Prescribing guide
Radicava ORS (edaravone)Dosing cycles, fasting and feeding tube administration, sulfite and hypersensitivity warnings and prior authorization criteria for ALSFor prescribers and their offices treating amyotrophic lateral sclerosis (ALS): what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
No REMS and no required labs; hypersensitivity and sulfite history (asthma), prior authorization, and a Benefits Investigation and Enrollment Form or prescription routed to an in-network specialty pharmacy.
Example PA threshold
FEP 5.75.020 example: age 18 or older, ALS, inadequate response to riluzole or continued riluzole, ALSFRS-R 2 or greater on each item or Japanese ALS Severity Scale grade 1 or 2, %FVC 80% or more, neurologist.
Monitoring
No laboratory monitoring in the label; monitor carefully for hypersensitivity reactions, and counsel on sulfite allergic reactions, which are more frequent in people with asthma.
Support line
Shionogi JourneyMate Support Program: Insurance & Access Specialists 1-844-772-4548, Monday to Friday, 8 AM to 8 PM ET (fax 1-888-782-6157); Resource Specialists 1-855-457-6968; Out-of-Pocket Savings Program to as little as $0 per dispense for commercial plans; Patient Assistance Program for the uninsured.
Give your patient their plan
A one-page handout for starting Radicava ORS, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/radicavaorsBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| No REMS | The label sets no REMS and no restricted dispensing program, and has no boxed warning. None of the 4 FDA approval letters reviewed mentions a REMS. | FDA label |
| Contraindication | History of hypersensitivity to edaravone or any of the inactive ingredients. Hypersensitivity reactions and anaphylactic reactions have occurred (section 4). | FDA label |
| Sulfite and asthma history | Both forms contain sodium bisulfite, which may cause allergic type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. Sulfite sensitivity occurs more frequently in asthmatic than non-asthmatic people (5.2). | FDA label |
| Baseline tests | None required by the label. Section 2 names no laboratory or pregnancy test before initiation. | FDA label |
| Benefits investigation | A Benefits Investigation and Enrollment Form (BIF), completed and signed by prescriber and patient, is one way to submit a prescription and check coverage through the JourneyMate Support Program. The prescriber's office sends it; an Insurance & Access Specialist returns a preliminary benefits summary to the patient and the doctor. | Starting Radicava ORS |
| Specialty pharmacy | Prescriptions are sent to an in-network specialty pharmacy, which may assist the office in obtaining a final coverage determination, applies financial support and schedules delivery. | Starting Radicava ORS |
| Starter Kit or Kit | Starter Kit (NDC 70510-2321-2): 2 inner cartons, each with 1 bottle of 735mg/35mL, for the 14-day first cycle. Radicava ORS Kit (NDC 70510-2322-1): 1 bottle of 1,050mg/50mL for a 10-day cycle. Each bottle comes with 2 oral dosing syringes and 1 bottle adapter. | FDA label |
| Brand injection | The label still lists Radicava 30mg/100mL single-dose bags (NDC 70510-2171), but Drugs@FDA lists both Radicava injection products under NDA 209176 as discontinued. Radicava ORS under NDA 215446 is listed as a prescription product. | Drugs@FDA |
| Generic injection | Drugs@FDA lists edaravone intravenous solution with prescription marketing status under ANDAs held by Gland, Hikma, Sandoz and Zydus. No ANDA for an oral suspension is listed. | Drugs@FDA generics |
| Company | Shionogi announced on April 2, 2026 that it had completed the transfer of all rights to Radicava from Tanabe Pharma Corporation. The label and adverse event line (1-888-292-0058) now name Shionogi Inc. | Shionogi press release |
| Patient cost support | Out-of-Pocket Savings Program: commercial prescription coverage required, as little as $0 per dispense up to an annual maximum; Medicare Part C, Part D, Medicaid, VA, DoD and Tricare are excluded. Patient Assistance Program: uninsured, in financial need, income no more than 5 times the Federal Poverty Level. | Radicava ORS financial support |
Prior authorization criteria and what to document
One public policy as the example: Blue Cross and Blue Shield Federal Employee Program, January 1, 2026. Approval approved for 12 months, and renewal for another 12 months needs documented stabilization, slowing of disease progression or improvement on one of the same 2 scoring tools. This version took effect January 1, 2026, after a review on December 12, 2025 that removed Radicava injection, so it covers Radicava ORS only. It cites the November 2022 label, which is older than the May 2026 label this page uses. The label's approved use is ALS without the score and breathing limits, which match the entry rules of the main trial. Other plans set their own criteria and their own approval lengths. It is here as an example of what a plan asks for, not as a rule.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Age | 18 years of age and older | Date of birth on the request | FEP policy |
| Diagnosis | Amyotrophic lateral sclerosis (ALS) | Neurology note with the diagnosis | FEP policy |
| Riluzole | Inadequate response to riluzole, or the patient will continue to take riluzole | Medication list and treatment history | FEP policy |
