Prescribing guide
Rilutek (riluzole)And riluzole liver monitoring, pancreatitis warning, CYP1A2 interactions, formulations 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 boxed warning; baseline serum aminotransferases, a CYP1A2 and hepatotoxic drug review, a hypersensitivity history, and for Tiglutik a prior authorization and a prescription sent to Anovo Specialty Pharmacy.
Example PA threshold
Cigna IP0258 example: ALS, neurologist, neuromuscular specialist or ALS physician; for Tiglutik or Teglutik, generic riluzole tablets tried or the patient cannot swallow or has difficulty swallowing tablets; 1-year approvals.
Monitoring
Aminotransferases before and during treatment; signs and symptoms of hepatic injury monthly for 3 months, then periodically; febrile illness (neutropenia, first 2 months); respiratory symptoms (ILD); abdominal symptoms (pancreatitis, weeks to years).
Support line
No Rilutek or generic tablet support program found; the Rilutek label lists Covis Pharma 1-866-488-4423 for adverse reaction reports. Tiglutik only: Anovo Specialty Pharmacy (844) 763-1198, EDW Pharma copay support to $0 per fill for eligible commercial patients.
Give your patient their plan
A one-page handout for starting Rilutek, 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/rilutekBefore 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 Rilutek label revised September 2025 sets no REMS and no restricted distribution, and has no boxed warning. The S-021 approval letter mentions no REMS. | FDA letter |
| Brand status | Drugs@FDA lists Rilutek 50mg tablets (NDA 020599, company Azurity) as Discontinued. The September 2025 label reads Manufactured for Covis Pharma, Zug, Switzerland, and the S-021 letter is addressed to Covis Pharma GmbH c/o Azurity Pharmaceuticals. | Drugs@FDA |
| Generic tablets | Drugs@FDA lists riluzole 50mg tablets as active Prescription products under ANDAs held by Alkem, Glenmark, Impax and Kenton, all AB rated. Tablet ANDAs held by Apotex, Daito, Pharmobedient and Sun are listed as Discontinued. | Drugs@FDA riluzole records |
| DailyMed | A DailyMed search for Rilutek returned no drug labels on November 12, 2026. The current Rilutek text is the PDF posted at Drugs@FDA. | DailyMed search |
| Baseline aminotransferases | Measure serum aminotransferases before treatment. Use is not recommended with baseline elevations greater than 5 times ULN or evidence of liver dysfunction (for example elevated bilirubin). | FDA label |
| Contraindication | History of severe hypersensitivity reactions to riluzole or to any of its components; anaphylaxis has occurred. | FDA label |
| Medication reconciliation | Review for strong or moderate CYP1A2 inhibitors, CYP1A2 inducers and other hepatotoxic drugs (sections 7.1 to 7.3). | FDA label |
| Oral suspension | Tiglutik 50mg/10mL (NDA 209080) and a generic riluzole oral suspension (ANDA 216035, Alkem, approved August 22, 2024, AB rated) are listed as active Prescription products. | Drugs@FDA riluzole records |
| Tiglutik routing | EDW Pharma states Anovo Specialty Pharmacy is the only pharmacy where Tiglutik is available. Anovo coordinates with the insurer, ships to the home at no extra charge and calls the patient or caregiver to confirm shipment; caller ID AnovoRx Group (901) 201-5470. | Tiglutik and Anovo |
| Tiglutik copay support | Eligible patients pay no more than $0 per filled prescription: commercially insured, Tiglutik covered, age 18 or older, filled at Anovo, USA including Puerto Rico. Medicare, Medicaid, TRICARE and other federal or state program patients are not eligible; a maximum savings limit applies. | Tiglutik cost page |
| Oral film | Exservan 50mg oral film (NDA 212640, Aquestive) is listed as Discontinued at Drugs@FDA. Its newest posted label is revised 5/2020 and has no section 5.4. | Exservan label, 2020 |
Prior authorization criteria and what to document
One public policy as the example: Cigna, May 15, 2026. Approval 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.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Diagnosis | ALS, the FDA-approved indication; the July 2024 revision removed the documented diagnosis requirement | Diagnosis on the request | Cigna policy |
| Prescriber | Prescribed by or in consultation with a neurologist, a neuromuscular disease specialist or a physician specializing in the treatment of ALS | Specialty on the request, or the consult note | Cigna policy |
