Humalog 200 U/ml Kwikpen Inj 3ml

Manufacturer LILLY Active Ingredient Insulin Lispro (U-200) Pens(IN soo lin LYE sproe) Pronunciation 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
Rapid-acting insulin analog
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Pregnancy Category
Category B
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FDA Approved
Mar 2015
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Humalog 200 U/ml KwikPen is a concentrated, fast-acting insulin used to lower high blood sugar in adults with diabetes. It is typically taken just before or after meals to help your body use sugar for energy. It comes in a pre-filled pen that delivers twice the amount of insulin in the same volume compared to standard insulin pens, so it's important to use only this specific pen and not to transfer the insulin to a syringe.
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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 under the skin. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.

Administration Instructions

Take the medication within 15 minutes before or immediately after 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.
Do not use the medication if the solution appears cloudy, is leaking, or contains particles, or if the solution has changed color.

Preparing the Dose

Remove all pen needle covers before injecting a dose. If you have any questions about the type of pen needle you are using or how to use it, consult your doctor.
Be aware that the device may produce a clicking sound when preparing the dose. However, do not rely on the clicks to determine the correct dose, as this could lead to an incorrect dose being administered.
After each injection, remove the needle from the device and do not store the device with the needle attached.

Safety Precautions

Do not transfer the medication from the pen to a syringe or mix it with other types of insulin.
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items, and follow local regulations for disposing of the box when it is full. 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 miss a meal or do not eat as much as usual.

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 forget to take a dose, be aware of the steps to take. If you are unsure, contact your doctor for guidance.
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Lifestyle & Tips

  • Follow your prescribed diet plan, including carbohydrate counting if advised.
  • Engage in regular physical activity as recommended by your doctor.
  • Monitor your blood glucose levels regularly as instructed.
  • Rotate injection sites within the same general area (e.g., abdomen, thigh, upper arm) to prevent lipodystrophy.
  • Never share your KwikPen with another person, 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. Administer subcutaneously 5-10 minutes before a meal or within 20 minutes after starting a meal. Dosing is in units, but the U-200 KwikPen delivers half the volume of a U-100 pen for the same number of units.

Condition-Specific Dosing:

Type 1 Diabetes: Typically 0.5 to 1 unit/kg/day total insulin, with rapid-acting insulin comprising 50-70% of daily dose, divided before meals.
Type 2 Diabetes: Initial dose often 4 units or 0.1 units/kg/day, adjusted based on blood glucose levels and carbohydrate intake.
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Pediatric Dosing

Neonatal: Not established (U-200 not recommended)
Infant: Not established (U-200 not recommended)
Child: Not established (U-200 not recommended)
Adolescent: Not established (U-200 not recommended)
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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.
Severe: Significant dose reduction likely required; monitor glucose closely and frequently.
Dialysis: Dose adjustment required; monitor glucose closely, especially post-dialysis.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Insulin lispro is a recombinant human insulin analog that is equipotent to human insulin on a molar basis but has a more rapid onset and shorter duration of action. It lowers 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: Not directly quantified for subcutaneous administration, but nearly 100% for IV.
Tmax: 0.5-1.5 hours (subcutaneous)
FoodEffect: Administered with meals to cover postprandial glucose excursions.

Distribution:

Vd: 0.26-0.36 L/kg
ProteinBinding: Minimal (<5%)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 1 hour (functional half-life is longer due to absorption kinetics)
Clearance: Not typically reported for subcutaneous insulin; primarily renal and hepatic clearance.
ExcretionRoute: Renal (primarily metabolites)
Unchanged: <2% (renal)
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Pharmacodynamics

OnsetOfAction: 15-30 minutes
PeakEffect: 0.5-2.5 hours
DurationOfAction: 3-5 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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 fatal.
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or discolored sputum
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Local reactions at the injection site, including:
+ Thick skin
+ Pits or lumps
Swelling in the arms or legs
Low blood sugar, which may cause:
+ Dizziness or fainting
+ Blurred vision
+ Mood changes
+ Slurred speech
+ Headache
+ Fatigue or weakness
+ Shaking
+ Rapid heartbeat
+ Confusion
+ Hunger
+ Sweating
+ Seizures
If you experience any of these symptoms, contact your doctor immediately. If you have low blood sugar, follow your doctor's instructions, which may include taking glucose tablets, liquid glucose, or certain 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 any of the following side effects or if they persist or bother you:

Weight gain
Flu-like symptoms
Nose or throat irritation
Common cold symptoms
Headache
Cough
Upset stomach
Stomach pain or diarrhea
Fatigue or weakness
* Irritation at the injection site

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:

  • Signs of low blood sugar (hypoglycemia): sweating, shakiness, dizziness, confusion, hunger, irritability, blurred vision. Treat immediately with fast-acting sugar.
  • Signs of high blood sugar (hyperglycemia): increased thirst, frequent urination, fatigue, blurred vision. Contact your doctor if persistent.
  • Signs of allergic reaction: rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing. Seek immediate medical attention.
  • Signs of injection site reactions: redness, swelling, itching, pain, or lumps at the injection site. Report persistent or severe reactions.
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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 disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have

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.

