the safety Radicava Generic Name: Edaravone Class: Central Nervous System Agents, Miscellaneous Chemical Name: 3-methyl-1-phenyl-2-pyrazolin-5-one Molecular Formula: C 10 H 10 N 2 O CAS Number: 89-25-8 Overview Side Effects Dosage Professional Pregnancy More User Reviews Support Group Q & A Pricing & Coupons Introduction Edaravone is a central nervous system agent. Uses for Radicava Edaravone has the following uses: Edaravone is indicated for the treatment of amyotrophic lateral sclerosis (ALS). 1 Slideshow Amyotrophic Lateral Sclerosis (ALS): Evolving Science For a Fatal Disease Radicava Dosage and Administration General Edaravone is available in the following dosage form(s) and strength(s): Injection: 30 mg/100 mL (0.3 mg/mL) in a single-dose polypropylene bag. 1 Dosage It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary: The recommended dosage is 60 mg administered as an intravenous infusion over 60 minutes as follows: 1 Initial treatment cycle: daily dosing for 14 days, followed by a 14-day drug-free period. 1 Subsequent treatment cycles: daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods. 1 Cautions for Radicava Contraindications Patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in the formulation. 1 Warnings/Precautions Hypersensitivity Reactions Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported in spontaneous postmarketing reports with edaravone. 1 Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue edaravone, treat per standard of care, and monitor until the condition resolves. 1 Sulfite Allergic Reactions Edaravone contains sodium bisulfite, a sulfite that may cause allergic type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown. Sulfite sensitivity occurs more frequently in asthmatic people. 1 Specific Populations Pregnancy Risk Summary: There are no adequate data on the developmental risk associated with the use of edaravone in pregnant women. In animal studies, administration of edaravone to pregnant rats and rabbits resulted in adverse developmental effects (increased mortality, decreased growth, delayed sexual development, and altered behavior) at clinically relevant doses. Most of these effects occurred at doses that were also associated with maternal toxicity. 1 In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 4% and 15 20%, respectively. The background risk for major birth defects and miscarriage in patients with ALS is unknown. 1 Animal Data: In rats, intravenous administration of edaravone (0, 3, 30, or 300 mg/kg/day) throughout the period of organogenesis resulted in reduced fetal weight at all doses. In dams allowed to deliver naturally, offspring weight was reduced at the highest dose tested. Maternal toxicity was also observed at the highest dose tested. There were no adverse effects on reproductive function in the offspring. A no-effect dose for embryofetal developmental toxicity was not identified; the low dose is less than the recommended human dose of 60 mg, on a body surface area (mg/m 2 ) basis. 1 In rabbits, intravenous administration of edaravone (0, 3, 20, or 100 mg/kg/day) throughout the period of organogenesis resulted in embryofetal death at the highest dose tested, which was associated with maternal toxicity. The higher no-effect dose for embryofetal developmental toxicity is approximately 6 times the recommended human dose (RHD) on a body surface area (mg/m 2 ) basis. 1 The effects on offspring of edaravone (0, 3, 20, or 200 mg/kg/day), administered by intravenous injection to rats from GD 17 throughout lactation, were assessed in two studies. In the first study, offspring mortality was observed at the high dose and increased activity was observed at the mid and high doses. In the second study, there was an increase in stillbirths, offspring mortality, and delayed physical development (vaginal opening) at the highest dose tested. Reproduction function in offspring was not affected in either study. Maternal toxicity was evident in both studies at all but the lowest dose tested. The no-effect dose for developmental toxicity (3 mg/kg/day) is less than the RHD on a mg/m 2 basis. 1 Lactation There are no data on the presence of edaravone in human milk, the effects on the breast-fed infant, or the effects of the drug on milk production. Edaravone and its metabolites are excreted in the milk of lactating rats. The developmental and health benefits of breast-feeding should be considered along with the mother s clinical need for edaravone and any potential adverse effects on the breastfed infant from edaravone or from the underlying maternal condition. 1 Pediatric Use Safety and effectiveness of edaravone in pediatric patients have not been established. 1 Geriatric Use Of the 184 patients with ALS who received edaravone in 3 placebo-controlled clinical trials, a total of 53 patients were 65 years of age or older, including 2 patients 75 years of age or older. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 1 Renal Impairment The effect of renal impairment on the pharmacokinetics of edaravone has not been studied. However, renal impairment is not expected to significantly affect the exposure to edaravone. No dose adjustment is needed in these patients. 1 Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of edaravone has not been studied. No dose adjustment is needed for patients with mild or moderate hepatic impairment. No specific dosing recommendation can be provided for patients with severe hepatic impairment. 1 Common Adverse Effects Most common adverse reactions (at least 10% and greater than placebo) are contusion, gait disturbance, and headache. 1 Drug Interactions Specific Drugs It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights: Please see product labeling for drug interaction information. Actions Mechanism Of Action The mechanism by which edaravone exerts its therapeutic effect in patients with ALS is unknown. 1 Advice to Patients Advise patients to read the FDA-approved patient labeling (Patient Information). 1 Hypersensitivity Reactions Advise patients to seek immediate medical care if they experience signs or symptoms of a hypersensitivity reaction. 1 Sulfite Allergic Reactions Advise patients about potential for sulfite sensitivity. Inform patients that edaravone contains 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. 1 Pregnancy and Breast-feeding Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during edaravone therapy. 1 Advise patients to notify their healthcare provider if they intend to breast-feed or are breast-feeding an infant. 1 Additional Information AHFS First Release . For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity. Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Edaravone Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral Injection 30 mg/100 mL Radicava MT Pharma America Inc. AHFS Drug Information. Copyright 2017, Selected Revisions May 22, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. MT Pharma America, Inc.. Radicava (edaravone) intravenous prescribing information. 2016 Mar. Next Pregnancy Warnings Print this page Add to My Med List More about Radicava (edaravone) Side Effects During Pregnancy Dosage Information Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: miscellaneous central nervous system agents Consumer resources Radicava Professional resources Radicava (FDA) Edaravone (AHFS Monograph) Related treatment guides Amyotrophic Lateral Sclerosis} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Miscellaneous central nervous system agents Related Drugs Amyotrophic Lateral Sclerosis riluzole , edaravone , Rilutek , More... Radicava Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } it's important
conventional Radicava is quite
EmoticonEmoticon