Insulin Aspa Mix 70/30 Flexpen, 3ml

Manufacturer NOVO NORDISK Active Ingredient Insulin Aspart Protamine and Insulin Aspart (Cartridges and Prefilled Pens)(IN soo lin AS part PROE ta meen & IN soo lin AS part) Pronunciation IN-soo-lin AS-part PROH-tuh-meen & IN-soo-lin AS-part
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 analog, biphasic
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Pregnancy Category
Category B
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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 Aspa Mix 70/30 is a pre-mixed insulin that contains both a fast-acting insulin (insulin aspart) and an intermediate-acting insulin (insulin aspart protamine). It helps control blood sugar levels in people with diabetes by helping the body use sugar for energy. It's typically injected under the skin before meals.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, 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 Guidelines

For individuals with type 1 diabetes, take the medication within 15 minutes before starting a meal.
For individuals with type 2 diabetes, take the medication within 15 minutes before or after starting a meal.
Rotate the injection site with each use to avoid tissue damage.
Avoid injecting into skin that is thickened, has pits or lumps, or is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.

Preparing the Medication

Before administering the dose, gently roll the container in your hands as instructed by your doctor. The medication should appear cloudy and milky when ready to use. Do not use the medication if:
The solution appears clear
The solution contains lumps
Powder is stuck to the sides of the container
The solution is leaking or contains particles
The solution has changed color

Disposing of Needles and Supplies

Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other supplies. When the box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.

Important Safety Information

Do not mix this insulin with other types of insulin in the same syringe.
Follow the diet and exercise plan recommended by your doctor.
Be aware of the steps to take if you miss a meal or do not eat as much as usual.
This medication is not suitable for use in an insulin pump. If you have questions, consult your doctor.

Using the Pen Device

Remove all pen needle covers before injecting a dose (there may be two covers).
If you are unsure about the type of pen needle or how to use it, consult your doctor.
The device may make a clicking sound when preparing the dose. Do not rely on the clicking sound to determine the dose, as this may lead to an incorrect dose.
Remove the needle after each injection and do not store the device with the needle attached.
Do not transfer the medication from the pen to a syringe.

Storage and Disposal

Store unopened containers in the refrigerator. Do not freeze the medication, and do not use it if it has been frozen.

Missing a Dose

If you forget to take a dose, follow the plan discussed with your doctor. If you are unsure about what to do, contact your doctor for guidance.
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Lifestyle & Tips

  • Follow your prescribed diet plan consistently.
  • Engage in regular physical activity as advised by your healthcare provider.
  • Monitor your blood glucose levels regularly as instructed.
  • Always carry a source of fast-acting sugar (e.g., glucose tablets, fruit juice) to treat low blood sugar.
  • Rotate injection sites to prevent skin problems (lipodystrophy).
  • Never share your insulin pen or needles with others.
  • Store insulin properly (refrigerated before opening, at room temperature after opening for a limited time).

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized based on metabolic needs, blood glucose monitoring, and HbA1c. Typically administered subcutaneously 15 minutes before a meal (breakfast and/or dinner). Initial dose often 6 units before breakfast and 6 units before dinner, or 0.1-0.2 units/kg/day divided into two doses.
Dose Range: 0.1 - 2.5 mg

Condition-Specific Dosing:

Type 1 Diabetes: Total daily dose typically 0.5-1.0 units/kg/day, with biphasic insulin often comprising 50-70% of the total daily insulin requirement.
Type 2 Diabetes: Initial dose often 6 units before breakfast and 6 units before dinner, or 0.1-0.2 units/kg/day. Titrate based on blood glucose levels.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Individualized based on metabolic needs and blood glucose monitoring. Initial dose typically 0.5-1.0 units/kg/day for Type 1 Diabetes, divided into two doses before meals.
Adolescent: Individualized based on metabolic needs and blood glucose monitoring. Initial dose typically 0.5-1.0 units/kg/day for Type 1 Diabetes, divided into two doses before meals.
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Dose Adjustments

Renal Impairment:

Mild: Dose adjustment may be required; monitor glucose closely.
Moderate: Dose reduction likely required; monitor glucose closely.
Severe: Significant dose reduction required; monitor glucose closely and frequently.
Dialysis: Dose reduction required; monitor glucose closely and frequently, especially post-dialysis.

Hepatic Impairment:

Mild: Dose adjustment may be required; monitor glucose closely.
Moderate: Dose reduction likely required; monitor glucose closely.
Severe: Significant dose reduction required; monitor glucose closely and frequently.

Pharmacology

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Mechanism of Action

Insulin aspart is a rapid-acting insulin analog, and insulin aspart protamine is an intermediate-acting insulin analog. Both lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin also inhibits lipolysis and proteolysis, and enhances protein synthesis.
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Pharmacokinetics

Absorption:

Bioavailability: High (subcutaneous administration)
Tmax: Insulin Aspart: 0.8-1.7 hours; Insulin Aspart Protamine: 4-12 hours (for the protamine component)
FoodEffect: Administered before meals to cover postprandial glucose excursions.