| Tiglutik | ONE of: the patient has tried generic riluzole tablets, or cannot swallow tablets or has difficulty swallowing tablets | Generic tablet fill history, or a note documenting dysphagia | Cigna policy |
| Teglutik | Same 2 options as Tiglutik, on employer plans and on individual and family plans | As for Tiglutik | Cigna policy |
| Generic tablets | The policy statement says prior authorization is required for benefit coverage of riluzole, but the product list and preferred product tables name only the oral suspensions | Check the plan's formulary for tablet requirements | Cigna policy |
| Exservan | Removed from the preferred product tables effective May 15, 2026; marked obsolete 10/31/2024 | Not applicable | Cigna policy |
| Duration | Approve for 1 year; no separate reauthorization criteria are listed | Refile yearly with the same elements | Cigna policy |
| Other uses | Riluzole for any other use is considered not medically necessary | Not applicable | Cigna policy |
Rilutek dosing and titration
| When | Label | Source |
|---|---|---|
| Recommended dose | 50mg orally twice daily, at least 1 hour before or 2 hours after a meal. No titration and no dose modification scheme in the label. | FDA label |
| Food effect | High fat meal: AUC down 20%, Cmax down 45% (tablets). Tiglutik: AUC down 9%, Cmax down 55%. | Tiglutik label |
| Missed dose | The Rilutek label revised September 2025 has no missed dose instruction. EDW Pharma's Tiglutik safety information says not to take an extra dose and to take the prescribed dose at the next regularly scheduled time. | Tiglutik cost page |
| Hepatic impairment | AUC about 1.7-fold higher in Child-Pugh A and about 3-fold higher in Child-Pugh B; Child-Pugh C not studied. No dose adjustment is given; these patients may be at increased risk of adverse reactions. | FDA label |
| Renal impairment and age | Age 65 or older and moderate to severe renal impairment have no meaningful effect on pharmacokinetics; hemodialysis not studied. | FDA label |
| Sex, race and smoking | Mean AUC about 45% higher in female patients; clearance 50% lower in male Japanese subjects than in Caucasian subjects after normalizing for body weight; clearance 20% greater in tobacco smokers. No dose adjustment is given for any of these. | FDA label |
| Tiglutik | 50mg (10mL) twice daily, every 12 hours, orally or via PEG tube (silicone or polyurethane), same meal timing. Gently shake the bottle for at least 30 seconds before administration. | Tiglutik label |
| Exservan | 50mg film twice daily on top of the tongue, same meal timing; do not cut or split, do not administer with liquids. High fat meal: AUC down 15%, Cmax down 45%. Supplied as a carton of 60 pouches. | Exservan label, 2020 |
| Supply, Rilutek | 50mg tablets, white, capsule-shaped, film-coated, engraved RPR 202, bottles of 60, NDC 70515-700-60; one bottle is 30 days at 2 tablets a day. Store at 20 to 25°C (68 to 77°F), protected from bright light. | FDA label |
| Supply, generic tablets | Ascend (Alkem) 50mg tablets: bottles of 60, 90, 500 and 1000 and a blister pack of 140. Store at 20 to 25°C (68 to 77°F), protected from bright light. | Generic tablet label |
| Supply, Tiglutik | 300mL multiple-dose bottle, 2 bottles per carton with 2 oral syringes and adapters, NDC 70726-0303-1. Store upright at 20 to 25°C, do not freeze, discard 15 days after first opening. | Tiglutik label |
| Efficacy basis | Study 1 (155 patients) and Study 2 (959 patients): among patients reaching tracheostomy or death, median survival differed by about 90 days and about 60 days. Measures of muscle strength and neurological function did not show a benefit. | FDA label |
Monitoring the Rilutek label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline | Serum aminotransferases | Not recommended at baseline elevations greater than 5 times ULN or with evidence of liver dysfunction such as elevated bilirubin | FDA label |
| Months 1 to 3 | Signs and symptoms of hepatic injury every month; aminotransferases during treatment | Maximum ALT increases occurred within 3 months; no fixed laboratory interval is named | FDA label |
| After month 3 | Signs and symptoms of hepatic injury periodically | Drug-induced liver injury, some fatal, has been reported; asymptomatic elevations have recurred on rechallenge in some patients | FDA label |
