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HUMALOG^®
INSULIN LISPRO INJECTION, USP
(rDNA ORIGIN)
100 UNITS PER ML (U-100)

DESCRIPTION

Humalog^® [insulin lispro injection, USP (rDNA origin)] is a human insulin analog that is a rapid–acting, parenteral blood glucose–lowering agent. Chemically, it is Lys(B28), Pro(B29) human insulin analog, created when the amino acids at positions 28 and 29 on the insulin B–chain are reversed. Humalog is synthesized in a special non–pathogenic laboratory strain of Escherichia coli bacteria that has been genetically altered to produce insulin lispro.

Humalog has the following primary structure:

Insulin lispro has the empirical formula C₂₅₇H₃₈₃N₆₅O₇₇S₆ and a molecular weight of 5808, both identical to that of human insulin.

The vials, cartridges, and Pens contain a sterile solution of Humalog for use as an injection. Humalog injection consists of zinc–insulin lispro crystals dissolved in a clear aqueous fluid.

Each milliliter of Humalog injection contains insulin lispro 100 units, 16 mg glycerin, 1.88 mg dibasic sodium phosphate, 3.15 mg Metacresol, zinc oxide span adjusted to provide 0.0197 mg zinc ion, trace amounts of phenol, and Water for Injection. Insulin lispro has a pH of 7.0 to 7.8. Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH.

CLINICAL PHARMACOLOGY

Antidiabetic Activity

The primary activity of insulin, including Humalog, is the regulation of glucose metabolism. In addition, all insulins have several anabolic and anti–catabolic actions on many tissues in the body. In muscle and other tissues (except the brain), insulin causes rapid transport of glucose and amino acids intracellularly, promotes anabolism, and inhibits protein catabolism. In the liver, insulin promotes the uptake and storage of glucose in the form of glycogen, inhibits gluconeogenesis, and promotes the conversion of excess glucose into fat.

Humalog has been shown to be equipotent to human insulin on a molar basis. One unit of Humalog has the same glucose–lowering effect as one unit of Regular human insulin, but its effect is more rapid and of shorter duration. The glucose–lowering activity of Humalog and Regular human insulin is comparable when administered to nondiabetic subjects by the intravenous route.

Pharmacokinetics

Pharmacodynamics

Studies in nondiabetic subjects and patients with diabetes demonstrated that Humalog has a more rapid onset of glucose–lowering activity, an earlier peak for glucose–lowering, and a shorter duration of glucose–lowering activity than Regular human insulin (see Figure 2). The earlier onset of activity of Humalog is directly related to its more rapid rate of absorption. The time course of action of insulin and insulin analogs, such as Humalog, may vary considerably in different individuals or within the same individual. The parameters of Humalog activity (time of onset, peak time, and duration) as presented in Figure 2 should be considered only as general guidelines. The rate of insulin absorption and consequently the onset of activity is known to be affected by the site of injection, exercise, and other variables (see General under PRECAUTIONS).

Figure 2: Blood Glucose Levels After Subcutaneous Injection of Regular Human Insulin or Humalog (0.2 U/kg) Immediately Before a High Carbohydrate Meal in 10 Patients with Type 1 Diabetes.Baseline insulin concentration was maintained by infusion of 0.2 mU/min/kg human insulin.

Special Populations

CLINICAL STUDIES

INDICATIONS AND USAGE

Humalog is an insulin analog that is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Humalog has a more rapid onset and a shorter duration of action than Regular human insulin. Therefore, in patients with type 1 diabetes, Humalog should be used in regimens that include a longer–acting insulin. However, in patients with type 2 diabetes, Humalog may be used without a longer–acting insulin when used in combination therapy with sulfonylurea agents.

Humalog may be used in an external insulin pump, but should not be diluted or mixed with any other insulin when used in the pump.

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

General

Information for Patients

Laboratory Tests

Drug Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Nursing Mothers

It is unknown whether Humalog is excreted in significant amounts in human milk. Many drugs, including human insulin, are excreted in human milk. For this reason, caution should be exercised when Humalog is administered to a nursing woman. Patients with diabetes who are lactating may require adjustments in Humalog dose, meal plan, or both.

