NovoLog Vials (insulin aspart)

What is NovoLog (insulin aspart)?

NovoLog is a rapid-acting insulin injection prescribed to improve blood sugar levels in patients with diabetes mellitus. NovoLog is prescribed to be used 5-10 minutes before a meal. Novolog will start working about 10 to 20 minutes after injection, and continues to work for 3 to 5 hours.

It belongs to the antidiabetic drug class and is categorized as a rapid-acting insulin analog. Insulin medications work by mimicking human insulin, which helps control blood sugar levels. When insulin made by the body decreases, blood sugar levels will rise to high levels. If left untreated, very high blood sugar levels can lead to serious complications such as diabetic ketoacidosis or hyperosmolar hyperglycemic state, which can be dangerous and life-threatening.

What are the Indications for NovoLog?

NovoLog is prescribed as part of a treatment plan to manage blood sugar levels, which includes exercise, diet changes, and regular blood sugar testing. Any change in diet and activity can affect blood sugar levels.

It is not recommended if you have or have had a severe allergic reaction to NovoLog or any ingredients in NovoLog.

How is NovoLog used?

NovoLog should be used as prescribed by your doctor. You should inject the medication under your skin through a needle and syringe, infusion pump, or injection pen.

Storage

NovoLog that has not been opened may be stored at room temperature up to 86°F (30°C) for up to 28 days or in the refrigerator between 36° to 46°F (2° to 8°C) up until the expiration date. NovoLog should not be stored in the freezer.

Once you’ve opened NovoLog, it must be used within 28 days. After 28 days, any opened remaining medication must be thrown away, even if there is still some medication left.

NovoLog vial

NovoLog vial that has been opened and is currently in use may be stored at room temperature or be refrigerated for up to 28 days. If using the vial with an insulin pump, the vial may be used and stored for up to 19 days.

NovoLog FlexPen

NovoLog FlexPen that has been opened and is currently in use should be stored at room temperature under 86°F or 30°C. NovoLog should be kept away from direct light and heat. Do not refrigerate NovoLog FlexPen.

Instruction

Follow the patient information pamphlet that comes with your medication. NovoLog needs to be injected under the skin of your stomach, thigh, buttocks, or upper arm. NovoLog should never be injected into a vein or muscle.

NovoLog should be injected 5-10 minutes before a meal. Novolog should only be prepared when you are ready to use it.

1. Before injecting NovoLog, prepare the insulin. Change the injection needle if it has not been changed since the last injection. Do not reuse needles.
2. Select your injection site and clean with an alcohol swab. The injection site should be rotated so as not to be in the exact same location as the last injection.

• Do not inject in areas with scars, stretch marks, bruises, or where the skin is tender, hard, or red.
• Do not use the medication if it appears to be broken, cloudy, has clumps or debris in it, or if it has expired.

1. Inject the medication as directed in the patient information pamphlet or as directed by your doctor.
2. After the injection, dispose of the needle in an FDA-cleared sharps disposal container immediately. Do not reuse or share needles with other people. You can create a sharps disposable container by using any heavy-duty plastic household container that you have that:

• Is leak-resistant
• Has a tight-fitting, puncture-proof lid so sharps such as needles cannot escape
• Has a label warning that there are hazardous materials inside the container

Dosage

NovoLog is a clear, colorless solution that is available in one strength, 100 units/mL (U-100), and various forms:

• 10 mL multiple-dose vial
• 3 mL single-patient-use PenFill cartridges for the 3 mL PenFill cartridge device
• 3 mL single-patient-use NovoLog FlexPen
• 3 mL single-patient-use NovoLog FlexTouch

The dose for each person will vary and can change depending on several factors; weight, current blood sugar level, activity levels, and how well you respond to insulin.

Side Effects

It’s important to understand that although NovoLog is FDA approved, it comes with side effects that may or may not affect you.

Before starting NovoLog, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As your body adjusts to NovoLog, side effects may go away.

Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own:

• Weight gain
• Reaction at the injection site (e.g. itching, thickening of the skin)
• Swelling of hands and feet
• Skin rash or redness

Serious Side Effects

Severe adverse reactions while taking NovoLog can occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

• Severe allergic reaction: severe rash or itching, swelling in the face, lips, tongue, or throat, rapid heartbeat, fainting or dizziness, or problems breathing or swallowing.
• Low blood sugar: headache, irritability, confusion, blurred vision, slurred speech, dizziness or light-headedness, shakiness, fast heartbeat, mood change, anxiety, or excessive hunger.
• Low potassium: constipation, fluttering in the chest or irregular heartbeats, leg cramps, increased thirst or need to urinate, muscle weakness or unusual tiredness, or tingling sensation.
• Heart problems: weight gain, shortness of breath even at rest, swelling of the legs and/or stomach, increased tiredness and weakness, nausea, abdominal pain, or persistent cough with blood-tinged mucus.

