Riluzole — Membership Pricing

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What Riluzole is approved for (FDA label)

TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS). TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS) ( 1 )

Source: Read the full FDA label on DailyMed. Label effective date: July 27, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Riluzole (FDA label)

Oral suspension: 50 mg/10 mL (5 mg/mL) slightly brown, opaque, homogeneous suspension in a 300-mL multiple-dose amber bottle. Oral suspension: 50 mg/10 mL (5 mg/mL) in 300 mL multiple-dose bottle ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 75d68f19-4208-109e-e053-2991aa0ac857. SPL document ID: 57997dd0-4d88-c2e5-e063-6394a90ae8ae. Label effective date: July 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Riluzole (FDA label)

The following adverse reactions are described below and elsewhere in the labeling: Hepatic Injury [see Warnings and Precautions (5.1) ] Neutropenia [see Warnings and Precautions (5.2) ] Interstitial Lung Disease [see Warnings and Precautions (5.3) ] Pancreatitis [see Warnings and Precautions (5.4)] Most common adverse reactions (incidence greater than or equal to 5% and greater than placebo) were oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact EDW Pharma, at 1-800-664-1490 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Source: FDA prescribing information (DailyMed). Set ID: 75d68f19-4208-109e-e053-2991aa0ac857. SPL document ID: 57997dd0-4d88-c2e5-e063-6394a90ae8ae. Label effective date: July 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Riluzole (FDA label)

TIGLUTIK is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see Adverse Reactions (6.1) ]. Patients with a history of severe hypersensitivity reactions to riluzole or to any of its components ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: 75d68f19-4208-109e-e053-2991aa0ac857. SPL document ID: 57997dd0-4d88-c2e5-e063-6394a90ae8ae. Label effective date: July 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Riluzole (FDA label)

Hepatic injury: Use of TIGLUTIK is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times the upper limit of normal; discontinue TIGLUTIK if there is evidence of liver dysfunction ( 5.1 ) Neutropenia: Advise patients to report any febrile illness ( 5.2 ) Interstitial lung disease: Discontinue TIGLUTIK if interstitial lung disease develops ( 5.3 ) Pancreatitis: There have been postmarketing reports of acute pancreatitis.If pancreatitis is suspected, promptly discontinue TIGLUTIK (5.4) 5.1 Hepatic Injury TIGLUTIK can cause liver injury. Cases of drug-induced liver injury, some of which were fatal, have been reported in patients taking riluzole. Asymptomatic elevations of hepatic transaminases have also been reported, and in some patients have recurred upon re-challenge with riluzole. In clinical studies, the incidence of elevations in hepatic transaminases was greater in riluzole-treated patients than placebo-treated patients.

Source: FDA prescribing information (DailyMed). Set ID: 75d68f19-4208-109e-e053-2991aa0ac857. SPL document ID: 57997dd0-4d88-c2e5-e063-6394a90ae8ae. Label effective date: July 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Riluzole (FDA label)

Strong to moderate CYP1A2 inhibitors: Co-administration may increase TIGLUTIK-associated adverse reactions ( 7.1 ) Strong to moderate CYP1A2 inducers: Co-administration may result in decreased efficacy ( 7.2 ) Hepatotoxic drugs: TIGLUTIK-treated patients that take other hepatotoxic drugs may be at increased risk for hepatotoxicity ( 7.3 ) 7.1 Agents that may Increase Riluzole Blood Concentrations CYP1A2 Inhibitors Co-administration of riluzole (a CYP1A substrate) with CYP1A2 inhibitors was not evaluated in a clinical trial; however, in vitro findings suggest an increase in riluzole exposure is likely.

Source: FDA prescribing information (DailyMed). Set ID: 75d68f19-4208-109e-e053-2991aa0ac857. SPL document ID: 57997dd0-4d88-c2e5-e063-6394a90ae8ae. Label effective date: July 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.