Distribution:

Vd: Approximately 0.1-0.2 L/kg
ProteinBinding: <10%
CnssPenetration: Limited

Elimination:

HalfLife: Insulin Aspart: Approximately 1 hour; Insulin Aspart Protamine: Longer, contributing to intermediate action (effective half-life of the mixture is longer than aspart alone)
Clearance: Not readily quantifiable due to complex metabolism and distribution.
ExcretionRoute: Renal (metabolites)
Unchanged: <2% (renal excretion of unchanged insulin)
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Pharmacodynamics

OnsetOfAction: Insulin Aspart: 10-20 minutes; Insulin Aspart Protamine: 1-2 hours
PeakEffect: Insulin Aspart: 1-3 hours; Insulin Aspart Protamine: 4-12 hours
DurationOfAction: Insulin Aspart: 3-5 hours; Insulin Aspart Protamine: Up to 24 hours (for the mixture)
Confidence: Medium

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 medical attention immediately:

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.
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An abnormal heartbeat
Unusual burning, numbness, or tingling sensations
Swelling in the arms or legs
Thick skin, pits, or lumps at the injection site
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 report any concerns to your doctor. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Headache
Back pain
Stomach pain or diarrhea
Heartburn
Weight gain
Irritation at the injection site
Flu-like symptoms
* Common cold symptoms

This is not an exhaustive list of possible side effects. If you have questions or concerns, contact 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, shaking, dizziness, confusion, hunger, irritability, blurred vision, headache. Treat immediately.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, fatigue, blurred vision. Report to your doctor.
  • Symptoms of allergic reaction: rash, itching, swelling, difficulty breathing. Seek immediate medical attention.
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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.
Certain health conditions, including:
+ Acidic blood problems
+ Low blood sugar

This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.

Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins

It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

This drug can cause low blood sugar, which may lead to seizures, loss of consciousness, permanent brain damage, and even death if not properly managed. It is crucial to discuss this risk with your doctor. Additionally, this medication can cause low blood potassium levels, which, if left untreated, may result in abnormal heart rhythms, severe breathing difficulties, and potentially death. If you experience any symptoms, consult your doctor promptly.

Until you understand how this medication affects you, avoid driving and other activities that require your full attention. Certain diabetes medications, such as pioglitazone or rosiglitazone, can increase the risk of heart failure, especially when used in combination with insulin. If you are taking one of these medications, consult your doctor to discuss the potential risks.

Ensure you are using the correct insulin product, as they come in various containers, including vials, cartridges, and pens. If you are unsure about measuring or preparing your dose, consult your doctor or pharmacist for guidance.

During stressful periods, such as illness, infection, injury, or surgery, it may be more challenging to control your blood sugar levels. Changes in physical activity, exercise, or diet can also impact your blood sugar control.

Wear a medical alert identification to ensure prompt care in case of an emergency. Avoid driving if you have experienced low blood sugar, as it can increase your risk of being involved in an accident.

Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests as scheduled. Consult your doctor before consuming alcohol or using products containing alcohol.

Do not share your insulin product, including pens, cartridge devices, needles, or syringes, with anyone else, even if the needle has been changed. Sharing can transmit infections, including those you may not be aware of having.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (very low blood sugar)
  • Confusion
  • Drowsiness
  • Blurred vision
  • Slurred speech
  • Muscle weakness
  • Seizures
  • Loss of consciousness
  • Coma

What to Do:

For mild to moderate hypoglycemia, consume 15-20 grams of fast-acting carbohydrates (e.g., glucose tablets, fruit juice, regular soda). Recheck blood glucose in 15 minutes and repeat if still low. For severe hypoglycemia (unconsciousness or inability to swallow), administer glucagon injection if available and call emergency medical services (e.g., 911 in the US). Call 1-800-222-1222 (Poison Control) for further guidance.

Drug Interactions

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Major Interactions

  • Beta-blockers (may mask symptoms of hypoglycemia, prolong recovery from hypoglycemia)
  • Thiazolidinediones (TZDs) (increased risk of fluid retention and heart failure)
  • Corticosteroids (may increase blood glucose, requiring higher insulin doses)
  • Diuretics (thiazide and loop diuretics may increase blood glucose)
  • Sympathomimetics (may increase blood glucose)
  • Growth hormone (may increase blood glucose)
  • Danazol (may increase blood glucose)
  • Oral contraceptives (may increase blood glucose)
  • Protease inhibitors (may increase blood glucose)
  • Atypical antipsychotics (may increase blood glucose)
  • Alcohol (may potentiate or reduce hypoglycemic effect)
  • Sulfonylureas (increased risk of hypoglycemia)
  • GLP-1 receptor agonists (increased risk of hypoglycemia)
  • Pramlintide (increased risk of hypoglycemia)
  • Salicylates (e.g., aspirin, may enhance hypoglycemic effect)
  • MAO inhibitors (may enhance hypoglycemic effect)
  • ACE inhibitors (may enhance hypoglycemic effect)
  • Angiotensin receptor blockers (ARBs) (may enhance hypoglycemic effect)
  • Somatostatin analogs (e.g., octreotide, may increase or decrease insulin requirements)
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Moderate Interactions

  • Certain antidepressants (e.g., SSRIs, may affect glucose metabolism)
  • Lithium (may affect glucose metabolism)
  • Pentamidine (may cause hypoglycemia followed by hyperglycemia)

Monitoring

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Baseline Monitoring

HbA1c

Rationale: To establish baseline glycemic control and guide initial dosing.