| Baseline function | ALSFRS-R with a score of 2 or greater on each individual item, or Japanese ALS Severity Scale with a grade of 1 or 2 | Dated, item-level ALSFRS-R or severity grade | FEP policy |
| Respiratory function | Normal respiratory function, %FVC of 80% or more | Pulmonary function report with date | FEP policy |
| Prescriber | Prescribed by or recommended by a neurologist | Specialty on the request, or the consult note | FEP policy |
| Product | The policy covers Radicava ORS; Radicava injection was removed in the December 2025 review | Product and form named on the request | FEP policy |
| Renewal | Documented stabilization, slowing of disease progression or improvement on the ALSFRS-R or the Japanese ALS Severity Scale; age 18 or older; approval for 12 months | Serial scores against the baseline | FEP policy |
Radicava ORS dosing and titration
| When | Label | Source |
|---|---|---|
| Radicava ORS dose | 105mg (5mL) orally or via feeding tube in the morning after overnight fasting. Food should not be consumed for 1 hour after administration except water. | FDA label |
| Initial cycle | Daily dosing for 14 days, followed by a 14-day drug-free period. | FDA label |
| Subsequent cycles | Daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods. The label does not specify which 10 days. | FDA label |
| Fasting, Table 1 | High-fat meal (800 to 1,000 calories, 50% fat): 8 hours before and 1 hour after. Low-fat meal (400 to 500 calories, 25% fat): 4 hours before and 1 hour after. Caloric supplement (250 calories, for example a protein drink): 2 hours before and 1 hour after. | FDA label |
| Preparation | Before opening, invert the bottle and shake vigorously up and down for at least 30 seconds. Administer with the 5mL oral syringe supplied; a household teaspoon is not an adequate measuring device. | FDA label |
| Feeding tube | Nasogastric or PEG tubes made of silicone, PVC or polyurethane can be used. Flush with at least 1 ounce (30mL) of water with a catheter-tip syringe before and after administration. Pharmacokinetics were similar via feeding tube and by mouth (12.3). | FDA label |
| Missed dose | Instructions for Use: if a dose is missed, do not take 2 doses the next day. Do not take a dose on days 15 through 28. | FDA label |
| Radicava injection | 60mg intravenously over 60 minutes, as 2 consecutive 30mg bags (about 1mg per minute), on the same cycles. Promptly discontinue the infusion at the first signs of a hypersensitivity reaction. Use within 24 hours of opening the overwrap. | FDA label |
| Switching from injection | Patients on 60mg intravenously may be switched to 105mg (5mL) of Radicava ORS using the same dosing frequency, following the ORS food recommendations (2.4). | FDA label |
| Renal and hepatic impairment | No dosage adjustment in mild to moderate renal impairment or in hepatic impairment; severe renal impairment has not been studied (12.3). | FDA label |
| Storage and discard | Pharmacy: refrigerate at 2 to 8 degrees Celsius, protect from light, do not freeze, store upright. Patient: upright at 20 to 25 degrees Celsius, protect from light. Discard 15 days after opening, or if unopened 30 days from the shipment date on the carton pharmacy label. | FDA label |
| Basis of approval | Efficacy of Radicava ORS rests on a bioavailability study against the injection. In the 6-month trial of the injection (69 on Radicava, 68 on placebo), the ALSFRS-R change was -5.01 against -7.50, a difference of 2.49 (95% CI 0.99 to 3.98, p=0.0013). | FDA label |
Monitoring the Radicava ORS label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline | No laboratory test is required by the label | Review history of hypersensitivity, sulfite sensitivity and asthma | FDA label |
| Any time | Hypersensitivity reactions (redness, wheals, erythema multiforme) and anaphylaxis (urticaria, decreased blood pressure, dyspnea), reported postmarketing | Monitor carefully; if they occur, discontinue, treat per standard of care and monitor until the condition resolves (5.1) | FDA label |
| Any time | Sulfite allergic reactions, including anaphylactic symptoms and asthmatic episodes | Advise patients to seek immediate medical care (5.2, 17) | FDA label |
| Trials of the injection | Most common adverse reactions, Radicava against placebo (184 patients each) | Contusion 15% and 9%, gait disturbance 13% and 9%, headache 10% and 6% | FDA label |
| Trials of the injection | Other reactions in Table 2 | Dermatitis 8% and 5%, eczema 7% and 4%, respiratory failure, respiratory disorder or hypoxia 6% and 4%, glycosuria 4% and 2%, tinea infection 4% and 2% | FDA label |
| Open-label ORS study | Fatigue | 7.6% of 185 patients over 6 months | FDA label |
| Pregnancy and lactation | Based on animal data, may cause fetal harm; no human data on milk | Advise patients to notify the prescriber of pregnancy, intent to become pregnant, or breastfeeding (8.1, 8.2, 17) | FDA label |
| Pediatric and geriatric use | Safety and effectiveness not established in pediatric patients | No overall differences in patients 65 and older, but greater sensitivity of some older individuals cannot be ruled out | FDA label |
Radicava ORS drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| No section 7 | The label has no drug interactions section and names no interaction that requires a dose change. | FDA label |
