Insulin Aspart Protamine, Recombinant (IN-su-lin AS-part PROE-ta-meen, ree-KOM-bi-nant), Insulin Aspart, Recombinant (IN-su-lin AS-part, ree-KOM-bi-nant)

Treats diabetes.

Brand Name(s):

NovoLOG Mix 70/30, NovoLOG Mix 70/30 FlexPen, Relion NovoLOG Mix 70/30, Relion NovoLOG Mix 70/30 FlexPen

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.
• Use this medicine 15 minutes before a meal. If you have type 2 diabetes, you can use it after a meal.
• Mix the medicine immediately before use. Allow it to warm to room temperature for easy mixing.
• The insulin should look white or cloudy after you mix it. Do not use this insulin if it is clear or has clumps or particles in it.
• 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.
• 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. Do not use this insulin combination in an insulin infusion pump.
• Cartridge and FlexPen® syringe: Mix the insulin before use by rolling the cartridge or pen between your palms 10 times. Then, turn it upside down at least 10 times, so the glass ball moves from one end to the other.
• Vial: Mix the insulin before use by rolling the vial between your palms 10 times.
• Do not mix this insulin with any other insulin.
• Do not store the cartridge delivery device or pen with a needle attached.
• Keep all medicine away from heat and direct light.
• New, unopened medicine: Store in the refrigerator in the original carton until the expiration date. Do not freeze. Do not use the insulin if it has been frozen. You may also store the unopened cartridge or FlexPen® at room temperature for up to 14 days, or the unopened vials at room temperature for up to 28 days.
• Opened medicine:
  • Vial: Store in the refrigerator. Do not freeze. If you cannot keep the vial in the refrigerator, you may store it at room temperature for up to 28 days in a cool place.
  • Cartridge or FlexPen®: Store at room temperature for up to 14 days. Do not store in the refrigerator. 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)
• Never share insulin pens, needles, or cartridges with anyone. Sharing these can pass hepatitis viruses, HIV, and 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
• 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:

• Cough, runny or stuffy nose, sore throat
• Diarrhea, upset stomach
• Headache
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Redness, itching, swelling, or any changes in your skin 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