Humulin R U-500

What is Humulin R U-500?

Humulin R U-500 is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus who need more than 200 units of insulin in a day.

Humulin R U-500 contains 5 times as much insulin (500 units/mL) in 1 mL as standard insulin (100 units/mL).

It is not known if Humulin R U-500 is safe and effective when used in combination with other insulins.

It is not known if Humulin R U-500 is safe and effective when given by continuous subcutaneous infusion.

It is not known if Humulin R U-500 is safe and effective in children.

Description

HUMULIN R U-500 (insulin human injection) is a human insulin solution used to lower blood glucose. Human insulin is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. HUMULIN R has the empirical formula C257H383N65O77S6 with a molecular weight of 5808.

HUMULIN R U-500 is a sterile, aqueous, and colorless solution. HUMULIN R U-500 contains 500 units of insulin in each milliliter. Each milliliter of HUMULIN R U-500 also contains glycerin 16 mg, metacresol 2.5 mg, zinc oxide to supplement the endogenous zinc to obtain a total zinc content of 0.017 mg/100 units, and Water for Injection. Sodium hydroxide and hydrochloric acid may be added during manufacture to adjust the pH.

Mechanism of Action

Regulation of glucose metabolism is the primary activity of insulins, including HUMULIN R U-500. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.

What is the most important information I should know about Humulin R U-500?

Do not share your Humulin R U-500 KwikPen or U-500 insulin 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.

Who should not use Humulin R U-500?

Do not take Humulin R U-500 if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to human insulin or any of the ingredients in Humulin R U-500. See the end of this Patient Information guide for a complete list of ingredients in Humulin R U-500.

What should I tell my healthcare provider before using Humulin R U-500?

Before using Humulin R U-500, tell your healthcare provider about all your medical conditions including, if you:

• have liver or kidney problems.
• take other medicines, especially ones called TZDs (thiazolidinediones).
• have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Humulin R U-500.
• are pregnant, planning to become pregnant. Talk with your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
• are breast-feeding or plan to breastfeed. Humulin R U-500 may pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby while using Humulin R U-500.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.
Before you start using Humulin R U-500, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use Humulin R U-500?

• Read the detailed Instructions for Use that come with your Humulin R U-500.
• Use Humulin R U-500 exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Humulin R U-500 to use and when to use it.
• Know the dose of Humulin R U-500 you use. Do not change the dose of Humulin R U-500 you use unless your healthcare provider tells you to.
• Check your insulin label each time you give your injection to make sure you are using the correct insulin.
• When using the Humulin R U-500 KwikPen: The Humulin R U-500 KwikPen is specially made to dial and deliver doses of Humulin R U-500 insulin. Do not use any syringe to remove Humulin R U-500 from your Humulin R U-500 KwikPen. The markings on certain syringes will not measure your dose correctly. A severe overdose can happen, causing low blood sugar, which may put your life in danger.
• When using the Humulin R U-500 vial: There is a special U-500 insulin syringe to measure Humulin R U-500. Use only a U-500 insulin syringe to draw up and inject your Humulin R U-500. If you do not use the right syringe type, you may take the wrong dose of Humulin R U-500. This can cause you to have too low blood sugar (hypoglycemia) or too high blood sugar (hyperglycemia). Your healthcare provider should show you how to draw up Humulin R U-500.
• Use Humulin R U-500 30 minutes before eating a meal.
• Inject Humulin R U-500 under the skin (subcutaneously) of your upper legs (thighs), upper arms, buttocks or stomach area (abdomen). Do not use Humulin R U-500 in an insulin pump or inject Humulin R U-500 into your vein (intravenously) or your muscle (intramuscularly).
• Do not mix Humulin R U-500 in the KwikPen or vial with any other type of insulin or liquid medicine.
• Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
  • Do not use the exact same spot for each injection.
  • Do not inject where the skin has pits, is thickened, or has lumps.
  • Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.

Keep Humulin R U-500 and all medicines out of reach of children.

