NovoLog

• Administer Novolog exactly as prescribed by your doctor.
• Follow the directions on your prescription label carefully.
• Your doctor will determine the best dose for you. The dosage of Novolog must be individualized.

Diabetes Mellitus

Treatment of type 1 (previously called insulin-dependent) or type 2 (previously called noninsulin-dependent) diabetes mellitus in adults who require a rapid-acting insulin for glycemic control.1

Generally used to provide prandial glycemic control in conjunction with an intermediate- or long-acting insulin preparation (e.g., isophane [NPH] insulin human, insulin aspart protamine [as the fixed combination Novolog Mix 70/30]) for basal insulin needs.1 15 18 19

May provide greater convenience in timing of insulin injections in relation to meals.1 2 3 4 5 10 11

Used by IV infusion in appropriately monitored patients with diabetes mellitus,1 but American Diabetes Association (ADA) states that insulin aspart offers no advantage over regular crystalline insulin in patients who require IV insulin.c

Many drugs affect glucose metabolism; if such drugs are used concomitantly, insulin aspart dosage adjustment and careful monitoring may be required.1

Specific Drugs1

• Provide copy of manufacturer’s patient information.1

• Provide information regarding the potential risks and advantages of insulin aspart-containing therapy.1 15

• Provide instructions regarding the use of sub-Q insulin infusion devices (e.g., infusion pumps and accessories) and intensive insulin therapy with multiple injections.1

• Provide instructions regarding self-monitoring of blood glucose, insulin storage and injection technique, adherence to meal planning, regular physical exercise, periodic HbA1c monitoring, and management of hypoglycemia or hyperglycemia.1 6 7 15

• Importance of not mixing insulin aspart with crystalline zinc insulin preparations, insulins of animal source, or preparations produced by other manufacturers.1 Importance of using insulin aspart only if solution is clear and colorless with no particles visible; resuspended insulin aspart in fixed combination with insulin aspart protamine must appear uniformly white and cloudy.1 15

• Importance of not mixing insulin aspart with other insulins or diluent when used in external sub-Q infusion pumps.1

• Importance of administering insulin aspart or the fixed combination of insulin aspart and insulin aspart protamine within 5–10 minutes or within 15 minutes, respectively, of the start of a meal.1 15

• Discuss potential for alterations in insulin requirements in special situations (e.g., illness, emotional disturbances or other stresses) or as a result of changes in physical activity or usual meal plan, missed doses, or inadvertent administration of incorrect doses.1 15 16

• Importance of patient informing clinician if skin reactions (erythema, pruritus, thickened skin) develop at infusion sites if using insulin infusion pumps.1 Importance of selection of a new infusion site, as continued infusion may increase skin reactions and/or alter absorption.1

• Importance of resumption of sub-Q insulin injection therapy and of contacting a clinician if pump malfunctions occur and cannot be corrected promptly.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 4

• Importance of informing patients of other important precautionary information.1 15 (See Cautions.)

Insulin aspart is a fast-acting type of insulin. Insulin is one of many hormones that help the body turn the food we eat into energy. This is done by using the glucose (sugar) in the blood as quick energy. Also, insulin helps us store energy that we can use later. When you have diabetes mellitus, your body cannot make enough or does not use insulin properly. So, you must take additional insulin to regulate your blood sugar and keep your body healthy. This is very important as too much sugar in your blood can be harmful to your health. Since insulin aspart acts faster than regular human insulin, you normally should use insulin aspart with a longer-acting insulin.

This medicine is available only with your doctor's prescription.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Anxious feeling
• behavior change similar to being drunk
• blurred vision
• cold sweats
• confusion
• convulsions (seizures)
• depression
• difficulty with thinking
• dizziness or lightheadedness
• drowsiness
• excessive hunger
• fast heartbeat
• headache
• irritability or abnormal behavior
• nightmares
• restless sleep
• shakiness
• slurred speech
• tingling in the hands, feet, lips, or tongue

• Depression of the skin at the place of injection
• dryness of the mouth
• fast or weak pulse
• feeling of pressure, itching, redness, soreness, stinging, swelling, or tingling at the place of injection
• increased thirst
• irregular heartbeat
• loss of appetite
• mood or mental changes
• muscle cramps or pain
• nausea or vomiting
• skin rash or itching over the whole body
• sweating
• thickening of the skin at the place of injection
• trouble breathing
• unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

NovoLog (insulin aspart)is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood.

