Humalog Mix 75/25 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 analog, rapid-acting and intermediate-acting
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Pregnancy Category
Category B
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FDA Approved
May 1999
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Humalog Mix 75/25 is a pre-mixed insulin that contains two types of insulin: a fast-acting insulin (lispro) and an intermediate-acting insulin (lispro protamine). It helps your body use sugar for energy and lowers blood sugar levels. It's typically given before meals to help control blood sugar spikes after eating and provide longer-lasting 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 the instructions provided by your doctor. 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 damaging the skin.

Important Administration Guidelines

Do not inject the medication into skin that is thickened, has pits or lumps, or is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. The medication should appear cloudy and milky when ready to use. Do not use the medication if the solution is clear or contains lumps. Additionally, do not use the medication if the powder is stuck to the sides of the container, the solution is leaking, or the solution contains particles or 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 use the clicks to determine the dose. Never transfer the medication from the pen to a syringe.

Disposing of Needles and Supplies

Dispose of used needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for disposal. If you have any questions, 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 do not eat as much as normal or if you skip a meal.

Important Warnings

Do not mix this insulin with other types of insulin in the same syringe. This medication is not suitable for use in an insulin pump. If you have any questions or concerns, consult your doctor.

Storage and Disposal

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

Missed Dose

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 healthcare provider's instructions for diet and exercise.
  • Monitor your blood glucose levels regularly as instructed.
  • Do not skip meals or delay meals after injecting this insulin.
  • Always carry a source of fast-acting sugar (e.g., glucose tablets, juice) to treat low blood sugar.
  • Rotate injection sites within the same region (e.g., abdomen) to prevent lipodystrophy.
  • Never share insulin pens or needles with others, even if the needle is changed, due to risk of infection.

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:

Type 1 Diabetes: Initial total daily dose often 0.5 to 1 unit/kg/day, with Humalog Mix 75/25 contributing to both basal and prandial needs. Dosing is highly individualized.
Type 2 Diabetes: Initial dose often 0.2 to 0.6 units/kg/day, or 6-10 units once or twice daily, adjusted based on blood glucose levels.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Individualized based on metabolic needs, blood glucose monitoring, and glycemic control goals. Dosing is highly individualized and requires close supervision.
Adolescent: Individualized based on metabolic needs, blood glucose monitoring, and glycemic control goals. Dosing is highly individualized and requires close supervision.
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Dose Adjustments

Renal Impairment:

Mild: Dose adjustment may be required; monitor glucose closely.
Moderate: Dose adjustment likely required; monitor glucose closely and frequently.
Severe: Significant dose reduction likely required; monitor glucose closely and frequently. Increased risk of hypoglycemia.
Dialysis: Dose adjustment required; monitor glucose closely. Insulin requirements may be reduced.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Insulin lispro protamine is an intermediate-acting insulin analog, and insulin lispro is a rapid-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 inhibits lipolysis and proteolysis, and enhances protein synthesis.
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Pharmacokinetics

Absorption:

Bioavailability: High (subcutaneous administration)
Tmax: Insulin Lispro: 0.5-1.5 hours; Insulin Lispro Protamine: 6-8 hours (for the mixture, peak effect is broader due to both components)
FoodEffect: Administered before or immediately after a meal to coincide with postprandial glucose rise.

Distribution:

Vd: Approximately 0.1-0.2 L/kg
ProteinBinding: Minimal
CnssPenetration: Limited

Elimination:

HalfLife: Insulin Lispro: Approximately 1 hour; Insulin Lispro Protamine: Longer, contributing to the prolonged action of the mixture.
Clearance: Varies, primarily renal and hepatic clearance.
ExcretionRoute: Renal
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: 10-20 minutes (due to insulin lispro component)
PeakEffect: 1-6 hours (due to combined action of both components)
DurationOfAction: Up to 18-24 hours (due to insulin lispro protamine component)
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 signs or symptoms, contact your doctor or seek medical attention immediately:

Allergic reaction symptoms, 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
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
Swelling in the arms or legs
Shortness of breath
Low blood sugar symptoms, which may include:
+ 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 for treatment, 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. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Irritation at the injection site
Weight gain

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to your doctor.

