RADICAVA- edaravone injection
MT Pharma America, Inc.
1 INDICATIONS AND USAGE
RADICAVA is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
2 DOSAGE AND ADMINISTRATION
2.1 Dosage Information
The recommended dosage of RADICAVA is an intravenous infusion of 60 mg administered over a 60-minute period according to the following schedule:
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An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug-free period
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Subsequent treatment cycles with daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods.
2.2 Preparation and Administration Information
RADICAVA is for intravenous infusion only.
Preparation
Do not use if the oxygen indicator has turned blue or purple before opening the package [see How Supplied/Storage and Handling (16.1,16.2)]. Once the overwrap package is opened, use within 24 hours [see Storage and Handling (16.2) ].
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Administration
Administer each 60 mg dose of RADICAVA injection as two consecutive 30 mg intravenous infusion bags over a total of 60 minutes (infusion rate approximately 1 mg per minute [3.33 mL per minute]).
Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction [seeWarnings and Precautions (5.1,5.2)].
Other medications should not be injected into the infusion bag or mixed with RADICAVA.
3 DOSAGE FORMS AND STRENGTHS
RADICAVA is supplied for intravenous infusion in a single-dose polypropylene bag containing 30 mg of edaravone in 100 mL of clear, colorless aqueous solution