| CYP, UGT and transporter inhibitors | Edaravone pharmacokinetics are not expected to be significantly affected by inhibitors of CYP enzymes, UGTs or major transporters (12.3). | FDA label |
| Sildenafil, rosuvastatin, furosemide | Oral edaravone 120mg did not change the Cmax or AUC of these CYP3A4, BCRP and OAT3 substrates. | FDA label |
| Riluzole | Over 90% of patients in each arm of the pivotal trial were treated with riluzole. The label gives no dose change for the combination. | FDA label |
| Food | A high-fat meal with the dose lowered Cmax by 82% and AUC by 61%; dosing 4 hours after a high-fat meal lowered them by 44% and 24%. Follow Table 1. | FDA label |
| QT interval | At exposures at least 5 times those of the recommended doses, edaravone does not prolong the QT interval to any clinically relevant extent (12.2). | FDA label |
Why a first fill stalls, and the fix
- Prior approval pending or deniedThe Federal Employee Program policy asks for age 18 or older and a diagnosis of ALS. It also asks for a baseline function score, normal breathing function and a neurologist who prescribes or recommends the medicine. The neurologist's office sends those records, so ask whether each one went in with the request.
- The plan asks about riluzoleThe same policy requires an inadequate response to riluzole, or a statement that the person will continue to take riluzole. Whether riluzole is part of your treatment is the neurologist's decision, and the office reports it to the plan.
- A function score or breathing result is outside the plan's rangeThe policy asks for a score of 2 or greater on each item of the ALS Functional Rating Scale. A grade of 1 or 2 on the Japanese ALS Severity Scale is accepted instead. It also asks for a forced vital capacity of 80% or more. These limits are the plan's own, because the label's approved use is ALS without them. The neurologist's office can explain how the plan's appeal process works.
- The prescription was written for the infusionThe Federal Employee Program removed Radicava injection from this policy in December 2025, and it now covers Radicava ORS. FDA records list brand Radicava for infusion as discontinued, while generic edaravone for infusion remains listed. The neurologist decides which form fits and rewrites the prescription if needed.
- A copay you cannot payWith commercial insurance, Shionogi's Out-of-Pocket Savings Program can lower the cost to as little as $0 per prescription, up to a yearly maximum. People on Medicare Part C or Part D, Medicaid, VA, DoD, Tricare or other government insurance are not eligible. Enrollment is by phone at 1-844-772-4548 or by a faxed or mailed form. Our help paying page lists charity funds that may also help.
- No insurance at allShionogi's Patient Assistance Program provides Radicava ORS at no charge to uninsured people in financial need who meet its requirements. One requirement is a household income of no more than 5 times the Federal Poverty Level. The program covers only the medicine, not healthcare provider visits.
- The prescription went to a regular pharmacyShionogi's site says prescriptions for Radicava ORS are sent to an in-network specialty pharmacy. An Insurance & Access Specialist helps you understand your options for getting Radicava ORS from an in-network specialty pharmacy. The neurologist's office then sends the prescription to one of them.
JourneyMate Support Program (Shionogi)
- Insurance & Access Specialists, who look into health plan coverage and benefits and explain the financial support options, after the doctor sends the Benefits Investigation and Enrollment Form
- Out-of-Pocket Savings Program for people with commercial prescription coverage, as little as $0 per Radicava ORS prescription up to a yearly maximum, for residents of the US or its territories aged 18 or older, with re-enrollment each year
- Not open to people on Medicare Part C, Medicare Part D, Medicaid, VA, DoD, Tricare or any other government insurance; Medicare Part A and Part B are allowed
- Savings program enrollment by phone, or by a form faxed to 1-888-782-6157 or mailed; Shionogi's page says the online portal is not currently available
- Patient Assistance Program, Radicava ORS at no charge for uninsured people in financial need whose income is no more than 5 times the Federal Poverty Level; it covers the medicine only
- General information about government health plan options, including Medicare, Medicaid, Social Security Disability Insurance, Veterans Affairs and DoD
- Shionogi's page says Medicare Part D patients pay a maximum of $2100 a year for all prescription medicines, with an option of set monthly payments
- Shionogi's page says veterans can get Radicava ORS at no cost through the VA, because ALS is a 100% service-connected condition
- Shionogi's page also names the ALS Association, the HealthWell Foundation and The Assistance Fund as other places to ask about support
- JourneyMate Resource Specialists for questions about starting treatment, at 1-855-457-6968, Monday through Friday, 9 AM to 9 PM Eastern Starting Radicava ORS
- A Clinical Educator, who may call with personalized education about Radicava ORS and does not give medical advice Starting Radicava ORS
Questions prescribers' offices ask about Radicava ORS
What is the Radicava ORS dose and cycle schedule?
