Important Safety Information for Humulin R U-500

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

• Humulin R U-500 is highly concentrated and contains 5 times as much insulin in 1 mL as standard U-100 (100 units/mL) insulin.
• Make sure you know the strength, dose, and type of insulin prescribed for you. Do not change the strength, dose, or type of insulin you use unless told to do so by your healthcare provider.
• The Humulin R U-500 vial, which contains 20 mL, versus the Humulin R U-100 vial, which contains 10 mL, is marked with a band of diagonal brown stripes to distinguish it from the U-100 vial, which has no stripes. "U-500" is also highlighted in red on the label.
• It is important that you take the right dose of Humulin R U-500. Taking too much can cause life-threatening low blood sugar (hypoglycemia) or death. Taking too little can cause high blood sugar (hyperglycemia).
• -Treat mild low blood sugar (hypoglycemia) by drinking or eating something sugary right away.
• -Your healthcare provider may prescribe a glucagon emergency kit so that others can give you an injection if your blood sugar becomes too low and you are unable to take sugar by mouth.

Who should not take Humulin R U-500?

Do not take Humulin R U-500 if your blood sugar is too low or you are allergic to any of the ingredients in Humulin R U-500.

What should I tell my doctor before taking Humulin R U-500?

Tell your healthcare provider:

• If you have liver, kidney, or heart problems or any other medical conditions.
• If you are pregnant, plan to become pregnant, or are breast-feeding.
• About all the medicines you take, including prescription (especially ones commonly called TZDs [thiazolidinediones]) and non-prescription medicines, vitamins, and herbal supplements.

How should I take Humulin R U-500?

• Take Humulin R U-500 exactly as prescribed. Your healthcare provider should show you how to prepare and inject Humulin R U-500 before you start taking it.
• Check the label carefully to make sure you have the right type and strength of insulin prescribed for you.
• Do not mix Humulin R U-500 with other types of insulin.
• Humulin R U-500 should look clear and colorless. Do not use Humulin R U-500 if it does not look clear, colorless, or has particles in it. Do not use Humulin R U-500 after the printed expiration date.
• Follow your healthcare provider’s instructions about how often you should check your blood sugar level.
• Humulin R U-500 starts working about 30 minutes after injection. The effects of Humulin R U-500 may last up to 24 hours. You should eat a meal within 30 minutes of injecting Humulin R U-500.
• Inject Humulin R U-500 under your skin (subcutaneously). Never inject into a vein or muscle. Change injection sites with each dose.
• Your healthcare provider should regularly check your diabetes with blood tests, including your blood sugar levels and A1C.
• To measure Humulin R U-500, you should use either a U-100 insulin syringe or volumetric (tuberculin or allergy) syringe as instructed by your healthcare provider. 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 or too high blood sugar.
• -If you are using U-100 insulin syringes, your healthcare provider should explain how to use this syringe to give the prescribed dose with the unit markings on the syringe.
• -If you are using volumetric syringes, your healthcare provider should explain how to use this syringe to give the prescribed dose with volume markings on the syringe.
• -Make sure you dispose of your used needles and syringes as your healthcare provider instructs.
• If you are hospitalized or go to an emergency room, make sure to tell the hospital staff the actual dose of Humulin R U-500 that your healthcare provider has prescribed for you.

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

• Drinking alcohol may affect your blood sugar when you take Humulin R U-500.
• You may have trouble paying attention or reacting if you have low blood sugar. Be careful when you drive a car or operate machinery. Ask your healthcare provider if it is all right for you to drive if you have low blood sugar or decreased or no warning signs of low blood sugar.

