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Brand Name
Radicava
Generic Name
Edaravone
View Brand Information FDA approval date: May 05, 2017
Form: Injection, Kit
What is Radicava (Edaravone)?
Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis . Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis .
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Brand Information
RADICAVA (EDARAVONE)
1INDICATIONS AND USAGE
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
2DOSAGE 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.
RADICAVA ORS is supplied as an oral suspension in a multi-dose amber glass bottle 105 mg/5 mL of white to off-white color.
3CONTRAINDICATIONS
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
4ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Reactions
- Sulfite Allergic Reactions
4.1Clinical 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
Table 2 lists the adverse reactions that occurred in ≥2% of patients in the RADICAVA-treated group and that occurred at least 2% more frequently than in the placebo-treated group in randomized placebo-controlled ALS trials. The most common adverse reactions that occurred in ≥10% of RADICAVA-treated patients were contusion, gait disturbance, and headache.
Additional Adverse Reactions with RADICAVA ORS
In an open-label study in patients with ALS (n=185) treated with RADICAVA ORS for 6 months, fatigue was observed in 7.6% of patients.
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of RADICAVA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: Hypersensitivity reactions and anaphylaxis [see
5DESCRIPTION
The active ingredient in RADICAVA and RADICAVA ORS 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 is C
The chemical structure is:
Edaravone is a white crystalline powder with a melting point of 129.7°C. It is freely soluble in acetic acid, methanol, or ethanol and slightly soluble in water or diethyl ether.
RADICAVA injection is a clear, colorless liquid provided as a sterile solution.
RADICAVA injection is supplied for intravenous infusion in a polypropylene bag containing 30 mg edaravone in 100 mL isotonic, sterile, aqueous solution, which is further overwrapped with polyvinyl alcohol (PVA) secondary packaging. The overwrapped package also contains an oxygen absorber and oxygen indicator to minimize oxidation. Each bag contains the following inactive ingredients: L-cysteine hydrochloride hydrate (10 mg), sodium bisulfite (20 mg). Sodium chloride is added for isotonicity and phosphoric acid and sodium hydroxide are added to adjust to pH 4.
RADICAVA ORS (edaravone) oral suspension is a white to off-white color, opaque, homogenous suspension containing 105 mg of edaravone per 5 mL of suspension.
RADICAVA ORS contains the following inactive ingredients: L-cysteine hydrochloride hydrate, polyvinyl alcohol, simethicone emulsion, sodium bisulfite, sorbitol, and xanthan gum. Phosphoric acid and sodium hydroxide are added to adjust to pH 4.
6CLINICAL STUDIES
The efficacy of RADICAVA ORS is based on a bioavailability study comparing RADICAVA and RADICAVA ORS
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 and met the following criteria at screening:
- Functionality retained most activities of daily living (defined as scores of 2 points or better on each individual item of the ALS Functional Rating Scale-Revised [ALSFRS-R; described below])
- Normal respiratory function (defined as percent-predicted forced vital capacity values of [%FVC] ≥80%)
- Definite or Probable ALS based on El Escorial revised criteria
- Disease duration of 2 years or less
The study enrolled 69 patients in the RADICAVA arm and 68 in the placebo arm. Baseline characteristics were similar between these groups, with over 90% of patients in each group being treated with riluzole.
RADICAVA was administered as an intravenous infusion of 60 mg given 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 (Cycle 1).
- Subsequent treatment cycles with daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods (Cycles 2-6).
The primary efficacy endpoint was a comparison of the change between treatment arms in the ALSFRS-R total scores from baseline to Week 24. The ALSFRS-R scale consists of 12 questions that evaluate the fine motor, gross motor, bulbar, and respiratory function of patients with ALS (speech, salivation, swallowing, handwriting, cutting food, dressing/hygiene, turning in bed, walking, climbing stairs, dyspnea, orthopnea, and respiratory insufficiency). Each item is scored from 0-4, with higher scores representing greater functional ability. The decline in ALSFRS-R scores from baseline was significantly less in the RADICAVA-treated patients as compared to placebo (see
Figure 1 Distribution of Change from Baseline to Week 24 in ALSFRS-R Scores
7PATIENT COUNSELING INFORMATION
Advise the patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Hypersensitivity Reactions
Advise patients to seek immediate medical care if they experience signs or symptoms of a hypersensitivity reaction
Sulfite Allergic Reactions
Advise patients about potential for sulfite sensitivity. Inform patients that RADICAVA and RADICAVA ORS contain sodium bisulfite, which may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes, and to seek immediate medical care if they experience these signs or symptoms
Pregnancy and Breastfeeding
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during RADICAVA or RADICAVA ORS therapy
Advise patients to notify their healthcare provider if they intend to breastfeed or are breastfeeding an infant
RADICAVA ORS Administration
Advise patients to take RADICAVA ORS in the morning on an empty stomach. Instruct patients to fast 8 hours before each dose if they consume a high-fat meal, 4 hours before each dose if they consume a low-fat meal, or 2 hours before each dose if they consume a caloric supplement
Advise caregivers, if administering RADICAVA ORS via feeding tube, to use a catheter-tip syringe and flush the feeding tube with approximately 1 ounce (30 mL) of water before and after use
8PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
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