HumuLIN 70/30 KwikPen

Insulin is a hormone that lowers blood glucose (sugar) levels. Insulin isophane is an intermediate-acting insulin, while insulin regular is a short-acting insulin. This combination insulin starts working within 10 to 20 minutes after injection, peaks in 2 hours, and lasts for up to 24 hours.

HumuLIN 70/30 KwikPen is a combination medicine that helps improve blood sugar control in adults with diabetes mellitus.

HumuLIN 70/30 KwikPen may also be used for other purposes not mentioned in this medication guide.

You should not use HumuLIN 70/30 KwikPen if you are experiencing low blood sugar.

Never share an injection pen or syringe with anyone else, even if you change the needle.

You should not use this medicine if you are allergic to insulin, or if you are experiencing hypoglycemia (low blood sugar).

This medicine is not approved for anyone younger than 18 years old.

Tell your doctor if you have ever had:

• congestive heart failure or other heart problems;
• liver or kidney disease; or
• low potassium levels in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes found in combinations with glimepiride or metformin). Taking some oral diabetes medicines while using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using insulin if you are pregnant or become pregnant. Managing diabetes is very important during pregnancy, and having high blood sugar can cause complications for both the mother and the baby.

Get emergency medical help if you have signs of an insulin allergy: redness or swelling where you injected, an itchy skin rash over your entire body, trouble breathing, chest tightness, feeling faint, or swelling in your tongue or throat.

HumuLIN 70/30 KwikPen may cause serious side effects. Call your doctor immediately if you have:

• fluid retention—weight gain, swelling in your hands or feet, feeling short of breath; or
• low potassium—leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or feeling limp.

Common side effects of HumuLIN 70/30 KwikPen may include:

• low blood sugar;
• weight gain, swelling in your hands or feet;
• itching, mild skin rash; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Insulin is injected under the skin. A healthcare provider can teach you how to properly use the medication by yourself.

Do not give HumuLIN 70/30 KwikPen with an insulin pump.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

This insulin should look cloudy after mixing. Do not use the mixture if it looks clear or has particles in it. Call your pharmacist for new medicine.

Your care provider will show you where on your body to inject HumuLIN 70/30 KwikPen. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

After using HumuLIN 70/30 KwikPen, you should eat a meal within 30 to 45 minutes.

If you use an injection pen, use only the injection pen that comes with this insulin. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share an injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Insulin is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) HumuLIN 70/30 KwikPen:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within the number of days specified in the Instructions for Use provided with your medicine.

Storing opened (in use) HumuLIN 70/30 KwikPen:

• Store the vial in a refrigerator or at room temperature.
• Store the injection pen at room temperature (do not refrigerate). Do not store the injection pen with a needle attached.
• In-use insulin is stable for only a certain number of days. Throw away any medicine not used within that time. Follow all storage directions provided with your medicine.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

Since this medicine is taken with a meal, you might not have a set schedule for taking it. Whenever you use this insulin, make sure to eat a meal within 45 minutes. Do not use extra medicine to compensate for a missed dose.

Get your prescription refilled before you completely run out of medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An insulin overdose can lead to life-threatening low blood sugar. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizures (convulsions), or loss of consciousness.

Insulin can cause low blood sugar. Do not drive or operate machinery until you understand how HumuLIN 70/30 KwikPen will affect you.

To avoid medication errors, always check the medicine label before injecting your insulin.

Do not drink alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

This insulin may not work as well if you take other medicines at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can also reduce your symptoms of hypoglycemia, making it harder to recognize when your blood sugar is low. Not all possible interactions are mentioned here. Inform your doctor about any medicines you begin or stop using.