When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to any insulin.

How to Use This Medicine:
Injectable

• IV: If you are in the hospital, a nurse or other health professional may give you this medicine through a needle placed in a vein.
• Your healthcare provider will work with you to personalize your dose and treatment based on your insulin needs and lifestyle. You will be taught how to give yourself the injections. Make sure you understand all instructions. Ask the doctor, nurse, or pharmacist if you have questions.
• You should start eating a meal within 30 minutes of injecting insulin.
• Always double-check both the concentration (strength) of your insulin and your dose. Concentration and dose are not the same. The dose is how many units of insulin you will use. The concentration tells how many units of insulin are in each milliliter (mL), such as 100 units/mL (U-100), but this does not mean you will use 100 units at a time.
• Humulin® R Concentrated U-500: Measure the dose carefully. This form has more medicine in the same amount of solution than the U-100 form of insulin. You will need to use less of the solution for each dose.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• This medicine should look clear before you use it. Do not shake the vial. Do not mix this medicine with any other insulin or with water.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Use a new needle and syringe each time you inject your medicine. If you use a syringe, use only the kind that is made for insulin injections. Some insulin must be given with a specific type of syringe or needle. Ask your pharmacist if you are not sure which one to use.
• Always check the label before use, to make sure you have the correct type of insulin. Do not change the brand, type, or concentration unless your doctor tells you to. If you use a pump or other device, make sure the insulin is made for that device.
• Unopened medicine:
  
  • KwikPen®: Store in the refrigerator. Do not freeze. You may also store at room temperature in a cool place, away from light and heat. Unopened medicine stored at room temperature must be thrown away within 28 days.
  • Humulin® R Concentrated U-500 vial: Store in the refrigerator. Do not freeze. You may also store at room temperature in a cool place, away from light and heat. Unopened medicine stored at room temperature must be thrown away within 40 days.
  • Humulin® vials: Store in the refrigerator. Do not freeze. Do not use the insulin if it has been frozen.
  • Novolin®: Store in the package in the refrigerator. Do not freeze. If you cannot store it in the refrigerator, store at room temperature in a cool place, away from light and heat, for up to 42 days.
• Opened medicine:
  
  • KwikPen®: Store at room temperature in a cool place, away from light and heat. Do not store in the refrigerator. Throw away an opened pen after 28 days, even if there is still insulin in it.
  • Humulin® R Concentrated U-500 vial: Store in the refrigerator. Do not freeze. You may also store at room temperature in a cool place, away from light and heat. Throw away any opened vial after 40 days.
  • Humulin® vials: Store in the refrigerator. Do not freeze. You may also store it at room temperature in a cool place, away from heat and light for up to 31 days.
  • Novolin®: Store at room temperature in a cool place, away from light and heat. Do not store in the refrigerator. Throw away an opened vial after 42 days, even if there is still insulin in it.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can change the amount of insulin you need to use and make it harder for you to control your diabetes. Tell your doctor about all other medicines you are using.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease, or heart failure.
• This medicine may cause the following problems:
  
  • Low blood sugar or low potassium levels in the blood
  • Fluid retention or heart failure (when used with thiazolidinedione [TZD] medicine)
• Never share insulin pens or needles with anyone. Sharing these can pass hepatitis viruses, HIV, or other illnesses from one person to another.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dry mouth, increased thirst, muscle cramps, nausea, vomiting, uneven heartbeat
• Rapid weight gain, swelling in your hands, ankles, or feet, trouble breathing, tiredness
• Shaking, trembling, sweating, fast or pounding heartbeat, lightheadedness, hunger, confusion

If you notice these less serious side effects, talk with your doctor:

• Redness, itching, swelling, or any skin changes where the shot is given

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088