Insulin Aspart Flexpen Inj, 3ml

Manufacturer NOVO NORDISK Active Ingredient Insulin Aspart (Cartridges & Prefilled Pens) (NovoLog)(IN soo lin AS part) Pronunciation IN-soo-lin AS-part FLEX-pen
It is used to lower blood sugar in patients with high blood sugar (diabetes).
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Drug Class
Antidiabetic agent
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Pharmacologic Class
Insulin, rapid-acting analog
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Pregnancy Category
Not available
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FDA Approved
Jun 2000
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Insulin Aspart is a fast-acting insulin that helps your body use sugar for energy. It starts working quickly, usually within 10-20 minutes, and is typically taken right before a meal to help control your blood sugar after eating. It comes in a pre-filled pen (FlexPen) for easy injection under the skin.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin in the upper arm, thigh, buttocks, or stomach area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.

Administration Instructions

Inject the dose within 5 to 10 minutes before a meal.
Rotate the injection site each time to avoid tissue damage.
Before injecting, remove all pen needle covers (there may be two).
If you are unsure about the type of pen needle or how to use it, consult your doctor.
After use, replace the cap on the pen.
Note that the device may produce a clicking sound when preparing the dose. However, do not rely on the clicks to determine the dose, as this may lead to an incorrect dose. Instead, follow the manufacturer's instructions.
Remove the needle after each injection and do not store the device with the needle attached.
Do not transfer this medication from the pen to a syringe or mix it with other types of insulin.

Storage and Disposal

Store unopened containers in the refrigerator at a temperature between 39°F and 46°F (4°C and 8°C). Do not freeze.
Do not use the medication if it has been frozen.

Missed Dose

If you forget to take a dose, be sure to follow your doctor's instructions. If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
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Lifestyle & Tips

  • Always take insulin aspart 5-10 minutes before a meal. If you forget to eat, skip the dose.
  • Rotate injection sites (abdomen, thigh, upper arm, buttocks) to prevent skin problems like lumps or pits.
  • Never share your insulin pen or needles with anyone else, even if the needle is changed, as this can transmit infections.
  • Monitor your blood sugar levels regularly as instructed by your doctor.
  • Carry a source of fast-acting sugar (e.g., glucose tablets, juice, candy) to treat low blood sugar (hypoglycemia).
  • Follow a consistent meal plan and exercise routine as advised by your healthcare provider.
  • Inform your doctor about all medications, supplements, and herbal products you are taking, as they can affect blood sugar levels.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on patient's metabolic needs, blood glucose monitoring, and glycemic control goals. Typically administered subcutaneously 5-10 minutes before a meal. Initial total daily insulin dose for Type 1 diabetes is often 0.5-1.0 units/kg/day, with 50-70% as basal and 30-50% as prandial. For Type 2 diabetes, initial dosing varies widely, often starting with 4-6 units before the largest meal or 0.1-0.2 units/kg/day.

Condition-Specific Dosing:

Type 1 Diabetes: Individualized, typically 50-70% of total daily insulin as prandial insulin, divided among meals.
Type 2 Diabetes: Individualized, often starting with 4-6 units before the largest meal, or adjusted based on blood glucose levels and carbohydrate intake.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution and expert guidance)
Infant: Individualized, based on metabolic needs and blood glucose monitoring. Typically for Type 1 Diabetes.
Child: Individualized, based on metabolic needs and blood glucose monitoring. Typically for Type 1 Diabetes.
Adolescent: Individualized, based on metabolic needs and blood glucose monitoring. Typically for Type 1 Diabetes.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required, but monitor glucose closely.
Moderate: Dose reduction may be required; monitor glucose closely and adjust based on glycemic control.
Severe: Significant dose reduction likely required; monitor glucose closely and adjust based on glycemic control.
Dialysis: Dose reduction likely required; monitor glucose closely and adjust based on glycemic control. Insulin requirements may decrease.

Hepatic Impairment:

Mild: No specific dose adjustment required, but monitor glucose closely.
Moderate: Dose reduction may be required; monitor glucose closely and adjust based on glycemic control.
Severe: Significant dose reduction likely required; monitor glucose closely and adjust based on glycemic control.

Pharmacology

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Mechanism of Action

Insulin aspart is a rapid-acting insulin analog that lowers blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis. It also increases the transport of amino acids into cells and accelerates protein synthesis.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (subcutaneous administration)
Tmax: 40-50 minutes (range 30-90 minutes)
FoodEffect: Administered before meals to cover postprandial glucose excursions.

