MEDAVON

MEDAVON

Edaravone Injection 1.5mg
Net Qty- 1 Injection
Self-Life- 2 Years

Medavon (Edaravone Injection) is a neuroprotective agent primarily used to treat neurological conditions involving oxidative stress. It is typically administered as an intravenous injection in hospitals or specialized care centers.

USE

✅ Use of Medavon (Edaravone Injection 1.5 mg)

Medavon (Edaravone Injection 1.5 mg) is a prescription medication primarily used for:

🧠 1. Amyotrophic Lateral Sclerosis (ALS):

  • Main approved use (especially in the U.S., Japan, and several other countries).
  • ALS is a progressive neurological disorder that damages motor neurons, leading to muscle weakness, paralysis, and eventually respiratory failure.
  • Edaravone helps slow the physical decline in ALS by protecting nerve cells from oxidative stress.

🩺 2. Acute Ischemic Stroke (in some regions like Japan):

  • Used within 24 hours of stroke onset.
  • Reduces neurological damage and improves outcomes by limiting free radical-induced brain injury.

📌 Noteworthy:

  • It is not a cure for ALS or stroke but helps in slowing progression and minimizing damage.
  • Administered under medical supervision in cycles or daily infusion protocols.

Key Benefits

🌟 Key Benefits of Edaravone Injection 1.5 mg

Edaravone is a powerful neuroprotective agent with proven benefits in specific neurological conditions. Here’s how it helps:

🧠 Slows Progression of ALS (Amyotrophic Lateral Sclerosis):

  • Primary FDA-approved indication.
  • Protects motor neurons from oxidative damage, thereby slowing the physical decline.
  • Helps preserve daily function and prolong independence in ALS patients.

🧬 Acts as a Potent Free Radical Scavenger:

  • Neutralizes reactive oxygen species (ROS), which are harmful by-products of cell damage.
  • Reduces oxidative stress that contributes to nerve cell death.

🩺 Neuroprotection in Acute Ischemic Stroke (Approved in some countries):

  • Administered soon after stroke onset, it limits brain injury.
  • Improves outcomes and neurological recovery when used early.

⚡ Well-Tolerated in Most Patients:

  • Can be used in long-term treatment cycles for ALS.
  • Side effects are generally manageable with monitoring.

📈 Enhances Quality of Life:

  • By slowing disease progression, it can extend functional abilities, especially walking and arm movement in ALS.

Mechanism
of Action

🧪 Mechanism of Action of Medavon (Edaravone Injection 1.5 mg)

Medavon (Edaravone Injection 1.5 mg) works primarily as a free radical scavenger, providing neuroprotection by reducing oxidative stress in the brain and nervous system.

 

🔬 Step-by-Step Mechanism:

  1. Oxidative Stress in Neurons:
    • In diseases like ALS or acute stroke, excessive free radicals (especially reactive oxygen species or ROS) are generated.
    • These ROS cause damage to lipids, proteins, and DNA of nerve cells, leading to cell death.
  2. Edaravone’s Role:
    • Edaravone selectively neutralizes ROS, such as:
      • Hydroxyl radicals (•OH)
      • Peroxyl radicals (ROO•)
    • This inhibits lipid peroxidation, a chain reaction that destroys cell membranes.
  3. Neuroprotective Effects:
    • By scavenging free radicals, Edaravone:
      • Reduces neuronal inflammation
      • Preserves mitochondrial function
      • Protects motor neurons in ALS
      • Limits ischemic brain injury in stroke

🧠 End Result:

  • Slows functional decline in ALS patients.
  • Limits brain damage post-stroke (when used early).
  • Improves overall neuronal survival under oxidative stress conditions.

Dosage and Administration

💉 Dosage and Administration of Medavon (Edaravone Injection 1.5 mg)

Medavon (Edaravone Injection 1.5 mg) is typically prescribed for the treatment of Amyotrophic Lateral Sclerosis (ALS) and in some countries, also for acute ischemic stroke. Below are the standard dosage guidelines for ALS:

 

🧪 Recommended Dosage (for ALS):

Initial Cycle (First Cycle):

  • 60 mg/day (administered as two 30 mg injections)
  • Once daily for 14 consecutive days, followed by a 14-day drug-free period.

Subsequent Cycles:

  • 60 mg/day, once daily for 10 out of 14 days (2-week treatment period)
  • Followed by a 14-day drug-free period.

💉 How It’s Given:

  • Route: Intravenous (IV) infusion
  • Infusion Time: Each 30 mg vial should be infused over 60 minutes
  • Frequency: Once daily during treatment days

📦 Formulation:

  • Supplied in 30 mg/20 mL vials
  • Two vials (60 mg) needed per day

⚠️ Important Administration Notes:

  • Should be administered under the supervision of a healthcare professional
  • Store vials at room temperature and protect from light
  • Do not mix with other IV solutions

🧑‍⚕️ Special Considerations:

  • Renal impairment: Use cautiously in severe renal disease
  • Hepatic impairment: Limited data; monitor liver function
  • Patients should be monitored for infusion reactions or allergic responses

Common Side Effects

⚠️ Common Side Effects of Medavon (Edaravone Injection 1.5 mg)

While Medavon (Edaravone Injection 1.5 mg) is generally well-tolerated, some patients may experience side effects. These may vary in intensity and frequency.

