HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use RADICAVA safely and effectively. See full prescribing information for RADICAVA.
RADICAVA (edaravone injection), for intravenous use
Initial U.S. Approval: 2017
INDICATIONS AND USAGE
RADICAVA is indicated for the treatment of amyotrophic lateral sclerosis (ALS) (1)
DOSAGE AND ADMINISTRATION
The recommended dosage is 60 mg administered as an intravenous infusion over 60 minutes as follows:
• Initial treatment cycle: daily dosing for 14 days followed by a 14-day drug-free period
• Subsequent treatment cycles: daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods ( 2 )
DOSAGE FORMS AND STRENGTHS
• Injection: 30 mg/100 mL in a single-dose polypropylene bag ( 3 )
CONTRAINDICATIONS
• Patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in RADICAVA ( 4 )
WARNINGS AND PRECAUTIONS
• Hypersensitivity Reactions: Advise patients to seek immediate medical care ( 5.1 )
• Sulfite Allergic Reactions: RADICAVA contains sodium bisulfite, which may cause allergic type reactions ( 5.2 )
ADVERSE REACTIONS
Most common adverse reactions (at least 10% and greater than placebo) are contusion, gait disturbance, and headache, (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact MT Pharma America, Inc. at 1-888-292-0058 or FDA at 1-800-FDA-1088 or HTTP://WWW.FDA.GOV/MEDWATCH
USE IN SPECIFIC POPULATIONS
• Pregnancy: Based on animal data, may cause fetal harm ( 8.1 )
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 3/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosage Information
2.2 Preparation and Administration Information
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
5.2 Sulfite Allergic Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Postmarketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
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:
•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 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 SUP