Distribution:

Vd: Not available
ProteinBinding: <10%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 81 minutes (functional half-life due to absorption kinetics is longer)
Clearance: Not available
ExcretionRoute: Renal (primarily metabolites)
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: 10-20 minutes
PeakEffect: 1-3 hours
DurationOfAction: 3-5 hours
Confidence: High

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Some allergic reactions can be life-threatening, so prompt medical attention is crucial.
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Injection site reactions, such as:
+ Thick skin
+ Pits or lumps
+ Changes in skin color
Swelling in the arms or legs
Painful urination or blood in the urine
Low blood sugar, which may cause:
+ Dizziness or fainting
+ Blurred vision
+ Mood changes
+ Slurred speech
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
+ Seizures

If you experience any of these symptoms, call your doctor right away. If you have low blood sugar, follow your doctor's instructions, which may include taking glucose tablets, liquid glucose, or some fruit juices.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:

Weight gain
Irritation at the injection site
Nose or throat irritation
* Signs of a common cold

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms of low blood sugar (hypoglycemia): sweating, shakiness, dizziness, confusion, hunger, irritability, blurred vision, rapid heartbeat, headache.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, increased urination, fatigue, blurred vision, unexplained weight loss.
  • Symptoms of severe allergic reaction: rash over the whole body, shortness of breath, wheezing, rapid heartbeat, sweating, swelling of face or tongue, trouble breathing.
  • Symptoms of fluid retention/heart failure (if also taking TZDs): unusual weight gain, swelling in ankles/feet, shortness of breath.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have low blood sugar (hypoglycemia), as this may affect your treatment plan.

This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of the following with your doctor and pharmacist:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or supplements you are using
Your vitamin regimen
Any existing health problems or conditions

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions or adverse effects.
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Precautions & Cautions

Important Warnings and Cautions

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Administration Precautions

Do not inject this medication into skin that is thickened, has pits or lumps, or is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.

Solution Inspection

Before use, check the solution for any visible signs of damage or contamination. Do not use the medication if the solution is cloudy, leaking, or contains particles. The solution should be clear and colorless; if it has changed color, do not use it.

Diet and Exercise

Follow the diet and exercise plan recommended by your doctor. Understand the steps to take if you miss a meal or do not eat as much as usual.

Low Blood Sugar Risk

This medication can cause low blood sugar, which may lead to seizures, loss of consciousness, long-term brain damage, and even death. Discuss this risk with your doctor.

Low Blood Potassium Risk

This medication can also cause low blood potassium levels, which may result in abnormal heart rhythms, severe breathing problems, and death if left untreated. Consult your doctor if you have concerns.

Alertness and Activity

Avoid driving and other activities that require alertness until you understand how this medication affects you.

Interactions with Other Diabetes Medications

If you are taking diabetes medications like pioglitazone or rosiglitazone, using insulin with these drugs may increase the risk of heart failure. Discuss this risk with your doctor if you are taking one of these medications.

Insulin Product Identification and Use

Ensure you have the correct insulin product and understand how to measure and prepare your dose. Insulin products are available in various containers, including vials, cartridges, and pens. If you have questions, consult your doctor or pharmacist.

Blood Sugar Control During Stressful Situations

Stressful events like fever, infection, injury, or surgery, as well as changes in physical activity, exercise, or diet, may affect blood sugar control.

Medical Alert Identification

Wear a medical alert ID to identify your condition.

Driving Precautions

Do not drive if you have experienced low blood sugar, as this increases the risk of accidents.

Blood Sugar Monitoring

Monitor your blood sugar levels as directed by your doctor.

Blood Work and Doctor Consultation

Have your blood work checked as recommended by your doctor and discuss the results with them.

Alcohol Consumption

Consult your doctor before consuming alcohol or products containing alcohol.

Insulin Product Sharing

Do not share your insulin product, including pens, cartridge devices, needles, or syringes, with others, even if the needle has been changed, as this can transmit infections.

Needle Disposal

Dispose of needles in a needle/sharp disposal box. Do not reuse needles or other items. Follow local regulations for disposing of the box when it is full, and consult a doctor or pharmacist if you have questions.

Age-Related Precautions

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding

Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of this medication for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (extremely low blood sugar)
  • Hypokalemia (low potassium levels)
  • Confusion
  • Seizures
  • Loss of consciousness (coma)

What to Do:

For mild hypoglycemia, consume fast-acting carbohydrates (e.g., glucose tablets, juice, candy). For severe hypoglycemia, administer glucagon injection if available and call emergency medical services. Seek immediate medical attention. Call 911 or 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Beta-blockers (may mask symptoms of hypoglycemia)
  • Thiazolidinediones (TZDs) (increased risk of fluid retention and heart failure)
  • Alcohol (may potentiate hypoglycemic effect)
  • Corticosteroids (may increase insulin requirements)
  • Diuretics (may increase insulin requirements)
  • Sympathomimetics (may increase insulin requirements)
  • Danazol (may increase insulin requirements)
  • Growth hormone (may increase insulin requirements)
  • Thyroid hormones (may increase insulin requirements)
  • Oral antidiabetic agents (additive effect on glucose lowering)
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Moderate Interactions

  • Salicylates (may enhance hypoglycemic effect)
  • Sulfonamide antibiotics (may enhance hypoglycemic effect)
  • MAO inhibitors (may enhance hypoglycemic effect)
  • ACE inhibitors (may enhance hypoglycemic effect)
  • Angiotensin II receptor blockers (ARBs) (may enhance hypoglycemic effect)
  • Octreotide/Lanreotide (may decrease or increase insulin requirements)
  • Lithium (may decrease or increase insulin requirements)

Monitoring

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Baseline Monitoring

HbA1c

Rationale: To establish baseline glycemic control and set treatment goals.

