Radicava

Name: Radicava

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What is the most important information I should know about edaravone?

Edaravone can cause serious allergic reactions. Get emergency medical help if you have hives, itching, trouble breathing, swelling in your face or throat, or if you feel light-headed.

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Advice to Patients

Advise patients to read the FDA-approved patient labeling (Patient Information).1

Hypersensitivity Reactions

Advise patients to seek immediate medical care if they experience signs or symptoms of a hypersensitivity reaction.1

Sulfite Allergic Reactions

Advise patients about potential for sulfite sensitivity. Inform patients that edaravone 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.1

Pregnancy and Breast-feeding

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during edaravone therapy.1

Advise patients to notify their healthcare provider if they intend to breast-feed or are breast-feeding an infant.1

Additional Information

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

What are some things I need to know or do while I take Radicava?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Unsafe allergic effects may rarely happen.
  • If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Radicava while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Radicava) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

How do I store and/or throw out Radicava?

  • If you need to store Radicava at home, talk with your doctor, nurse, or pharmacist about how to store it.

Dosage Forms and Strengths

Radicava is supplied for intravenous infusion in a single-dose polypropylene bag containing 30 mg of edaravone in 100 mL of clear, colorless aqueous solution.

Adverse Reactions

The following serious adverse reactions are described elsewhere in the labeling:

  • Hypersensitivity Reactions [see Warnings and Precautions (5.1)]   • Sulfite Allergic Reactions [see Warnings and Precautions (5.2)]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In randomized, placebo-controlled trials, 184 ALS patients were administered Radicava 60 mg in treatment cycles for 6 months. The population consisted of Japanese patients who had a median age of 60 years (range 29-75) and were 59% male. Most (93%) of these patients were living independently at the time of screening.

Most Common Adverse Reactions Observed During Clinical Studies

Table 1 lists the adverse reactions that occurred in ≥ 2% of patients in the Radicava-treated group and that occurred at least 2% more frequently than in the placebo-treated group in randomized placebo-controlled ALS trials. The most common adverse reactions that occurred in ≥10% of Radicava-treated patients were contusion, gait disturbance, and headache.

Table 1: Adverse Reactions from Pooled Placebo-Controlled Trialsa that Occurred in ≥ 2% of Radicava-Treated Patients and ≥ 2% More Frequently than in Placebo Patients

Adverse Reaction

Radicava

(N=184)

%

Placebo

(N=184)

%

Contusion

15

9

Gait disturbance

13

9

Headache

10

6

Dermatitis

8

5

Eczema

7

4

Respiratory failure, respiratory disorder, hypoxia

6

4

Glycosuria

4

2

Tinea infection

4

2

  a Pooled placebo-controlled studies include two additional studies with 231 additional patients, all using the same treatment regimen [see Clinical Studies (14)].

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Radicava outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and subcutaneous tissue disorders: Hypersensitivity reactions and anaphylaxis.

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 your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms:

• hives • breathing problem • itching • swelling of the lips, tongue, face • dizziness • wheezing • fainting

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 allergic reactions, for example, 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 • trouble breathing or swallowing • itching • swelling of the lips, tongue, face • dizziness • asthma attack (in people with asthma) • wheezing • fainting

Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects.

The most common side effects of Radicava include bruising (contusion), problems walking (gait disturbance), and headache.

These are not all the possible side effects of Radicava. Call your healthcare provider for medical advice about side effects. You may report side effects to Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058 orFDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What are the ingredients in Radicava?

Active ingredient: edaravone

Inactive ingredients: L-cysteine hydrochloride hydrate, sodium bisulfite, sodium chloride, phosphoric acid, and sodium hydroxide.

Marketed and distributed by: Mitsubishi Tanabe Pharma America, Inc., a US subsidiary of Mitsubishi Tanabe Pharma Corporation, 525 Washington Blvd., Suite 400, Jersey City, NJ 07310

For more information, go to www.Radicava.com or call 1-888-292-0058.

  This Patient Information or Medication Guide has been approved by the U.S. Food and Drug Administration Revised or Issued: 08/2017
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