105mg (5mL) orally or via feeding tube in the morning after overnight fasting, daily for 14 days followed by a 14-day drug-free period, then daily for 10 days out of 14-day periods followed by 14-day drug-free periods, per the May 2026 label (section 2.1). The label does not specify which 10 days of each 14-day period. Radicava injection is 60mg intravenously over 60 minutes on the same schedule.
What are the Radicava ORS fasting requirements?
8 hours of fasting after a high-fat meal, 4 hours after a low-fat meal and 2 hours after a caloric supplement, with no food for 1 hour after the dose except water, per Table 1 of the May 2026 label (section 2.3). With a high-fat meal, Cmax fell by 82% and AUC by 61% compared with fasted conditions (section 12.3).
Does Radicava ORS have a REMS, boxed warning or required labs?
No. The May 2026 label has no REMS, no boxed warning and no laboratory monitoring requirement, and none of the 4 FDA approval letters reviewed (2017, 2019 and 2 from 2022) mentions a REMS. The 2 warnings are hypersensitivity reactions (5.1) and sulfite allergic reactions (5.2), and the contraindication is a history of hypersensitivity to edaravone or any inactive ingredient.
How is Radicava ORS supplied and how long is an opened bottle good for?
15 days after opening, or 30 days from the date of shipment on the carton pharmacy label, whichever comes first, per the May 2026 label (sections 2.3 and 16.2). The Starter Kit is 2 bottles of 735mg/35mL for the 14-day first cycle, and the Radicava ORS Kit is 1 bottle of 1,050mg/50mL for a 10-day cycle. Pharmacies store it refrigerated; patients store it upright at room temperature, protected from light.
What do insurers ask for to approve Radicava ORS?
The FEP policy shown here, effective January 1, 2026 and citing the November 2022 label, asks for age 18 or older, ALS, an inadequate response to riluzole or continued riluzole, a baseline ALSFRS-R score of 2 or greater on each item or a Japanese ALS Severity Scale grade of 1 or 2, %FVC of 80% or more, and a neurologist. Approval is for 12 months, and renewal needs documented stabilization, slowing of progression or improvement on one of those scales. The policy predates the May 2026 label and no longer covers Radicava injection.
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Sources
- RADICAVA- edaravone injection; RADICAVA ORS- edaravone kit: prescribing information, revised 5/2026, with Patient Information and Instructions for Use, issued 05/2026, Shionogi Inc., via DailyMed, 2026-05-05.
- NDA 209176/S-009 supplement approval letter, Radicava (edaravone), FDA, 2019-11-01.
- How to Start RADICAVA ORS® (edaravone) Treatment, Shionogi Inc., 2026-11-12.
- Financial Support for RADICAVA ORS® (edaravone), Shionogi Inc., 2026-11-12.
- Policy 5.75.020, Radicava (Prescription Drugs, Neuromuscular Agents), Blue Cross and Blue Shield Federal Employee Program, 2026-01-01.
- Drugs@FDA records for NDA 209176 (Radicava injection) and NDA 215446 (Radicava ORS), via openFDA, FDA, 2026-11-12.
- Drugs@FDA records for generic edaravone applications (ANDA), via openFDA, FDA, 2026-11-12.
- Shionogi Completes Acquisition of All Rights to RADICAVA (edaravone), Shionogi & Co., Ltd., Business Wire press release carried by BioSpace, 2026-04-02.
- NDA 209176/S-012 supplement approval letter, labeling aligned with Radicava ORS, FDA, 2022-11-18.
- NDA 215446 approval letter, Radicava ORS (edaravone) oral suspension for amyotrophic lateral sclerosis, FDA, 2022-05-12.
- NDA 209176 approval letter, Radicava (edaravone) injection for amyotrophic lateral sclerosis, FDA, 2017-05-05.
A reference drawn from the May 5, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 12, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.