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Before using NovoLog, tell your doctor or pharmacist:

• If you are allergic to any medications such as insulin
• If you have or have had liver or kidney disease
• If you have or have had heart problems,
• If you have or have had low levels of potassium such as hypokalemia
• If you are pregnant or plan to become pregnant
• If you are breastfeeding

Heart Failure and Fluid Retention

Taking insulin such as NovoLog with thiazolidinediones (TZDs) can result in fluid retention, leading to heart failure. Your doctor will monitor your symptoms and adjust your medications as needed.

Hyperglycemia or High Blood Sugar Due to Insulin Pump Failure

High blood sugar and ketoacidosis can result from insulin pump failure. You should be aware of the signs and symptoms of high blood sugar and be prepared with an alternative treatment plan, such as self-injection.

Hypoglycemia or Low Blood Sugar

The risks of having low blood sugar levels increase:

• If there is a change in your diet and exercise
• If you consume alcohol
• If you take medications for diabetes such as NovoLog
• If you are over 65 years of age
• If you have liver or kidney problems

Symptoms include the inability to concentrate, irritability, shakiness, fast heartbeat, unusual weakness or tiredness, excessive hunger, and confusion.

Severe low blood sugar may become life-threatening, cause seizures, or result in death. Your doctor will create a treatment plan that includes monitoring your blood sugar level to determine if a change in treatment is necessary.

Hypokalemia

Taking insulin such as NovoLog can result in low potassium levels, especially if you are taking another medication that may also lower potassium levels. Low potassium levels can be dangerous, resulting in ventricular arrhythmia, respiratory paralysis, or death. Your doctor may monitor your potassium levels to determine if a change in treatment is necessary.

Mixing Insulins

Take precautions such as carefully reviewing labels to ensure you use the correct insulin before making an injection. Using the wrong insulin and/or dose may lead to overdose and severe low blood sugar. There have been reports of accidental insulin mix-ups of patients using different insulins in the incorrect amount.

Pregnant or Plan to Become Pregnant

Having high blood sugar during pregnancy may cause complications during pregnancy and delivery for both mother and baby. Complications include premature birth, low birth weight, and breathing problems. There is also an increased risk of miscarriage or stillbirth. Your doctor will create a treatment plan to monitor your blood sugar levels.

Sharing of Cartridges, Needles, Pens, and Vials

Cartridges, needles, pens, and vials should never be reused or shared with anyone else. Doing so creates risks of dangerous diseases spread through blood transmission.

Interactions & Contraindications

Increased Risk of Low Blood Sugar

Taking NovoLog with the following types of medications may increase your risk of low blood sugar. Your doctor will monitor your treatment plan and make changes as necessary.

• Salicylates
• Angiotensin II receptor blocking agents
• Somatostatin analogs (e.g., Sandostatin and Mycapssa)
• Antidiabetic agents (e.g. metformin, glyburide, and glipizide)
• Sulfonamide antibiotics
• Fluoxetine
• Disopyramide
• Pramlintide
• Fibrates
• Pentoxifylline
• Monoamine oxidase inhibitors (e.g., Azilect and Marplan)
• ACE inhibitors (e.g., Benazepril and Lisinopril)

Taking NovoLog with the following types of medications may weaken the signs and symptoms of low blood sugar. Check your blood sugar regularly and contact your doctor with any concerns.

• Beta-blockers (e.g., Atenolol and Metoprolol)
• Clonidine
• Guanethidine
• Reserpine

Effectiveness of Blood Sugar Lowering Ability

Taking NovoLog with the following types of medications may decrease the effectiveness of NovoLog in lowering blood sugar. Your doctor will monitor your treatment plan and make changes as necessary.

• Corticosteroids (e.g., betamethasone, prednisone, and prednisolone).
• Isoniazid
• Niacin
• Estrogens (e.g., Estradiol and Imvexxy)
• Oral contraceptives
• Phenothiazines (e.g., prochlorperazine and promethazine)
• Danazol
• Diuretics
• Sympathomimetic agents (e.g., albuterol inhalers and EpiPen)
• Somatropin (e.g., Humatrope and Omnitrope)
• Atypical antipsychotics (e.g., risperidone and aripiprazole)
• Glucagon
• Protease inhibitors (e.g., Reyataz and Norvir)
• Thyroid hormones (e.g., Synthroid)

Taking NovoLog with the following medications can either decrease or increase the effectiveness of NovoLog to lower blood sugar levels. Your doctor will monitor your treatment plan and make changes as necessary.

• Beta-blockers (e.g., Atenolol, Metoprolol, Nadolol, and Propranolol)
• Clonidine
• Lithium salts
• Alcohol
• Pentamidine

Frequently Asked Questions

Disclaimer

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