- What is
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
The mechanism by which
RADICAVA®exerts its therapeutic effect in patients with ALS is unknown.1
- How is
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-SRCHLGT (1-844-772-4548)or go here.
RADICAVA®be received with riluzole?
Yes. In the clinical trials for
RADICAVA®, >90% of participants also received a steady dose of riluzole.1
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
- How long do patients stay on
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®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
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®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®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
RADICAVA®covered by insurance?
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.2 This includes treatment with
RADICAVA®, which is on the VA National Formulary, subject to National Prior Authorization criteria. You can learn more about these services and accessing RADICAVA®for veterans here.
- RADICAVA Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2018.
- ALS Association. VA provides benefits to veterans with ALS and families. http://web.alsa.org/site/PageServer?pagename=va_provides_benefits. Accessed May 29, 2019.