Your first 90 days
Your first 90 days on Radicava ORS for amyotrophic lateral sclerosis (ALS)
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Radicava ORS comes with no safety program forms and no blood tests the label requires. What it asks for instead is a steady routine at home. The dose is taken in the morning on an empty stomach. Its calendar of dosing days and days off changes after the first cycle. Each bottle also has its own clock once it is opened. This page lays out the first 90 days from the FDA label, Shionogi's own Radicava ORS pages and one insurer's written rules.
What has to happen before the first bottle ships
Radicava ORS has no REMS, so the first bottle waits on an allergy and asthma review, an insurance approval and a specialty pharmacy delivery. These are the 7 things in the way, in order.
An allergy and asthma review
The label says Radicava and Radicava ORS must not be used by anyone with a past allergic reaction to edaravone or to an inactive ingredient.
- Both forms contain sodium bisulfite, a sulfite that can cause allergic reactions.
- The Patient Information asks you to tell your healthcare provider if you have asthma or are allergic to other medicines.FDA label
A word about pregnancy and breastfeeding
The label says that, based on animal studies, edaravone may harm an unborn baby.
- The Patient Information asks you to tell your healthcare provider if you are pregnant, plan to become pregnant, are breastfeeding or plan to breastfeed.FDA label
A full medicine list
The Patient Information asks you to tell your healthcare provider about all the medicines you take.
- That list includes prescription and over-the-counter medicines, vitamins and herbal supplements.FDA label
The benefits form your neurologist sends
Shionogi's site says the first step is a Benefits Investigation and Enrollment Form completed with your doctor, which includes your signature.
- The doctor sends it, and Shionogi's site says not to send the form yourself.
- An Insurance & Access Specialist then sends you and your doctor a summary of your coverage.Starting Radicava ORS
The insurance approval
Plans such as the Blue Cross and Blue Shield Federal Employee Program require prior approval before they pay for Radicava ORS.
- That plan asks for a baseline function score, a breathing test result, a neurologist and a statement about riluzole.
- The criteria from that policy are listed further down this page.FEP policy
A specialty pharmacy delivery
Shionogi's site says prescriptions for Radicava ORS are sent to an in-network specialty pharmacy.
- That pharmacy calls to confirm coverage and payment, apply any financial support and schedule the delivery.Starting Radicava ORS
Someone to help with the syringe, if needed
The Instructions for Use say people who have problems using their hands may need assistance to draw up and give the correct dose.
- The dose is measured with an oral syringe and a bottle adapter that come in the carton.FDA label
The days that matter
Counted from the first dose, with 14 dosing days, 14 days off, and the 28-day rhythm of the cycles that follow. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.Benefits form and insurance approval
The neurologist's office sends the benefits form, and the plan reviews its prior approval request.
- The Federal Employee Program policy asks for a baseline function score and a breathing test result.
Specialty pharmacy call and delivery
Shionogi's site says the specialty pharmacy calls to confirm approval of coverage and payment.
- It also applies any financial support you are eligible for and schedules the delivery of Radicava ORS to you.
First dose, and the start of 14 daily doses
The first cycle is one 105mg (5mL) dose every morning for 14 days.
- A Starter Kit holds 2 bottles of 35mL for this cycle.
- The Instructions for Use say to write the opening date on the bottle label.
Second Starter Kit bottle
The Instructions for Use say to open the second bottle only when the first is finished.
- Some medicine may remain in each bottle after the doses on day 7 and day 14, and the instructions say to throw it away.
Fourteen days without the medicine
The first cycle ends with 14 days without the medicine.
- The Instructions for Use say not to take a dose of Radicava ORS on days 15 through 28.
Next cycle and a new bottle, then every 28 days
Each later cycle is 10 doses within a 14-day period, followed by 14 days off.
- One 50mL bottle holds the 10 doses for a cycle.
- The label does not name which 10 days, so the neurologist sets them.
Fourteen days off again
Every cycle after the first ends with the same 14-day drug-free period.
- Any medicine left in the bottle after 10 doses is thrown away, according to the Instructions for Use.
