Please wait while the formulary information is being retrieved.
Drug overview for RADICAVA ORS (edaravone):
Generic name: edaravone (e-DAR-a-vone)
Drug class: Amyotrophic Lateral Sclerosis Agents - Antioxidants
Therapeutic class: Locomotor System
Edaravone is a free radical scavenger.
No enhanced Uses information available for this drug.
Generic name: edaravone (e-DAR-a-vone)
Drug class: Amyotrophic Lateral Sclerosis Agents - Antioxidants
Therapeutic class: Locomotor System
Edaravone is a free radical scavenger.
No enhanced Uses information available for this drug.
DRUG IMAGES
No Image Available
The following indications for RADICAVA ORS (edaravone) have been approved by the FDA:
Indications:
Amyotrophic lateral sclerosis
Professional Synonyms:
None.
Indications:
Amyotrophic lateral sclerosis
Professional Synonyms:
None.
The following dosing information is available for RADICAVA ORS (edaravone):
The recommended adult IVdosage of edaravone for the treatment of amyotrophic lateral sclerosis (ALS) is 60 mg (2 consecutive 30-mg IV infusions over a total of 60 minutes) daily, administered in 28-day treatment cycles. In the initial treatment cycle, patients should receive edaravone for the first 14 days, followed by a 14-day drug-free period. In subsequent treatment cycles, patients should receive the drug for 10 out of the first 14 days, followed by a 14-day drug-free period.
The recommended adultoral dosage of edaravone for the treatment ofALS is 105 mg (5 mL) administered orally or via feeding tube in the morning after overnight fasting. In the initial treatment cycle, patients should receive edaravone for the first 14 days, followed by a 14-day drug-free period. In subsequent treatment cycles, patients should receive the drug for 10 out of the first 14 days, followed by a 14-day drug-free period.
The recommended adultoral dosage of edaravone for the treatment ofALS is 105 mg (5 mL) administered orally or via feeding tube in the morning after overnight fasting. In the initial treatment cycle, patients should receive edaravone for the first 14 days, followed by a 14-day drug-free period. In subsequent treatment cycles, patients should receive the drug for 10 out of the first 14 days, followed by a 14-day drug-free period.
Edaravone is administered orally (as an oral suspension) or by IV infusion.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| RADICAVA ORS STARTER KIT SUSP | Maintenance | Adults take 5 milliliters (105 mg) by oral route once daily for 10 out of 14 days, followed by 14-day drug-free period |
| RADICAVA ORS 105 MG/5 ML SUSP | Maintenance | Adults take 5 milliliters (105 mg) by oral route once daily for 10 out of 14 days, followed by 14-day drug-free period |
No generic dosing information available.
The following drug interaction information is available for RADICAVA ORS (edaravone):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for RADICAVA ORS (edaravone):
Drug contraindication overview.
*Patients with a history of hypersensitivity to the drug or any other ingredient in the formulation.
*Patients with a history of hypersensitivity to the drug or any other ingredient in the formulation.
There are 0 contraindications.
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Pregnancy |
There are 0 moderate contraindications.
The following adverse reaction information is available for RADICAVA ORS (edaravone):
Adverse reaction overview.
Most common adverse reactions (>=10%) include contusion, gait disturbance, and headache.
Most common adverse reactions (>=10%) include contusion, gait disturbance, and headache.
There are 4 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Hypoxia |
| Rare/Very Rare |
|---|
|
Acute respiratory failure Anaphylaxis Hypersensitivity drug reaction |
There are 11 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Bruising Gait abnormality Headache disorder |
Dermatophytosis Eczema Glycosuria Skin inflammation Skin rash |
| Rare/Very Rare |
|---|
|
Dyspnea Erythema Urticaria |
The following precautions are available for RADICAVA ORS (edaravone):
Efficacy and safety of edaravone have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no adequate data to determine whether edaravone is associated with a risk of developmental abnormalities when used during pregnancy. In animal studies, administration of edaravone to pregnant rats and rabbits resulted in adverse developmental effects (e.g., increased mortality, decreased growth, delayed sexual development, altered behavior) at clinically relevant doses. Most of these effects occurred at doses that were also associated with maternal toxicity.
It is not known whether edaravone is distributed into human milk or if the drug has any effects on milk production or the nursing infant. Edaravone and its metabolites are distributed into milk of lactating rats. The known benefits of breast-feeding should be considered along with the woman's clinical need for edaravone and any potential adverse effects of the drug or disease on the infant.
Dosage adjustments are not needed in geriatric patients; however, greater sensitivity to the drug for some older individuals cannot be ruled out. No overall differences in efficacy or safety of edaravone have been observed in geriatric patients compared with younger adults. However, the possibility that some geriatric patients may exhibit increased sensitivity to the drug cannot be ruled out.
The following prioritized warning is available for RADICAVA ORS (edaravone):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for RADICAVA ORS (edaravone)'s list of indications:
| Amyotrophic lateral sclerosis | |
| G12.21 | Amyotrophic lateral sclerosis |
Formulary Reference Tool