NovoLog PenFill

Insulin is a hormone that helps lower glucose (sugar) levels in the blood. NovoLog PenFill is a fast-acting insulin that begins working about 15 minutes after injection, reaches its peak effect in about 1 hour, and continues to work for 2 to 4 hours.

NovoLog PenFill is used to help control blood sugar levels in adults and children with diabetes mellitus. It is sometimes used along with a long-acting or intermediate-acting insulin.

NovoLog PenFill may also be used for other reasons not mentioned in this medication guide.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed.

You should not use NovoLog PenFill if you are allergic to it, or if you are experiencing hypoglycemia (low blood sugar).

NovoLog PenFill is not approved for use by anyone younger than 2 years old, and should not be used to treat type 2 diabetes in a child of any age. Fiasp is for use only in adults.

Tell your doctor if you have ever had:

• liver or kidney disease; or
• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes found in combinations with glimepiride or metformin). Taking certain 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. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications for both the mother and the baby.

Get emergency medical help if you have signs of an insulin allergy: redness or swelling at the injection site, an itchy skin rash all over your body, trouble breathing, a fast heartbeat, feeling faint, or swelling in your tongue or throat.

NovoLog PenFill may cause serious side effects. Call your doctor immediately if you experience:

• heart problems – swelling, rapid weight gain, 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 NovoLog PenFill may include:

• low blood sugar;
• weight gain;
• low potassium;
• swelling in your hands and feet;
• skin rash, itching, redness, or swelling; or
• thickening or hollowing of the skin at the injection site.

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.

NovoLog PenFill is injected under the skin, or as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Your healthcare provider will show you where on your body to inject NovoLog PenFill. 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 NovoLog PenFill into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

After using Novolog, you should eat a meal within 5 to 10 minutes. Fiasp should be given at the start of a meal or within 20 minutes after starting a meal.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Prepare an injection only when you are ready to give it. This medicine should be clear and colorless. Do not use the medicine if it has changed colors or has particles in it. Call your pharmacist for new medicine.

If you use an injection pen, use only the pen provided with your medicine. If you use this medicine with an insulin pump, do not mix or dilute NovoLog PenFill with any other insulin. Change the medicine in the reservoir at least every 6 days.

Never share an injection pen, cartridge, 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.

NovoLog PenFill 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) NovoLog PenFill:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within 28 days.

Storing opened (in use) NovoLog PenFill:

• Store the vial in a refrigerator or at room temperature and use within 28 days.
• Store the cartridge or injection pen at room temperature (do not refrigerate) and use within 28 days. Do not store the injection pen with a needle attached.

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 you take NovoLog PenFill before meals, you might not have a strict dosing schedule. Whenever you use NovoLog PenFill, make sure to eat a meal within 5 to 10 minutes. Do not use extra of this medicine to compensate for a missed dose.

Always keep insulin available. Refill your prescription before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of insulin 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, seizure (convulsions), or loss of consciousness.

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how NovoLog PenFill will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol or using medicines that contain alcohol. Alcohol can cause low blood sugar and may interfere with your diabetes treatment.

Insulin may not work as effectively when you are taking other medications at the same time. Some drugs can also make you have fewer signs of low blood sugar, which can make it harder to notice when your blood sugar is low. This includes both prescription and over-the-counter medications, vitamins, and herbal products. Not all possible interactions are included here. Inform your doctor about all medications you begin or stop using.

Biosimilar and interchangeable products are biological products that are very similar to and have no significant differences from the reference product.

Reference products

These are biological products that have already received FDA approval, against which biosimilar products are compared. There is 1 for NovoLog PenFill.

Fiasp (insulin aspart) - Novo Nordisk Inc.

View Fiasp information in detail.

biosimilar products

Biosimilar products can only be given instead of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may differ by state.

Merilog (insulin aspart-szjj) - Sanofi-Aventis U.S. LLC

View Merilog information in detail.