RADICAVA ORS
EDARAVONE · KIT · Shionogi Inc.
Radicava Ors (edaravone) is a prescription medication used to treat amyotrophic lateral sclerosis (ALS), a progressive neurological disease that affects nerve cells in the brain and spinal cord. It comes as an oral kit formulation to be used as directed by your healthcare provider.
Key Facts
- Brand Name
- RADICAVA ORS
- Generic Name
- EDARAVONE
- NDC Code (Product)
70510-2322- Manufacturer
- Shionogi Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- NDA215446
- Marketing Start
- 05/12/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS). RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION RADICAVA: The recommended dosage is 60 mg administered as an intravenous infusion over 60 minutes ( 2.1 ) RADICAVA ORS: The recommended dosage is 105 mg (5 mL) taken orally or via feeding tube in the morning after overnight fasting. Food should not be consumed for 1 hour after administration except water ( 2.1 , 2.3 ) For RADICAVA and RADICAVA ORS: Initial treatment cycle: daily dosing for 14 days followed by a 14-day drug-free period ( 2.1 ) Subsequent treatment cycles: daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods ( 2.1 ) 2.1 Dosage Information The recommended dosage of RADICAVA and RADICAVA ORS is as follows: RADICAVA: an intravenous infusion of 60 mg administered over a 60-minute period RADICAVA ORS: 105 mg (5 mL) taken orally or via feeding tube in the morning after overnight fasting [see Dosage and Administration (2.3) ] Administer RADICAVA or RADICAVA ORS according to the following schedule: An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug-free period Subsequent treatment cycles with daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods 2.2 Pre…
Contraindications
4 CONTRAINDICATIONS RADICAVA and RADICAVA ORS are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in this product. Hypersensitivity reactions and anaphylactic reactions have occurred [see Warnings and Precautions (5.1 , 5.2) ]. Patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in RADICAVA and/or RADICAVA ORS ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Sulfite Allergic Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (at least 10% of patients treated with RADICAVA and greater than placebo) are contusion, gait disturbance, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Shionogi Inc. at 1-888-292-0058 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In randomized, placebo-controlled trials, 184 patients with ALS were administered RADICAVA 60 mg in treatment cycles for 6 months. The population consisted of Japanese patients who had a median age of 60 years (range 29-75) and were 59% male. Most (93%) of these patients were living independently at the time of screening. Most Common Adverse Reactions Observed During Clinical Studies …
Frequently Asked Questions
What is RADICAVA ORS used for?
Radicava Ors (edaravone) is a prescription medication used to treat amyotrophic lateral sclerosis (ALS), a progressive neurological disease that affects nerve cells in the brain and spinal cord. It comes as an oral kit formulation to be used as directed by your healthcare provider.
Is RADICAVA ORS a controlled substance?
RADICAVA ORS is not classified as a controlled substance by the DEA.
What is the generic name for RADICAVA ORS?
The generic name for RADICAVA ORS is EDARAVONE. There are 6 other brand versions of EDARAVONE.
What is the NDC code for RADICAVA ORS ?
The NDC (National Drug Code) for RADICAVA ORS is 70510-2322, listed by Shionogi Inc..