Your first 90 days
Your first 90 days on Rilutek 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.
Riluzole tablets come with no safety program forms, and their label names no special pharmacy. What the label does ask for is a blood test of the liver before day 1 and a short list of symptoms to report quickly. The label says the largest rises in a liver enzyme came within the first 3 months. Severe drops in white blood cells were reported within the first 2 months. This page lays out that stretch from the FDA label for Rilutek, the labels of the other riluzole forms and one insurer's written rules.
What has to happen before the first bottle ships
Riluzole has no REMS, so the first fill waits on a liver blood test, a medicine review and, for the liquid form, an insurance approval. These are the 8 things in the way, in order.
A liver blood test
The label says to measure liver enzymes, called serum aminotransferases, before and during treatment.
- Riluzole is not recommended when these enzymes start out above 5 times the upper limit of normal.
- Cases of drug-induced liver injury, some of them fatal, have been reported in people taking riluzole.FDA label
Liver conditions
In the label's studies, riluzole exposure was about 1.7 times higher with mild liver impairment and about 3 times higher with moderate impairment.
- The label says these patients may be at increased risk of side effects, and severe liver impairment has not been studied.
- Riluzole is not recommended with evidence of liver dysfunction, such as elevated bilirubin.FDA label
Any past severe allergic reaction to riluzole
The label's one contraindication is a history of severe hypersensitivity reactions to riluzole or to any of its components.
- The label notes that anaphylaxis, a severe allergic reaction, has occurred.FDA label
A medicine list, with CYP1A2 in mind
Riluzole is broken down by a liver enzyme called CYP1A2.
- The label says strong or moderate blockers of that enzyme may raise the risk of riluzole side effects.
- Its examples include ciprofloxacin, fluvoxamine, mexiletine, zileuton and oral contraceptives.
- Medicines that speed the enzyme up may lower riluzole levels, and other medicines that can harm the liver may add to that risk.FDA label
Pregnancy and breastfeeding
The label says riluzole may cause harm to an unborn baby, based on animal studies, and there are no studies in pregnant women.
- It is not known whether riluzole passes into human milk.
- The Tiglutik label asks patients to tell their healthcare provider about a pregnancy, a planned pregnancy or breastfeeding.Tiglutik label
Which form of riluzole
FDA records list the Rilutek brand tablet and the Exservan oral film as discontinued.
- They list generic 50mg tablets from 4 applicants, Tiglutik oral suspension and a generic oral suspension as active prescription products.
- The neurologist chooses the form, and each form has its own label.Drugs@FDA riluzole records
Insurance, mainly for the liquid form
Cigna's riluzole policy requires prior authorization and a neurologist or other ALS specialist.
- For Tiglutik, it asks that generic riluzole tablets were tried, or that the patient cannot swallow tablets or has difficulty swallowing them.
- The policy's product list names the oral suspensions and does not list generic tablets.Cigna policy
The pharmacy
The Rilutek label sets no REMS and names no required pharmacy.
- Tiglutik is different, because EDW Pharma says Anovo Specialty Pharmacy is the only pharmacy where it is available.
- The doctor sends a Tiglutik prescription to Anovo, which ships it to the home.Tiglutik and Anovo
The days that matter
Counted from the first dose, with the monthly liver checks of the first 3 months and the refill every 30 days. 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.Liver enzyme blood test
The label asks for serum aminotransferases to be measured before treatment starts.
- It does not set an exact number of days ahead, so the neurologist's office picks the date.
Medicine review and the right pharmacy
The neurologist or pharmacist checks the medicine list for CYP1A2 blockers and for other medicines that can harm the liver.
- A Tiglutik prescription goes to Anovo Specialty Pharmacy, the only pharmacy where EDW Pharma makes it available.
First dose, 50mg twice a day
One 50mg tablet twice a day, each taken at least 1 hour before or 2 hours after a meal.
- The label gives the full dose from day 1, with no build-up schedule.
First monthly liver check
The label asks prescribers to monitor for signs and symptoms of liver injury every month for the first 3 months.
- It also says to measure liver enzymes during treatment, without naming exact days, so the neurologist sets the blood test dates.
Refill, then every 30 days
A Rilutek bottle holds 60 tablets, which is 30 days at 2 tablets a day.
