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Humalog®

Generic name: insulin lispro [ IN-soo-lin-LISS-pro ]
Drug class: Insulin

What is Humalog?

Humalog is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood.

Humalog is used to improve blood sugar control in adults and children with diabetes mellitus.

Humalog is used to treat type 2 diabetes in adults.

Humalog is also used to treat type 1 diabetes in adults and children who are at least 3 years old.

Dosage Forms And Strengths

Injection: 100 units/mL (U-100) clear and colorless solution available as:

10 mL multiple-dose vial

3 mL multiple-dose vial

3 mL single-patient-use KwikPen prefilled pen

3 mL single-patient-use Tempo Pen prefilled pen

3 mL single-patient-use Junior KwikPen prefilled pen

3 mL single-patient-use cartridges

Injection: 200 units/mL (U-200) clear and colorless solution available as:

3 mL single-patient-use KwikPen prefilled pen

3 mL single-patient-use Tempo Pen prefilled pen

How Supplied

HUMALOG (insulin lispro) injection is a clear and colorless solution available as:

HUMALOG	Total Volume	Concentration	Package Size
U-100 multiple-dose vial	10 mL	100 units/mL	1 vial
U-100 multiple-dose vial	3 mL	100 units/mL	1 vial
U-100 multiple-dose vial	3 mL	100 units/mL	1 vial
U-100 single-patient-use cartridge	3 mL	100 units/mL	5 cartridges
U-100 single-patient-use KwikPen	3 mL	100 units/mL	5 pens
U-100 single-patient-use Tempo Pen	3 mL	100 units/mL	5 pens
U-100 single-patient-use Junior KwikPen	3 mL	100 units/mL	5 pens
U-200 single-patient-use KwikPen	3 mL	200 units/mL	2 pens
U-200 single-patient-use Tempo Pen	3 mL	200 units/mL	2 pens

A Tempo Pen contains a component that allows for data connectivity when used with a compatible transmitter.
The U-100 KwikPen, U-100 Tempo Pen, U-200 KwikPen, and U-200 Tempo Pen dial in 1-unit increments. The U-100 Junior KwikPen dials in 0.5-unit increments.

Each prefilled pen, cartridge, and reusable pen compatible with Lilly 3 mL cartridges is for single-patient-use only. HUMALOG prefilled pens, 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 vials must never share needles or syringes with another person.

Warnings

Humalog is a fast-acting insulin that begins to work very quickly. If you use this medication with meal, use it within 15 minutes before or just after you eat.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed.

You should not use Humalog if you are having an episode of hypoglycemia (low blood sugar).

Humalog is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Humalog side effects

Get emergency medical help if you have signs of insulin allergy to Humalog: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.
Call your doctor at once if you have:

weight gain, swelling in your hands or feet, feeling short of breath;

low blood sugar - headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or

low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Humalog side effects may include:

low blood sugar;

weight gain;

swelling in your hands or feet;

itching; or

thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking this medicine

You should not use Humalog if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Humalog should not be given to a child younger than 3 years old. Humalog should not be used to treat type 2 diabetes in a child of any age.

To make sure Humalog is safe for you, tell your doctor if you have ever had:

liver or kidney disease;

heart problems; or

low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using Humalog if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use Humalog?

Use Humalog exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Humalog is injected under the skin using a syringe and needle, an injection pen, or with an infusion pump. A healthcare provider will teach you how to properly use this medicine by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors or has particles in it. Call your pharmacist for new medicine.

Humalog is to be used within 15 minutes before a meal, or right after eating.

Your healthcare provider will show you where on your body to inject insulin lispro. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Do not inject into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Concentrated Humalog (200 units) must not be given with an insulin pump, or mixed with other insulins. Do not transfer insulin lispro from an injection pen to a syringe or a severe overdose could occur.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Keep this medicine in its original container protected from heat and light. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) insulin lispro:

Refrigerate and use until expiration date; or

Store at room temperature and use within 28 days.

Storing opened (in use) Humalog:

Store the vial in a refrigerator or at room temperature and use within 28 days.

Store the cartridge or injection pen (without a needle attached) at room temperature and use within 28 days.

Use a needle and syringe only once and place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Since Humalog is used before meals, you may not be on a timed dosing schedule. Whenever you use Humalog, be sure to eat a meal within 15 minutes. Do not use two doses at one time.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

Storage & Handling

Dispense in the original sealed carton with the enclosed Instructions for Use.

Protect from direct heat and light. Do not freeze and do not use if it has been frozen.

	Not In-Use (Unopened) Room Temperature (Up to 86°F [30°C])	Not In-Use (Unopened) Refrigerated (36° to 46°F [2° to 8°C])	In-Use (Opened) (see temperature below)
HUMALOG U-100*
10 mL multiple-dose vial	28 days	Until expiration date	28 days Refrigerated or room temperature.
3 mL multiple-dose vial	28 days	Until expiration date	28 days Refrigerated or room temperature.
3 mL single-patient-use cartridge	28 days	Until expiration date	28 days Room temperature only (Do not refrigerate)
3 mL single-patient-use Humalog KwikPen	28 days	Until expiration date	28 days Room temperature only (Do not refrigerate)
3 mL single-patient-use Humalog Tempo Pen	28 days	Until expiration date	28 days Room temperature only (Do not refrigerate)
3 mL single-patient-use Humalog Junior KwikPen	28 days	Until expiration date	28 days Room temperature only (Do not refrigerate)
HUMALOG U-200*
3 mL single-patient-use Humalog KwikPen	28 days	Until expiration date	28 days Room temperature only (Do not refrigerate)
3 mL single-patient-use Humalog Tempo Pen	28 days	Until expiration date	28 days Room temperature only (Do not refrigerate)

* When stored at room temperature, HUMALOG U-100 and U-200 can only be used for a total of 28 days, including both not in-use (unopened) and in-use (opened) storage time.

What should I avoid while using Humalog?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

What other drugs will affect Humalog?

Drugs That May Increase the Risk of Hypoglycemia
Drugs:	Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics.
Intervention:	Dose adjustment and increased frequency of glucose monitoring may be required when HUMALOG is co-administered with these drugs.
Drugs That May Decrease the Blood Glucose Lowering Effect of HUMALOG
Drugs:	Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.
Intervention:	Dose adjustment and increased frequency of glucose monitoring may be required when HUMALOG is co-administered with these drugs.
Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of HUMALOG
Drugs:	Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
Intervention:	Dose adjustment and increased frequency of glucose monitoring may be required when HUMALOG is co-administered with these drugs.
Drugs That May Blunt Signs and Symptoms of Hypoglycemia
Drugs:	Beta-blockers, clonidine, guanethidine and reserpine.
Intervention:	Increased frequency of glucose monitoring may be required when HUMALOG is co-administered with these drugs.

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Most recent revision June 30, 2025 08:08:46 PM

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