Humalog Mix 50/50 Kwikpen Inj 3ml

Manufacturer LILLY Active Ingredient Insulin Lispro Protamine and Insulin Lispro (Pens)(IN soo lin LYE sproe PROE ta meen & IN soo lin LYE sproe) Pronunciation IN soo lin LYE sproe PROE ta meen & IN soo lin LYE sproe
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 and intermediate-acting combination
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Pregnancy Category
B
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FDA Approved
May 2000
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Humalog Mix 50/50 KwikPen is an injectable medicine that contains two types of insulin: a fast-acting insulin (insulin lispro) and an intermediate-acting insulin (insulin lispro protamine). It helps control blood sugar levels in people with diabetes by helping the body use sugar for energy. The '50/50' means it's half fast-acting and half intermediate-acting, providing both immediate and longer-lasting sugar control.
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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 instruct you on the proper technique.

Preparation and Administration

Before use, this medication must be mixed according to your doctor's instructions. Use the medication immediately after mixing. It is recommended to take the medication within 15 minutes before a meal. Rotate the injection site each time 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.

Inspecting the Medication

Before use, check the medication for any visible issues. The solution should appear cloudy and milky. Do not use the medication if it looks clear or contains lumps. Also, do not use the medication if the powder is stuck to the sides of the container, the solution is leaking, or it contains particles. Additionally, do not use the medication if the solution has changed color.

Using the Pen Needle

Remove all pen needle covers before injecting a dose. If you are unsure about the type of pen needle you have or how to use it, consult your doctor. After each injection, remove the needle and do not store the device with the needle attached. You may hear a clicking sound when preparing the dose, but do not rely on the clicks to determine the correct dose.

Important Safety Information

Do not transfer this medication from the pen to a syringe. Dispose of used needles in a needle/sharp disposal box and do not reuse them. When the box is full, follow local regulations for disposal. If you have any questions or concerns, consult your doctor or pharmacist.

Diet and Exercise

Follow the diet and exercise plan recommended by your doctor. Be aware of what to do if you miss a meal or do not eat as much as usual.

Mixing with Other Insulins

Do not mix this insulin with other types of insulin in the same syringe.

Use in Insulin Pumps

This medication is not suitable for use in insulin pumps. If you have questions, consult your doctor.

Storage and Disposal

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

Missed Doses

If you miss a dose, be aware of what to do. If you are unsure, consult your doctor.
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Lifestyle & Tips

  • Follow your prescribed diet plan and exercise regimen.
  • Monitor your blood sugar levels regularly as instructed by your healthcare provider.
  • Always carry a source of fast-acting sugar (e.g., glucose tablets, juice) to treat low blood sugar.
  • Rotate injection sites to prevent skin problems (lipodystrophy).
  • Do not share your KwikPen with others, even if the needle is changed, due to risk of infection.
  • Store unopened pens in the refrigerator; opened pens can be kept at room temperature for a limited time (check package insert).

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized based on metabolic needs, blood glucose monitoring, and glycemic control goals. Typically administered subcutaneously 15 minutes before a meal or immediately after a meal.

Condition-Specific Dosing:

type1Diabetes: Initial total daily dose often 0.5 to 1 unit/kg/day, with Humalog Mix 50/50 contributing a portion of this, typically split before meals.
type2Diabetes: Initial dose may be 0.2 to 0.6 units/kg/day, adjusted based on blood glucose response.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Individualized based on metabolic needs, similar to adults but with careful monitoring to avoid hypoglycemia.
Adolescent: Individualized based on metabolic needs, similar to adults but with careful monitoring to avoid hypoglycemia.
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Dose Adjustments

Renal Impairment:

Mild: Dose adjustment may be required; monitor glucose closely.
Moderate: Dose reduction often required due to decreased insulin clearance; monitor glucose closely.
Severe: Significant dose reduction often required; monitor glucose closely and frequently.
Dialysis: Dose reduction required; monitor glucose closely, especially post-dialysis.