- Generic bottles of 60 are listed too, and one generic label also lists bottles of 90.
Second monthly liver check
This is the second of the 3 monthly checks for signs of liver injury.
- The label says cases of severe neutropenia, a very low white blood cell count, were reported within the first 2 months.
- It asks patients to report any illness with fever.
Refill, number 2
Third monthly liver check
The label says the largest rises in the liver enzyme ALT occurred within 3 months of starting.
- After month 3, it asks for monitoring periodically.
- Pancreatitis has been reported weeks to several years after starting, so stomach symptoms still matter later.
Refill, number 3
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Rilutek 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.
Label dated September 11, 2025, read from the FDA's website. FDA label
- November 2026
Not every generic riluzole tablet label carries the 2025 pancreatitis warning yet. The Ascend label, revised April 2026, has it. The Florida Pharmaceutical Products and AvKARE labels in the FDA's label database did not, as of November 12th.openFDA label records
- September 2025
A new warning on pancreatitis was added on September 11th. The FDA had told the maker on August 7, 2025 that the risk of acute pancreatitis should be included in the labeling for riluzole products.FDA letter
- May 2020
Pancreatitis was added to the list of side effects reported since approval.FDA letter
- April 2016
The label was converted to the FDA's current prescribing information format.FDA letter
- December 1995
Rilutek 50mg tablets were first approved on December 12th, with priority review and orphan status.Drugs@FDA
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.
- Twice a day, away from meals
The label gives 50mg twice a day, taken at least 1 hour before or 2 hours after a meal.
- In the label's study, a high fat meal lowered the amount of riluzole absorbed by 20% and the peak level by 45%.FDA label
- If you miss a dose
The current Rilutek label gives no instruction for a missed dose, so that question goes to the neurologist or pharmacist.
- For Tiglutik, EDW Pharma's safety information says not to take an extra dose to make up for a missed one.
- It says to take the prescribed dose at the next regularly scheduled time.Tiglutik cost page
- Liver blood tests continue
The label says to measure liver enzymes during treatment as well as before it.
- About 50% of people on riluzole in the main studies had at least one ALT result above normal.
- About 8% had a result above 3 times the upper limit, and 2% had one above 5 times.FDA label
- What the label says about high liver enzymes
Riluzole is not recommended if liver enzymes rise above 5 times the upper limit of normal.
- The label tells prescribers to discontinue it if there is evidence of liver dysfunction, such as elevated bilirubin.
- Your neurologist reads the results and decides what happens next.FDA label
- Medicines that can raise riluzole levels
The label lists ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib and zileuton as strong or moderate CYP1A2 blockers.
- It says taking one with riluzole may raise the risk of riluzole side effects.
- The combination was not tested in a clinical trial.FDA label
- Medicines that can lower riluzole levels
The label says medicines that speed up CYP1A2, called inducers, are likely to lower riluzole levels.
- It says lower levels may result in decreased efficacy.
- The current label names no examples, so the pharmacist checks your list.FDA label
- Other medicines that can harm the liver
The ALS studies left out people taking medicines that could harm the liver, such as allopurinol, methyldopa and sulfasalazine.
- The label says people who take such medicines with riluzole may be at increased risk of liver injury.FDA label
- Smoking
The label reports that tobacco smokers cleared riluzole from the body 20% faster than nonsmokers.
- The current label gives no dose change and no instruction for smokers.
- The neurologist decides whether smoking matters for your treatment.FDA label
- Who may have higher riluzole levels
The label says Japanese patients are more likely to have higher riluzole levels, so their risk of side effects may be greater.
- Average exposure was also about 45% higher in women than in men.
- The label gives no dose change for either group.FDA label
- Pregnancy and breastfeeding
The Rilutek label says women should be advised of a possible risk to the fetus during pregnancy.
- It says the potential for serious side effects in nursing infants is unknown.
- In rat studies described in the label, riluzole lowered measures of fertility.FDA label
- The liquid form, Tiglutik
Tiglutik is 50mg in 10mL, taken twice a day, every 12 hours, by mouth or through a PEG feeding tube.
- Its label says both silicone and polyurethane PEG tubes can be used.
- Its label keeps the same meal timing and says to shake the bottle gently for at least 30 seconds.