Your dose of Humulin R U-500 may need to change because of:

• change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, because of other medicines you take.

What should I avoid while taking Humulin R U-500?

While using Humulin R U-500 do not:

• drive or operate heavy machinery, until you know how Humulin R U-500 affects you.
• drink alcohol or use over-the-counter medicines that contain alcohol.

What are the possible side effects of Humulin R U-500?

Humulin R U-500 may cause serious side effects that can lead to death, including:

• low blood sugar (hypoglycemia). Signs and symptoms of low blood sugar may include:
  • dizziness or lightheadedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood changes, hunger.
  • your healthcare provider may prescribe a glucagon emergency kit so that others can give you an injection if your blood sugar becomes too low (hypoglycemic) and you are unable to take sugar by mouth.
• severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction:
  • a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating.
• low potassium in your blood (hypokalemia).
• heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Humulin R U-500 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take TZDs with Humulin R U-500. Your healthcare provider should monitor you closely while you are taking TZDs with Humulin R U-500. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
  • shortness of breath, swelling of your ankles or feet, sudden weight gain

Treatment with TZDs and Humulin R U-500 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

Get emergency medical help if you have:

• severe hypoglycemia needing hospitalization or emergency room care, and be sure to tell the hospital staff the units of Humulin R U-500 that your healthcare provider has prescribed for you.
• trouble breathing,
• shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

The most common side effects of Humulin R U-500 include:

• low blood sugar (hypoglycemia), 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 of Humulin R U-500. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Humulin R U-500

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Humulin R U-500 for a condition for which it was not prescribed. Do not give Humulin R U-500 to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information guide summarizes the most important information about Humulin R U-500. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Humulin R U-500 that is written for healthcare professionals. For more information go to www.humulin.com or call 1-800-545-5979.

How should I store Humulin R U-500?

Vials

• Keep away from heat and out of direct light.
• Do not shake the vial.

Unopened vials:

• Store unopened vials in the refrigerator.
• Do not freeze Humulin R U-500. If it has been frozen, do not use it.
• If unopened vials have been stored in the refrigerator, you may use them until the expiration date.

After the vial has been opened:

• Store opened vials in the refrigerator or at room temperature (less than 86°F [30°C]) for up to 40 days.
• Throw away the opened vial after 40 days, even if there is still insulin left in the vial.

KwikPen

Unused Pens

• Store unused Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze Humulin R U-500. Do not use if it has been frozen.
• Unused Pens may be used until the expiration date printed on the Label, if the Pen has been kept in the refrigerator.

In-use Pen

• Store the Pen you are currently using at room temperature up to 86°F (30°C). Keep away from heat and light.
• Throw away the Pen you are using after 28 days, even if it still has insulin left in it.

What are the ingredients in Humulin R U-500?

Active ingredient: human insulin
Inactive ingredients: glycerin, metacresol, zinc oxide, water for injection, sodium hydroxide and hydrochloric acid

Label

PACKAGE CARTON – HUMULIN R U-500 VIAL 20 ML 1CT

• NDC 0002-8501-01
• 20 mL
• Humulin® R U-500
• insulin human injection
• 10,000 units per 20 mL
• 500 units per mL
• Rx only
• 500 units/mL
• Warning – Highly Concentrated
• IMPORTANT: Use only with a U-500 syringe.
• For subcutaneous use only
• Multiple-dose vial
• www.humulin.com
• Lilly

PACKAGE CARTON – HUMULIN R U-500 KWIKPEN 3 ML (500 UNITS PER ML)

• Dispense in this sealed carton
• NDC 0002-8824-27
• Humulin®R U-500 KwikPen®
• insulin human injection
• For Single Patient Use Only
• prefilled insulin delivery device
• 500 units/mL
• 500 units per mL
• 2 x 3 mL prefilled pens
• Rx only
• For subcutaneous use.
• Read Humulin®R U-500 KwikPen® Instructions for Use.
• NEEDLES NOT INCLUDED
• This device is recommended for use with Becton, Dickinson and Company’s insulin pen needles.