Pediatric Use

In a 9–month, cross–over study of pre–pubescent children (n=60), aged 3 to 11 years, comparable glycemic control as measured by HbA_1c was achieved regardless of treatment group: Regular human insulin 30 minutes before meals 8.4%, Humalog immediately before meals 8.4%, and Humalog immediately after meals 8.5%. In an 8–month, cross–over study of adolescents (n=463), aged 9 to 19 years, comparable glycemic control as measured by HbA_1c was achieved regardless of treatment group: Regular human insulin 30 to 45 minutes before meals 8.7% and Humalog immediately before meals 8.7%. The incidence of hypoglycemia was similar for all three treatment regimens. Adjustment of basal insulin may be required. To improve accuracy in dosing in pediatric patients, a diluent may be used. If the diluent is added directly to the Humalog vial, the shelf–life may be reduced (see DOSAGE AND ADMINISTRATION).

Geriatric Use

Of the total number of subjects (n=2834) in eight clinical studies of Humalog, twelve percent (n=338) were 65 years of age or over. The majority of these were patients with type 2 diabetes. HbA_1c values and hypoglycemia rates did not differ by age. Pharmacokinetic/pharmacodynamic studies to assess the effect of age on the onset of Humalog action have not been performed.

ADVERSE REACTIONS

Clinical studies comparing Humalog with Regular human insulin did not demonstrate a difference in frequency of adverse events between the two treatments.

Adverse events commonly associated with human insulin therapy include the following:

Body as a Whole — allergic reactions (see PRECAUTIONS).

Skin and Appendages — injection site reaction, lipodystrophy, pruritus, rash.

Other — hypoglycemia (see WARNINGS and PRECAUTIONS).

OVERDOSAGE

Hypoglycemia may occur as a result of an excess of insulin relative to food intake, energy expenditure, or both. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise, may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery.

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

Literature issued September 6, 2007

KwikPens manufactured by
Eli Lilly and Company, Indianapolis, IN 46285, USA
Pens manufactured by
Eli Lilly and Company, Indianapolis, IN 46285, USA or
Lilly France, F-67640 Fegersheim, France
Vials manufactured by
Eli Lilly and Company, Indianapolis, IN 46285, USA or
Hospira, Inc., Lake Forest, IL 60045, USA or
Lilly France, F-67640 Fegersheim, France
Cartridges manufactured by
Lilly France, F-67640 Fegersheim, France

for Eli Lilly and Company, Indianapolis, IN 46285, USA

www.humalog.com

Supplement Patient Material Section

Patient Information
Humalog^® (HU-ma-log)
insulin lispro injection, USP (rDNA origin)

Important:

Know your insulin. Do not change the type of insulin you use unless told to do so by your healthcare provider. Your insulin dose and the time you take your dose can change with different types of insulin.

Make sure you have the right type and strength of insulin prescribed for you.

Read the Patient Information that comes with Humalog 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. Make sure that you know how to manage your diabetes. Ask your healthcare provider if you have questions about managing your diabetes.

What is Humalog?

Humalog is an injectable fast-acting man-made insulin. Humalog is used to control high blood sugar (glucose) in people with diabetes.

Humalog comes in:

10 mL vials (bottles) for use with a syringe or external insulin pump
Prefilled pens
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 anything in Humalog. See the end of this leaflet for a complete ul of ingredients in Humalog.

Tell your healthcare provider:

about all your medical conditions. Medical conditions can affect your insulin needs and your dose of Humalog.
if you are pregnant or breastfeeding. You and your healthcare provider should talk about 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. Many medicines can affect your blood sugar levels and insulin needs. Your Humalog dose may need to change if you take other medicines.

Know the medicines you take. Keep a ul of your medicines with you to show to all of your healthcare providers.

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. Your healthcare provider will tell you the right syringes to use with Humalog vials. Your healthcare provider should show you how to inject Humalog before you start using it.