Next cycle and a new bottle, number 2
Next cycle and a new bottle, number 3
Three months in
By day 90 the fourth cycle has begun, counting 28 days for each cycle.
- The Federal Employee Program policy approves 12 months at a time and asks for a function score again at renewal.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Radicava ORS label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated May 5, 2026, read from the FDA's label database today. FDA label
- May 2026
The prescribing information, Patient Information and Instructions for Use now on DailyMed carry a May 2026 date and name Shionogi Inc. as the company. FDA's records post no approval letter for that revision, so what else changed is not confirmed here.Drugs@FDA
- November 2022
The label for Radicava given into a vein was aligned with the label for Radicava ORS, which is why one document now covers both forms.FDA letter
- May 2022
Radicava ORS, the oral suspension, was approved on May 12, 2022 for the treatment of ALS.FDA letter
- May 2017
Radicava injection was first approved on May 5, 2017 for the treatment of ALS. The FDA also required further studies after approval, including one in people with severe liver impairment.FDA letter
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- In the morning, after an overnight fast
The label says Radicava ORS is taken in the morning on an empty stomach.
- The Patient Information says you should stop eating at bedtime.
- In the label's study, a high-fat meal with the dose cut the peak blood level of edaravone by 82%.FDA label
- How long to fast depends on the last meal
The Patient Information says not to eat or drink anything for 8 hours before a dose after a high-fat meal.
- The wait is 4 hours after a low-fat meal and 2 hours after a calorie supplement such as a protein drink.
- The label describes a high-fat meal as 800 to 1,000 calories and a low-fat meal as 400 to 500 calories.FDA label
- One hour after the dose
The Patient Information says to wait at least 1 hour after the medicine before eating or drinking anything except water.
- The Instructions for Use allow up to 8 ounces, or 1 cup, of water to help swallow the dose.FDA label
- The dosing calendar
The first cycle is a dose every day for 14 days, then 14 days without the medicine.
- Each later cycle is a dose on 10 days out of a 14-day period, then 14 days without the medicine.
- The Patient Information says your healthcare provider tells you how often to take it.FDA label
- If you miss a dose
The Instructions for Use say that if you miss a dose, do not take 2 doses of Radicava ORS the next day.
- They do not say more than that, so the neurologist or pharmacist can explain what to do next.
- The instructions also say not to share Radicava ORS with anyone else and to keep it out of the reach of children.FDA label
- Shake, then measure with the syringe provided
Before opening the bottle, the label says to turn it upside down and shake hard for at least 30 seconds.
- If small pieces remain at the bottom, shake for another 30 seconds.
- The dose is measured with the 5mL oral syringe that comes with the bottle, and the label says a household teaspoon is not adequate.FDA label
- Through a feeding tube
The label allows nasogastric and PEG tubes made of silicone, polyvinyl chloride or polyurethane.
- The tube is flushed with 1 ounce (30mL) of water from a catheter-tip syringe before the dose and again after it.
- The dose itself is pushed in slowly with the oral syringe provided.FDA label
- Storage and the 15-day clock
At home the label says to store the bottle upright at room temperature, 68 to 77 degrees Fahrenheit, and protect it from light.
- The label says to use an opened bottle within 15 days.
- It also says to discard an unopened bottle 30 days after the shipment date on the carton pharmacy label.FDA label
- A white crust on the bottle
The Instructions for Use say a white crust may form on the neck or side of an opened bottle.
- They describe this as normal use and say the medicine can still be used as prescribed.
- The instructions say to keep the bottle tightly closed between each use.FDA label
- Caring for the syringes
Each carton holds 1 bottle, 1 bottle adapter and 2 reusable 5mL oral syringes.
- After a dose, the Instructions for Use say to pull the syringe apart, rinse it with water only and let it air dry.
- The instructions say to use a new syringe and adapter with each new bottle.FDA label
- Other medicines, including riluzole
The label has no section on drug interactions with other medicines.
- It says medicines that block common drug-clearing enzymes and transporters are not expected to change edaravone levels significantly.