Reporting Side Effects

To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor is also available to provide guidance on managing side effects.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms of low blood sugar (hypoglycemia): sweating, shaking, dizziness, confusion, hunger, irritability, headache. Treat immediately with fast-acting sugar.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, fatigue, blurred vision. Contact your doctor if persistent.
  • Symptoms of allergic reaction: rash, itching, swelling of face/tongue/throat, severe dizziness, trouble 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.
If you have low blood sugar (hypoglycemia), as this may affect your treatment plan.

This medication may interact with other medications or health conditions. Therefore, 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 existing health problems

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication in combination with your other medications and health conditions.
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Precautions & Cautions

Important Warnings and Cautions

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

Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and other tasks that require alertness.

Risk of Low Blood Sugar
This medication can cause low blood sugar, which may lead to seizures, loss of consciousness, permanent brain damage, and even death. Consult your doctor to discuss this risk.

Risk of Low Blood Potassium
This medication can also cause low blood potassium levels, which can lead to abnormal heart rhythms, severe breathing problems, and death if left untreated. Talk to your doctor about this potential risk.

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, especially if you already have heart failure. Discuss this risk with your doctor.

Proper Insulin Product Handling
Ensure you have the correct insulin product and understand how to measure and prepare your dose. Insulin products come in various containers, such as vials, cartridges, and pens. If you have any questions, consult your doctor or pharmacist.

Blood Sugar Control During Stressful Situations
Stressful events like fever, infection, injury, or surgery can make it more challenging to control your blood sugar levels. Changes in physical activity, exercise, or diet can also affect your blood sugar levels.

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 can increase your risk of being involved in an accident.

Monitoring Your Condition
Check your blood sugar levels as directed by your doctor and have regular blood work done as recommended.

Alcohol Consumption
Consult your doctor before consuming alcohol or using products that contain alcohol.

Insulin Product Sharing
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 spread infections, including those you may not be aware of having.

Special Precautions for Older Adults and Pregnant or Breastfeeding Women
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
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Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (extremely low blood sugar)
  • Confusion
  • Seizures
  • Unconsciousness
  • Hypokalemia (low potassium levels)

What to Do:

For mild to moderate hypoglycemia, consume fast-acting carbohydrates. For severe hypoglycemia, administer glucagon injection or seek immediate medical attention. Call 911 or 1-800-222-1222 (Poison Control Center).

Drug Interactions

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Major Interactions

  • Pramlintide (increased risk of severe hypoglycemia; reduce insulin dose)
  • Thiazolidinediones (TZDs) (increased risk of fluid retention and heart failure)
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Moderate Interactions

  • Beta-blockers (may mask symptoms of hypoglycemia, prolong recovery from hypoglycemia)
  • ACE inhibitors (may enhance insulin's glucose-lowering effect)
  • Angiotensin Receptor Blockers (ARBs) (may enhance insulin's glucose-lowering effect)
  • Salicylates (e.g., aspirin) (may enhance insulin's glucose-lowering effect)
  • Sulfonamide antibiotics (may enhance insulin's glucose-lowering effect)
  • MAO inhibitors (may enhance insulin's glucose-lowering effect)
  • Alcohol (may potentiate or diminish insulin's glucose-lowering effect)
  • Corticosteroids (may decrease insulin's glucose-lowering effect)
  • Diuretics (e.g., thiazides, loop diuretics) (may decrease insulin's glucose-lowering effect)
  • Sympathomimetics (e.g., decongestants, beta-2 agonists) (may decrease insulin's glucose-lowering effect)
  • Niacin (may decrease insulin's glucose-lowering effect)
  • Oral contraceptives (may decrease insulin's glucose-lowering effect)
  • Thyroid hormones (may decrease insulin's glucose-lowering effect)
  • Atypical antipsychotics (e.g., olanzapine, clozapine) (may decrease insulin's glucose-lowering effect)
  • Protease inhibitors (may decrease insulin's glucose-lowering effect)

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 glucose levels.

Timing: Prior to initiation of therapy

Renal function (e.g., SCr, eGFR)

Rationale: To assess kidney function, as insulin clearance can be affected by renal impairment.