Timing: Prior to initiation of therapy.

Fasting Plasma Glucose (FPG)

Rationale: To establish baseline glycemic control.

Timing: Prior to initiation of therapy.

Renal function (e.g., eGFR, serum creatinine)

Rationale: To assess kidney function, as insulin requirements may decrease in renal impairment.

Timing: Prior to initiation and periodically thereafter.

Hepatic function (e.g., ALT, AST)

Rationale: To assess liver function, as insulin requirements may decrease in hepatic impairment.

Timing: Prior to initiation and periodically thereafter.

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Routine Monitoring

Blood Glucose (Self-Monitoring Blood Glucose - SMBG)

Frequency: Multiple times daily (e.g., pre-meal, 1-2 hours post-meal, bedtime, overnight) depending on patient's needs and treatment regimen.

Target: Individualized, typically 80-130 mg/dL pre-meal, <180 mg/dL post-meal.

Action Threshold: Hypoglycemia (<70 mg/dL), Hyperglycemia (>180-250 mg/dL depending on target).

HbA1c

Frequency: Every 3-6 months.

Target: <7% for most adults (individualized).

Action Threshold: >7% (or individualized target) indicates need for therapy adjustment.

Weight

Frequency: Periodically (e.g., every 3-6 months).

Target: Maintain healthy weight; monitor for significant weight gain.

Action Threshold: Significant or rapid weight gain may indicate fluid retention or over-insulinization.

Injection sites

Frequency: With each injection.

Target: Rotate sites to prevent lipodystrophy.

Action Threshold: Presence of lumps, pits, or thickening at injection sites.

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Symptom Monitoring

  • Symptoms of hypoglycemia (e.g., sweating, shakiness, dizziness, confusion, hunger, irritability, blurred vision, rapid heartbeat)
  • Symptoms of hyperglycemia (e.g., increased thirst, increased urination, fatigue, blurred vision, unexplained weight loss)
  • Symptoms of allergic reactions (e.g., rash, itching, swelling, difficulty breathing)
  • Symptoms of fluid retention/heart failure (e.g., unusual weight gain, swelling in ankles/feet, shortness of breath)

Special Patient Groups

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Pregnancy

Insulin aspart is generally considered safe and effective for managing diabetes during pregnancy. Insulin requirements typically change during pregnancy, often increasing in the second and third trimesters. Close monitoring of blood glucose is essential.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital malformations attributed to insulin aspart. Strict glycemic control is crucial to minimize risks associated with maternal hyperglycemia.
Second Trimester: Insulin requirements typically increase. Close monitoring and dose adjustments are necessary.
Third Trimester: Insulin requirements continue to increase. Close monitoring and dose adjustments are necessary. Risk of neonatal hypoglycemia if maternal glucose is not well-controlled at delivery.
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Lactation

Insulin aspart is considered compatible with breastfeeding. Insulin is a normal component of breast milk and is not expected to cause adverse effects in a breastfed infant. Maternal insulin requirements may decrease during lactation.

Infant Risk: L1 (Safest - compatible with breastfeeding)
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Pediatric Use

Insulin aspart is approved for use in pediatric patients with diabetes mellitus. Dosing is individualized based on age, weight, and metabolic needs. Close monitoring of blood glucose is crucial to prevent hypoglycemia.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity to insulin's effects may occur in some older individuals. Dose adjustments may be necessary due to age-related decline in renal or hepatic function. Close glucose monitoring is recommended.

Clinical Information

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Clinical Pearls

  • Insulin aspart is a rapid-acting insulin, meaning it should be injected 5-10 minutes before a meal. If a meal is delayed or missed, the dose should be skipped to avoid hypoglycemia.
  • Patients should be educated on proper injection technique, site rotation, and storage of the FlexPen.
  • Always confirm the correct insulin type (rapid-acting vs. long-acting) before administration to prevent dosing errors.
  • Hypoglycemia is the most common and serious adverse effect. Patients should be aware of symptoms and how to treat it.
  • Insulin requirements can change due to illness, stress, changes in diet or exercise, or other medications. Patients should be advised to monitor blood glucose more frequently during these times.
  • The FlexPen is a pre-filled, disposable pen. Patients should be instructed on how to attach a new needle for each injection and how to prime the pen.
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Alternative Therapies

  • Other rapid-acting insulins: Insulin lispro (Humalog), Insulin glulisine (Apidra)
  • Ultra-rapid-acting insulins: Insulin aspart (Fiasp), Insulin lispro (Lyumjev)
  • Short-acting insulins: Regular insulin (Humulin R, Novolin R)
  • Other classes of antidiabetic agents (for Type 2 Diabetes): Metformin, Sulfonylureas, GLP-1 receptor agonists, SGLT2 inhibitors, DPP-4 inhibitors, etc.
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Cost & Coverage

Average Cost: Varies widely, typically $100-$300 per 3ml FlexPen (300 units)
Insurance Coverage: Tier 2 or Tier 3 (preferred brand or non-preferred brand) on most commercial and Medicare Part D plans. Coverage varies by plan.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.