NovoLog FlexTouch Pen

How does Novolog FlexTouch Pen work?

The primary activity of NovoLog is glucose metabolism regulation. Insulins, including insulin aspart, exert their action by binding to insulin receptors. Receptor-bound insulin lowers blood glucose by facilitating the cellular uptake of glucose into skeletal muscle and adipose tissue and inhibiting the output of glucose from the liver.

Dosage and How to Use

NovoLog FlexTouch Pens are only available as 100 units of insulin aspart per ml (U-100) in 3 ml pens.

General dosing information

• NovoLog insulin dosing must be individualized.
• NovoLog has an earlier onset of action than regular human insulin.
• NovoLog FlexTouch Pen is given subcutaneously and should generally be given in combination with an intermediate or long-acting insulin.

Important administration information

• Do not use NovoLog if it is viscous or cloudy; only use it if it is clear and colorless.
• Never use NovoLog beyond its expiration date.

Subcutaneous injection

• NovoLog FlexTouch Pen should be administered by subcutaneous injection in the abdominal region, buttocks, thigh, or upper arm.
• NovoLog should be injected immediately (within 5-10 minutes) before a meal.
• Injection sites should be rotated within the same region to reduce the risk of lipodystrophy.

Storage

NovoLog FlexTouch Pens should not be exposed to excessive heat or sunlight.

Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze NovoLog, and do not use NovoLog if it has been frozen.

Keep unused NovoLog FlexTouch Pens in the carton so they will stay clean and protected from light.

Summary of Storage for NovoLog FlexTouch Pen

Overdosage

Mild overdose of insulin can result in hypoglycemia and hypokalemia. Mild hypoglycemia can be treated with oral glucose. If you have severely overdosed your insulin, seek medical attention immediately, as more severe episodes of hypoglycemia can lead to coma, seizures, or neurological impairment. Severe hypoglycemia can be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Hypokalemia must be corrected appropriately.

Side Effects

Common side effects of NovoLog FlexTouch Pen may include:

• Reactions at the injection site
• Itching and rash
• Skin thickening or pits at the injection site (lipodystrophy)
• Weight gain
• Swelling of the hands and feet

Serious side effects that are possible with NovoLog FlexTouch Pen are:

• Hypoglycemia
  • Signs of hypoglycemia may include:
    •  Light-headedness
    •  Dizziness
    •  Confusion
    •  Blurred vision
    •  Shakiness
    •  Anxiety or mood changes
    •  Hunger
• Hypokalemia
• Serious allergic reactions
  • Seek medical attention immediately if you have any one of the following signs of a severe allergic reaction:
    • Rash over your whole body
    • Trouble breathing
    • Fast heartbeat
    • Swelling of your face, tongue, or throat
    • Sweating
    • Extreme drowsiness

Warnings & Precautions

Never Share a NovoLog FlexTouch Pen between Patients

• FlexTouch Pens should never be shared, even if the needle is changed. Sharing poses a risk for the transmission of blood-borne pathogens.

Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

• Changes in insulin, insulin strength, manufacturer, type, or method of administration may affect glycemic control. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia. A sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia.

Hypoglycemia

• Hypoglycemia is the most common adverse reaction of all insulin therapies. Severe hypoglycemia can lead to seizures, unconsciousness, and even death. Patients at higher risk for hypoglycemia or who have reduced symptomatic awareness of hypoglycemia may need to monitor blood glucose more frequently.

Hypoglycemia Due to Medication Errors

• Accidental mix-ups between insulin products have been reported. Instruct patients to always check the insulin label before each injection to minimize medication errors.

Hypersensitivity Reactions

• Severe, life-threatening, generalized allergies, including anaphylaxis, can occur with insulin products.

Hypokalemia

• All insulin products can cause a shift of potassium from the extracellular space to the intracellular space, potentially leading to hypokalemia. Untreated hypokalemia can lead to respiratory paralysis, ventricular arrhythmia, and death.

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonist

• Thiazolidinediones (TZDs) are peroxisome proliferator-activated receptor (PPAR)­ gamma agonists and can cause fluid retention, particularly when used in combination with insulin. Fluid retention can lead to heart failure or exacerbate existing heart failure.

This is not a comprehensive list of all the possible side effects of NovoLog FlexTouch Pen. Please reach out to your doctor or pharmacist for more information.

Drug Interactions and Other Interactions

Drugs That May Increase the Risk of Hypoglycemia

• Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics

Drugs That May Decrease the Blood Glucose Lowering Effect of NovoLog

• Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of NovoLog

• Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia

Drugs That May Blunt Signs and Symptoms of Hypoglycemia

• Beta-blockers, clonidine, guanethidine, and reserpine

Contraindications

NovoLog is contraindicated in any of the following:

• During episodes of hypoglycemia
• In patients with known hypersensitivity to insulin aspart or one of the excipients in NovoLog FlexTouch Pen