Timing: Prior to initiation of therapy

Hepatic function (e.g., LFTs)

Rationale: To assess liver function, as insulin metabolism can be affected by hepatic impairment.

Timing: Prior to initiation of therapy

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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 as needed)

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

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

HbA1c

Frequency: Every 3-6 months

Target: Individualized, typically <7%

Action Threshold: >7% (consider dose adjustment or therapy change)

Signs and symptoms of hypoglycemia

Frequency: Daily, ongoing

Target: N/A

Action Threshold: Presence of symptoms (e.g., sweating, tremor, confusion, hunger, dizziness)

Signs and symptoms of hyperglycemia

Frequency: Daily, ongoing

Target: N/A

Action Threshold: Presence of symptoms (e.g., polyuria, polydipsia, polyphagia, fatigue, blurred vision)

Injection site inspection

Frequency: Daily

Target: N/A

Action Threshold: Presence of lipodystrophy, redness, swelling, or pain

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Symptom Monitoring

  • Hypoglycemia: Sweating, tremor, dizziness, confusion, hunger, irritability, headache, blurred vision, rapid heartbeat, anxiety, weakness, slurred speech, seizures, unconsciousness.
  • Hyperglycemia: Increased thirst, increased urination, increased hunger, fatigue, blurred vision, headache, dry mouth, fruity breath odor (in severe cases).

Special Patient Groups

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Pregnancy

Insulin is the preferred treatment for managing diabetes in pregnancy, as it does not cross the placenta in significant amounts. Humalog Mix 75/25 can be used, but careful monitoring and dose adjustments are crucial to maintain strict glycemic control.

Trimester-Specific Risks:

First Trimester: Poor glycemic control in early pregnancy increases risk of congenital malformations. Insulin is generally safe.
Second Trimester: Insulin requirements may increase. Close monitoring of blood glucose is essential.
Third Trimester: Insulin requirements may continue to increase. Close monitoring of blood glucose is essential. Risk of macrosomia and other complications if glucose is not controlled.
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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. Insulin requirements may be lower in breastfeeding mothers.

Infant Risk: L1 (Safest)
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Pediatric Use

Dosing must be individualized and carefully monitored in pediatric patients. Insulin requirements can vary significantly with age, puberty, and growth spurts. Close supervision by a healthcare professional experienced in pediatric diabetes is essential.

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Geriatric Use

Older adults may be more susceptible to hypoglycemia due to impaired renal/hepatic function, polypharmacy, and reduced awareness of hypoglycemic symptoms. Dosing should be conservative, and blood glucose monitoring should be frequent. Glycemic targets may be less stringent to avoid hypoglycemia.

Clinical Information

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Clinical Pearls

  • Humalog Mix 75/25 is a suspension; it must be gently rolled between the palms 10 times and inverted 10 times immediately before each injection to ensure uniform mixing.
  • Administer 15 minutes before a meal or immediately after a meal. Consistency in timing relative to meals is important.
  • Never administer intravenously. This product is for subcutaneous injection only.
  • Do not mix with other insulins or solutions.
  • Patients should be educated on recognizing and treating hypoglycemia, and on proper injection technique and site rotation.
  • Unopened pens should be stored in the refrigerator (36°F-46°F [2°C-8°C]). Once opened, pens can be stored at room temperature (below 86°F [30°C]) for up to 10 days. Do not freeze.
  • Insulin requirements may change during illness, stress, or changes in diet/exercise.
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Alternative Therapies

  • Basal-bolus insulin regimens (e.g., long-acting insulin + rapid-acting insulin)
  • Oral antidiabetic medications (e.g., metformin, sulfonylureas, SGLT2 inhibitors, GLP-1 receptor agonists) for Type 2 Diabetes
  • Other insulin regimens (e.g., multiple daily injections, continuous subcutaneous insulin infusion)
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Cost & Coverage

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

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with additional patient information leaflets, so it is a good idea to consult with your pharmacist for more details. If you have any questions or concerns about your 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 reporting the incident, be prepared to provide information about the medication taken, the amount, and the time it occurred.