- In the main trial, more than 90% of people in each group were also taking riluzole.
- The Patient Information still asks you to tell your healthcare provider about every medicine and supplement.FDA label
- Pregnancy and breastfeeding
The label says there is not enough information about Radicava ORS in pregnant women, and animal studies showed harm to the offspring.
- It asks you to tell your healthcare provider about a pregnancy or a plan for one.
- The Patient Information says you and your provider should decide together about breastfeeding.FDA label
- Kidney and liver conditions
The label says no dose change is needed with mild or moderate kidney impairment, or with liver impairment.
- It says the effect of severe kidney impairment on edaravone levels has not been studied.FDA label
- The form given into a vein
The label also covers Radicava as a 60mg infusion into a vein over 60 minutes, on the same cycles.
- It says a person on the infusion may be switched to 105mg of Radicava ORS on the same schedule.
- FDA records list both strengths of brand Radicava for infusion as discontinued.Drugs@FDA
- Generic edaravone
FDA records list generic edaravone for infusion into a vein from 4 companies with an active prescription listing.
- Those records list no generic version of the oral suspension, Radicava ORS.Drugs@FDA generics
- The company behind Radicava
Shionogi announced on April 2, 2026 that it had completed the transfer of all rights to Radicava from Tanabe Pharma Corporation.
- Its announcement describes the infusion as a previously available formulation.
- The current label and the JourneyMate Support Program now carry the name of Shionogi Inc.Shionogi press release
- Reporting a side effect
The Patient Information lists Shionogi at 1-888-292-0058 and the FDA at 1-800-FDA-1088 for reporting side effects.
- It also says to call your doctor for medical advice about side effects.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Signs of an allergic reaction
Hives, breathing problems, itching, swelling of the lips, tongue or face, dizziness, wheezing or fainting.
- The Patient Information says to tell your healthcare provider right away or go to the nearest emergency room.
- It says these reactions can happen after the medicine has been given.FDA label
Signs of a sulfite reaction
Hives, trouble breathing or swallowing, itching, swelling of the lips, tongue or face, dizziness, wheezing, fainting, or an asthma attack in people with asthma.
- The Patient Information gives the same instruction, to tell your healthcare provider right away or go to the nearest emergency room.
- It says sulfite sensitivity happens more often in people who have asthma.FDA label
Bruising, problems walking and headache
These were the most common side effects in the trials of Radicava given into a vein.
- Bruising affected 15% of people on Radicava against 9% on placebo.
- Problems walking affected 13% against 9%, and headache 10% against 6%.FDA label
Tiredness on the oral form
In a 6-month study of 185 people taking Radicava ORS, fatigue was reported in 7.6%.
- It was an open-label study, meaning everyone took the medicine, so the label gives no placebo figure.FDA label
Skin, breathing and urine findings in the trials
Dermatitis affected 8% on Radicava against 5% on placebo, and eczema 7% against 4%.
- Respiratory failure, respiratory disorder or low oxygen was reported in 6% against 4%.
- Sugar in the urine and tinea, a fungal skin infection, each affected 4% against 2%.FDA label
A pregnancy, or a plan for one
The label asks patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment.
- It asks the same about breastfeeding or a plan to breastfeed.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- 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.FEP policy
- 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.FEP policy
- 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.FEP policy
- 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.FEP policy
- 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.Radicava ORS financial support
- 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.Radicava ORS financial support
- 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.Starting Radicava ORS
Blue Cross and Blue Shield Federal Employee Program prior authorization policy, January 1, 2026
- Age 18 or older, with amyotrophic lateral sclerosis (ALS)
- An inadequate response to riluzole, or the patient will continue to take riluzole
- A baseline evaluation with one scoring tool, either the ALS Functional Rating Scale-Revised with a score of 2 or greater on each item or the Japanese ALS Severity Scale with a grade of 1 or 2
- Normal respiratory function, meaning a forced vital capacity of 80% of predicted or more
- Prescribed by or recommended by a neurologist
Approval length. 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. FEP policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- 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
Details as the drugmaker publishes them. Radicava ORS financial support
Five questions for the pharmacist or the support line
- Which days of each 14-day period are my 10 dosing days, and when does my next bottle ship?
