Insulin lispro protamine/insulin lispro (Injection)

Introduction

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 mellitus.

Brand Name(s)

Humalog Mix 75/25, Humalog Mix75/25, Humalog Mix 50/50

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.
• Do not change the brand or dose of your insulin unless your doctor tells you to. When you receive a new supply of insulin, check the label to be sure it is the correct type of insulin.
• You may use this medicine just before or just after a meal.
• A doctor, nurse, or pharmacist should teach you how to give your insulin shots. Make sure you understand how to use the medicine and give yourself the shots.
• You will be shown several places on your body where this shot can be given. Use a different body area to give your shot each time you use your medicine. Keeping a record of where you give each injection will help make sure you rotate body areas.
• Use a new needle with the Humalog® Mix 75/25? Pen each time you give yourself insulin.
• Do not mix Humalog® 75/25? with any other insulin.
• Each time before using Humalog® 75/25? Pen, mix the insulin by rolling the Pen between your palms 10 times, then turning it upside down 10 times. After mixing, the insulin should look cloudy or milky. Do not use the insulin if the white material is still separated from the clear liquid, or if it looks lumpy, discolored, or has white particles sticking to the bottom or side of the Pen.
• Do not share your needles, syringes, or medicine with anyone else.

If a dose is missed:

• Ask your doctor what to do if you miss a dose of insulin.

How to Store and Dispose of This Medicine

• Store unused Pens in the refrigerator. Do not freeze. The expiration date on the insulin package tells you how long you can keep the medicine in the refrigerator.
• Keep the Pen at room temperature in a cool place, away from sunlight or heat. Throw the Pen away after 10 days, even if it still has insulin in it.
• If you can't keep unused Pens in the refrigerator, you may keep them at room temperature in a cool place, away from sunlight or heat, for 28 days. Throw the medicine away after 28 days.
• Each Humalog® 75/25? Pen is to be used for only 10 days in a row.
• After giving yourself the injection, remove the needle from the Pen immediately, and throw it away. You should receive a container for throwing away your used needles and Pens. Otherwise, throw your used needles away in a hard, closed container that the needles cannot poke through.
• Throw the medicine away after the expiration date has passed.
• Keep all medicine out of the reach of children and never share your medicine with anyone.

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 make it harder for you to control your diabetes. Make sure your doctor knows about all other medicines you are using.

Warnings While Using This Medicine

• Follow the special diet and use the correct dose of insulin that your doctor orders. Diet, exercise, medicine, and checking your blood sugar are important to control your diabetes.
• Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other blood-borne illnesses.
• Your doctor may want to check your progress and blood sugar at regular visits. Be sure to keep all appointments.
• You may have low blood sugar while you are using insulin, especially if you miss a meal, exercise for a long time, or drink alcohol.
• If your blood sugar gets too low, you may feel shaky, weak, drowsy, cold, confused, or very hungry. You may sweat or have blurred vision, a fast heartbeat, trouble concentrating, or a headache that doesn't go away.
• Ask your doctor what to do if you have low blood sugar. You will need to control it quickly. Teach your friends, co-workers, or family members what they can do to help you in case you have low blood sugar.
• Tell your doctor if you are pregnant, are planning to become pregnant, or are breastfeeding.
• Make sure your doctor knows if you have kidney disease.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Fainting
• Fast or irregular heartbeat
• Rash or hives
• Seizures (convulsions)
• Wheezing or trouble breathing

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

• Redness, itching, or swelling 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