RADICAVA

Generic Name/API: RADICAVA®
(edaravone) injection, for intravenous use
RADICAVA ORS®
(edaravone) oral suspension

Manufacturer: Mitsubishi Tanabe Pharma Corporation

Dosage Forms & Strength & Pack Size:
• Injection: 30 mg/100 mL in a single-dose polypropylene bag
• Oral suspension: 105 mg/5 mL in a multi-dose amber glass bottle

Storage:
Storage:
RADICAVA
Store RADICAVA at up to 25°C (77°F). Excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP
Controlled RoomTemperature]. 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 theoverwrap package is opened, use within 24 hours.

RADICAVA ORS
Pharmacy
Store RADICAVA ORS refrigerated between 2ºC to 8ºC (36°F to 46°F) and protect from light. Do not freeze.
Store upright.
Patient
Store RADICAVA ORS upright at room temperature between 20°C to 25°C (68°F to 77°F). Protect from light.
Discard 15 days after opening bottle or if unopened 30 days from date of shipment indicated on the carton
pharmacy label.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION

RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).

IMPORTANT SAFETY INFORMATION
Do not receive RADICAVA (edaravone) or RADICAVA ORS (edaravone) if you are allergic to edaravone or any of the ingredients in RADICAVA and RADICAVA ORS.
Before you take RADICAVA or RADICAVA ORS, tell your healthcare provider about all of your medical conditions, including if you:
have asthma.
are allergic to other medicines.
are pregnant or plan to become pregnant. It is not known if RADICAVA or RADICAVA ORS will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if RADICAVA or RADICAVA ORS passes into your breastmilk. You and your healthcare provider should decide if you will receive RADICAVA or RADICAVA ORS or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of RADICAVA and RADICAVA ORS?
RADICAVA and RADICAVA ORS may cause serious side effects, including hypersensitivity (allergic) reactions and sulfite allergic reactions.
Hypersensitivity reactions have happened in people receiving RADICAVA or taking RADICAVA ORS and can happen after your medicine has been given.

RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe asthma episodes in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma.

Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: hives; swelling of the lips, tongue, or face; fainting; breathing problems; wheezing; trouble swallowing; dizziness; itching; or an asthma attack (in people with asthma).
Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects and allergic reactions.
The most common side effects include bruising (contusion), problems walking (gait disturbance) and headache.
These are not all the possible side effects of RADICAVA or RADICAVA ORS.

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