- What is the shipment date on my carton, and what is the last day I can use this bottle?
- I have asthma or a sulfite sensitivity. Is that on the record my neurologist and the pharmacy have?
- I use a feeding tube. Is my tube made of silicone, polyvinyl chloride or polyurethane, as the label lists?
- If I miss a morning dose, what does my neurologist want me to do that day?
Questions people ask in the first weeks
How is Radicava ORS taken?
The label gives 105mg (5mL) by mouth or through a feeding tube, in the morning after an overnight fast. No food is eaten for 1 hour after the dose, although water is allowed. The dose is measured with the 5mL oral syringe that comes with the bottle.
What is the Radicava ORS dosing schedule?
The first cycle is a dose every day for 14 days, followed by 14 days without the medicine. Each later cycle is 10 doses within a 14-day period, followed by another 14 days off. The label does not name which 10 days, so the neurologist sets them.
How long do I have to fast before Radicava ORS?
The Patient Information says 8 hours after a high-fat meal, 4 hours after a low-fat meal and 2 hours after a calorie supplement. It also says to stop eating at bedtime and to wait at least 1 hour after the dose before eating.
Can Radicava ORS be given through a feeding tube?
Yes, the label allows nasogastric and PEG tubes made of silicone, polyvinyl chloride or polyurethane. The tube is flushed with 1 ounce (30mL) of water before the dose and again after it, using a catheter-tip syringe.
How long does a bottle of Radicava ORS last once opened?
The label says to use an opened bottle within 15 days. An unopened bottle is discarded 30 days after the shipment date on the carton pharmacy label. Bottles are stored upright at room temperature at home and protected from light.
Does Radicava ORS contain sulfites?
Yes, both Radicava and Radicava ORS contain sodium bisulfite, a sulfite. The label says it may cause allergic reactions, including anaphylactic symptoms and asthma episodes that can be life-threatening, in susceptible people. It says sulfite sensitivity is seen more often in people with asthma.
Is Radicava still given as an infusion?
The current label still describes Radicava as a 60mg infusion over 60 minutes on the same cycles. FDA records list brand Radicava for infusion as discontinued, and they list generic edaravone for infusion from other companies. Shionogi's patient site describes only the oral form, Radicava ORS.
Is there a REMS or required blood test for Radicava ORS?
No, the label sets no REMS and has no boxed warning. None of the 4 FDA approval letters read for this page mentions a REMS. The label does not require a blood test before or during treatment. It asks the care team to watch carefully for allergic reactions.
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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, May 5, 2026.
- NDA 209176/S-009 supplement approval letter, Radicava (edaravone), FDA, November 1, 2019.
- How to Start RADICAVA ORS® (edaravone) Treatment, Shionogi Inc., November 12, 2026.
- Financial Support for RADICAVA ORS® (edaravone), Shionogi Inc., November 12, 2026.
- Policy 5.75.020, Radicava (Prescription Drugs, Neuromuscular Agents), Blue Cross and Blue Shield Federal Employee Program, January 1, 2026.
- Drugs@FDA records for NDA 209176 (Radicava injection) and NDA 215446 (Radicava ORS), via openFDA, FDA, November 12, 2026.
- Drugs@FDA records for generic edaravone applications (ANDA), via openFDA, FDA, November 12, 2026.
- Shionogi Completes Acquisition of All Rights to RADICAVA (edaravone), Shionogi & Co., Ltd., Business Wire press release carried by BioSpace, April 2, 2026.
- NDA 209176/S-012 supplement approval letter, labeling aligned with Radicava ORS, FDA, November 18, 2022.
- NDA 215446 approval letter, Radicava ORS (edaravone) oral suspension for amyotrophic lateral sclerosis, FDA, May 12, 2022.
- NDA 209176 approval letter, Radicava (edaravone) injection for amyotrophic lateral sclerosis, FDA, May 5, 2017.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing neurologist. Found an error? Use the report link in the footer and it will be checked against the source.