NovoLog is used to improve blood sugar control in adults and children with diabetes mellitus.

This medicine is sometimes used together with a long-acting or intermediate-acting insulin.

NovoLog is used to treat type 2 diabetes in adults.

NovoLog is also used to treat type 1 diabetes in adults and children who are at least 2 years old.

Get emergency medical help if you have signs of an allergic reaction to NovoLog: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once 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 limp feeling.

Common NovoLog side effects may include:

• low blood sugar;

• 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 FDA at 1-800-FDA-1088.

Common side effects of Novolog include: hypoglycemia. See below for a comprehensive list of adverse effects.

Applies to insulin aspart: subcutaneous solution

General

Adverse reactions observed have included hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus.[Ref]

Hypersensitivity

Hypersensitivity side effects have included both local and systemic reactions. Anaphylaxis has been reported. Local reactions have presented as erythema, local edema, and pruritus at the injection site. Most minor reactions to insulin at the injection site resolve in a few days to a few weeks.

Generalized allergy to insulin may present as a whole body rash, dyspnea, wheezing, hypotension, tachycardia, or diaphoresis. In clinical trials, allergic reactions were reported in 0.7% (10/1394) patients receiving insulin aspart (the active ingredient contained in Novolog) [Ref]

Very rare (less than 0.01%): Anaphylaxis
Frequency not reported: Allergic reactions[Ref]

Metabolic

Weight gain has been reported with insulin therapy and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.[Ref]

Very common (10% or more): Hypoglycemia
Frequency not reported: Weight gain[Ref]

Cardiovascular

Common (1% to 10%): Chest pain
Uncommon (0.1% to 1%): Peripheral edema[Ref]

Insulin may cause sodium retention and edema, especially as metabolic control is improving.[Ref]

Dermatologic

Long-term use of insulin may cause lipodystrophy at the site of repeated injection. Lipodystrophy includes lipohypertrophy, a thickening of adipose tissue, and lipoatrophy, thinning of adipose tissue.[Ref]

Common (1% to 10%): Skin disorder
Uncommon (0.1% to 1%): Urticaria, rash
Frequency not reported: Lipodystrophy including lipohypertrophy and lipoatrophy[Ref]

Immunologic

Common (1% to 10%): Onychomycosis
Frequency not reported: Anti-insulin antibody titers[Ref]

The clinical significance of the development of these antibody titers is unknown.[Ref]

Ocular

Rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder and worsening of diabetic retinopathy. However, long-term glycemic control decreases the risk of diabetic retinopathy.[Ref]

Uncommon (0.1% to 1%): Refraction disorder, worsening of diabetic retinopathy[Ref]

Nervous system

Rapid improvement in glucose control has been associated with a transitory, reversible acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk.[Ref]

Very common (10% or more): Headache (up to 12%)
Common (1% to 10%): Hyporeflexia, sensory disturbance
Rare (less than 0.1%): Painful peripheral neuropathy[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, abdominal pain[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

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

• 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 NovoLog. 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 NovoLog. If not treated, this can lead to a heartbeat that is not normal, very bad breathing problems, and sometimes death. Talk with the doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• 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.
• If you are 65 or older, use NovoLog with care. You could have more side effects.
• 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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• A burning, numbness, or tingling feeling that is not normal.
• Change in eyesight.
• Chills.
• Very bad dizziness or passing out.
• Mood changes.
• Seizures.
• Slurred speech.
• Very bad irritation where the shot was given.
• Change in skin to thick or thin where the shot was given.
• Low blood sugar may occur. Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call the doctor right away if any of these signs occur. Follow what you have been told to do if low blood sugar occurs. This may include taking glucose tablets, liquid glucose, or some fruit juices.