Insulin Glarg U300 Max Solstr Inj
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
- Insulin Aspart 100/ml Inj,10ml
- Insulin Aspa Mix 70/30 Inj Sus 10ml
- Insulin Aspart Penfill Inj, 3ml
- Insulin Aspart Flexpen Inj, 3ml
- Insulin Aspa Mix 70/30 Flexpen, 3ml
- Insulin Lispro Junior Kwikpen 5x3ml
- Insulin Lispro Prt Mix 75/25kwikpen
- Insulin Lispro 100u/ml Vial 10ml
- Insulin Lispro 100u/ml Kwikpen 3ml
- Insulin Glarg-Yfgn 100u/ml Sol 10ml
- Insulin Glarg-Yfgn 100u/ml Pen Inj
- Insulin Glarg Solostar Pen Inj 3ml
- Insulin Glargine 100u/ml, 10ml
- Insulin Degludec U100 Inj Vial 10ml
- Insuln Glargne Solstr U300 PN 1.5ml
- Insulin Glarg U300 Max Solstr Inj
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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.
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.
Before Using This Medicine
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.
Precautions & 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.
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
Major Interactions
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
Baseline Monitoring
Rationale: To establish baseline glycemic control and guide initial dosing.
Timing: Prior to initiation
Rationale: To establish baseline glycemic control and guide initial dosing.
Timing: Prior to initiation
Rationale: To assess kidney function, as renal impairment can increase risk of hypoglycemia.
Timing: Prior to initiation
Rationale: To assess liver function, as hepatic impairment can increase risk of hypoglycemia.
Timing: Prior to initiation
Routine Monitoring
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.
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.
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).
Frequency: Regularly, with each injection.
Target: N/A
Action Threshold: Presence of lipodystrophy, redness, swelling, or pain requires site rotation or medical evaluation.
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
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:
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.
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.
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
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.
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)