RADICAVA Solution for injection (2018)
Βιβλιογραφική αναφορά
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Mitsubishi Tanabe Pharma America, Inc.
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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 ...
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.
4. Contraindications
RADICAVA is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions and anaphylactic reactions have occurred ...
5. Warnings and Precautions
5.1 Hypersensitivity Reactions Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported in spontaneous ...
6. Adverse Reactions
The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions <em>[see Warnings and Precautions (5.1)]</em> Sulfite Allergic Reactions <em>[see Warnings and ...
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 ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during postapproval use of RADICAVA outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, ...
8.1. Pregnancy
Risk Summary There are no adequate data on the developmental risk associated with the use of RADICAVA in pregnant women. In animal studies, administration of edaravone to pregnant rats and rabbits resulted ...
8.2. Lactation
Risk Summary There are no data on the presence of edaravone in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Edaravone and its metabolites are excreted ...
8.4. Pediatric Use
Safety and effectiveness of RADICAVA in pediatric patients have not been established.
8.5. Geriatric Use
Of the 184 patients with ALS who received RADICAVA in 3 placebo-controlled clinical trials, a total of 53 patients were 65 years of age and older, including 2 patients 75 years of age and older. No overall ...
8.6. Renal Impairment
The effect of renal impairment on the pharmacokinetics of RADICAVA has not been studied. However, renal impairment is not expected to significantly affect the exposure to edaravone. No dose adjustment ...
8.7. Hepatic Impairment
The effect of hepatic impairment on the pharmacokinetics of RADICAVA has not been studied. No dose adjustment is needed for patients with mild or moderate hepatic impairment. No specific dosing recommendation ...
11. Description
The active ingredient in RADICAVA is edaravone, which is a member of the substituted 2-pyrazolin-5-one class. The chemical name of edaravone is [3-methyl-1-phenyl-2-pyrazolin-5-one]. The molecular formula ...
12.1. Mechanism of Action
The mechanism by which RADICAVA exerts its therapeutic effect in patients with ALS is unknown.
12.3. Pharmacokinetics
RADICAVA is administered by IV infusion. The maximum plasma concentration (C<sub>max</sub>) of edaravone was reached by the end of infusion. There was a trend of more than dose-proportional increase in ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis The carcinogenic potential of edaravone has not been adequately assessed. Mutagenesis Edaravone was negative in <em>in vitro</em> (bacterial reverse mutation and Chinese hamster lung chromosomal ...
14. Clinical Studies
The efficacy of RADICAVA for the treatment of ALS was established in a 6-month, randomized, placebo-controlled, double-blind study conducted in Japanese patients with ALS who were living independently ...
16.1. How Supplied
RADICAVA injection is supplied as a 30 mg/100 mL (0.3 mg/mL) clear, colorless, sterile solution for intravenous infusion in single-dose polypropylene bags, each overwrapped with polyvinyl alcohol (PVA) ...
16.2. Storage and Handling
Store at up to 25°C (77°F). Excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in overwrapped package to protect from oxygen degradation ...
17. Patient Counseling Information
Advise the patients to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Reactions Advise patients to seek immediate medical care if they experience signs or symptoms of a ...