PLIED/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 [SEEWARNINGS AND PRECAUTIONS (5.1,5.2)].
Other medications should not be injected into the infusion bag or mixed with RADICAVA.
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.
4 CONTRAINDICATIONS
RADICAVA is 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 WARNINGSAND 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, treat per standard of care, and monitor until the condition resolves [see CONTRAINDICATIONS (4)].
5.2 Sulfite Allergic Reactions
RADICAVA contains 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 preva lence of sulfite sensitivity in the general population is unknown. Sulfite sensitivity occurs more frequently in 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 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 Reac |
