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Dosage and Administration

Learn about patient considerations when prescribing RADICAVA® (edaravone), how to administer RADICAVA®, and the modes of infusion.

Considerations for Use

Considerations when deciding if RADICAVA® is appropriate for your patients1:

green check mark in circle badge
FDA-approved and indicated for the treatment of ALS
green infusion bag with plus symbol
May be received with riluzole
two green prescription drug bottles
No known drug interactionsa (see full Prescribing Information)

aBased on in vitro drug interaction studies.

When prescribing RADICAVA®, advise patients to read the Patient Information for RADICAVA®, and to tell you1,2:

  • If they have asthma
  • If they are allergic to other medicines
  • If they are pregnant or intend to become pregnant
  • If they are breastfeeding or intend to breastfeed
  • About all of the medicines they are taking
benefit investigation and enrollment form (BIF) for RADICAVA® (edaravone), an FDA approved treatment option for ALS
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Administering RADICAVA®

RADICAVA® is an intravenous (IV) medication for the treatment of ALS. The recommended dosage is 60 mg administered over a 60-minute period.1 RADICAVA® may be administered at an infusion center, a doctor's office, a hospital, or at home. Patients should consult their healthcare provider (HCP) and insurance plan to determine which option is right for them.

blue infusion bag icon
IV infusion (60 mg)1
two blue infusion bags
Two 30 mg bags
60 min within a circle
60 minutes to receive full dose1

Preparation and administration information1

  • Do not use if the oxygen indicator has turned blue or purple before opening the package; once overwrap package is opened, use within 24 hours (see video below for more details)
  • Visually inspect for particulate matter and discoloration prior to administration
  • Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction
  • Other medications should not be injected into the infusion bag or mixed with RADICAVA®
  • Patients should be monitored carefully for hypersensitivity reactions, and if they occur, discontinue RADICAVA®, treat per standard of care, and monitor until the condition resolves
  • Advise patients to seek immediate medical care if they experience signs or symptoms of a hypersensitivity reaction or a sulfite allergic reaction

How to infuse RADICAVA®

Watch a brief video that explains how to administer and store RADICAVA®. See the full Prescribing Information for complete dosage and administration information.

Administration Video



Preparing the infusion bag

Follow these instructions to help prevent damage to the stopper and avoid leakage of medication. You can also download these instructions.

Step 1: Align Spike

Handle the bag gently. Hold the bag with the rubber stopper facing upward. If the bag is already hanging, remove it from the IV pole. Align the spike to the center of the stopper without twisting. DO NOT spike upward. It is important NOT to insert the spike at an angle.

hands holding the rubber stopper facing upwards to demonstrate the correct way to align the spike

Step 2: Carefully Insert Spike

Very gently and carefully insert the spike straight into the center of the stopper. It is important not to twist the spike when inserting it into the IV bag. Be sure to only spike once.

hands inserting the spike straight into the center of the stopper to demonstrate the correct way to insert the spike

Avoid Damage to the Stopper

During insertion:

  • DO NOT twist the spike
  • DO NOT insert the spike at an angle
  • DO NOT insert the spike too deep
  • DO NOT spike multiple times

Doing so may damage the stopper and cause medication leakage.

NEVER INFUSE A BAG IF THE SPIKE HAS BEEN IMPROPERLY INSERTED INTO THE RUBBER STOPPER, CAUSING MEDICATION LEAKAGE.

hands demonstrating the incorrect way of inserting the spike at an angle
hands holding the rubber stopper facing upwards to demonstrate the correct way to align the spike
hands inserting the spike straight into the center of the stopper to demonstrate the correct way to insert the spike
hands demonstrating the incorrect way of inserting the spike at an angle

Infusion schedule

RADICAVA® is an ongoing treatment for ALS. For the first cycle, RADICAVA® is infused for 14 days, followed by a 14-day drug-free period. Subsequent cycles are infused for 10 days within a 14-day period, followed by a 14-day drug-free period.1

First cycle

blue calendar day with 14 in green
consecutive days on
grey calendar day with 14 in grey
consecutive days off

Subsequent cycles

blue calendar day with 10 in green
out of 14 days on
grey calendar with 14 in grey
consecutive days off
video screen with play arrow
Hear real patients talk about receiving RADICAVA® at home and at an infusion center

Modes of Infusion

RADICAVA® may be administered via a central or peripheral IV device. To learn more, you can download information about these modes of infusion.

Download
ALS Care Locator, a tool to help patients locate healthcare providers and infusion centers that treat ALS
Searching for an infusion site of care? Use our ALS Care Locator
    References:
  1. RADICAVA Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2018.
  2. RADICAVA Patient Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2018.
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Important Safety Information

Hypersensitivity Reactions

Radicava® (edaravone) is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in Radicava®. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported. Patients should be monitored carefully for hypersensitivity reactions, and if they occur, discontinue Radicava®, treat per standard of care, and monitor until the condition resolves.

Sulfite Allergic Reactions

Radicava® contains sodium bisulfite, and 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, but occurs more frequently in asthmatic people.

Most Common Adverse Reactions

Most common adverse reactions (at least 10% and greater than placebo) are contusion, gait disturbance, and headache.

Pregnancy

Based on animal data, Radicava® may cause fetal harm.

Geriatric Use

No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indication

Radicava® is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Please see full Prescribing Information.

For more information about RADICAVA®, call 1-888-292-0058.