Insulin Glarg-Yfgn 100u/ml Pen 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 under the skin, typically in the thigh, abdominal 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 with each use to avoid injecting into the same area repeatedly.
Important Administration Guidelines
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.
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.
Do not transfer the medication from the pen to a syringe.
You may hear a clicking sound when preparing the dose, but do not rely on the clicks to determine the correct dose.
After each injection, remove the needle and do not store the device with the needle attached.
Dispose of used needles in a designated sharps disposal container. Do not reuse needles or other items, and follow local regulations for disposing of the container when it is full.
Additional Instructions
Do not mix this insulin with other types of insulin or liquids in the same syringe.
Follow the diet and exercise plan recommended by your doctor.
This medication is not compatible with 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.
If an unopened container has been stored at room temperature, consult your doctor or pharmacist to determine how long it can be safely used.
After opening, store the medication at room temperature for up to 28 days. Discard any unused portion after 28 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 extra doses.
If you are unsure about what to do if you miss a dose, consult your doctor.
Lifestyle & Tips
- Administer once daily at the same time each day, usually in the evening or morning.
- Inject subcutaneously (under the skin) into the abdomen, thigh, or upper arm. Rotate injection sites within the same region to prevent lipodystrophy.
- Do not inject into a vein or muscle.
- Do not mix with other insulins or solutions.
- Do not share pens or needles with other people, even if the needle is changed, as this carries a risk of transmitting blood-borne pathogens.
- Follow a healthy diet plan and exercise regularly as advised by your healthcare provider.
- Monitor blood glucose levels regularly as instructed.
- Always have a source of fast-acting sugar (e.g., glucose tablets, fruit juice, candy) readily available to treat hypoglycemia.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking.
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
While rare, some people may experience severe and potentially life-threatening side effects when 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
+ 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 some fruit juices.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:
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 a complete list of possible side effects. If you have questions or concerns, talk to 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, dizziness, lightheadedness, tremor, hunger, confusion, irritability, headache, blurred vision, rapid heartbeat. Treat immediately with fast-acting sugar.
- Symptoms of high blood sugar (hyperglycemia): increased thirst, increased urination, fatigue, blurred vision, nausea, vomiting. Contact your doctor if these symptoms are severe or persistent.
- Signs of allergic reaction: rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing. Seek immediate medical attention.
- Signs of heart failure (if taking TZDs): unusual weight gain, swelling in ankles/feet, shortness of breath. Contact 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 prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication in combination with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
When using this drug, you are at risk for low blood sugar (hypoglycemia), which can lead to severe complications, including seizures, loss of consciousness, permanent brain damage, and even death. It is crucial to discuss this risk with your doctor.
Additionally, this medication may cause low blood potassium levels (hypokalemia), which can result in abnormal heart rhythms, severe breathing difficulties, and potentially be fatal if left untreated. You should consult with your doctor if you experience any symptoms.
Until you understand how this medication 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 combined with insulin. If you are taking one of these medications, consult with your doctor to discuss the potential risks.
To ensure safe use, verify that you have the correct insulin product and are familiar with its administration. Insulin products are available in various containers, including vials, cartridges, and pens. If you have any questions or concerns about measuring or preparing your dose, 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 your physical activity, exercise routine, or diet can also impact your blood sugar levels.
For your safety, wear a medical alert identification (ID) that indicates your condition. Avoid driving if you have experienced low blood sugar, as it 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 to ensure your safety while taking this medication. Consult with your doctor before consuming alcohol or using products that contain alcohol.
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 transmit infections, including those you may not be aware of having.
When using this medication in children, they may be more susceptible to side effects. Consult with your doctor to discuss the potential risks and benefits. 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, inform your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Severe hypoglycemia (low blood sugar)
- Hypokalemia (low potassium levels)
What to Do:
Mild hypoglycemia can be treated by oral glucose. Severe hypoglycemia requires immediate administration of glucagon (intramuscular or subcutaneous) or intravenous glucose. Medical attention is required. Call 911 or 1-800-222-1222 (Poison Control Center).
Drug Interactions
Major Interactions
- Thiazolidinediones (TZDs): Increased risk of fluid retention and heart failure when co-administered with insulin.
- Beta-blockers: May mask symptoms of hypoglycemia and delay recovery from hypoglycemia.
