RADICAVA SIDE EFFECTS
SIDE EFFECTS
The following serious adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Reactions
- Sulfite Allergic Reactions
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 2975) 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. | ||
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.
SRC: NLM .