- Each 300mL bottle is used within 15 days of opening, and a carton holds 2 bottles.
- In a study of 36 healthy people, 29% had numbness in the mouth on Tiglutik, against 6% on tablets.Tiglutik label
- The oral film, Exservan
FDA records list Exservan, a 50mg film that dissolves on the tongue, as discontinued.
- Cigna's policy calls it obsolete as of October 31, 2024.
- The newest Exservan label on the FDA's site is dated May 2020 and predates the pancreatitis warning.Exservan label, 2020
- Brand or generic
The FDA's database lists Rilutek as discontinued and generic 50mg tablets from Alkem, Glenmark, Impax and Kenton as active prescription products.
- The generic label read for this page gives the same dose, meal timing and warnings as Rilutek.Drugs@FDA riluzole records
- The leaflet with your tablets may be older
The FDA told riluzole makers in August 2025 that the risk of acute pancreatitis should be added to the labeling.
- On November 12, 2026, at least 2 current generic tablet labels in the FDA's label database still lacked that warning section.
- The Rilutek, Tiglutik and Ascend generic labels all carry it.openFDA label records
- Too much riluzole
The label lists drowsiness, memory loss, coma, a brain condition called acute toxic encephalopathy and a blood problem called methemoglobinemia after large overdoses.
- It gives the National Poison Control Center number, 1-800-222-1222, for current advice.FDA label
- Reporting a side effect
The Rilutek label lists Covis Pharma at 1-866-488-4423 and the FDA at 1-800-FDA-1088 for reporting side effects.
- Each generic label lists its own company's number for the same purpose.FDA label
- Storage
Room temperature, 68 to 77 degrees Fahrenheit, protected from bright light.
- An opened Tiglutik bottle is stored upright, is not frozen, and is discarded 15 days after first opening.Tiglutik 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 the label ties to liver injury
Unexplained nausea, vomiting, stomach pain, tiredness, loss of appetite, yellowing of the skin or eyes, or dark urine.
- The label says to contact a healthcare provider promptly if these appear.
- It says riluzole can cause liver injury, which can be fatal.FDA label
Fever
The label asks patients to report a fever to their healthcare provider.
- Riluzole can cause neutropenia, a low count of infection-fighting white blood cells.
- Severe cases were reported within the first 2 months of treatment.FDA label
A dry cough, or difficult or labored breathing
The label asks patients to report these breathing symptoms to their healthcare provider.
- Riluzole can cause interstitial lung disease, including a form called hypersensitivity pneumonitis.
- The label tells prescribers to discontinue riluzole immediately if interstitial lung disease develops.FDA label
Stomach pain, nausea, vomiting or loss of appetite
The label says these can be symptoms of pancreatitis that require prompt medical evaluation.
- Acute pancreatitis, including fatal cases, has been reported in people taking riluzole.
- It has occurred weeks to several years after starting.
- The label tells prescribers to stop riluzole promptly if pancreatitis is suspected.FDA label
A severe allergic reaction
The label says anaphylaxis, a severe allergic reaction, has occurred with riluzole.
- A history of severe hypersensitivity to riluzole or its components is the label's one contraindication.FDA label
Side effects in the main studies
In the main studies, weakness affected 19% of people on riluzole against 12% on placebo, and nausea 16% against 11%.
- Decreased lung function affected 10% against 9%, high blood pressure 5% against 4%, and stomach pain 5% against 4%.FDA label
Dizziness and sleepiness
Dizziness affected 4% of people on riluzole against 3% on placebo, and was more common in women (11%) than in men (4%).
- Sleepiness affected 2% against 1%, and vertigo 2% against 1%.
- The current label has no driving or machinery warning.FDA label
A pregnancy, or too many tablets
The Tiglutik label asks patients to notify their healthcare provider about a pregnancy or a plan to become pregnant.
- For an overdose, the Rilutek label points to the National Poison Control Center at 1-800-222-1222.Tiglutik 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.
