Riluzole (Exservan, Rilutek, Tiglutik, generic riluzole)

Riluzole (Exservan, Rilutek, Tiglutik, generic riluzole)

SELF-ADMINISTRATION

FDA Approved Indications:

• Amyotrophic Lateral Sclerosis (ALS):  Indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). 

Coverage Criteria :

1. For diagnosis of amyotrophic lateral sclerosis (ALS):

• For brand Rilutek (tablets), Tiglutik (suspension), Exservan (film):

  • Dose does not exceed 50 mg twice daily, AND

  • Diagnosis of amyotrophic lateral sclerosis (ALS), AND

  • Inadequate response, intolerance, or contraindication to generic riluzole tablets

•  For generic riluzole (tablets):

  • Dose does not exceed 50 mg twice daily, AND

  • Diagnosis of amyotrophic lateral sclerosis (ALS)

Reauthorization Criteria:

1. Diagnosis of amyotrophic lateral sclerosis (ALS):

• Dose does not exceed 50 mg twice daily, AND

• Documentation of a positive clinical response to therapy

Coverage Duration:

• Initial: 12 months

• Reauthorization: 12 months

Dosing:

• 50 mg twice daily

Authorization is not covered for the following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Dose adjustment for toxicity

  • Pulmonary toxicity: if interstitial lung disease develops, discontinue riluzole immediately

• Drug-Drug-Interactions

  • Strong to moderate CYP1A2 inhibitors: coadministration may increase adverse reactions

  • Strong to moderate CYP1A2 inducers: coadministration may results in decreased efficacy

  • Hepatotoxic drugs: patients that take other hepatotoxic drugs may be at increased risk for hepatotoxicity

Policy Updates:

• 02/15/2022 – New policy approved by P&T.

References:

1. Rilutek Prescribing Information. Covis Pharma. Zug, Switzerland. March 2020.

2. Tiglutik Prescribing Information. ITF Pharma, Inc. Berwyn, PA. April 2021.

3. Exservan Prescribing Information. Aquestive Therapeutics. Warren, NJ. April 2020.