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RADICAVA is a brand name for Edaravone, supplied as a suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PrRADICAVA® is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). 1.1 Pediatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1.2 Geriatrics Evidence from clinical studies and experience suggests that use in the…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Not applicable. 2 Recommended Dose and Dosage Adjustment The recommended dose of RADICAVA (oral suspension) is 105 mg (5 mL) taken orally or via a feeding tube [Nasogastric (NG) tube or Percutaneous Endoscopic Gastrostomy (PEG) tube] 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.
RADICAVA (oral suspension) should be taken in the morning after fasting overnight for at least 8 hours and waiting at least 1 hour before eating or drinking anything except water. For patients who are unable to fast overnight, the required fasting interval can be shortened depending on the type of meal (see Table 1 for specific fasting conditions, and see 10 CLINICAL PHARMACOLOGY and PATIENT MEDICATION INFORMATION, How to take RADICAVA (oral suspension).
, protein drink) 2 hours before administration and one hour after administration No dosage adjustment is required in patients with hepatic impairment or mild and moderate renal impairment (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Hepatic Insufficiency; Renal Insufficiency).
4 Administration Take RADICAVA (oral suspension) using a 5 mL oral syringe that is provided to the patient with the product. Shake the RADICAVA (oral suspension) bottle vigorously up and down for at least 30 seconds before use. RADICAVA (oral suspension) can be administered by mouth or via feeding tube.
Silicone and polyvinyl chloride (PVC) feeding tubes can be used. Administration via Tube Type (Tube diameter) Flush volume Nasogastric tube Silicone, PVC (12-16 Fr) 30 mL Gastrostomy tube Silicone, PVC (12-24 Fr) 30 mL Before and after administration with a feeding tube, flush the tube with 30 mL (1 ounce) of water.
For complete details, refer to the PATIENT MEDICATION INFORMATION, How to take RADICAVA (oral suspension) and Instructions for Use. 5 Missed Dose In case of a missed dose of RADICAVA (oral suspension), take the next dose as soon as possible after the time of the missed dose.
Do not double the daily dose. Product Monograph RADICAVA (oral suspension) Page 6 of 37 5 OVERDOSE For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764- 7669).
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.
4 Geriatrics). 2 CONTRAINDICATIONS Edaravone is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity Reactions).
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1 Dosing Considerations Not applicable. 2 Recommended Dose and Dosage Adjustment The recommended dose of RADICAVA (oral suspension) is 105 mg (5 mL) taken orally or via a feeding tube [Nasogastric (NG) tube or Percutaneous Endoscopic Gastrostomy (PEG) tube] 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.
RADICAVA (oral suspension) should be taken in the morning after fasting overnight for at least 8 hours and waiting at least 1 hour before eating or drinking anything except water. For patients who are unable to fast overnight, the required fasting interval can be shortened depending on the type of meal (see Table 1 for specific fasting conditions, and see 10 CLINICAL PHARMACOLOGY and PATIENT MEDICATION INFORMATION, How to take RADICAVA (oral suspension).
, protein drink) 2 hours before administration and one hour after administration No dosage adjustment is required in patients with hepatic impairment or mild and moderate renal impairment (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Hepatic Insufficiency; Renal Insufficiency).
4 Administration Take RADICAVA (oral suspension) using a 5 mL oral syringe that is provided to the patient with the product. Shake the RADICAVA (oral suspension) bottle vigorously up and down for at least 30 seconds before use. RADICAVA (oral suspension) can be administered by mouth or via feeding tube.
Edaravone is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity Reactions).
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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
Silicone and polyvinyl chloride (PVC) feeding tubes can be used. Administration via Tube Type (Tube diameter) Flush volume Nasogastric tube Silicone, PVC (12-16 Fr) 30 mL Gastrostomy tube Silicone, PVC (12-24 Fr) 30 mL Before and after administration with a feeding tube, flush the tube with 30 mL (1 ounce) of water.
For complete details, refer to the PATIENT MEDICATION INFORMATION, How to take RADICAVA (oral suspension) and Instructions for Use. 5 Missed Dose In case of a missed dose of RADICAVA (oral suspension), take the next dose as soon as possible after the time of the missed dose.
Do not double the daily dose. Product Monograph RADICAVA (oral suspension) Page 6 of 37 5 OVERDOSE For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764- 7669).
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2: Dosage Forms, Strengths, Composition and Packaging Description RADICAVA (oral suspension) is a white to off-white suspension in a multi-dose child resistant 60 mL amber glass bottle which is supplied as two configurations: Unit of sale Package configuration RADICAVA (oral suspension) Starter Kit Carton of two (2) inner cartons, each containing of one (1) bottle of 35 mL (105 mg/5 mL dose), two (2) oral dosing syringes and one bottle adapter.
RADICAVA (oral suspension) Kit One carton of one (1) bottle of 50 mL (105 mg/5 ml dose), two (2) oral dosing syringes and one (1) bottle adapter 7 WARNINGS AND PRECAUTIONS Note RADICAVA (injection) was discontinued from sale on April 1, 2025.
2 Clinical Trial Adverse Reactions). Neurological findings were also observed in dogs and monkeys administered edaravone (see 16 NON-CLINICAL TOXICOLOGY, Neurotoxicity).
Sensitivity/Resistance Hypersensitivity Reactions:
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Suspension / 105 mg / 5 mL L-cysteine hydrochloride hydrate, phosphoric acid, polyvinyl alcohol, simethicone emulsion, sodium bisulfite, sodium hydroxide, sorbitol, xanthan gum, purified water Product Monograph RADICAVA (oral suspension) Page 7 of 37 Hypersensitivity reactions (redness, wheals and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure and dyspnea) have been reported in spontaneous post marketing reports with RADICAVA (injection).
Based on the spontaneous post marketing reports, it appears RADICAVA (injection) can cause anaphylactic reactions. Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA (injection)/ RADICAVA (oral suspension), treat per standard of care and monitor until the condition resolves.
(see 2 CONTRAINDICATIONS).
Sulfite Allergic Reactions:
RADICAVA (injection) / RADICAVA (oral suspension) 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 people with asthma. Skin A higher incidence of skin-related adverse events was identified in RADICAVA […]