- The prescription says RilutekThe FDA's database lists the Rilutek brand as discontinued. It lists generic riluzole 50mg tablets from 4 applicants as active prescription products. The pharmacist and the neurologist's office decide how the prescription is filled.Drugs@FDA
- The plan wants tablets tried before the liquidFor Tiglutik, Cigna asks for one of 2 things. Either generic riluzole tablets were tried, or the patient cannot swallow tablets or has difficulty swallowing them. The neurologist's office tells the plan which one applies.Cigna policy
- Prior authorization pending or deniedCigna requires riluzole to be prescribed by, or in consultation with, a neurologist, a neuromuscular disease specialist or a physician who treats ALS. The 2024 version of the policy dropped a rule asking for a documented ALS diagnosis, and approval lasts 1 year.Cigna policy
- Tiglutik was sent to a local pharmacyEDW Pharma says Anovo Specialty Pharmacy is the only pharmacy where Tiglutik is available. The doctor's office sends the prescription to Anovo, which works with the insurer and ships to the home at no extra charge.Tiglutik and Anovo
- A Tiglutik copay you cannot payEDW Pharma's copay support lets eligible patients pay no more than $0 per filled Tiglutik prescription. It is for commercially insured patients aged 18 and older whose plan covers Tiglutik, filled at Anovo. People on Medicare, Medicaid, TRICARE or other federal or state programs are not eligible. Our help paying page lists charity funds.Tiglutik cost page
- The prescription is for Exservan filmCigna removed Exservan from its policy in May 2026 and calls the product obsolete as of October 31, 2024. The FDA's drug database also lists Exservan as discontinued. The neurologist decides which available form of riluzole replaces it.Cigna policy
- Riluzole prescribed for something other than ALSCigna's policy says riluzole for any use other than ALS is considered not medically necessary. Every riluzole label read for this page lists ALS as the only approved use.Cigna policy
Cigna prior authorization policy, May 15, 2026
- Amyotrophic lateral sclerosis (ALS), the FDA-approved use
- Prescribed by or in consultation with a neurologist, a neuromuscular disease specialist or a physician specializing in the treatment of ALS
- Tiglutik oral suspension: the patient has tried generic riluzole tablets, or cannot swallow tablets or has difficulty swallowing tablets
- Teglutik oral suspension: the same 2 options as Tiglutik
- The same product rules apply on employer plans and on individual and family plans
- Riluzole for any other use is considered not medically necessary
Approval length. Approved for 1 year. The policy lists no separate renewal criteria.
This version took effect May 15, 2026, when Cigna removed Exservan as obsolete. It cites the September 2025 Rilutek and Tiglutik labels, and DailyMed's Tiglutik label is now marked revised July 2026. Its product list names Tiglutik and Teglutik oral suspensions and does not list generic tablets. Other plans set their own criteria and approval lengths. It is here as an example of what a plan asks for, not as a rule. Cigna 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.
- The Rilutek label gives this Covis Pharma number for reporting side effects. The label names no copay card, bridge supply or free drug program
- No required pharmacy is named in the Rilutek label or in the generic tablet label read for this page
- FDA records list the Rilutek brand as discontinued, under the company name Azurity, and generic 50mg tablets from 4 applicants as active Drugs@FDA
- For Tiglutik liquid only: Anovo Specialty Pharmacy at (844) 763-1198, described by EDW Pharma as available 24 hours per day, 7 days per week. Anovo works with the insurer, ships to the home at no extra charge and sends refill reminders Tiglutik and Anovo
- For Tiglutik liquid only: EDW Pharma copay support, no more than $0 per filled prescription for eligible commercially insured patients aged 18 and older, at Anovo. Medicare, Medicaid, TRICARE and other federal or state program patients are not eligible, and a maximum savings limit applies Tiglutik cost page
Details as the drugmaker publishes them. FDA label
Five questions for the pharmacist or the support line
- Is this prescription being filled with a generic riluzole tablet, and which company makes it?
- I take these medicines and supplements. Are any of them CYP1A2 blockers or inducers, or hard on the liver?
- I take birth control pills, ciprofloxacin or fluvoxamine. Does my neurologist know?
- Does the leaflet with my tablets include the pancreatitis warning added in 2025?
- If swallowing tablets gets harder, what does my plan need before it covers the liquid form?
- What should I do if I miss a dose?
Questions people ask in the first weeks
How is Rilutek taken?
The label gives one 50mg tablet twice a day, taken at least 1 hour before or 2 hours after a meal. A high fat meal lowered the amount absorbed by 20% in the label's study. The label gives no build-up schedule, so the full dose starts on day 1.