- Alcohol: May potentiate the blood glucose lowering effect of insulin, increasing risk of hypoglycemia.
Moderate Interactions
- Oral antidiabetic agents (e.g., sulfonylureas, metformin, DPP-4 inhibitors, SGLT2 inhibitors): Increased risk of hypoglycemia.
- ACE inhibitors, Angiotensin Receptor Blockers (ARBs): May increase insulin sensitivity and risk of hypoglycemia.
- Salicylates (e.g., aspirin): May increase insulin sensitivity and risk of hypoglycemia.
- Somatostatin analogs (e.g., octreotide, lanreotide): May increase or decrease insulin requirements.
- Corticosteroids, Sympathomimetics (e.g., epinephrine, albuterol), Diuretics (e.g., thiazides, loop diuretics), Thyroid hormones, Atypical antipsychotics, Protease inhibitors: May decrease the blood glucose lowering effect of insulin, leading to hyperglycemia.
Monitoring
Baseline Monitoring
Rationale: To establish baseline glycemic control and guide initial dosing.
Timing: Prior to initiation of therapy
Rationale: To establish baseline glucose levels and guide initial dosing.
Timing: Prior to initiation of therapy
Rationale: To assess kidney function, as insulin requirements may decrease in renal impairment.
Timing: Prior to initiation of therapy
Rationale: To assess liver function, as insulin requirements may decrease in hepatic impairment.
Timing: Prior to initiation of therapy
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 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 unstable).
Target: Individualized, typically <7% for most adults.
Action Threshold: Above target range indicating need for therapy adjustment.
Frequency: Daily, ongoing
Target: N/A
Action Threshold: Any occurrence of symptoms (e.g., sweating, tremor, confusion, hunger) requires immediate action.
Frequency: Daily, ongoing
Target: N/A
Action Threshold: Persistent redness, swelling, itching, or lipodystrophy requires evaluation and rotation of injection sites.
Symptom Monitoring
- Symptoms of hypoglycemia (e.g., sweating, dizziness, lightheadedness, tremor, hunger, confusion, irritability, headache, blurred vision, slurred speech, anxiety, rapid heartbeat)
- Symptoms of hyperglycemia (e.g., increased thirst, increased urination, fatigue, blurred vision, nausea, vomiting)
- Signs of allergic reactions (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 co-administered with TZDs.
Special Patient Groups
Pregnancy
Insulin glargine-yfgn is generally considered safe and is often the preferred treatment for diabetes in pregnancy when insulin is required. Careful monitoring of blood glucose is essential. The benefits of strict glycemic control outweigh potential risks.
Trimester-Specific Risks:
Lactation
Insulin is compatible with breastfeeding. It is a large protein molecule and is not excreted into breast milk in clinically significant amounts. It is not expected to cause adverse effects in a breastfed infant.
Pediatric Use
Insulin glargine-yfgn is approved for use in pediatric patients 6 years and older with Type 1 diabetes and in pediatric patients 6 years and older with Type 2 diabetes. Dosing must be individualized and carefully titrated based on blood glucose monitoring.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity to insulin's effects may occur. Dose selection should be cautious, starting at the low end of the dosing range, due to the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy. Increased risk of hypoglycemia.
Clinical Information
Clinical Pearls
- Insulin glargine-yfgn is a biosimilar to Lantus and is interchangeable with Lantus.
- It is a basal insulin, providing a relatively constant glucose-lowering effect over 24 hours, typically administered once daily.
- Always check the insulin label carefully before administration to avoid medication errors (e.g., confusing U-100 with U-300 concentrations, or rapid-acting with long-acting insulin).
- Patients should be educated on proper injection technique, site rotation, and storage of insulin.
- Never share insulin pens or needles between patients due to the risk of blood-borne pathogen transmission.
- Patients should be aware of the signs and symptoms of hypoglycemia and how to treat it.
- Dose adjustments are often needed in patients with renal or hepatic impairment due to decreased insulin clearance and increased risk of hypoglycemia.
Alternative Therapies
- Other long-acting insulins (e.g., insulin detemir, insulin degludec, other insulin glargine products like Lantus, Toujeo)
- Intermediate-acting insulins (e.g., NPH insulin)
- Rapid-acting insulins (e.g., insulin aspart, insulin lispro, insulin glulisine) for mealtime coverage
- Oral antidiabetic agents (e.g., metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists) for Type 2 Diabetes