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HUMALOG®
insulin lispro injection, USP (rDNA origin)

Read the “Patient Information” that comes with HUMALOG (HU-ma-log) before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your diabetes or treatment. If you have questions about HUMALOG or diabetes, talk with your healthcare provider.

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

• Do not change the insulin you use without talking to your healthcare provider. Anychange in insulin strength, manufacturer, type (regular, NPH, analog) may need a change in the dose you are using. This dose change may be needed right away or later on. Sometimes this dose change may happen during the first several weeks or months on the new insulin. Doses of oral anti-diabetic medicines may also need to change if your insulin is changed.
• You must test your blood sugar levels while using an insulin such as HUMALOG. Your healthcare provider will tell you how often you should test your blood sugar level, and what to do if it is high or low.
• When used in a pump do not mix HUMALOG with any other insulin or liquid.

What is HUMALOG?

HUMALOG insulin lispro injection, USP (rDNA origin) is an injectable rapid-acting man-made insulin. HUMALOG is used to treat people with diabetes for the control of high blood sugar.

• HUMALOG is a clear, colorless, sterile solution for injection under the skin (subcutaneously).
• You need a prescription to get HUMALOG. Always be sure you receive the right insulin from the pharmacy.

HUMALOG comes in:

• 10 mL vials (bottles) for use with a syringe or external insulin pump
• 3 mL prefilled pens
• 3 mL Humalog® KwikPen™
• 3 mL cartridges for use with a reusable pen or external insulin pump

Who should not take HUMALOG?

Do not take HUMALOG if:

• your blood sugar is too low (hypoglycemia). After treating your low blood sugar, follow your healthcare provider's instructions on the use of HUMALOG.
• you are allergic to insulin lispro or any of the ingredients in HUMALOG. See the end of this leaflet for a complete list of ingredients in HUMALOG. Check with your healthcare provider if you are not sure.

What should I tell my healthcare provider before taking HUMALOG?

Tell your healthcare provider:

• about all your medical conditions, including liver or kidney problems. Your dose may need to be adjusted.
• if you are pregnant or breastfeeding. You and your healthcare provider should talkabout the best way to manage your diabetes while you are pregnant or breastfeeding. HUMALOG has not been studied in pregnant or nursing women.
• about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Your HUMALOG dose may need to change if you take other medicines.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers when you get a new medicine.

How should I use HUMALOG?

HUMALOG can be used with a syringe, prefilled pen, reusable pen or external insulin pump. Talk to your healthcare provider if you have any questions.

• Read the instructions for use that comes with your HUMALOG product. Talk to your healthcare provider if you have any questions. Your healthcare provider should show you how to inject HUMALOG before you start taking it.
• HUMALOG is a rapid-acting insulin. You should take HUMALOG within fifteen minutes before eating or right after eating a meal.
• Only use HUMALOG that is clear and colorless. If your HUMALOG is cloudy, colored, or has solid particles or clumps in it, return it to your pharmacy for a replacement.
• Do not mix HUMALOG:
  • with any type of insulin other than NPH when used with injections by syringe.
  • with any other insulin or liquid when used in a pump.
• If your doctor recommends diluting HUMALOG, follow your doctor's instructions exactly so that you know:
  • How to make HUMALOG more dilute (that is, a smaller number of units of HUMALOG for a given amount of liquid) and
  • How to use this more dilute form of HUMALOG. Do not use dilute insulin in a pump.
• Inject HUMALOG under your skin (subcutaneously) in your upper arm, abdomen (stomach area), thigh (upper leg), or buttocks. Never inject it into a vein or muscle.
• Change (rotate) your injection site with each dose.
• If you have type 1 diabetes, you need to take a longer-acting insulin in addition to HUMALOG (except when using an external insulin pump).
• If you have type 2 diabetes, you may be taking oral anti-diabetic medicines and/or a longer-acting insulin in addition to HUMALOG.
• Follow the instructions given by your healthcare provider about the type or types ofinsulin you are using. Do not make any changes with your insulin unless you have talked to your healthcare provider. Always make sure that you received the correct type of HUMALOG from the pharmacy. Check to make sure you are injecting the correct insulin and dose, especially if you use other insulin with HUMALOG.
• If you take too much HUMALOG, your blood sugar may fall low (hypoglycemia).You can treat mild low blood sugar by drinking or eating something sugary right away (fruit juice, sugar candies, or glucose tablets). It is important to treat low blood sugar right away because it could get worse and you could pass out (become unconscious). If you pass out, you will need help from another person or emergency medical services right away, and will need treatment with glucagon injection or treatment at a hospital. See “What are the possible side effects of HUMALOG?” for more information on low blood sugar.
• If you forget to take your dose of HUMALOG, your blood sugar may go too high (hyperglycemia). If high blood sugar is not treated it can lead to serious problems like loss of consciousness (passing out), coma or even death. Follow your healthcare provider's instructions for treating high blood sugar. Know your symptoms of high blood sugar which may include:
  • increased thirst
  • frequent urination
  • drowsiness
  • loss of appetite
  • a hard time breathing
  • fruity smell on the breath
  • high amounts of sugar and ketones in your urine
  • nausea, vomiting (throwing up) or stomach pain
• Your insulin dosage may need to change because of:
  • illness
  • stress
  • other medicines you take
  • change in diet
  • change in physical activity or exercise