Do I need blood tests on riluzole?
Yes, the label says to measure liver enzymes, called serum aminotransferases, before and during treatment. It asks prescribers to monitor for signs of liver injury every month for the first 3 months, then periodically. The label names no exact blood test days, so the neurologist sets them.
Is Rilutek still available?
The FDA's drug database lists the Rilutek brand tablet as discontinued, under the company name Azurity. The label itself was last revised in September 2025 and names Covis Pharma. The same database lists generic riluzole 50mg tablets from 4 applicants as active prescription products.
Why does fever matter on riluzole?
The label asks patients to report a fever because riluzole can cause neutropenia, a low white blood cell count. Cases of severe neutropenia were reported within the first 2 months of treatment. The label tells prescribers to advise patients to report any illness with fever.
What is the pancreatitis warning on riluzole?
In September 2025 the FDA approved a new warning about acute pancreatitis, including fatal cases, reported in people taking riluzole. The label says stomach pain, nausea, vomiting or loss of appetite can be symptoms that require prompt medical evaluation. Cases occurred weeks to several years after starting.
Does smoking affect riluzole?
The label reports that tobacco smokers cleared riluzole from the body 20% faster than nonsmokers. The current label gives no dose change and no instruction for smokers. The neurologist decides whether smoking matters for your treatment.
Which medicines interact with riluzole?
The label names strong or moderate CYP1A2 blockers, including ciprofloxacin, fluvoxamine, mexiletine, zileuton and oral contraceptives, which may raise the risk of side effects. Medicines that speed up CYP1A2 may lower riluzole levels. Other medicines that can harm the liver, such as allopurinol, methyldopa and sulfasalazine, may add to the liver risk.
Is there a liquid form of riluzole?
Yes, Tiglutik is a riluzole oral suspension, 50mg in 10mL, taken twice a day by mouth or through a PEG feeding tube. EDW Pharma says it is available only from Anovo Specialty Pharmacy. Cigna covers it when generic tablets were tried or the patient cannot swallow tablets or has difficulty swallowing them.
Is there a REMS for riluzole?
No, the Rilutek label sets no REMS and has no boxed warning. Its one contraindication is a history of severe hypersensitivity reactions to riluzole or its components.
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Sources
- RILUTEK (riluzole) tablets, for oral use: prescribing information, Revised: 09/2025, Covis Pharma, via FDA, accessdata.fda.gov, September 11, 2025.
- DailyMed - Search Results for rilutek, National Library of Medicine, DailyMed, November 12, 2026.
- DailyMed - RILUZOLE tablet (Ascend Laboratories, prescribing information, Revised: 4/2026), Ascend Laboratories, LLC, via DailyMed, July 15, 2026.
- DailyMed - TIGLUTIK- riluzole liquid (prescribing information with Instructions for Use), EDW Pharma, Inc., via DailyMed, July 27, 2026.
- EXSERVAN (riluzole) oral film: prescribing information, Revised: 5/2020, Aquestive Therapeutics, via FDA, accessdata.fda.gov, May 11, 2020.
- openFDA drug label records for riluzole (10 records, including Florida Pharmaceutical Products, AvKARE, Ascend and Tiglutik), FDA, openFDA, November 12, 2026.
- Drugs@FDA: FDA-Approved Drugs, New Drug Application (NDA) 020599, FDA, November 12, 2026.
- Drugs@FDA records for all riluzole applications (NDA and ANDA), via openFDA, FDA, November 12, 2026.
- NDA 020599/S-021 supplement approval letter, acute pancreatitis safety labeling change, FDA, September 11, 2025.
- NDA 020599/S-019 supplement approval letter, pancreatitis added to postmarketing experience, FDA, May 11, 2020.
- NDA 20599/S-17 supplement approval letter, labeling format conversion, FDA, April 8, 2016.
- Drug Coverage Policy IP0258, Riluzole Products (Neurology, Riluzole Products), Cigna, May 15, 2026.
- What Does TIGLUTIK Cost? - TIGLUTIK (riluzole) - ALS Treatment, EDW Pharma, Inc., November 12, 2026.
- Helping Patients Get TIGLUTIK - TIGLUTIK (riluzole) - ALS Treatment, EDW Pharma, Inc., November 12, 2026.
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.