 

🩺 Common Side Effects:

  1. Bruising or bleeding at the injection site
  2. Headache
  3. Gait disturbance (difficulty walking)
  4. Skin rash or itching
  5. Respiratory issues (shortness of breath or cough)
  6. Fatigue or weakness
  7. Swelling in hands or feet (peripheral edema)
  8. Nausea or upset stomach
  9. Dizziness
  10. Allergic reactions (rash, flushing, or wheezing)

🚨 Serious (but rare) Side Effects:

  • Hypersensitivity reactions
  • Anaphylaxis
  • Acute kidney injury

👨‍⚕️ When to Seek Medical Help:

  • Difficulty breathing
  • Swelling of the face/lips/tongue
  • Severe dizziness or rash
  • Signs of infection or kidney issues (e.g., reduced urine output)

📝 Note:

  • Most side effects are mild to moderate and resolve without stopping treatment.
  • Always report unusual or persistent symptoms to your doctor promptly.

Monitoring

🔍 Monitoring of Medavon (Edaravone Injection 1.5 mg)

To ensure safety and efficacy during Medavon (Edaravone Injection 1.5 mg) therapy—especially in conditions like Amyotrophic Lateral Sclerosis (ALS) or acute ischemic stroke—regular monitoring is essential.

 

📋 Key Monitoring Parameters:

  1. Renal Function Tests (RFTs)
  • Why: Medavon (Edaravone Injection 1.5 mg) is excreted through the kidneys.
  • Monitor:
    • Serum creatinine
    • Blood urea nitrogen (BUN)
    • Glomerular filtration rate (GFR)
  1. Allergic or Hypersensitivity Reactions
  • Monitor for:
    • Skin rash
    • Itching
    • Swelling (face, tongue, throat)
    • Shortness of breath
  1. Infusion Site Reactions
  • Check for:
    • Redness
    • Swelling
    • Pain at the IV site
  1. Liver Function Tests (LFTs)
  • Though rare, liver enzyme elevation may occur in some cases.
  • Monitor if: Pre-existing liver disease or long-term use.
  1. Vital Signs During Infusion
  • Especially during the first few doses.
  • Monitor: Blood pressure, heart rate, and oxygen saturation.
  1. Neurological Status
  • For stroke patients: Monitor improvement or deterioration of neurological symptoms.
  • For ALS patients: Track progression of motor function decline.

🧠 Additional Notes:

  • Frequency of Monitoring:
    • Before starting treatment
    • Periodically during treatment (as advised by the physician)
  • Patient Education: Encourage patients to report any new symptoms or discomfort during infusion immediately.

Precautions

⚠️ Precautions for Medavon (Edaravone Injection 1.5 mg)

Medavon (Edaravone Injection 1.5 mg) is used as a neuroprotective agent in conditions like Amyotrophic Lateral Sclerosis (ALS) and acute ischemic stroke. While generally well-tolerated, it requires certain precautions to ensure safe use.

 

✅ Important Precautions to Follow:

  1. Allergic Reactions
  • Caution: Serious hypersensitivity reactions (e.g., anaphylaxis, rash, swelling) have been reported.
  • Tip: Avoid if you have a known allergy to edaravone or sulfite-containing products.
  1. Asthma or Sulfite Sensitivity
  • Warning: Contains sodium bisulfite, which may cause allergic-type reactions, especially in asthmatic patients.
  • Action: Monitor closely in such individuals or consider alternative treatment.
  1. Kidney Impairment
  • Reason: Edaravone is eliminated via the kidneys.
  • Action: Use with caution in patients with renal impairment and consider renal function monitoring.
  1. Liver Dysfunction
  • Though rare, abnormal liver enzymes may occur.
  • Action: Monitor liver function in patients with existing hepatic conditions.
  1. Infusion Reactions
  • Symptoms: Swelling, redness, or discomfort at the injection site.
  • Action: Ensure slow, proper IV administration and monitor the site regularly.
  1. Pregnancy and Breastfeeding
  • Use only if clearly needed and prescribed by a physician.
  • Reason: Limited human data available.
  1. Pediatric and Geriatric Use
  • Not well studied in children.
  • Elderly patients may require additional monitoring due to comorbidities.
  1. Concomitant Medications
  • Always inform your doctor about all medications, especially those that may affect the kidneys or immune system.

Drug Interactions

💊 Drug Interactions of Medavon (Edaravone Injection 1.5 mg)

Edaravone is generally considered to have a low potential for drug interactions, but due caution should still be exercised, especially in patients on multiple medications or with organ dysfunction.

