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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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Your
Blood
Sugar

What to expect

Everyone’s experience with mealtime insulin is different, but there are some things you can look out for.

Dose changes

Your Humalog dose will probably change over time. Your doctor gave you a starting dose, but most people need to increase their Humalog dose over time.

Blood sugar variations

When you track your blood sugar every day, you will probably see different numbers all the time. These variations in your blood sugar from day to day are normal.

Changes are normal

Your blood sugar varies based on stress, what you eat, other medications, exercise, and other factors. Don't be discouraged by changes in your blood sugar. With your doctor’s input, these variations may provide learning opportunities.

Testing your blood sugar

When using mealtime insulin like Humalog, you must test your blood sugar (glucose) regularly. For example, you may need to test before and after meals and at bedtime. Your doctor will tell you when and how often you should test.

Why keep track?

Keeping track of your blood sugar levels will help you and your doctor:

  • Know if you’re meeting your blood sugar goals
  • Learn how different foods affect your blood sugar levels
  • Figure out how much insulin you should be taking

Your doctor will tell you what to do if your blood sugar is high or low. If you take too much Humalog, your blood sugar may fall too low (hypoglycemia). If you forget to take your dose of Humalog, your blood sugar may go too high (hyperglycemia).

Your blood sugar goals

The American Diabetes Association recommends blood sugar goals for people with diabetes. These don’t apply to everyone, however, so work with your doctor to set the right goals for you.

Before meals (Blood sugar self-check)

80-130 mg/dL

1-2 hours after starting your meal (Blood sugar self-check)

Less than 180 mg/dL

A1C (Tested by your doctor)

Less than 7%

These goals are not applicable to pregnant women or children. These goals should be individualized.

About high blood sugar

One of the goals of your diabetes treatment is to keep blood sugar levels within the target range determined by your doctor. When your blood sugar level is above the target range, this is called high blood sugar (hyperglycemia).

Possible causes of high blood sugar

RX BOTTLE

Not taking diabetes medication, or taking too little, or timing it wrong

APPLE AND BURGER

Eating too much or not eating the appropriate balance of food

THERMOMETER

Illness or infection

SAD FACE

Trauma/stress—physical and/or emotional

What to do if you have high blood sugar

GLUCOSE METER

Adjust your insulin dose to bring the blood sugar levels back into your recommended range*

WATER BOTTLE

Drink extra water

PH TEST STRIP

Check for ketones in a blood or urine sample if your blood sugar levels are above 250 mg/dL

These are guidelines only. Please discuss specific high blood sugar recommendations with your healthcare team.

*Your recommended range as directed by your healthcare team.

†Your healthcare team can provide more details on how to check for ketones.

How you might feel

Hungry

Hungry

Tired

Tired

Frequent Urination

Frequent
Urination

Thirsty

Thirsty

Blurred Vision

Blurred Vision

High blood sugar can include any combination of these symptoms and/or others not listed.

About low blood sugar

Low blood sugar, also called hypoglycemia (70 mg/dL or below), is the most common side effect associated with insulins, including Humalog. It can be caused by:

  • Being more physically active than usual
  • Taking too much diabetes medication
  • Eating at the wrong time for the medication you take
  • Taking other medication in addition to Humalog
  • Skipping or not finishing meals or snacks

Low blood sugar can also be caused by a combination of these or other factors.

What does low blood sugar feel like?

Hungry

Hungry

Tired

Tired

Shaky

Shaky

Sweaty

Sweaty

Irritable

Irritable

Headachy

Headachy

Low blood sugar can include one or any combination of these symptoms—and they might not be the same every time, depending on how low your blood sugar gets and which factors caused it to drop. You may even have no symptoms—that’s why it’s important to test your blood sugar regularly.

Over time, you may learn to recognize the symptoms of low blood sugar and its effects on the body.

Managing low blood sugar

Low blood sugar is very serious, but it usually can be managed. Here are the American Diabetes Association recommendations for what to do immediately if you think you have low blood sugar:

  • Check your blood sugar level. Remember, below 70 mg/dL is usually too low.
  • If your blood sugar is too low, eat something with sugar right away (see below).
  • After 15 minutes, check your blood sugar level again.
  • Repeat treatment if necessary. If your blood sugar is still low after another 15 minutes, call your emergency service (911) or your doctor.

After you have treated your low blood sugar, be sure to eat regular meals and snacks.

How to quickly raise your blood sugar

Three good options for quickly raising low blood sugar levels include:

LINE DRAWING OF TABLET

4-5 glucose tablets

LINE DRAWING OF JELLYBEANS

15 small, sugary, chewable candies (such as jelly beans)

LINE DRAWING OF JUICE BOX

½ cup of fruit juice

Stick to these or similar options. A chocolate bar, for example, has fats and protein that prevent the sugar from being absorbed quickly.

These are guidelines only. These are examples of items that contain 15 grams of carbohydrates. Check food product labels to ensure that you are getting the right amount of carbohydrates. Please discuss recommendations specific to your low blood sugar with your doctor or nurse.

Low blood sugar (hypoglycemia) is the most common side effect of Humalog that may be severe and cause unconsciousness (passing out), seizures, and death. Test your blood sugar levels as your doctor instructs.

Remember that if low blood sugar is not treated quickly, it can become severe. And severe low blood sugar is very serious.

