Insulin Glarg U300 Max Solstr Inj

Manufacturer WINTHROP, US Active Ingredient Insulin Glargine (U-300) Pens(IN soo lin GLAR jeen) Pronunciation IN-soo-lin GLAR-jeen
It is used to lower blood sugar in patients with high blood sugar (diabetes).
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Drug Class
Antidiabetic agent, Insulin
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Pharmacologic Class
Long-acting insulin analog
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Pregnancy Category
Category B
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FDA Approved
Feb 2015
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Insulin glargine U-300 is a long-acting insulin that helps your body use sugar for energy. It works by slowly releasing insulin into your body over more than 36 hours, helping to keep your blood sugar levels stable throughout the day and night. It is used to treat diabetes.
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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, typically on the top of the thigh, belly area, or upper arm. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.

Before use, wash your hands thoroughly. If you are taking this medication once daily, you can administer it at any time of day, but be sure to take it at the same time every day. Rotate the injection site each time to avoid tissue damage.

Important Administration Guidelines

Do not inject 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 is cloudy, leaking, or contains particles, or if the solution has changed color.
Remove all pen needle covers before injecting a dose (note that there may be two covers).
If you are unsure about the type of pen needle you have or how to use it, consult your doctor.
Do not transfer the medication from the pen to a syringe.
Be aware that the pen may make a clicking sound as you prepare the dose; however, do not rely on the clicks to determine the correct dose.

Post-Administration Instructions

Remove the needle after each injection and do not store the device with the needle attached.
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 or concerns, consult your doctor or pharmacist.

Mixing and Pump Use

Do not mix this insulin with other types of insulin in the same syringe.
Do not mix this insulin with other liquids.
This medication is not compatible with insulin pumps. If you have questions, consult your doctor.

Storage and Disposal

Store unopened pens in the refrigerator, but do not freeze. Do not use if the medication has been frozen.
If an unopened container has been stored at room temperature, consult your doctor or pharmacist to determine how long it can be safely stored before disposal.
Store opened pens at room temperature, but do not refrigerate. Discard any unused portion after 56 days.

Missed Dose Instructions

If you miss a dose, take it as soon as you remember.
If it is close to the time for your next injection, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or administer extra doses. If you are unsure about what to do if you miss a dose, consult your doctor.
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Lifestyle & Tips

  • Always check your blood sugar levels regularly as instructed by your doctor.
  • Follow your prescribed diet and exercise plan.
  • Inject insulin glargine U-300 once daily at the same time each day. It can be injected at any time of day.
  • Rotate injection sites within the same general area (e.g., abdomen, thigh, upper arm) to prevent lipodystrophy (skin changes).
  • Never share your insulin pen or needles with anyone else, even if the needle is changed, as this carries a risk of infection.
  • Do not mix insulin glargine U-300 with any other insulin or solution.
  • Store unopened pens in the refrigerator. Once opened, store at room temperature (below 86°F/30°C) for up to 56 days and discard after this period.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose for type 1 diabetes: Approximately one-third of the total daily insulin requirement. Initial dose for type 2 diabetes: 0.2 units/kg once daily. Titrate dose based on individual blood glucose response, typically by 2-4 units once or twice weekly to achieve target fasting plasma glucose.
Dose Range: 0.1 - 2 mg

Condition-Specific Dosing:

Type 1 Diabetes: Initial dose is typically 1/3 of total daily insulin requirement, given once daily. The remainder is given as short-acting insulin. Titrate based on blood glucose.
Type 2 Diabetes: Initial dose 0.2 units/kg once daily. Titrate based on blood glucose. May be given at any time of day, but at the same time each day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Approved for children 6 years and older with type 1 or type 2 diabetes. Dosing similar to adults, individualized based on metabolic needs and blood glucose monitoring.
Adolescent: Approved for adolescents 6 years and older with type 1 or type 2 diabetes. Dosing similar to adults, individualized based on metabolic needs and blood glucose monitoring.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment, but monitor glucose closely and adjust dose as needed.
Moderate: No specific dose adjustment, but monitor glucose closely and adjust dose as needed. Increased risk of hypoglycemia.
Severe: No specific dose adjustment, but monitor glucose closely and adjust dose as needed. Increased risk of hypoglycemia.
Dialysis: No specific dose adjustment, but monitor glucose closely and adjust dose as needed. Increased risk of hypoglycemia.

Hepatic Impairment:

Mild: No specific dose adjustment, but monitor glucose closely and adjust dose as needed. Increased risk of hypoglycemia.
Moderate: No specific dose adjustment, but monitor glucose closely and adjust dose as needed. Increased risk of hypoglycemia.
Severe: No specific dose adjustment, but monitor glucose closely and adjust dose as needed. Increased risk of hypoglycemia.

