Insulin Glarg-Yfgn 100u/ml Sol 10ml

Insulin glargine-yfgn 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. It also increases the transport of amino acids into cells and accelerates protein synthesis.

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 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 low blood sugar, follow your doctor's instructions for treatment, which may include taking glucose tablets, liquid glucose, or consuming certain fruit juices.

Other Possible Side Effects

Most people experience few or no side effects when taking this medication. However, some individuals may encounter the following side effects:

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

If any of these side effects bother you or persist, contact your doctor for guidance. This is not an exhaustive list of possible side effects. If you have questions or concerns, consult 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 can also provide guidance on reporting side effects.

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. Never start, stop, or change the dose of any medication without first consulting your doctor.

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

You are at risk for low blood sugar (hypoglycemia) while taking this drug. Severe hypoglycemia can lead to seizures, loss of consciousness, permanent brain damage, and even death. Discuss this risk with your doctor to understand how to manage it.

Additionally, this medication may cause low blood potassium levels (hypokalemia). If left untreated, hypokalemia can result in abnormal heart rhythms, severe breathing difficulties, and potentially death. Consult your doctor if you have concerns about this potential side effect.

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 used in combination with insulin. If you are taking one of these medications, discuss this risk with your doctor.

Ensure you are using 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 control may be affected 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 crucial to wear a medical alert identification (ID) to inform others of your condition in case of an emergency.

Do not operate a vehicle if you have recently experienced low blood sugar, as this can increase your risk of being involved in an accident. Monitor your blood sugar levels as directed by your doctor and have regular blood tests to assess your condition.

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

Do not share your insulin product or any related devices, including pens, cartridges, needles, or syringes, with others. Sharing can transmit infections, including those you may not be aware of having.

When using this medication in children, be aware that they may be more susceptible to side effects. Discuss this with your doctor to determine the best course of treatment.

If you are 65 or older, use this medication with caution, as you may be more prone to side effects. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as they will need to discuss the potential benefits and risks with you.

• Thiazolidinediones (TZDs): Increased risk of fluid retention and heart failure when co-administered with insulin, especially in patients with pre-existing heart failure or renal impairment.
• Beta-blockers: May mask symptoms of hypoglycemia (e.g., tachycardia, palpitations) and delay recovery from hypoglycemia. Non-selective beta-blockers may also increase the risk of hypoglycemia.

• Oral antidiabetic agents (e.g., sulfonylureas, metformin, DPP-4 inhibitors, SGLT2 inhibitors): Increased risk of hypoglycemia when co-administered with insulin. Dose adjustments of insulin or oral agents may be required.
• Corticosteroids: May increase blood glucose levels, requiring an increase in insulin dose.
• Diuretics (e.g., thiazides, loop diuretics): May cause hyperglycemia, requiring an increase in insulin dose.
• Sympathomimetics (e.g., albuterol, epinephrine): May increase blood glucose levels, requiring an increase in insulin dose.
• Growth hormone: May increase blood glucose levels, requiring an increase in insulin dose.
• Danazol: May increase blood glucose levels, requiring an increase in insulin dose.
• Atypical antipsychotics (e.g., olanzapine, clozapine): May cause hyperglycemia, requiring an increase in insulin dose.
• Protease inhibitors: May cause hyperglycemia, requiring an increase in insulin dose.
• Somatostatin analogs (e.g., octreotide, lanreotide): May decrease or increase insulin requirements.
• Salicylates (e.g., aspirin): May enhance the glucose-lowering effect of insulin, increasing the risk of hypoglycemia.
• ACE inhibitors: May enhance the glucose-lowering effect of insulin, increasing the risk of hypoglycemia.
• Angiotensin Receptor Blockers (ARBs): May enhance the glucose-lowering effect of insulin, increasing the risk of hypoglycemia.
• Disopyramide: May enhance the glucose-lowering effect of insulin, increasing the risk of hypoglycemia.
• Fibrates: May enhance the glucose-lowering effect of insulin, increasing the risk of hypoglycemia.
• Fluoxetine: May enhance the glucose-lowering effect of insulin, increasing the risk of hypoglycemia.
• MAO inhibitors: May enhance the glucose-lowering effect of insulin, increasing the risk of hypoglycemia.
• Propoxyphene: May enhance the glucose-lowering effect of insulin, increasing the risk of hypoglycemia.
• Sulfonamide antibiotics: May enhance the glucose-lowering effect of insulin, increasing the risk of hypoglycemia.

• Symptoms of hypoglycemia: Sweating, tremor, dizziness, confusion, irritability, hunger, headache, blurred vision, slurred speech, anxiety, palpitations, weakness, seizures, unconsciousness.
• Symptoms of hyperglycemia: Increased thirst, increased urination, increased hunger, fatigue, blurred vision, weight loss, dry skin, slow-healing sores.
• Symptoms of allergic reaction: Rash, itching, hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, severe dizziness.

Insulin glargine-yfgn is generally considered safe and effective for use during pregnancy to manage gestational diabetes or pre-existing diabetes. Insulin requirements may change during pregnancy.

Insulin glargine-yfgn is considered compatible with breastfeeding. Insulin is a normal component of breast milk and is not expected to cause adverse effects in breastfed infants. Insulin requirements may need adjustment during lactation.

Approved for use in children 6 years and older with Type 1 Diabetes. Dosing must be individualized and carefully titrated based on blood glucose monitoring. Increased risk of hypoglycemia, especially in younger children.

Use with caution in elderly patients due to increased susceptibility to hypoglycemia and potential for renal/hepatic impairment. Start with lower doses and titrate slowly with careful glucose monitoring. May have difficulty recognizing hypoglycemia symptoms.

• Insulin glargine-yfgn is an interchangeable biosimilar to Lantus (insulin glargine).
• Administer once daily at the same time each day, regardless of meals.
• Do not dilute or mix insulin glargine-yfgn with any other insulin or solution, as this may alter its time-action profile and lead to precipitation.
• Patients should be educated on proper injection technique, site rotation, and storage of insulin.
• Emphasize the importance of consistent blood glucose monitoring to guide dose adjustments and prevent hypoglycemia.
• Patients transitioning from other basal insulins may require dose adjustments and close monitoring.
• Be aware of the potential for weight gain with insulin therapy.

• Other long-acting insulins: Insulin glargine (Lantus, Toujeo), Insulin detemir (Levemir), Insulin degludec (Tresiba)
• Intermediate-acting insulins: NPH insulin
• Rapid-acting insulins: Insulin lispro (Humalog), Insulin aspart (Novolog), Insulin glulisine (Apidra)
• Short-acting insulins: Regular insulin (Humulin R, Novolin R)
• Oral antidiabetic agents (for Type 2 Diabetes): Metformin, Sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists, Thiazolidinediones, Alpha-glucosidase inhibitors, Meglitinides.

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets; consult with your pharmacist to determine if this applies to your prescription. 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 detailed information, including the name of the medication taken, the quantity, and the time it occurred.