Medical Editor: John P. Cunha, DO, FACOEP
What Is Radicava?
What Are Side Effects of Radicava?
Common side effects of Radicava include:
- gait disturbance,
- skin inflammation or rash,
- respiratory failure,
- respiratory disorder,
- oxygen deficiency,
- glucose in the urine, and
- fungal skin infections (such as ringworm, jock itch, athlete's foot).
Patients whoto are sensitive to sulfites may have an allergic reaction, including anaphylaxis, to Radicava, which contains sodium bisulfite.
Dosage for Radicava
The recommended dosage of Radicava is 60 mg administered as an intravenous infusion over 60 minutes as follows: Initial treatment cycle: daily dosing for 14 days followed by a 14-day drug-free period. Subsequent treatment cycles: daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods. Radicava may interact with other drugs.
What Drugs, Substances, or Supplements Interact with Radicava?
Tell your doctor all medications and supplements you use.
Radicava During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Radicava; it may harm a fetus. It is unknown if Radicava passes into breast milk. Consult your doctor before breastfeeding.
Our Radicava (edaravone injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Sulfite Allergic Reactions [see WARNINGS AND PRECAUTIONS]
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 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
|Respiratory failure, respiratory disorder, hypoxia||6||4|
|a Pooled placebo-controlled studies include two additional studies with 231 additional patients, all using the same treatment regimen [see Clinical Studies].|
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.
Read the entire FDA prescribing information for Radicava (Edaravone Injection)