 

⚠️ Potential Drug Interactions:

  1. Nephrotoxic Drugs
  • Examples: Aminoglycosides, NSAIDs, amphotericin B, cisplatin.
  • Risk: Increased chances of kidney damage when used together.
  • Action: Avoid co-administration or monitor renal function closely.
  1. Drugs That Affect Liver Enzymes
  • Edaravone is metabolized in the liver.
  • Drugs to watch: Phenytoin, carbamazepine, rifampicin (enzyme inducers) or ketoconazole, erythromycin (enzyme inhibitors).
  • Effect: May alter edaravone’s metabolism and effectiveness.
  1. Other Antioxidants
  • Caution: Combining with agents like Vitamin E or N-acetylcysteine may increase antioxidant load.
  • Significance: No well-documented harm, but use cautiously unless advised by a physician.
  1. Corticosteroids or Immunosuppressants
  • These may alter inflammatory response or immune status.
  • Caution: Monitor immune response and infections.
  1. Intravenous Infusions
  • Avoid mixing edaravone with other IV drugs in the same line.
  • Reason: Incompatibility or precipitation may occur.

✅ Safe Practice Tips:

  • Always maintain an updated medication history with your healthcare provider.
  • Consider renal and hepatic function before adding other medications.
  • Use a dedicated IV line for administration to avoid incompatibility.

 

Clinical Effectiveness

🧪 Clinical Effectiveness of Medavon (Edaravone Injection 1.5 mg)

Edaravone is a neuroprotective agent that has shown proven clinical effectiveness in treating neurodegenerative and acute neurological conditions, particularly acute ischemic stroke and amyotrophic lateral sclerosis (ALS).

 

✅ Acute Ischemic Stroke

  • Efficacy:
    • Clinical trials in Japan and other countries demonstrated that Edaravone significantly improves neurological outcomes when administered within 24 hours of stroke onset.
    • It reduces brain damage caused by free radicals during ischemia-reperfusion injury.
  • Results:
    • Patients treated with Edaravone had better recovery scores (e.g., NIHSS, mRS) compared to those who received standard care alone.
    • Shows improved motor function and reduction in infarct volume.

✅ Amyotrophic Lateral Sclerosis (ALS)

  • FDA Approval:
    • Approved in the US, Japan, and other countries for ALS treatment.
  • Effectiveness:
    • Clinical studies (e.g., MCI186-19 study) showed Edaravone slows the progression of physical decline in ALS patients.
    • Most effective in patients with early-stage ALS and relatively preserved function.

🔬 Mechanism Supporting Effectiveness

  • Acts as a free radical scavenger, reducing oxidative stress—a key factor in neuronal injury.
  • Prevents lipid peroxidation and maintains cellular membrane integrity.

📊 Supporting Data

Condition

Improvement Observed

Acute Stroke

Reduced infarct size, improved neurological function

ALS

Slowed physical deterioration, prolonged function

 

📝 Clinical Conclusion:

Medavon (Edaravone Injection 1.5 mg) has been clinically validated as an effective neuroprotective agent in managing stroke and ALS, especially when started early in the disease course. It offers measurable improvements in outcomes and quality of life for patients when integrated into a timely treatment protocol.

Tips for Patients

Here are important Tips for Patients receiving Medavon (Edaravone Injection 1.5 mg):

 

💡 General Tips

  1. Follow Timing Strictly
    • Take Edaravone exactly as prescribed by your doctor. The dosing schedule is usually daily for 14 days, followed by a break, especially in ALS treatment.
  2. Report Any Allergies
    • Inform your doctor of any history of drug allergies, especially to Edaravone or sulfites.
  3. Stay Hydrated
    • Drink plenty of fluids unless otherwise directed to help your kidneys clear the medication.

⚠️ During Treatment

  1. Watch for Side Effects
    • Notify your doctor if you experience rash, trouble breathing, swelling, dizziness, or fever.
  2. Monitor Kidney Function
    • Regular blood tests may be recommended to monitor renal health, especially for patients with pre-existing kidney conditions.
  3. Infusion Site Care
    • If you’re getting the injection via IV, monitor for redness, pain, or swelling at the injection site.

🚫 Avoid These During Treatment

  1. Avoid Alcohol and Smoking
    • These can worsen oxidative stress and interfere with treatment effectiveness.
  2. No Self-Medication
    • Do not combine with other medications or supplements without consulting your doctor.

👨‍⚕️ Consult Your Doctor If:

  1. You experience worsening neurological symptoms or no improvement.
  2. You have liver or kidney disease or are taking other neuroprotective drugs.
  3. You are pregnant, breastfeeding, or planning to conceive.

📌 Reminder:

Never skip doses or change the treatment schedule on your own. Adherence to your treatment plan ensures the best outcome.