VIBERZI Film-coated tablet (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Allergan, Inc.
Λέξεις κλειδιά
61874-075 61874-100
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1. Indications and Usage
VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
2. Dosage and Administration
The recommended dosage of VIBERZI is 100 mg taken orally twice daily with food. The recommended dosage of VIBERZI is 75 mg taken orally twice daily with food in patients: unable to tolerate the 100 mg ...
3. Dosage Forms and Strengths
75 mg tablets: capsule-shaped tablets are coated in pale-yellow to light tan color debossed with FX75 on one side. Each tablet contains 75 mg eluxadoline. 100 mg tablets: capsule-shaped tablets are coated ...
4. Contraindications
VIBERZI is contraindicated in patients: Without a gallbladder. These patients are at increased risk of developing serious adverse reactions of pancreatitis and/or sphincter of Oddi spasm <em>[see Warnings ...
5. Warnings and Precautions
5.1 Pancreatitis Pancreatitis, with or without sphincter of Oddi spasm <em>[see Warnings and Precautions (5.1)]</em>, has been reported in patients taking either the 75 mg or 100 mg dosage of VIBERZI, ...
6. Adverse Reactions
The following adverse reactions described below and elsewhere in the labeling include: Pancreatitis <em>[see Warnings and Precautions (5.1)]</em> Sphincter of Oddi Spasm <em>[see Warnings and Precautions ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during post-approval use of VIBERZI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...
7. Drug Interactions
Tables 2 and 3 include drugs which demonstrated a clinically important drug interaction with VIBERZI or which potentially may result in clinically relevant interactions. <b>Table 2. Established and Other ...
8.1. Pregnancy
Risk Summary There are no studies with VIBERZI in pregnant women that inform any drug-associated risks. The background risk of major birth defects and miscarriage for the indicated population is unknown. ...
8.2. Lactation
Risk Summary No data are available regarding the presence of eluxadoline in human milk, the effects of eluxadoline on the breastfed infant, or the effects of eluxadoline on milk production. However, eluxadoline ...
8.4. Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Juvenile Toxicology Data Eluxadoline was orally administered to juvenile rats at 500, 750, and 1500 mg/kg/day (about 16, 54 and ...
8.5. Geriatric Use
Of 1795 IBS-D patients in clinical trials of VIBERZI who received 75 mg or 100 mg twice daily, 139 (7.7%) were at least 65 years of age, while 15 (0.8%) were at least 75 years old. No overall differences ...
8.6. Hepatic Impairment
Plasma concentrations of eluxadoline increase in patients with hepatic impairment <em>[see Clinical Pharmacology (12.3)]</em>. VIBERZI is contraindicated in patients with severe hepatic impairment (Child-Pugh ...
8.7. Renal Impairment
In patients with severe renal impairment (eGFR 15 to 30 mL/min/1.73 m²) and ESRD not yet on dialysis (eGFR less than 15 mL/min/1.73 m²), exposure of eluxadoline was increased compared to healthy subjects ...
9.1. Controlled Substance
Eluxadoline is listed in Schedule IV of the Controlled Substances Act.
9.2. Abuse
In a drug discrimination study in monkeys, intravenous administration of eluxadoline hydrochloride produced full generalization to the morphine cue. In a self-administration study in monkeys, eluxadoline ...
9.3. Dependence
In studies with monkeys and rats in which eluxadoline and eluxadoline hydrochloride were chronically administered, discontinuation of the drug did not lead to behavioral signs of withdrawal, a measure ...
10. Overdosage
No reports of overdosage with VIBERZI have been reported. In the event of acute overdose, the stomach should be emptied and adequate hydration maintained. The patient should be carefully observed and given ...
11. Description
The active ingredient in VIBERZI is eluxadoline, a mu-opioid receptor agonist. The full chemical name is 5-[[[(2S)-2-amino-3-[4-(aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)1(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic ...
12.1. Mechanism of Action
Eluxadoline is a mu-opioid receptor agonist; eluxadoline is also a delta opioid receptor antagonist and a kappa opioid receptor agonist. The binding affinities (Ki) of eluxadoline for the human mu and ...
12.2. Pharmacodynamics
Cardiac Electrophysiology At a dose 10 times the maximum recommended dose (100 mg), VIBERZI does not prolong the QT interval to any clinically relevant extent.
12.3. Pharmacokinetics
Following oral administration of 100 mg VIBERZI in healthy subjects, the C<sub>max</sub> of eluxadoline was approximately 2 to 4 ng/mL and AUC was 12 to 22 ng.h/mL. Eluxadoline has approximately linear ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis Two-year oral carcinogenicity studies have been conducted with eluxadoline in CD-1 mice at doses up to 1500 mg/kg/day (about 14 times the human AUC of 24 ng.h/mL after a single oral dose ...
14. Clinical Studies
The efficacy and safety of VIBERZI in IBS-D patients was established in two randomized, multi-center, multi-national, double-blind, placebo-controlled trials (Studies 1 and 2). A total of 1281 patients ...
16.1. How Supplied
VIBERZI is available as: <u>75 mg tablets:</u> capsule-shaped tablets, coated in pale-yellow to light tan color, debossed with FX75 on one side. Bottle of 60: NDC 61874-075-60 <u>100 mg tablets:</u> capsule-shaped ...
16.2. Storage and Handling
Store VIBERZI tablets at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Instruct patients to: stop VIBERZI immediately and seek medical attention if unusual or severe abdominal pain that may radiate ...