RADICAVA

RADICAVA- edaravone injection
RADICAVA ORS- edaravone
Mitsubishi Tanabe Pharma America, Inc.

1 INDICATIONS AND USAGE

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

2 DOSAGE AND ADMINISTRATION

2.1 Dosage Information

The recommended dosage of RADICAVA and RADICAVA ORS is as follows:
RADICAVA: an intravenous infusion of 60 mg administered over a 60-minute period
RADICAVA ORS: 105 mg (5 mL) taken orally or via feeding tube in the morning after overnight fasting [see Dosage and Administration (2.3)]
Administer RADICAVA or RADICAVA ORS according to the following schedule:
An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug-free period
Subsequent treatment cycles with daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods

2.2 Preparation and Administration Information for RADICAVA Injection

RADICAVA is for intravenous infusion only.

Preparation

Do not use if the oxygen indicator has turned blue or purple before opening the package [see How Supplied/Storage and Handling (16.1, 16.2)]. Once the overwrap package is opened, use within 24 hours [see Storage and Handling (16.2)].

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Administration

Administer each 60 mg dose of RADICAVA injection as two consecutive 30 mg intravenous infusion bags over a total of 60 minutes (infusion rate approximately 1 mg per minute [3.33 mL per minute]).

Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction [see Warnings and Precautions (5.1, 5.2)].

Other medications should not be injected into the infusion bag or mixed with RADICAVA.

2.3 Preparation and Administration Information for RADICAVA ORS Oral Suspension

See the Instruction for Usefor further preparation and administration details.

Preparation

Prior to opening the bottle, turn it upside down (invert) and shake vigorously up and down for at least 30 seconds.

Administration

RADICAVA ORS can be administered by mouth or via feeding tube (see Feeding Tube Administration).

RADICAVA ORS should be taken in the morning on an empty stomach after overnight fasting. Food should not be consumed for 1 hour after administration except water [see Clinical Pharmacology (12.3)]. See Table 1 for specific fasting conditions.

Table 1: RADICAVA ORS Administration Relative to Type of Food Consumption

Type of food/caloric supplement consumed

Fasting time before and after RADICAVA ORS dose administration with regards to meal type

High-fat meal (800-1,000 calories, 50% fat)

8 hours before administration and one hour after administration

Low-fat meal (400-500 calories, 25% fat)

4 hours before administration and one hour after administration

Caloric supplement (250 calories, e.g., protein drink)

2 hours before administration and one hour after administration

Administer RADICAVA ORS using a 5 mL oral syringe that comes with the product. A household teaspoon is not an adequate measuring device.

Dispose of any RADICAVA ORS that is not used within 15 days after opening the bottle or within the 30 days from the date of shipment indicated on the carton pharmacy label, which ever happens first.

Feeding Tube Administration

Nasogastric (NG) tubes or percutaneous endoscopic gastrostomy (PEG) tubes made of silicone, polyvinyl chloride (PVC), or polyurethane can be used
Before and after administration, use a catheter-tip syringe to flush the tube with at least 1 ounce (30 mL) of water

2.4 Switching from RADICAVA to RADICAVA ORS

Patients treated with 60 mg of RADICAVA intravenous infusion may be switched to 105 mg (5 mL) RADICAVA ORS using the same dosing frequency. Upon switching to RADICAVA ORS, patients should follow RADICAVA ORS dosing recommendations with regards to food consumption [see Dosage and Administration (2.3)].

3 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.

RADICAVA ORS is supplied as an oral suspension in a multi-dose amber glass bottle 105 mg/5 mL of white to off-white color.

4 CONTRAINDICATIONS

RADICAVA and RADICAVA ORS are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions and anaphylactic reactions have occurred [see Warnings and Precautions (5.1, 5.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported in spontaneous postmarketing reports with RADICAVA.

Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA and/or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves [see Contraindications (4)].

5.2 Sulfite Allergic Reactions

RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that 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. Sulfite sensitivity occurs more frequently in asthmatic than non-asthmatic people.

6 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)]

6.1 Clinical Trials 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 2 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 2: 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 IV

(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)].

Additional Adverse Reactions with RADICAVA ORS

In an open-label study in ALS patients (n=185) treated with RADICAVA ORS for 6 months, fatigue was observed in 7.6% of patients.

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