| Aminotransferases above 5 times ULN | On treatment | Use is not recommended | FDA label |
| Evidence of liver dysfunction | For example elevated bilirubin | Discontinue | FDA label |
| First 2 months | Febrile illness | Severe neutropenia (ANC below 500 per mm3) has been reported within the first 2 months; advise patients to report febrile illnesses. The current label does not specify a white cell count | FDA label |
| Any time | Dry cough, difficult or labored breathing | Interstitial lung disease, including hypersensitivity pneumonitis; discontinue immediately if ILD develops | FDA label |
| Any time | Abdominal pain, nausea, vomiting, anorexia | Acute pancreatitis, including fatal and non-fatal necrotizing pancreatitis, weeks to several years after initiation; if suspected, promptly discontinue and manage; reinitiation may be considered if an alternative cause is identified | FDA label |
| Counseling | Section 17 | Unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine; fever; dry cough and difficult or labored breathing. No driving or machinery statement in the current label | FDA label |
| Pooled Studies 1 and 2 | Riluzole 50mg twice daily (N=313) against placebo (N=320) | Asthenia 19% and 12%, nausea 16% and 11%, decreased lung function 10% and 9%, hypertension 5% and 4%, abdominal pain 5% and 4%, dizziness 4% and 3% (11% in females, 4% in males) | FDA label |
| Postmarketing | Section 6.2 | Acute hepatitis and icteric toxic hepatitis, renal tubular impairment, pancreatitis | FDA label |
| Tiglutik | Oral hypoesthesia | 29% on Tiglutik against 6% on tablets in a fasting pharmacokinetic study of 36 healthy subjects | Tiglutik label |
| Overdose | Ingestions of 1.5 to 3 grams | Acute toxic encephalopathy, coma, drowsiness, memory loss, methemoglobinemia; no specific antidote; Poison Control 1-800-222-1222 | FDA label |
| Generic labels | Section 5.4 status in openFDA on November 12, 2026 | Present: Ascend (revised April 2026) and Tiglutik. Absent: Florida Pharmaceutical Products (effective October 12, 2026), AvKARE (March 4, 2026), Glenmark and Sun (2020) | openFDA label records |
Rilutek drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Strong or moderate CYP1A2 inhibitors (ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton) | Not evaluated in a clinical trial; in vitro findings suggest increased riluzole exposure. Concomitant use may increase the risk of riluzole-associated adverse reactions. | FDA label |
| CYP1A2 inducers | Not evaluated in a clinical trial; in vitro findings suggest decreased exposure, which may result in decreased efficacy. The current label names no example agents. | FDA label |
| Hepatotoxic drugs (allopurinol, methyldopa, sulfasalazine) | Excluded from the ALS trials; patients who take other hepatotoxic drugs may be at increased risk for hepatotoxicity. | FDA label |
| Smoking | Clearance 20% greater in tobacco smokers than in nonsmokers; the label gives no dose adjustment or counseling instruction. | FDA label |
| Highly protein-bound drugs | In vitro, riluzole did not displace warfarin, and its binding was unaffected by warfarin, digoxin, imipramine and quinine at high therapeutic concentrations. | FDA label |
| Pregnancy | No studies in pregnant women; developmental toxicity in animals at clinically relevant doses. Advise women of a possible risk to the fetus. | FDA label |
| Lactation | Not known if excreted in human milk; detected in rat milk. The potential for serious adverse reactions in nursing infants is unknown. | FDA label |
| Japanese patients | More likely to have higher riluzole concentrations; the risk of adverse reactions may be greater (section 8.7). | FDA label |
| Label history | Pancreatitis was added to section 6.2, Postmarketing Experience, on May 11, 2020 (S-019), 5 years before it became a warning. | FDA letter |
| PLR conversion | S-017, approved April 8, 2016, converted the labeling to the current content and format rule. | FDA letter |
Why a first fill stalls, and the fix
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
No Rilutek patient support program found (the number shown is the Covis Pharma side effect reporting line)
- 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
Questions prescribers' offices ask about Rilutek
What liver monitoring does the riluzole label require?