Read the User Manual that comes with your Humalog prefilled pen and the manufacturer's instructions that comes with your external insulin pump. Use Humalog exactly as prescribed by your healthcare provider.
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 diabetes pills and/or a longer-acting insulin in addition to Humalog.
Humalog starts working faster than other insulins that contain regular human insulin. Inject Humalog within fifteen minutes before eating or right after eating a meal.
Check your blood sugar levels as told by your healthcare provider.
Look at your Humalog before using. Humalog should be clear, have no color and look like water. If your Humalog is cloudy, thickened, even slightly colored, or has solid particles or clumps in it, do not use. Return it to your pharmacy for new Humalog.
Humalog can be mixed with a longer-acting human insulin, but only if you are told to do so by your healthcare provider. If you are mixing two types of insulin, always draw Humalog into the syringe first. Talk with your healthcare provider about how to properly mix Humalog with a different insulin.
Humalog can be used in an external insulin pump either by withdrawing Humalog from a vial or using a 3 mL Humalog cartridge that is inserted into the pump.
Humalog was tested with MiniMed®¹ Models 506, 507, and 508 insulin pumps using MiniMed Polyfin®¹ infusion sets. Humalog was also tested with the Disetronic®² H-TRONplus®² V100 insulin pump (with plastic 3.15 mL insulin reservoir), using the Disetronic Rapid®² infusion set.
A Humalog cartridge used in the D-TRON² or D-TRONplus² pump, may be used for up to 7 days. Humalog in the external insulin pump reservoir and the complete infusion set should be replaced and a new infusion site selected every 48 hours or less.
Humalog in an external insulin pump should not be exposed to temperature above 98.6°F (37°C), such as in a sauna or hot tub, hot showers, direct sunlight, or radiant heaters.
Inject your dose of Humalog under the skin of your stomach area, upper arm, upper leg, or buttocks. Never inject Humalog into a muscle or vein.
Change (rotate) your injection site with each dose.
Your insulin needs may change because of:
- illness
- stress
- other medicines you take
- changes in eating
- physical activity changes
Follow your healthcare provider's instructions to make changes in your insulin dose.

Never dilute or mix Humalog with another insulin in the same prefilled pen, cartridge or external insulin pump.
Always carry a quick source of sugar to treat low blood sugar, such as glucose tablets, hard candy, or juice.

What are the possible side effects of Humalog?

Low Blood Sugar (Hypoglycemia). Symptoms of low blood sugar include:

hunger
dizziness
feeling shaky or shakiness
lightheadedness
sweating
irritability
headache
fast heartbeat
confusion

Low blood sugar symptoms can happen suddenly. Symptoms of low blood sugar may be different for each person and may change from time to time. Severe low blood sugar can cause 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. Low blood sugar can be treated by drinking juice or regular soda or eating glucose tablets, sugar, or hard candy. 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 reactions (whole body allergic reaction). Severe, life-threatening allergic reactions can happen with insulin. Get medical help right away if you develop a rash over your whole body, have trouble breathing, wheezing, 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 injection site reactions or they are serious, you need to call your healthcare provider. Do not inject insulin into a skin area that is red, swollen, or itchy.
Skin thickens or pits at the injection site (lipodystrophy). This can happen if you don't change (rotate) your injection sites enough.

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

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 that has been frozen.
Do not use after the expiration date printed on the carton and label.
Protect Humalog from extreme heat, cold or 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 open vials away from direct heat or light. Throw away an opened vial 28 days after first use, even if there is insulin left in the vial.
Cartridge and Prefilled Pens: Do not store a cartridge or prefilled pen that you are using in the refrigerator. Keep at room temperature below 86°F (30°C) for up to 28 days. Throw away a cartridge or prefilled pen 28 days after first use, even if there is insulin left in the cartridge or the pen.

General information about Humalog

Use Humalog only to treat your diabetes. Do not share it with anyone else, even if they also have diabetes. It may harm them.

This leaflet summarized the most important information about Humalog. If you would like more information about Humalog or diabetes, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Humalog that is written for health professionals.

For questions you may call 1–800–LillyRx (1–800–545–5979) or visit www.humalog.com.

What are the ingredients in Humalog?

Active ingredient: insulin lispro.

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

__________

¹ MiniMed® and Polyfin® are registered trademarks of MiniMed, Inc.

² Disetronic®, H-TRONplus®, D-TRON®, D-TRONplus and Rapid® are registered trademarks of Roche Diagnostics GMBH.

Patient Information issued September 6, 2007