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, can 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 drug affects you, avoid driving and other activities that require your full attention. Certain diabetes medications, such as pioglitazone or rosiglitazone, may 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 have the correct insulin product and understand how to measure and prepare your dose, as insulin products are available in various containers, including vials, cartridges, and pens. If you have any questions or concerns, contact your doctor or pharmacist.

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

It is recommended that you wear a medical alert identification to ensure prompt treatment 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.

Regularly check your blood sugar levels as instructed by your doctor and undergo blood tests as recommended to monitor your condition.

Be aware that this particular brand of insulin is twice as potent as other brands, requiring extra caution when measuring your dose to avoid accidental overdose, which can lead to severe side effects or life-threatening low blood sugar. Consult your doctor if you have any concerns.

This insulin product is not suitable for use in an insulin pump. If you have any questions or concerns, discuss them with your doctor.

Before consuming alcohol or using products containing alcohol, consult your doctor to understand the potential risks and interactions.

Do not share your insulin product or any related devices, 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 (low blood sugar)
  • Confusion
  • Seizures
  • Loss of consciousness
  • Coma

What to Do:

For mild hypoglycemia, consume oral glucose (e.g., glucose tablets, fruit juice, candy). For severe hypoglycemia, administer glucagon injection if available, or seek immediate medical attention. Call 911 or your local emergency number. Call 1-800-222-1222 for Poison Control.

Drug Interactions

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Major Interactions

  • Drugs that may increase the risk of hypoglycemia: Oral antidiabetic agents, ACE inhibitors, angiotensin receptor blockers (ARBs), disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), sulfonamide antibiotics.
  • Drugs that may decrease the blood glucose lowering effect: Corticosteroids, diuretics (thiazide and loop), sympathomimetics (e.g., epinephrine, albuterol, terbutaline), growth hormone, danazol, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, atypical antipsychotics (e.g., olanzapine, clozapine).
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Moderate Interactions

  • Beta-blockers: May mask symptoms of hypoglycemia and delay recovery from hypoglycemia.
  • Alcohol: May potentiate or reduce the hypoglycemic effect of insulin.
  • Clonidine, guanethidine, reserpine: May mask symptoms of hypoglycemia.

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., eGFR, creatinine)

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

Timing: Prior to initiation of therapy.

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

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, 1-2 hours 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: <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

Action Threshold: Significant unexplained weight gain or loss

Injection Site Inspection

Frequency: Regularly (e.g., daily)

Target: No signs of lipodystrophy, redness, swelling

Action Threshold: Presence of lipohypertrophy, atrophy, or signs of infection

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Symptom Monitoring

  • Symptoms of hypoglycemia: sweating, tremor, dizziness, confusion, hunger, irritability, blurred vision, headache, rapid heartbeat.
  • Symptoms of hyperglycemia: increased thirst, increased urination, fatigue, blurred vision, unexplained 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 lispro is generally considered safe and is the preferred treatment for diabetes in pregnancy. Careful monitoring of blood glucose is essential to achieve optimal glycemic control.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital malformations compared to general population when diabetes is well-controlled.
Second Trimester: No specific risks identified; continued close monitoring and dose adjustments as needed.
Third Trimester: No specific risks identified; continued close monitoring and dose adjustments as needed.
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Lactation

Insulin lispro 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.

Infant Risk: Low risk (L1)
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Pediatric Use

Humalog U-200 KwikPen is not recommended for use in pediatric patients. Humalog U-100 is typically used for pediatric patients requiring insulin lispro.

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Geriatric Use

Use with caution in elderly patients due to increased risk of hypoglycemia, particularly in those with renal or hepatic impairment. Start with lower doses and titrate slowly. Monitor blood glucose levels more frequently.

Clinical Information

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Clinical Pearls

  • Humalog U-200 KwikPen is a concentrated insulin (200 units/mL) and should only be used with the specific KwikPen device. Do NOT transfer the insulin from the pen to a syringe, as this can lead to significant dosing errors and severe hypoglycemia.
  • This formulation is intended for adult patients requiring more than 20 units of rapid-acting insulin per day, as it allows for a smaller injection volume.
  • Always verify the insulin concentration (U-100 vs U-200) before administration to prevent dosing errors.
  • Administer 5-10 minutes before a meal or within 20 minutes after starting a meal. The timing is crucial for optimal postprandial glucose control.
  • Rotate injection sites within the same general area to reduce the risk of lipodystrophy (lumps or indentations in the skin).
  • Patients should be educated on the signs and symptoms of hypoglycemia and how to treat it promptly.
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Alternative Therapies

  • Other rapid-acting insulin analogs (e.g., insulin aspart, insulin glulisine, insulin lispro U-100)
  • Short-acting human insulin (e.g., Regular insulin)
  • Other classes of antidiabetic agents (e.g., metformin, sulfonylureas, GLP-1 receptor agonists, SGLT2 inhibitors, DPP-4 inhibitors, thiazolidinediones)
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Cost & Coverage

Average Cost: Highly variable; check current market per 3ml KwikPen
Insurance Coverage: Tier 2 or Tier 3 (varies by insurance 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.