PHOTO OF CLOSED GLUCAGON KIT

Glucagon is a treatment for insulin coma or insulin reaction resulting from severe low blood sugar.

Treating severe low blood sugar with Glucagon

You’ll want to be ready in case you or someone close to you ever experiences severe low blood sugar. If it happens, loss of consciousness may occur. When a person’s blood sugar falls this low, they may be physically unable to eat or drink a fast-acting source of sugar (glucose). They may need a Glucagon shot—and since they’ll be unable to administer it themselves, you, a family member, or another adult will need to be ready to give it to them.

Glucagon is a medicine that’s different from insulin. It works by telling the body to release sugar (glucose) into the bloodstream to bring the blood sugar level back up. The possibility of severe low blood sugar and of giving a Glucagon injection can be scary. But it’s very important that you understand how to recognize symptoms of severe low blood sugar and that you, a family member, or another adult are ready to give a Glucagon injection if you have to.

Remember to call 911 immediately after giving a Glucagon injection and to notify your doctor that an episode of severe low blood sugar (hypoglycemia) has occurred.

For complete instructions on how to administer Glucagon, please click to access full Information for the User.

PHOTO OF OPEN GLUCAGON KIT

Be better prepared to treat severe low blood sugar with a Lilly Glucagon Emergency Kit.

Glucagon is a treatment for insulin coma or insulin reaction resulting from severe low blood sugar.

Important Safety Information for Glucagon

What is the most important information I should know about Glucagon?

  • Glucagon should not be used if you have pheochromocytoma or if you are allergic to Glucagon.
  • Make sure you tell your healthcare provider if you have been diagnosed with or have been suspected of having an insulinoma as Glucagon should be used cautiously in this situation.
  • You and anyone who may need to help you during an emergency should become familiar with how to use Glucagon before an emergency arises. Read the Information for the User provided in the kit.
  • Make sure that your relatives or close friends know that if you become unconscious, medical assistance must always be sought. If you are unconscious, Glucagon can be given while awaiting medical assistance.
  • Do not use the kit after the date stamped on the bottle label.
  • If you have questions concerning the use of this product, consult a doctor, nurse or pharmacist.

WARNING: YOU MAY BE IN A COMA FROM SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) RATHER THAN HYPOGLYCEMIA. IN SUCH A CASE, YOU WILL NOT RESPOND TO GLUCAGON AND REQUIRE IMMEDIATE MEDICAL ATTENTION.

Who should not use Glucagon?
Glucagon should not be used if you have pheochromocytoma or if you are allergic to Glucagon.

What should I tell my doctor before taking Glucagon?
Tell your doctor about all of your medical conditions and prescription and over-the-counter drugs. Tell your doctor if you have been diagnosed with or have been suspected of having pheochromocytoma or an insulinoma.

How should I use Glucagon?

  • Act quickly. Prolonged unconsciousness may be harmful.
  • Make sure your family and friends know to turn you on your side to prevent choking if you are unconscious.
  • The contents of the syringe are inactive and must be mixed with the Glucagon in the accompanying bottle immediately before giving injection. Do not prepare Glucagon for Injection until you are ready to use it.
  • Glucagon should not be used unless the solution is clear and of a water-like consistency.
  • The usual adult dose is 1 mg (1 unit). For children weighing less than 44 lbs (20 kg), give ½ adult dose (0.5 mg). For children, withdraw ½ of the solution from the bottle (0.5 mg mark on syringe). Discard unused portion.
  • You should eat as soon as you awaken and are able to swallow. Inform a doctor or emergency services immediately.

What is some important Information I should know about Low Blood Sugar (Hypoglycemia)?

  • Early symptoms of low blood sugar include: sweating, drowsiness, dizziness, sleep disturbances, palpitation, anxiety, tremor, blurred vision, hunger, slurred speech, restlessness, depressed mood, tingling in the hands, feet, lips, or tongue, irritability, lightheadedness, abnormal behavior, inability to concentrate, unsteady movement, headache, and personality changes. These symptoms may be different for each person and can happen suddenly.
  • If your low blood sugar is not treated, you may progress to severe low blood sugar that can include: disorientation, seizures, unconsciousness, and death.
  • Low blood sugar symptoms should be treated with a quick source of sugar which should always be carried with you. If you do not improve or you are unable to take a quick source of sugar, you should be treated with Glucagon or with intravenous glucose at a medical facility.

What are the possible side effects of Glucagon?

  • Severe side effects are very rare, although nausea and vomiting may occur occasionally.
  • A few people may be allergic to Glucagon or to one of the inactive ingredients in Glucagon, or may experience rapid heart beat for a short while.
  • If you experience any other reactions which are likely to have been caused by Glucagon, please contact your doctor.

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.

How should I store Glucagon?

  • Before dissolving Glucagon with diluting solution, store the kit at controlled room temperature between 20° to 25°C (68° to 77°F).
  • After dissolving Glucagon with diluting solution, use immediately. Discard any unused portion. Glucagon should be clear and of a water-like consistency at time of use.

Glucagon is available by prescription only.

For more safety information, please see Information for the User and
Information for the Physician.

HI GLUC CON ISI 09OCT2014

The Lilly Answers Center

Talk with your doctor or call if you have questions. We’re here to help.
To chat, click the “Ask Lilly” box in the upper right corner. Or call 1-800-LillyRx (1-800-545-5979), Monday through Friday from 9 AM to 8 PM ET.

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