Hepatic Impairment:

Mild: Dose adjustment may be required; monitor glucose closely.
Moderate: Dose reduction often required due to decreased gluconeogenesis and insulin clearance; monitor glucose closely.
Severe: Significant dose reduction often required; monitor glucose closely and frequently.

Pharmacology

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Mechanism of Action

Insulin lispro protamine and insulin lispro are human insulin analogs that lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis. Insulin lispro has a rapid onset and short duration of action due to its rapid absorption, while insulin lispro protamine is an intermediate-acting insulin due to its slower absorption from the injection site.
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Pharmacokinetics

Absorption:

Bioavailability: Highly variable (subcutaneous administration); not typically expressed as a percentage.
Tmax: Insulin Lispro: 0.5-1.5 hours; Insulin Lispro Protamine: 6-8 hours
FoodEffect: Administered in relation to meals (15 minutes before or immediately after) to optimize postprandial glucose control.

Distribution:

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

Elimination:

HalfLife: Insulin Lispro: Approximately 1 hour; Insulin Lispro Protamine: Longer due to delayed absorption, contributing to up to 24-hour duration.
Clearance: Not precisely quantified for combination, but cleared by insulin-degrading enzyme.
ExcretionRoute: Primarily renal
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Insulin Lispro: 10-20 minutes; Insulin Lispro Protamine: 60-90 minutes
PeakEffect: Insulin Lispro: 0.5-1.5 hours; Insulin Lispro Protamine: 6-8 hours
DurationOfAction: Insulin Lispro: 3-5 hours; Insulin Lispro Protamine: Up to 24 hours
Confidence: Medium

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Attention Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:

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
Note: In rare cases, allergic reactions can be life-threatening.
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Thick skin, pits, or lumps at the injection site
Swelling in the arms or legs
Shortness of breath
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 low blood sugar, follow your doctor's instructions, which may include taking glucose tablets, liquid glucose, or consuming 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:

Irritation at the injection site
* Weight gain

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, shaking, dizziness, confusion, hunger, irritability, blurred vision, rapid heartbeat. Treat immediately.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, fatigue, blurred vision, unexplained weight loss. Contact your doctor.
  • Signs of allergic reaction: rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing. Seek immediate medical attention.
  • Signs of injection site reactions: redness, swelling, itching, pain, or changes in skin texture (lumps or pits) at the injection site.
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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 medication can interact with other drugs and health conditions. To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or diseases

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 any potential interactions or adverse effects.
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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. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

Be aware that this medication can cause low blood sugar, which may lead to seizures, loss of consciousness, permanent brain damage, and even death if not properly managed. Discuss this risk with your doctor.

Additionally, this medication can cause low blood potassium levels, which, if left untreated, can result in abnormal heart rhythms, severe breathing difficulties, and potentially death. Consult your doctor if you have concerns.

If you are taking diabetes medications like pioglitazone or rosiglitazone, be aware that they may increase the risk of heart failure or worsen existing heart failure. Using insulin with these medications may further increase this risk. If you are taking one of these medications, discuss this with your doctor.

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, contact your doctor or pharmacist.

Stressful situations, such as fever, infection, injury, or surgery, can make it more challenging to control blood sugar levels. Changes in physical activity, exercise, or diet can also impact blood sugar control.

Wear a medical alert identification to indicate your condition. Avoid driving if you have experienced low blood sugar, as it increases the risk of accidents.

Monitor your blood sugar levels as directed by your doctor. Regular blood tests, as recommended by your doctor, are also crucial to ensure safe treatment.

Before consuming alcohol or using products containing alcohol, consult your doctor. 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.