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

• Humulin R U-500 can cause low blood sugar that is severe and that can last a long time. Symptoms of low blood sugar may happen suddenly and may include sweating, dizziness, drowsiness, headache, or other symptoms. Severe low blood sugar can cause you to become confused, pass out (become unconscious), have seizures or coma, and could cause death. Talk to your healthcare provider about how to tell if you have low blood sugar and what to do if this happens while taking Humulin R U-500. Follow your healthcare provider’s instructions for treating your low blood sugar. Tell your healthcare provider if low blood sugar is a problem for you. Your healthcare provider may need to change the amount of Humulin R U-500 that you take, change your meal plans, or your exercise program to help you avoid low blood sugar.
• If you forget to take your dose of Humulin R U-500, your blood sugar may go too high.
• Get medical help right away if you have any of these symptoms of a severe allergic reaction: rash all over your body, shortness of breath, trouble breathing (wheezing), fast heartbeat, sweating, feel faint.
• You may develop low potassium (hypokalemia). Your healthcare provider may do a blood test to check your potassium level.
• Additional side effects of Humulin R U-500 include:
• -Skin thickening or pits at the injection site (lipodystrophy). Do not inject insulin into this type of skin.
• -Injection site reactions (local allergic reaction). Symptoms may include: redness, swelling and itching at the injection site. Tell your healthcare provider if you have skin reactions that do not go away.
• -Weight gain
• Serious side effects can include:
• -swelling of your hands and feet
• -heart failure when taking certain pills called thiazolidinediones or “TZDs” with Humulin R U-500. 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 or Humulin R U-500.
• Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Humulin R U-500. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Humulin R U-500?

• Unopened vials of Humulin R U-500 should be kept in a refrigerator, and should not be used after the expiration date stamped on the label. Do not use Humulin R U-500 if it has been frozen.
• Opened (in-use) vial of Humulin R U-500 should be kept in the refrigerator or at room temperature and used within 31 days of opening. Keep Humulin R U-500 away from heat and direct sunlight. Throw away any opened vial after 31 days of use, even if there is insulin left in the vial.

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

Humulin R U-500 is available by prescription only.

For additional information, talk to your healthcare provider and please click to access Information for the Physician and Patient Information.

HI U500 CON ISI 29MAR2013

Humulin^® is a registered trademark of Eli Lilly and Company.

Indication for Humulin R U-500

Humulin R U-500 insulin is used along with diet and exercise to treat high blood sugar in people with diabetes who need more than 200 units of insulin a day.

Humulin R U-500 may be considered in people with diabetes who need more than 200 units of insulin a day in managing their diabetes.

Humulin R U-500 allows people with diabetes to inject 1/5 the insulin volume when compared to injecting the same dose of a U-100 insulin.

When managing diabetes with Humulin R U-500, important steps must be taken to reduce the risk of prescribing and administration errors.

Click a topic to learn more:

Review the Distinct Label >
Verify Syringe Type and Dosing >
Reference the Dosing Table >

Review the Distinct Label

• Humulin R U-500 is distinctively labeled from Humulin^® R U-100.
• It’s important to ensure you have received the correct insulin.
• Check for the distinctive Humulin R U-500 packaging, which is marked with a band of diagonal brown stripes, black-and-white label, and specific important information called out in red text.

Verify Syringe Type and Dosing

• A U-100 insulin syringe or volumetric (tuberculin or allergy) syringe is recommended for measuring the dose of Humulin R U-500.
• When Humulin R U-500 is prescribed, the type of syringe should be specified, and the amount of insulin to be taken should be explained in both actual dose and unit markings (insulin syringe) or mL (volumetric syringe).
• It is extremely important that people prescribed Humulin R U-500 understand that the unit markings or volume on these syringes are different from the prescribed actual unit dose of Humulin R U-500.

Reference the Dosing Table

• For accurate dosing, it is important to refer to the conversion table, which is based on the following formulas:

  U-100 insulin syringe

  Divide the prescribed dose of Humulin R U-500 (actual units) by 5 = Unit markings in a U-100 insulin syringe.

  Volumetric (tuberculin or allergy) syringe

  Divide prescribed Dose (actual units of Humulin R U-500) by 500 = Volume (mL) in a volumetric syringe.

• The conversion table and formulas can help people prescribed Humulin R U-500 determine the proper unit markings or milliliters (mL) that correspond to the amount of insulin they should inject.

If you have additional questions about Humulin R U-500, please contact your healthcare provider or call The Lilly Answers Center at
1-800-LillyRx (1-800-545-5979).

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