Note RADICAVA (injection) was discontinued from sale on April 1, 2025. 1 Adverse Reaction Overview The most common adverse reactions with RADICAVA in pooled placebo-controlled trials were contusion, gait disturbance, and headache. Discontinuation due to an adverse event occurred in 2% (4/184) of RADICAVA (injection) patients vs 5% (10/184) of patients on placebo in pooled placebo-controlled trials.
Discontinuation due to an adverse event occurred in 6% (11/185) of RADICAVA (oral suspension) patients in an open-label safety trial. Overall, 4 patients (2%) on RADICAVA (injection) and 2 (1%) patients on placebo died during pooled placebo-controlled trials.
All deaths in the trials were from respiratory disorder/failure. Six patients (3%) on RADICAVA (oral suspension) died during an open-label safety trial. The majority of deaths in the trial were from respiratory failure including 3 patients on RADICAVA (oral suspension).
2 Clinical Trial Adverse Reactions RADICAVA (injection) Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real world use. The safety profile of RADICAVA (injection) was compared to placebo in 3 clinical trials: • Two double-blind, randomized, placebo-controlled studies in patients with grade 1-2 ALS (Japanese severity classification).
From these 2 studies, 171 patients received RADICAVA and 160 of the 171 patients completed the placebo-controlled period (6 months). • One double-blind, randomized, placebo-controlled study in 25 patients with grade 3 ALS. Thirteen patients received RADICAVA and 9 of the 13 patients completed the 6-month trial.
In these double-blind randomized, placebo-controlled trials, patients were administered RADICAVA (injection) 60 mg (n=184) or placebo (n=184) in treatment cycles for 6 months of which 169 RADICAVA (injection) and 162 patients on placebo completed 6 months of treatment.
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. Product Monograph RADICAVA (oral suspension) Page 9 of 37 RADICAVA (oral suspension) The safety profile of RADICAVA (oral suspension) was evaluated in an open-label safety study in ALS patients (n=185).
Of the 185 patients that received RADICAVA (oral suspension), 160 patients completed 6 months (interim analysis). The population consisted of White (58%), Japanese (35%), Asian – not Japanese (2%), and Black (2%) patients. The median age was 61 years (range 22-75) and 64% of patients were male.
Most Common Adverse Reactions Observed During Clinical Trials Table 3:
Adverse Reactions from Pooled Placebo-Controlled Trialsa that Occurred in ≥2% of patients treated with RADICAVA (injection) and ≥2% More Frequently than in Placebo Patients Adverse Reaction RADICAVA (injection) (N=184) n (%) Placebo (N=184) n (%) Contusion 27 (15%) 16 (9%) Gait disturbance 23 (13%) 17 (9%) Headache 18 (10%) 11 (6%) Dermatitis 14 (8%) 10 (5%) Eczema 12 (7%) 7 (4%) Respiratory failure, respiratory disorder, hypoxia 11 (6%) 7 (4%) Glycosuria 7 (4%) 3 (2%) Tinea infection 7 (4%) 4 (2%) a Pooled placebo-controlled studies include two additional studies [MCI186-16 (102 RADICAVA patients and 104 placebo patients) and MCI186-18 (13 RADICAVA patients and 12 placebo patients)], all using the same treatment regimen (see 14 CLINICAL TRIALS).
3 Less Common Clinical Trial Adverse Reactions List of less common adverse reactions reported in ≤ 2% of RADICAVA patients and that occurred at least 1% more frequently than in placebo patients, in pooled placebo-controlled trials.
• Gastrointestinal disorders: Abdominal pain, Abdominal pain upper, Gastritis • General disorders and administration site conditions: Gait inability, Chest pain • Hepatobiliary disorders: Hepatic steatosis, Liver disorder • Infections and infestations: Tinea infection • Injury, poisoning and procedural complications: Procedural pain • Musculoskeletal and connective tissue disorders: Neck pain Abnormal Laboratory Findings In an open-label safety trial, CK elevation >3x ULN was noted in 16 (10%) RADICAVA oral suspension patients.
5 Post-Market Adverse Reactions – RADICAVA The following adverse reactions have been identified during post-approval use of RADICAVA. 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.
• Hypersensitivity reactions and anaphylaxis • Skin and subcutaneous tissue disorders