Insulin Lispro Protamine, Recombinant (IN-su-lin LIS-pro PROE-ta-meen, ree-KOM-bi-nant), Insulin Lispro, Recombinant (IN-su-lin LIS-pro, ree-KOM-bi-nant)

Treats diabetes.

Brand Name(s):

HumaLOG Mix 50/50, HumaLOG Mix 50/50 KwikPen, HumaLOG Mix 75/25, HumaLOG Mix 75/25 KwikPen

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• 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.
• 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 be white and cloudy after mixing. Do not use if it is clear, or has lumps or particles in it.
• Use this medicine 15 minutes before a meal (2 meals or a meal and a snack).
• 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.
• 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. Do not use the exact same spot for each injection.
• Do not inject into skin areas that are tender, bruised, scaly, hard, damaged, thick, or has pits, lumps, or scars.
• 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 insulins must be given with a specific type of syringe or needle. Ask your pharmacist if you are not sure which one to use.
• Vial:
  • Wash your hands with soap and water.
  • Gently roll the vial between the palm of your hands and move the vial up and down at least 10 times.
  • Use only syringes that are made for insulin injections. Use a new syringe and needle each time you give yourself an injection.
  • Do not mix this medicine with any other insulin.
• Kwik® Pen:
  • Wash your hands with soap and water.
  • Gently roll the pen between your hands at least 10 times. Move the pen up and down at least 10 times.
  • Prime the pen by removing the air from the needle and cartridge. Select 2 units when turning the dose knob.
  • Hold the pen with the needle pointing up, then gently tap the cartridge holder to collect the air bubbles at the top.
  • Press the dose knob until it stops. You should see a "0" in the dose window.
  • You should see insulin at the needle tip. If you do not see insulin, repeat the priming steps but not more than 4 times. If there is still no insulin, change the needle and repeat the priming steps.
  • Turn the dose knob, be careful not to press it.
  • Insert the needle into your skin and press the dose knob all the way in for at least 5 seconds. Keep pressing until the needle has been pulled out from the skin. This will make sure that you have received the full dose.
  • Use a new needle each time you give yourself an injection. Always remove and throw the needle after each injection. Store the pen without a needle attached. Do not use the pen if it is broken or damaged.
• 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. Do not use a an infusion pump or other device to use this medicine.
• Missed dose: Call your doctor or pharmacist for instructions.
• Unopened medicine: Keep the medicine in its original carton. You may store the pen or vial in the refrigerator until its expiry date. Do not freeze. Do not use the insulin if it has been frozen. You may also store the pen for 10 days or vial for 28 days at room temperature.
• Opened medicine:
  • Pen: Store at room temperature for up to 10 days. Do not refrigerate.
  • Vials: Store in the refrigerator or at room temperature for up to 28 days. Do not freeze.
• 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 that 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 together with a thiazolidinedione [TZD] medicine)
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Never share insulin pens or needles with anyone. Sharing these can pass hepatitis viruses, HIV, or other illnesses from one person to another.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• 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
• Blurred vision, change in how much or how often you urinate, fruit-like breath odor, stomach pain, weakness
• Dry mouth, increased thirst, muscle cramps, nausea, vomiting
• Rapid weight gain, swelling in your hands, ankles, or feet, chest pain, trouble breathing, tiredness
• Shaking, trembling, sweating, fast, pounding, or uneven heartbeat, lightheadedness, hunger, confusion

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

• Redness, itching, swelling, or 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