About Radicava

What is Radicava?

Radicava® (edaravone) is the only FDA-approved treatment option for amyotrophic lateral sclerosis (ALS) in the last 20 years. In a pivotal clinical trial, Radicava® was shown to slow the decline of physical function in people with ALS.1,2

Radicava® is an intravenous (IV) medication. Each infusion takes about 60 minutes.1

Timeliness is essential

Because ALS can progress rapidly, beginning treatment as soon as possible can be important in slowing the decline of physical function. It may be important to let patients know that1:

  • Radicava® is an ongoing treatment for ALS
  • It is not a cure
  • It does not restore function
  • It can only help if treatment is continued as directed, even though they may feel like it is not making a difference
  • Individual results may vary

Ordering Radicava

To learn how to order Radicava® for your patients, go here.

Radicava is on the VA National Formulary

The Department of Veterans Affairs (VA) provides assistance to veterans with ALS, and access to treatment options, including Radicava®. Learn more today

FAQs About Radicava

What is Radicava®?

Radicava® is an FDA-approved prescription medicine indicated for the treatment of amyotrophic lateral sclerosis (ALS). Radicava® is a clear, colorless liquid provided as a sterile solution.1

What is the mechanism of action of Radicava®?

The mechanism by which Radicava® exerts its therapeutic effect in patients with ALS is unknown.1

How is Radicava® administered?

Each 60 mg dose of Radicava® is administered as 2 consecutive 30 mg intravenous infusion bags over a total of 60 minutes (infusion rate approximately 1 mg per minute). 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®.1

Where do patients go for infusions?

Radicava® may be administered at an infusion center, a doctor's office, a hospital, or home. Patients should consult their healthcare provider and insurance plan to determine which option is right for them. The Searchlight Support™ program can help patients find an infusion site of care. To learn more, call 1-844-772-4548 or go here.

Can Radicava® be received with riluzole?

Yes. In clinical trials, Radicava® was safely received concomitantly with a steady dose of riluzole by >90% of participants.1

Does Radicava® have any drug interactions?

The pharmacokinetics of edaravone is not expected to be significantly affected by inhibitors of CYP enzymes, UGTs, or major transporters.1

In vitro studies demonstrated that, at clinical dose, edaravone and its metabolites are not expected to significantly inhibit cytochrome P450 enzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4), UGT1A1, UGT2B7, or transporters (P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, and OCT2) in humans. Edaravone and its metabolites are not expected to induce CYP1A2, CYP2B6, or CYP3A4 at the clinical dose level of Radicava®.1

How long do patients stay on Radicava®?

The duration of treatment with Radicava® should be based on the professional judgment of the healthcare provider in consultation with patients and caregivers. Work with patients to decide how long to continue treatment with Radicava®.

What are the contraindications for Radicava®?

Radicava® is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of Radicava®. Hypersensitivity reactions and anaphylactic reactions have occurred. For a full list of ingredients, see the next question.1

What are the ingredients in Radicava®?

The active ingredient is edaravone. The inactive ingredients are L-cysteine hydrochloride hydrate, sodium bisulfite, sodium chloride, phosphoric acid, and sodium hydroxide.1

Can patients receive Radicava® if they are pregnant?

There are no adequate data on the developmental risk associated with the use of Radicava® in pregnant women. Based on animal data, Radicava® may cause fetal harm. Advise patients to notify the appropriate healthcare provider if they become pregnant or intend to become pregnant during treatment with Radicava®.1

Can patients receive Radicava® if they are breastfeeding?

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 in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Radicava® and any potential adverse effects on the breastfed infant from Radicava® or from the underlying maternal condition. Advise patients to notify the appropriate healthcare provider if they intend to breastfeed or are breastfeeding an infant.1

How is Radicava® supplied?

Radicava® 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 bag is overwrapped with polyvinyl alcohol (PVA) secondary packaging containing an oxygen absorber and oxygen indicator, which should be pink to reflect appropriate oxygen levels.1

Radicava® is supplied in cartons as listed1:

NDC 70510-2171-2    2 bags per carton

How is Radicava® stored?

Store Radicava® at up to 25°C (77°F). Excursions permitted from 15°C to 30°C (59°F to 86°F). Protect from light. Store in overwrapped package to protect from oxygen degradation until time of use. The oxygen indicator will turn blue or purple if the oxygen has exceeded acceptable levels. Once the overwrap package is opened, use within 24 hours.1

Is Radicava® covered by insurance?

Searchlight Support™ can help you and your patients navigate insurance questions. To learn more, call 1-844-SRCHLGT (1-844-772-4548).

Is access to Radicava® available for veterans with ALS?

Yes. The Department of Veterans Affairs (VA) recognizes ALS as a service-connected condition and provides assistance and access to treatment options for veterans with ALS.3 This includes treatment with Radicava®, which is on the VA National Formulary with a national prior authorization. You can learn more about these services and accessing Radicava® for veterans here.

References: 1. Radicava Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America; 2017. 2. Rilutek Prescribing Information. Cary, NC: Covis Pharmaceuticals Inc.; 2016. 3. ALS Association. VA provides benefits to veterans with ALS and families. http://web.alsa.org/site/PageServer?pagename=va_provides_benefits. Accessed February 1, 2018.

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.