Pharmacology

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Mechanism of Action

Insulin glargine is a long-acting human insulin analog. 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 applicable (subcutaneous administration)
Tmax: Not applicable (peakless profile); steady state reached after 2-4 days of once-daily dosing.
FoodEffect: Not applicable (subcutaneous administration, not affected by food intake)

Distribution:

Vd: Not available (similar to endogenous insulin)
ProteinBinding: Low (approximately 6% for insulin glargine)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 18-19 hours (effective half-life for U-300, due to slow absorption)
Clearance: Not available
ExcretionRoute: Renal (primarily metabolites)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Approximately 6 hours
PeakEffect: No pronounced peak (relatively flat profile)
DurationOfAction: Greater than 36 hours (for U-300 concentration)
Confidence: High

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 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
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 changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Fainting
+ Changes in vision
Thick skin, pits, or lumps at the injection site
Swelling in the arms or legs
Low blood sugar, which may cause:
+ Dizziness or fainting
+ Blurred vision
+ Mood changes
+ Slurred speech
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Rapid heartbeat
+ Confusion
+ Hunger
+ Sweating
+ Seizures

If you experience any of these symptoms, contact your doctor right away. If you have low blood sugar, follow your doctor's instructions, which may include taking glucose tablets, liquid glucose, or consuming 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 attention if you experience any of the following side effects or if they persist or bother you:

Irritation at the injection site
Back pain
Diarrhea
Headache
Weight gain
Common cold symptoms
Nose or throat irritation
Flu-like symptoms
Joint pain
* Pain in the arms or legs

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, shakiness, dizziness, confusion, hunger, irritability, blurred vision, headache, rapid heartbeat. If these occur, consume a quick source of sugar (e.g., glucose tablets, fruit juice, candy) and seek medical attention if severe.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, increased urination, fatigue, blurred vision, unexplained weight loss. Report these to your doctor.
  • Signs of allergic reaction: rash, itching, hives, swelling of your face or tongue, difficulty breathing. Seek immediate medical attention.
  • Signs of heart failure (if taking certain other diabetes medications like TZDs): unusual weight gain, swelling in your ankles or feet, shortness of breath. Report to your doctor.
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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. Do not initiate, stop, or modify the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is crucial to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This brand of insulin has a concentrated formula, containing 3 times as much insulin as other brands, and is designed to be used with a prefilled pen. Do not attempt to withdraw insulin from the pen using a syringe, as this can lead to severe side effects or life-threatening hypoglycemia (low blood sugar).

To ensure safe use, it is essential to use the correct dose of this medication. Consult your doctor to confirm the proper dosage. Be aware that hypoglycemia may occur with this medication, and severe cases can cause seizures, loss of consciousness, permanent brain damage, and even death. If you experience any symptoms of hypoglycemia, contact your doctor immediately.

Additionally, this medication may cause hypokalemia (low blood potassium), which can lead to abnormal heart rhythms, severe breathing difficulties, and potentially death if left untreated. If you have concerns, discuss them with your doctor.

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

Verify that you have the correct insulin product, as insulin is available in various containers, including vials, cartridges, and pens. Ensure you understand how to measure and prepare your dose correctly. If you have any questions, contact your doctor or pharmacist.

Be aware that stress, illness, injury, or surgery can affect blood sugar control, as can changes in physical activity, exercise, or diet. Wear a medical alert identification (ID) to inform others of your condition.

Do not drive if you have experienced hypoglycemia, as this 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.

Before consuming alcohol or using products containing alcohol, consult your doctor. Never share your insulin product or any associated devices, including pens, cartridges, needles, or syringes, as this can transmit infections between individuals.

When using this medication in children, be aware that they may be more susceptible to side effects. If you are 65 or older, use this medication with caution, as you may be more prone to side effects. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks with your doctor.
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Overdose Information

Overdose Symptoms:

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

What to Do:

For mild hypoglycemia, consume oral glucose. For severe hypoglycemia, administer glucagon injection or intravenous glucose. Seek immediate medical attention. Call 911 or 1-800-222-1222 (Poison Control Center).

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 when used with insulin)
  • Alcohol (may potentiate hypoglycemic effect)
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Moderate Interactions

  • Oral antidiabetic agents (additive glucose-lowering effect)
  • ACE inhibitors (may enhance insulin sensitivity and increase risk of hypoglycemia)
  • Angiotensin receptor blockers (ARBs) (may enhance insulin sensitivity and increase risk of hypoglycemia)
  • Salicylates (e.g., aspirin) (may enhance insulin sensitivity and increase risk of hypoglycemia)
  • Sulfonamide antibiotics (may enhance insulin sensitivity and increase risk of hypoglycemia)
  • Monoamine oxidase inhibitors (MAOIs) (may enhance insulin sensitivity and increase risk of hypoglycemia)
  • Corticosteroids (may increase blood glucose, requiring higher insulin doses)
  • Diuretics (e.g., thiazides, loop diuretics) (may increase blood glucose, requiring higher insulin doses)
  • Sympathomimetics (e.g., decongestants, asthma medications) (may increase blood glucose, requiring higher insulin doses)
  • Growth hormone (may increase blood glucose, requiring higher insulin doses)
  • Danazol (may increase blood glucose, requiring higher insulin doses)
  • Atypical antipsychotics (e.g., olanzapine, clozapine) (may cause hyperglycemia)
  • Protease inhibitors (may cause hyperglycemia)

