Humalog Mix 50 / 50 (Insulin Lispro Protamine / Insulin Lispro (Pens))

• It is used to lower blood sugar in patients with high blood sugar (diabetes).

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Allergic reactions have happened with Humalog Mix 50/50. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
• Low blood sugar may happen with this medicine. Very low blood sugar can lead to seizures, passing out, long lasting brain damage, and sometimes death. Talk with the doctor.
• Low blood potassium may happen with Humalog Mix 50/50. If not treated, this can lead to a heartbeat that is not normal, very bad breathing problems, and sometimes death. Talk with the doctor.
• Some diabetes drugs like pioglitazone or rosiglitazone may cause heart failure or make it worse in people who already have it. Using insulin with these drugs may increase this risk. If you also take one of these drugs, talk with the doctor.
• Be sure you have the right insulin product. Insulin products come in many containers like vials, cartridges, and pens. Be sure that you know how to measure and get your dose ready. If you have any questions, call your doctor or pharmacist.
• It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
• Wear disease medical alert ID (identification).
• Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
• Check your blood sugar as you have been told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor before you drink alcohol.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
• Do not share pen or cartridge devices with another person even if the needle has been changed. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.

Use Humalog Mix 50/50 as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
• Take 15 minutes before a meal.
• Move site where you give the shot each time.
• Do not give into red or irritated skin.
• Do not use if the solution is leaking or has particles.
• Do not use if solution changes color.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
• Follow the diet and workout plan that your doctor told you about.
• Be sure you know what to do if you do not eat as much as normal or if you skip a meal.
• Do not use out dated insulin.
• Do not mix this insulin in the same syringe with other types of insulin.

What do I do if I miss a dose?

• Be sure you know what to do if you forget to take a dose
• If you are not sure what to do if you miss a dose, call your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store unopened pens in a refrigerator. Do not freeze.
• Store opened pens at room temperature. Throw away any part not used after 10 days.
• Take off the needle after each shot. Do not store this device with the needle on it.
• Do not use if it has been frozen.
• Protect opened containers from heat.
• Protect opened containers from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to insulin lispro / insulin lispro protamine: subcutaneous suspension

General

The most common adverse reactions observed with insulin therapy include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus.[Ref]

Metabolic

Very common (10% or more): Hypoglycemia[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Local reactions such as redness, swelling, or itching at the injection site
Very rare (less than 0.01%): Systemic reactions[Ref]

Hypersensitivity side effects have included both local and systemic reactions. These reactions are becoming rare (less than 1% of patients) due to the use of biosynthetic human insulin. Local reactions have presented as erythema, swelling, heat, or subcutaneous nodules. They usually occurred within the first two weeks of therapy and then disappear. Systemic allergy is a generalized allergy to insulin which may present as a rash over the whole body, shortness of breath, wheezing, drop in blood pressure, fast pulse, or sweating. Severe cases may be life-threatening.[Ref]

Cardiovascular

Frequency not reported: Peripheral edema[Ref]

Insulin may cause sodium retention and edema, especially if previously poor metabolic control is improved by intensified insulin therapy.[Ref]

Dermatologic

Uncommon (0.1% to 1%): Lipodystrophy
Frequency not reported: Rash, pruritus[Ref]

Immunologic

Frequency not reported: Anti-insulin antibodies[Ref]

Other

Frequency not reported: Weight gain[Ref]

Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria.[Ref]

Local

Frequency not reported: Injection site reactions[Ref]

Injection site reactions including pain, redness, hives, inflammation, bruising, swelling, and itching, may occur. These reactions are usually transitory and may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.[Ref]

Some side effects of insulin lispro / insulin lispro protamine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.