Serum aminotransferases before and during treatment, plus monitoring for signs and symptoms of hepatic injury every month for the first 3 months and periodically thereafter, per the Rilutek label revised September 2025 (sections 2 and 5.1). The label names no fixed laboratory interval. ALT rose above ULN in about 50% of treated patients in pooled Studies 1 and 2, above 3 times ULN in about 8% and above 5 times ULN in 2%.
When does the label say to stop riluzole for liver findings?
Use is not recommended at aminotransferases greater than 5 times ULN, at baseline or on treatment, and the label says to discontinue if there is evidence of liver dysfunction such as elevated bilirubin, per the Rilutek label revised September 2025. The label gives no dose reduction scheme. Maximum ALT increases occurred within 3 months of starting.
What is the riluzole dose and how is it timed with meals?
50mg orally twice daily, at least 1 hour before or 2 hours after a meal, per the Rilutek label revised September 2025. A high fat meal reduced AUC by 20% and Cmax by 45%. Tiglutik is 50mg (10mL) twice daily, every 12 hours, by mouth or PEG tube, with the same meal timing.
What changed in the riluzole label in 2025?
Section 5.4, Pancreatitis, was added on September 11, 2025 (NDA 020599/S-021), after an FDA safety labeling notification dated August 7, 2025. It describes acute pancreatitis, including fatal and non-fatal necrotizing pancreatitis, weeks to several years after initiation, and says to discontinue promptly if pancreatitis is suspected. As of November 12, 2026 some generic tablet labels in openFDA do not yet carry section 5.4.
What do insurers ask for to approve riluzole oral suspension?
Cigna IP0258, effective May 15, 2026, approves for 1 year when a neurologist, neuromuscular disease specialist or ALS physician prescribes or is consulted, and the patient has tried generic riluzole tablets or cannot swallow tablets or has difficulty swallowing them. The policy lists Tiglutik and Teglutik and removed Exservan as obsolete. It cites the September 2025 Rilutek and Tiglutik labels.
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Sources
- RILUTEK (riluzole) tablets, for oral use: prescribing information, Revised: 09/2025, Covis Pharma, via FDA, accessdata.fda.gov, 2025-09-11.
- DailyMed - Search Results for rilutek, National Library of Medicine, DailyMed, 2026-11-12.
- DailyMed - RILUZOLE tablet (Ascend Laboratories, prescribing information, Revised: 4/2026), Ascend Laboratories, LLC, via DailyMed, 2026-07-15.
- DailyMed - TIGLUTIK- riluzole liquid (prescribing information with Instructions for Use), EDW Pharma, Inc., via DailyMed, 2026-07-27.
- EXSERVAN (riluzole) oral film: prescribing information, Revised: 5/2020, Aquestive Therapeutics, via FDA, accessdata.fda.gov, 2020-05-11.
- openFDA drug label records for riluzole (10 records, including Florida Pharmaceutical Products, AvKARE, Ascend and Tiglutik), FDA, openFDA, 2026-11-12.
- Drugs@FDA: FDA-Approved Drugs, New Drug Application (NDA) 020599, FDA, 2026-11-12.
- Drugs@FDA records for all riluzole applications (NDA and ANDA), via openFDA, FDA, 2026-11-12.
- NDA 020599/S-021 supplement approval letter, acute pancreatitis safety labeling change, FDA, 2025-09-11.
- NDA 020599/S-019 supplement approval letter, pancreatitis added to postmarketing experience, FDA, 2020-05-11.
- NDA 20599/S-17 supplement approval letter, labeling format conversion, FDA, 2016-04-08.
- Drug Coverage Policy IP0258, Riluzole Products (Neurology, Riluzole Products), Cigna, 2026-05-15.
- What Does TIGLUTIK Cost? - TIGLUTIK (riluzole) - ALS Treatment, EDW Pharma, Inc., 2026-11-12.
- Helping Patients Get TIGLUTIK - TIGLUTIK (riluzole) - ALS Treatment, EDW Pharma, Inc., 2026-11-12.
A reference drawn from the September 11, 2025 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.