What are the possible side effects of HUMALOG?

• low blood sugar (hypoglycemia). Symptoms of low blood sugar may include:
  • sweating
  • dizziness or lightheadedness
  • shakiness
  • hunger
  • fast heart beat
  • tingling of lips and tongue
  • trouble concentrating or confusion
  • blurred vision
  • slurred speech
  • anxiety, irritability or mood changes
  • headache
• Severe low blood sugar can cause unconsciousness (passing out), seizures, and death. Low blood sugar may affect your ability to drive a car or use mechanical equipment, risking injury to yourself or others. Know your symptoms of low blood sugar. Follow your healthcare provider's instructions for treating low blood sugar. Talk to your healthcare provider if low blood sugar is a problem for you.
• Serious allergic reaction (whole body reaction). Get medical help right away, if you develop a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating.
• Reactions at the injection site (local allergic reaction). You may get redness, swelling, and itching at the injection site. If you keep having skin reactions or they are serious, talk to your healthcare provider. You may need to stop using HUMALOG and use a different insulin. Do not inject insulin to skin that is red, swollen or itchy.
• Skin thickens or pits at the injection site (lipodystrophy). Change (rotate) when youinject your insulin to help to prevent these skin changes from happening. Do not inject insulin into this type of skin.
• Swelling of your hands and feet
• Low potassium in your blood (hypokalemia)
• Weight gain

These are not all of the possible side effects from HUMALOG. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

How should I store HUMALOG?

• Store all unopened (unused) HUMALOG in the original carton in a refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze. Do not use HUMALOG if it has been frozen.
• Keep unopened HUMALOG in the carton to protect from light.

After starting use (open)

Vials:

• Keep in the refrigerator or at room temperature below 86°F (30°C) for up to 28 days.
• Keep vials away from direct heat or light.
• Throw away an opened vial after 28 days or use, even if there is insulin left in the vial.
• Unopened vials can be used until the expiration date on the HUMALOG carton and label, if the medicine has been stored in a refrigerator.

Cartridge and Prefilled Pens:

• Keep at room temperature below 86°F (30°C) for up to 28 days.
• Do not store a cartridge or prefilled pen that you are using in the refrigerator.
• Keep cartridges and prefilled pens away from direct heat or light.
• A cartridge used in the D-Tron or D-Tronplus pump may be used for up to 7 days.
• Throw away a used cartridge or prefilled pen after 28 days, even if there is insulin left in the cartridge or syringe.

General Information about HUMALOG

• HUMALOG in the pump reservoir and the complete external pump infusion set:
  • When HUMALOG is used in pumps, use only pumps that are recommended by your healthcare provider.
  • The infusion set and infusion site should be changed at least every 3 days.
  • The insulin in the reservoir should be changed at least every 7 days even if you havenot used all of the insulin.
  • Change the infusion set and infusion site more often than every 3 days if you have high blood sugar (hyperglycemia), the pump alarms sounds, or the insulin flow is blocked (occlusion).
• Do not use HUMALOG for a condition for which it was not prescribed. Do not give orshare HUMALOG with another person, even if they also have diabetes. It may harmthem.
• This leaflet summarizes the most important information about HUMALOG. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information about HUMALOG that is written for healthcare providers. For more information about HUMALOG, call 1-800-LillyRx (1-800-545-5979) or visit www. humalog.com.

What are the ingredients in HUMALOG?

insulin lispro, glycerin, dibasic sodium phosphate, metacresol, zinc oxide (zinc ion), trace amounts of phenol and water for injection.

Helpful information for people with diabetes is published by the American Diabetes Association,1660 Duke Street, Alexandria, VA 22314 and on www.diabetes.org.

Last reviewed on RxList: 6/3/2011
This monograph has been modified to include the generic and brand name in many instances.