Monitoring

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Baseline Monitoring

HbA1c

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

Timing: Prior to initiation

Fasting Plasma Glucose (FPG)

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

Timing: Prior to initiation

Renal function (eGFR, BUN, Creatinine)

Rationale: To assess kidney function, as renal impairment can increase risk of hypoglycemia.

Timing: Prior to initiation

Hepatic function (ALT, AST, Bilirubin)

Rationale: To assess liver function, as hepatic impairment can increase risk of hypoglycemia.

Timing: Prior to initiation

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Routine Monitoring

Self-monitoring of Blood Glucose (SMBG)

Frequency: Multiple times daily (e.g., fasting, pre-meal, post-meal, bedtime) or as directed by healthcare provider.

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

Action Threshold: Below target range (hypoglycemia) or above target range (hyperglycemia) requiring dose adjustment or intervention.

HbA1c

Frequency: Every 3-6 months (or more frequently if glycemic control is suboptimal or therapy is changed).

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 patient education.

Target: N/A

Action Threshold: Any occurrence of symptoms (e.g., sweating, tremor, confusion, hunger) requires immediate action (glucose intake).

Injection site inspection

Frequency: Regularly, with each injection.

Target: N/A

Action Threshold: Presence of lipodystrophy, redness, swelling, or pain requires site rotation or medical evaluation.

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Symptom Monitoring

  • Symptoms of hypoglycemia (e.g., sweating, shakiness, dizziness, confusion, hunger, irritability, blurred vision, headache, rapid heartbeat, anxiety, weakness)
  • Symptoms of hyperglycemia (e.g., increased thirst, increased urination, fatigue, blurred vision, unexplained weight loss)
  • Signs of allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing)
  • Signs of fluid retention/heart failure (e.g., unusual weight gain, swelling in ankles/feet, shortness of breath) if used with TZDs

Special Patient Groups

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Pregnancy

Insulin glargine U-300 is considered a Category B drug in pregnancy. Insulin is the preferred treatment for diabetes in pregnancy. Close monitoring of blood glucose is essential.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital malformations observed with insulin use.
Second Trimester: Careful glycemic control is crucial to prevent complications.
Third Trimester: Insulin requirements may increase. Close monitoring and dose adjustments are necessary.
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Lactation

Insulin is compatible with breastfeeding. It is not excreted in human milk in clinically significant amounts and is not expected to harm the breastfed infant.

Infant Risk: Low risk to infant.
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Pediatric Use

Approved for children 6 years and older with type 1 or type 2 diabetes. Dosing should be individualized based on metabolic needs and blood glucose monitoring. Younger children (under 6 years) have not been studied.

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Geriatric Use

No overall differences in safety or effectiveness were observed between older and younger patients, but greater sensitivity to insulin and increased risk of hypoglycemia may occur in some older individuals. Careful glucose monitoring and dose titration are recommended.

Clinical Information

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Clinical Pearls

  • Insulin glargine U-300 (Toujeo) is a more concentrated formulation (300 units/mL) of insulin glargine compared to U-100 (Lantus, Basaglar). This allows for a smaller injection volume.
  • Its duration of action is prolonged beyond 24 hours, often exceeding 36 hours, providing a flatter and more consistent basal insulin profile.
  • Due to its prolonged action, it can be administered at any time of day, but should be given at the same time each day.
  • When converting from U-100 glargine to U-300 glargine, a dose reduction of approximately 20% is often recommended to minimize the risk of hypoglycemia, followed by careful titration.
  • Patients should be educated on the correct injection technique for the specific pen device (Solostar or Max Solostar) and the importance of not diluting or mixing this insulin.
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Alternative Therapies

  • Other long-acting insulins (e.g., insulin glargine U-100 [Lantus, Basaglar], insulin detemir [Levemir], insulin degludec [Tresiba])
  • Intermediate-acting insulins (e.g., NPH insulin)
  • Oral antidiabetic agents (e.g., metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists)
  • Other injectable non-insulin antidiabetic agents (e.g., GLP-1 receptor agonists, amylin analogs)
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Cost & Coverage

Average Cost: Varies widely, typically $300-$600+ per 3 mL pen (U-300)
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's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't 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 details about the overdose, including the medication taken, the amount, and the time it occurred.