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 benefits and risks of this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (very low blood sugar)
  • Confusion
  • Seizures
  • Loss of consciousness (coma)

What to Do:

If conscious, consume fast-acting carbohydrates (e.g., glucose tablets, fruit juice, candy). If unconscious, administer glucagon injection (if available and trained) and seek immediate medical attention. Call 911 or your local emergency number. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

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Major Interactions

  • Beta-blockers (may mask hypoglycemia symptoms, prolong hypoglycemia)
  • Corticosteroids (increase blood glucose, may require increased insulin dose)
  • Thiazide diuretics (increase blood glucose, may require increased insulin dose)
  • Sympathomimetics (increase blood glucose, may require increased insulin dose)
  • Growth hormone (increase blood glucose, may require increased insulin dose)
  • Danazol (increase blood glucose, may require increased insulin dose)
  • Alcohol (potentiates hypoglycemic effect)
  • 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)
  • Sulfonylureas (increased risk of hypoglycemia)
  • Thiazolidinediones (TZDs) (increased risk of fluid retention and heart failure when used with insulin)
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Moderate Interactions

  • Certain atypical antipsychotics (may cause hyperglycemia)
  • Protease inhibitors (variable effects on glucose metabolism)
  • Somatostatin analogs (e.g., octreotide, may decrease insulin requirements)

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 Blood Glucose (FBG)

Rationale: To establish baseline glycemic control.

Timing: Prior to initiation of therapy.

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

Rationale: To assess kidney function, as insulin clearance can be affected, requiring dose adjustments.

Timing: Prior to initiation and periodically thereafter.

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

Rationale: To assess liver function, as insulin metabolism can be affected, requiring dose adjustments.

Timing: Prior to initiation and periodically thereafter.

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Routine Monitoring

Self-Monitoring 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 post-meal

Action Threshold: Below 70 mg/dL (hypoglycemia) or consistently above target range (hyperglycemia)

HbA1c

Frequency: Every 3-6 months

Target: Individualized, typically <7% for most adults

Action Threshold: Consistently above target range

Weight

Frequency: Periodically

Target: Maintain healthy weight

Action Threshold: Significant unexplained weight gain or loss

Injection sites

Frequency: With each injection

Target: Rotate sites

Action Threshold: Presence of lipodystrophy or irritation

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Symptom Monitoring

  • Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger, irritability, blurred vision, palpitations)
  • Symptoms of hyperglycemia (e.g., increased thirst, increased urination, fatigue, blurred vision, unexplained weight loss)
  • Signs of injection site reactions (e.g., redness, swelling, itching, pain, lipodystrophy)

Special Patient Groups

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Pregnancy

Insulin is the preferred treatment for diabetes in pregnancy. Humalog Mix 50/50 can be used, but careful monitoring of blood glucose is essential to minimize risks to both mother and fetus. Dose requirements may change throughout pregnancy.

Trimester-Specific Risks:

First Trimester: Risk of congenital malformations is associated with poor glycemic control, not insulin itself. Tight control is crucial.
Second Trimester: Insulin requirements typically increase.
Third Trimester: Insulin requirements typically increase, then may decrease shortly before delivery.
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Lactation

Insulin is compatible with breastfeeding. Insulin is a normal component of breast milk and is not harmful to the infant. Dose adjustments may be needed for the mother.

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

Dosing must be individualized and carefully monitored in pediatric patients due to varying insulin sensitivity and growth patterns. Risk of hypoglycemia is a concern.

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Geriatric Use

Elderly patients may be more susceptible to the hypoglycemic effects of insulin and may have impaired renal or hepatic function, requiring lower doses and more careful monitoring. Cognitive impairment may affect self-management.

Clinical Information

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Clinical Pearls

  • Humalog Mix 50/50 should be administered subcutaneously 15 minutes before a meal or immediately after a meal.
  • Always rotate injection sites within the same region (e.g., abdomen, thigh, upper arm) to reduce the risk of lipodystrophy.
  • Do not mix Humalog Mix 50/50 with other insulins or solutions.
  • Visually inspect the suspension before use; it should appear uniformly cloudy. If it looks clear or has particles, do not use it.
  • Patients should be educated on the symptoms and management of hypoglycemia.
  • Ensure patients understand the difference between the rapid-acting and intermediate-acting components and how they contribute to overall glucose control.
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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, SGLT2 inhibitors, GLP-1 receptor agonists - often used in combination with insulin or as monotherapy for Type 2 Diabetes)
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Cost & Coverage

Average Cost: Varies widely, typically $100-$300+ per 3ml KwikPen
Insurance Coverage: Tier 2 or 3 (Brand-name prescription drug)
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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 your 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.