Timing: Prior to initiation of therapy.

Fasting Plasma Glucose (FPG)

Rationale: To establish baseline glycemic control.

Timing: Prior to initiation of therapy.

Renal function (eGFR, BUN, Creatinine)

Rationale: To assess kidney function as insulin clearance can be affected.

Timing: Prior to initiation and periodically thereafter.

Hepatic function (ALT, AST, Bilirubin)

Rationale: To assess liver function as insulin metabolism can be affected.

Timing: Prior to initiation and periodically thereafter.

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Routine Monitoring

Self-monitoring of Blood Glucose (SMBG)

Frequency: Multiple times daily (e.g., pre-meal, 2-hour post-meal, bedtime, overnight if needed)

Target: Individualized, typically 80-130 mg/dL pre-meal, <180 mg/dL 2-hour post-meal

Action Threshold: Hypoglycemia (<70 mg/dL) or persistent hyperglycemia (>180 mg/dL) requiring dose adjustment.

HbA1c

Frequency: Every 3-6 months

Target: Individualized, typically <7% for most adults

Action Threshold: Above target range indicating need for therapy adjustment.

Signs and symptoms of hypoglycemia

Frequency: Daily, ongoing

Target: Absence of symptoms

Action Threshold: Presence of symptoms requires immediate action (e.g., consume fast-acting carbohydrates).

Injection site inspection

Frequency: Regularly (e.g., daily)

Target: Absence of lipodystrophy, redness, swelling

Action Threshold: Presence of abnormalities requires site rotation or medical evaluation.

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Symptom Monitoring

  • Symptoms of hypoglycemia: sweating, tremor, dizziness, confusion, hunger, irritability, blurred vision, headache, rapid heartbeat, anxiety, slurred speech, weakness, seizures, unconsciousness.
  • Symptoms of hyperglycemia: increased thirst, increased urination, fatigue, blurred vision, weight loss.
  • Symptoms of allergic reaction: rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing.

Special Patient Groups

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Pregnancy

Insulin is the preferred treatment for diabetes in pregnancy. Insulin aspart is considered safe for use during pregnancy. Close monitoring of blood glucose is essential, and insulin requirements may change throughout pregnancy.

Trimester-Specific Risks:

First Trimester: Insulin requirements may decrease due to nausea/vomiting. Close monitoring needed to prevent hypoglycemia.
Second Trimester: Insulin requirements typically increase due to hormonal changes and insulin resistance.
Third Trimester: Insulin requirements continue to increase, often peaking in the late third trimester. Close monitoring for hypoglycemia and hyperglycemia is crucial.
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Lactation

Insulin is compatible with breastfeeding. Insulin is a large protein molecule and is not excreted into breast milk in clinically significant amounts. It is not expected to cause adverse effects in breastfed infants.

Infant Risk: Low risk to infant.
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Pediatric Use

Dosing must be individualized and carefully titrated based on blood glucose monitoring, dietary intake, and activity levels. Children and adolescents with Type 1 diabetes often require insulin. Close supervision by a healthcare professional experienced in pediatric diabetes management is essential.

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Geriatric Use

Older adults may be at increased risk of hypoglycemia due to impaired renal/hepatic function, polypharmacy, and reduced awareness of hypoglycemic symptoms. Dosing should be conservative, and blood glucose targets may be less stringent. Close monitoring is crucial.

Clinical Information

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Clinical Pearls

  • Always check the insulin label carefully before each injection to ensure the correct type of insulin is being used.
  • Never share insulin pens or needles between patients, even if the needle is changed, due to the risk of bloodborne pathogen transmission.
  • Inject insulin subcutaneously into the abdomen, thigh, or upper arm. Rotate injection sites within the same region to reduce the risk of lipodystrophy.
  • This product is a suspension and must be gently rolled or inverted 10 times before each injection until the mixture appears uniformly white and cloudy.
  • Administer 15 minutes before a meal. If a meal is missed, do not administer the dose.
  • Educate patients on the signs and symptoms of hypoglycemia and how to treat it effectively.
  • Patients should carry medical identification indicating they have diabetes.
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Alternative Therapies

  • Basal-bolus insulin regimens (e.g., long-acting insulin + rapid-acting insulin with meals)
  • Basal insulin only (e.g., insulin glargine, insulin detemir, insulin degludec)
  • Oral antidiabetic medications (e.g., metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists) for Type 2 Diabetes.
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Cost & Coverage

Average Cost: Varies widely, typically $100-$300 per 3ml FlexPen
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.