Information and Patient Information

The Lilly Answers Center

Talk with your doctor or call if you have questions. We’re here to help. Call
1-800-LillyRx (1-800-545-5979), Monday through Friday from 9 AM to 8 PM ET.

Where to inject Humalog U-100

Humalog may be injected under the skin of the stomach area, back of upper arms, upper legs, or buttocks (see diagram). Never inject Humalog into a muscle or vein. Work with your healthcare team to determine the most appropriate injection sites.

Be sure to use a different injection site each time and do not overuse any site.

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.

Reactions at the injection site (local allergic reaction) such as redness, swelling, and itching can happen. If you keep having skin reactions or they are serious, talk to your doctor. Do not inject insulin into a skin area that is red, swollen, or itchy.

Front side appropriate injection sites. Stomach, upper legs, back of upper arms.
Back side appropriate injection sites. Back of upper arms, buttocks
 

Storage and disposal for Humalog U-100 KwikPen

Fridge icon

Unopened Humalog should be stored in a refrigerator and can be used until the expiration date on the carton or label.

Fire flame

Humalog should be stored away from light and heat.

Snowflake

Do not use insulin if it has been frozen.

Thermometer

Opened cartridges or prefilled pens should be kept at room temperature.

28 days calendar

Prefilled pens and cartridges should be thrown away 28 days after the first use even if there is insulin remaining.

Toxic Garbage Can

Dispose of needles and pens as directed by your doctor.

Humalog vial and LUXURA HD pen

Other ways to take Humalog U-100

There are other ways to take Humalog besides Humalog KwikPen. The choices currently available are vial and syringe, Humalog Junior KwikPen, HumaPen® LUXURA® HD, and an insulin pump. To decide which way is right for you, ask your doctor about these options and discuss the pros and cons.

Click here to learn how to use a vial and syringe for Humalog U-100.

NEW TO TYPE 1
DIABETES?

Storage and disposal for vials

Icon: Refrigerator

Store all unopened (unused) vials in the original carton in a refrigerator. Do not freeze.

Icon: Refrigerator and vial

Unopened, refrigerated vials can be kept until expiration date.

Icon: Thermometer

After first use (opened), store vial in the refrigerator (not the freezer) or, if necessary, at room temperature below 86°F (30°C). Do not use if vial has been frozen.

Icon: 28 days calendar

Throw away open vials 28 days after first use, even if there is insulin left in the vial.

Icon: Toxic Garbage Can

Do not use after the expiration date printed on the carton and label.

Icon: Avoid Sunlight

Protect from direct heat and light.

Safely dispose of needles and syringes as directed by your doctor.

For full storage and disposal information, please see the Patient Information leaflet that comes with your insulin.

Disposal of needles and syringes

Icon: Toxic Garbage Can

Place all needles and syringes in a sharps disposal container immediately after they have been used.

  • Never place loose needles in any trash can or recycling bin and never flush them down the toilet
  • Carry a small, travel-size sharps disposal container when leaving home
Icon: Do not reuse sharps containers

Dispose of the sharps container according to community guidelines.

  • Do not reuse sharps containers

For information about disposal of syringes and needles, visit the US Food and Drug Administration website at fda.gov/safesharpsdisposal or call 1-888-INFO-FDA (1-888-463-6332).

Humalog Junior KwikPen and HumaPen® LUXURA® HD

Primarily for people with type 1 diabetes who need small, precise doses, Humalog Junior KwikPen and HumaPen LUXURA HD allow dosing in half-units starting at 0.5 units.

Humalog Junior KwikPen
Humalog Junior KwikPen logo
More information about Humalog Junior KwikPen
HumaPen LUXURA
More information about HumaPen LUXURA HD

Why use a pump?

