TIGLUTIK is only available from Anovo Specialty Pharmacy.
EDW Pharma, the maker of TIGLUTIK, recognizes the important medical need that TIGLUTIK fulfills for many people with ALS. This is why AnovoRx is our exclusive Specialty Pharmacy. Anovo is different from local pharmacies. Anovo’s focus is intentionally centered on the unique needs of patients and their TIGLUTIK therapy.
Anovo not only works with the prescriber’s office to help coordinate the TIGLUTIK ordering process with the patient’s insurance company, but they also do a lot more. They are available 24 hours per day, 7 days per week, to answer any questions about TIGLUTIK. Once all of the insurance paperwork is completed, Anovo calls the patient or their caregiver to confirm their shipment of TIGLUTIK, which is sent directly to the patient’s home. The Caller ID will be AnovoRx Group: (901) 201-5470.
Benefits of Anovo Specialty Pharmacy
Administrative support
Anovo provides ongoing assistance to patients and their doctor’s office staff with expert handling of the necessary paperwork and insurance requirements
Direct-to-patient convenience
TIGLUTIK is shipped from Anovo directly to your home at no extra charge
Ongoing assistance
Anovo reminds patients about their refills of TIGLUTIK and manages insurance and challenges with reimbursement
Comprehensive communication
Knowledgeable and highly trained staff are available to answer any TIGLUTIK treatment-related questions – 24 hours per day, 7 days per week
No questions left unanswered
If you have any questions, you are encouraged to call Anovo at (844) 763-1198 – they are there to help
Expand
Indication
TIGLUTIK is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).
Important Safety Information
Contraindication
TIGLUTIK is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components.
Warnings and Precautions
TIGLUTIK can cause liver injury and there have been cases of drug-induced liver injury, some of which were fatal, in patients taking riluzole. Asymptomatic elevations of hepatic transaminases have been reported and, in some patients, have recurred upon re-challenge with riluzole. Maximum increases in ALT occurred within 3 months after starting riluzole. Monitor patients for hepatic injury every month for the first 3 months of treatment, and periodically thereafter; TIGLUTIK should be discontinued if there is evidence of liver dysfunction, for example, elevated bilirubin. Use of TIGLUTIK with other hepatotoxic drugs may increase the risk for hepatotoxicity.
TIGLUTIK can cause neutropenia. Cases of severe neutropenia (absolute neutrophil count less than 500 per mm3) within the first 2 months of riluzole treatment have been reported. Advise patients to report febrile illnesses.
TIGLUTIK can cause interstitial lung disease, including hypersensitivity pneumonitis. Discontinue TIGLUTIK immediately if interstitial lung disease develops.
Acute pancreatitis, including fatal and non-fatal necrotizing pancreatitis, has been observed in patients treated with riluzole in the postmarketing setting. Pancreatitis has occurred weeks to several years after initiation of riluzole.
Patients and caregivers should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation. If pancreatitis is suspected promptly discontinue TIGLUTIK and initiate appropriate management. If an alternative cause is identified, reinitiation of TIGLUTIK may be considered.
Adverse Reactions
The most common adverse reactions (incidence greater than or equal to 5% and greater than placebo) of TIGLUTIK were oral hypoesthesia (29%), asthenia (19%), nausea (16%), decreased lung function (10%), hypertension (5%), and abdominal pain (5%).
Coadministration of TIGLUTIK with strong or moderate CYP1A2 inhibitors, such as ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, and zileuton, may increase the risk of TIGLUTIK-associated adverse reactions.
Coadministration of TIGLUTIK with CYP1A2 inducers may result in decreased efficacy of TIGLUTIK.
Use in Specific Populations
Patients with mild or moderate hepatic impairment (Child-Pugh’s score A or B) had increases in AUC compared to patients with normal hepatic function. Thus, patients with mild or moderate hepatic impairment may be at increased risk of adverse reactions. Use of TIGLUTIK is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times the upper limit of normal or evidence of liver dysfunction.
Japanese patients are more likely to have higher riluzole concentrations, and thus may be at a greater risk of adverse reactions.
