TIGLUTIK- riluzole liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RILUZOLE (UNII: 7LJ087RS6F) (RILUZOLE - UNII:7LJ087RS6F)

Available from:

EDW PHARMA, INC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS). 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)]. Risk Summary There are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. The background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. In studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see Data] . Based on these results, women should be advised of a possible risk to the fetus associated with use of TIGLUTIK during pregnancy. Data Animal Data Oral administration of riluzole (3, 9, or 27 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreases in fetal growth (body weight and length) at the high dose. The mid dose, a no-effect dose for embryofetal developmental toxicity, is approximately equal to the recommended human daily dose (RHDD, 100 mg) on a mg/m2 basis. When riluzole was administered orally (3, 10, or 60 mg/kg/day) to pregnant rabbits during the period of organogenesis, embryofetal mortality was increased at the high dose and fetal body weight was decreased and morphological variations increased at all but the lowest dose tested. The no-effect dose (3 mg/kg/day) for embryofetal developmental toxicity is less than the RHDD on a mg/m2 basis. Maternal toxicity was observed at the highest dose tested in rat and rabbit. When riluzole was orally administered (3, 8, or 15 mg/kg/day) to male and female rats prior to and during mating and to female rats throughout gestation and lactation, increased embryofetal mortality and decreased postnatal offspring viability, growth, and functional development were observed at the high dose. The mid dose, a no-effect dose for pre- and postnatal developmental toxicity, is approximately equal to the RHDD on a mg/m2 basis. Risk Summary There are no data on the presence of riluzole in human milk, the effects on the breastfed infant, or the effects on milk production. Riluzole or its metabolites have been detected in milk of lactating rat. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TIGLUTIK and any potential adverse effects on the breastfed infant from TIGLUTIK or from the underlying maternal condition. In rats, oral administration of riluzole resulted in decreased fertility indices and increases in embryolethality [see Nonclinical Toxicology (13.1)]. Safety and effectiveness in pediatric patients have not been established. In clinical studies of riluzole, 30% of patients were 65 years and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Patients with mild [Child-Pugh's (CP) score A] or moderate (CP score B) hepatic impairment 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. The impact of severe hepatic impairment on riluzole exposure is unknown. Use of TIGLUTIK is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times upper limit of normal or evidence of liver dysfunction (e.g., elevated bilirubin) [see Clinical Pharmacology (12.3)]. Japanese patients are more likely to have higher riluzole concentrations. Consequently, the risk of adverse reactions may be greater in Japanese patients [see Clinical Pharmacology (12.3)].

Product summary:

TIGLUTIK (50 mg/10 mL) oral suspension is supplied in amber glass bottles closed with child-resistant tamper evident screw caps. Each bottle contains 300 mL of oral suspension and is intended for multi-dose use, NDC 70726-0303-2. TIGLUTIK is supplied in a carton, NDC 70726-0303-1, containing: Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature], and protect from bright light. Do not freeze. Store upright. Use within 15 days after initially opening of each bottle. Discard any unused TIGLUTIK remaining after 15 days of first opening of the bottle.

Authorization status:

New Drug Application

Summary of Product characteristics

TIGLUTIK- RILUZOLE LIQUID
EDW PHARMA, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TIGLUTIK® SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TIGLUTIK.
TIGLUTIK (RILUZOLE) ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Dosage and Administration ( 2.1, 2.3)
12/2019
INDICATIONS AND USAGE
TIGLUTIK is indicated for the treatment of amyotrophic lateral
sclerosis (ALS) ( 1)
DOSAGE AND ADMINISTRATION
Recommended dosage: 50 mg (10 mL), twice daily, taken orally or via
percutaneous endoscopic
gastrostomy tubes (PEG-tubes), every 12 hours ( 2.1)
Measure serum aminotransferases before and during treatment ( 2.2,
5.1)
Take at least 1 hour before or 2 hours after a meal ( 2.3)
DOSAGE FORMS AND STRENGTHS
Oral suspension: 50 mg/10 mL (5 mg/mL) in 300 mL multiple-dose bottle
( 3)
CONTRAINDICATIONS
Patients with a history of severe hypersensitivity reactions to
riluzole or to any of its components ( 4)
WARNINGS AND PRECAUTIONS
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)
ADVERSE REACTIONS
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 ITF PHARMA INC. AT
1-800-664-1490 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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