Sulfite Allergic Reactions
Advise patients about potential for sulfite sensitivity. Inform patients that RADICAVA 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 [see WARNINGS AND PRECAUTIONS (5.2)].
Pregnancy and Breastfeeding
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during RADICAVA therapy [see USE IN SPECIFIC POPULATIONS (8.1)].
Advise patients to notify their healthcare provider if they intend to breastfeed or are breastfeeding an infant [see USE IN SPECIFIC POPULATIONS (8.2)].
Marketed and distributed by:
MT Pharma America, Inc., a US subsidiary of Mitsubishi Tanabe Pharma Corporation
525 Washington Blvd., Suite 400,
Jersey City, NJ 07310
RADICAVA is a trademark of Mitsubishi Tanabe Pharma Corporation
© Mitsubishi Tanabe Pharma Corporation [2017]
XXXXXXX [05/2017] Iss. 05/17
PATIENT INFORMATION
RADICAVA (ra di ká vah)
(edaravone injection)
for intravenous infusion
What is RADICAVA?
RADICAVA is a prescription medicine used to treat people with Amyotrophic Lateral Sclerosis (ALS).
It is not known if RADICAVA is safe and effective in children.
Do not receive RADICAVA if you are allergic to edaravone or any of the ingredients in RADICAVA. See the end of this leaflet for a complete list of ingredients in RADICAVA.
Before you receive RADICAVA, 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 will harm your unborn baby.
•are breastfeeding or plan to breastfeed. It is not known if RADICAVA passes into your breastmilk. You and your healthcare provider should decide if you will receive RADICAVA or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive RADICAVA?
•You will be prescribed RADICAVA by a healthcare provider. RADICAVA will be given by intravenous (IV) infusion into your vein.
•It takes about 1 hour to receive the full dose of RADICAVA.
•Your healthcare provider will tell you how often you will receive RADICAVA.
•Your healthcare provider will monitor you closely during your treatment with RADICAVA.
What are the possible side effects of RADICAVA?
RADICAVA may cause serious side effects including:
1. Hypersensitivity (allergic) reactions. Hypersensitivity reactions have happened in people receiving RADICAVA and can happen after your infusion is finished. Tell you healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms:
2. Sulfite allergic reactions. RADICAVA contains 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:
Your healthcare provider will m |