For some people, an insulin pump can help improve diabetes management and make it more flexible. A pump may be a good option if any of these apply:

  • You regularly test your blood sugar
  • You are active and have an inconsistent meal and physical activity schedule
  • You have demonstrated the ability to manage your diabetes but don't want to draw attention to it
Image of external insulin pump

Have your healthcare team discuss the pros and cons of external insulin pumps with you. They can help you decide whether taking Humalog with an external insulin pump is right for you.

Select Safety Information

Failure of your insulin pump or infusion set or degradation of the insulin in the pump can cause hyperglycemia and ketoacidosis. Always carry an alternative form of insulin administration in case of pump failure.

When used in a pump, do not mix Humalog U-100 with any other insulin or liquid. Do not use Humalog Mix75/25, Humalog Mix50/50, or Humalog U-200 in a pump.

An insulin pump is another way to deliver Humalog U-100 to your body. The insulin pump stores Humalog inside it and has a small, bendable, plastic tube attached at one end. This tube goes into the skin through a small needle. Once the tube is set in place, the needle is removed. To deliver the amount of insulin needed, a button on the pump is pushed. The pump is small enough to be worn on a belt or kept in a pocket.

Frequently Asked Questions

How long does Humalog KwikPen last once I’ve begun using it?

You will need to discard your Humalog KwikPen after 28 days in use, even if insulin remains.

Will there be insulin left in my pen when it’s time to discard it?

KwikPen is designed to deliver a total of 300 units of insulin. The cartridge contains an additional small amount of insulin that cannot be delivered, so you will see a small amount of insulin left in your pen when it’s time to discard it. Remember: Never withdraw Humalog from the pen using a syringe. It could result in an overdose causing severe low blood sugar, which may put your life in danger.

Must I prime my pen before using it?

Yes, you need to prime your pen. If you do not prime, you may get too much or too little insulin. You will turn the dose knob to 2 units. Hold your pen with the needle pointing up. Tap the cartridge holder gently to collect air bubbles at the top. Continue holding your pen with the needle pointing up. Push the dose knob in until it stops and "0" is seen in the dose window. Hold the dose knob in and count to 5 slowly. You should see insulin at the tip of the needle.

Where do I inject U-100 insulin?

Rotate between typical injection sites, such as the abdomen, buttocks, upper legs, or upper arms. Never inject Humalog into a muscle or vein. View the demonstration video for more information.

What should I do if the dose knob is hard to push?

  • Pushing the dose knob more slowly will make it easier to inject
  • Your needle may be blocked. Put on a new needle and prime the pen
  • You may have dust, food, or liquid inside the pen. Throw the pen away and get a new pen

Do not withdraw insulin from the pen with a syringe. If the dose knob is still difficult to push, contact your pharmacy or The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979). View the demonstration video for more information.

What are the potential side effects for U-100?

Low blood sugar is the most common side effect. Other possible side effects include severe life-threatening allergic reactions and reactions at the injection site. Please see Important Safety Information for additional side effects. Ask your healthcare provider for more information or for medical advice.

What should I do if I am experiencing any side effects?

If you are experiencing any side effects, please contact your doctor. You may also report side effects to the Food and Drug Administration at 1-800-FDA-1088 or contact The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).

Why use a pump?

For some people, an insulin pump can help improve diabetes management and make it more flexible. A pump may be a good option if any of these apply:

  • You regularly test your blood sugar
  • You are active and have an inconsistent meal and physical activity schedule
  • You have demonstrated the ability to manage your diabetes but don't want to draw attention to it

Ask your doctor to discuss the pros and cons of external insulin pumps with you. He or she can help you decide whether taking Humalog with an external insulin pump is right for you.

What if I need additional help getting started with Humalog U-100?

Humalog offers a health mentor to help you get started on mealtime insulin therapy with your best foot forward. This phone-based support program provides eligible patients with live phone calls from a trained health mentor. Your health mentor can help you get started with Humalog, explain Humalog in more detail, and answer any questions you might have. To find out if you're eligible to speak with a health mentor, call (855) 232-1059.

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