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VIBERZI is a brand name for Eluxadoline, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VIBERZI (eluxadoline tablets) is indicated for: • treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. In clinical trials VIBERZI improved abnormal stool consistency more prominently than abdominal pain. 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore,…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Physicians should periodically assess the need for continued treatment with VIBERZI. • Patients on treatment who develop severe constipation should stop taking VIBERZI and contact their physician. 2 Recommended Dose and Dosage Adjustment • The recommended dosage of VIBERZI is 100 mg taken orally twice daily with food.
• For patients who are unable to tolerate the 100 mg dose, the recommended dosage of VIBERZI is 75 mg taken orally twice daily with food. • For patients 65 years or older, the starting dose should be 75 mg twice daily with food. If the 75 mg BID dose is well tolerated but not efficacious, the dose could be increased to 100 mg twice daily.
4 Geriatrics). • Health Canada has not authorized an indication for pediatric use. 4 Administration VIBERZI should be taken orally twice daily with food. 5 Missed Dose In the event that a dose is missed (delay of > 4 hours), the patient should skip that dose.
Do not take two tablets to account for the missed dose. Wait until it is time for the next dose and then take the usual dose with food.
). Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction (see 2 CONTRAINDICATIONS). 1 Pregnant Women Eluxadoline was not studied in pregnant women, therefore, VIBERZI should not be used during pregnancy.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY). 2 Breast-feeding Eluxadoline was not studied in nursing women; therefore, VIBERZI should not be used in nursing women.
It is unknown if VIBERZI is excreted in human milk. Precaution should be exercised because many drugs can be excreted in human milk. In animal studies, eluxadoline was excreted in the milk of lactating rats after oral administration (See Reproductive and Developmental Toxicology).
3 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 8%) were at least 75 years old. There were no overall differences in the types of adverse reactions observed between elderly and younger patients; however, a higher proportion of elderly patients than younger patients experienced adverse reactions (66% vs 59%), serious adverse reactions (9% vs 4%), and gastrointestinal adverse reactions (39% vs 28%).
2 Recommended Dose and Dosage Adjustment). 1 Adverse Reaction Overview Exposure in placebo-controlled clinical trials in adult patients with IBS-D included 1032 patients exposed to 100 mg BID (505 for 6 months, and 243 for 1 year), and 807 patients exposed to 75 mg BID (496 for 6 months, and 245 for 1 year).
In the Phase 3 trials, the proportion of patients treated with 100 mg VIBERZI who reported mild, moderate, and severe adverse events were 24%, 25% and 10%, respectively. The most common adverse reactions (incidence of >5%) reported were constipation, nausea and abdominal pain.
Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Dependence/Tolerance In a 52-week clinical study, no evidence of physical dependence or withdrawal from VIBERZI was detected based on adverse event reporting or administration of the subjective opiate withdrawal scale (SOWS).
2 Pharmacodynamics). 8%). 2 Pharmacodynamics). Driving and Operating Machinery Due to events of somnolence and sedation observed in clinical studies, caution should be exercised when driving or operating a vehicle or potentially dangerous machinery.
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet 75 mg and 100 mg Colloidal silica, crospovidone, magnesium stearate, mannitol, Opadry II (iron oxide red, iron oxide yellow, polyethylene glycol, partially hydrolyzed polyvinyl alcohol, talc and titanium dioxide) and silicified microcrystalline cellulose VIBERZI® (eluxadoline) Page 7 of 28 Gastrointestinal Constipation Constipation, sometimes requiring hospitalization, has been reported following VIBERZI administration, sometimes after one or two doses.
In postmarketing experience, severe cases with development of intestinal obstruction, ileus, fecal impaction and ischemic colitis, including rectal hemorrhage, requiring intervention, have also been reported. Instruct patients to stop VIBERZI and immediately contact their healthcare provider if they experience symptoms suggestive of severe constipation, which may present with an abrupt onset of abdominal pain, nausea, vomiting, and abdominal distention.
4 Drug-drug Interactions). Hepatic/Biliary/Pancreatic Pancreatitis Pancreatitis, with or without sphincter of Oddi spasm, including serious cases resulting in hospitalization, have been reported in patients taking either the 75 mg or 100 mg dosage of VIBERZI, primarily in patients without a gallbladder.
Fatal cases have also been reported in patients without a gallbladder. VIBERZI is contraindicated in patients without a gallbladder (see 2 CONTRAINDICATIONS). Most of the reported cases of serious pancreatitis occurred within a week of starting treatment with VIBERZI and some developed symptoms after one or two doses.
Eluxadoline is contraindicated in patients with: • Hypersensitivity to eluxadoline or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Known or suspected biliary duct obstruction; or sphincter of Oddi disease or dysfunction. These patients are at increased risk for sphincter of Oddi spasm. • Patients without a Gallbladder. These patients are at increased risk for pancreatitis and/or sphincter of Oddi spasm.
• Alcoholism, alcohol abuse or alcohol addiction, or in patients who drink more than 3 alcoholic beverages per day. These patients are at increased risk for acute pancreatitis. • A history of pancreatitis; or structural diseases of the pancreas, including known or suspected pancreatic duct obstruction.
These patients are at increased risk for acute pancreatitis. • Hepatic impairment (Child-Pugh Class A, B, and C). These patients are at risk for significantly increased plasma concentrations of eluxadoline. • A history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction.
These patients may be at risk for severe complications of bowel obstruction. g. cyclosporine). 4 Drug-drug Interactions). VIBERZI® (eluxadoline) Page 5 of 28
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6% of patients treated with placebo. There were no serious adverse events of constipation. Serious adverse reactions of pancreatitis and sphincter of Oddi spasm may occur uncommonly (less than 1% of patients). 3% of patients treated with placebo discontinued prematurely due to adverse reactions.
In the VIBERZI treatment groups, the most common reasons for discontinuation due to adverse reactions were constipation (1% for 75 mg and 2% for 100 mg) and abdominal pain (1% for both 75 mg and 100 mg). In comparison, less than 1% of patients in the placebo group withdrew due to constipation or abdominal pain.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The data below describes adverse events that occurred in the 3 double-blind, placebo-controlled clinical trials involving over 1700 adult patients with IBS-D treated with 75 mg or 100 mg of VIBERZI twice daily for up to 52 weeks in one phase 3 study, up to 26 weeks in another phase 3 study, and up to 12 weeks in a phase 2 study (See Table 2).
1) 24. 5) Psychiatric Disorders […]
In patients with a gallbladder, evaluate a patient’s alcohol intake prior to starting VIBERZI. Instruct patients to avoid chronic or acute excessive alcohol use while taking VIBERZI. Monitor for signs and symptoms of pancreatitis. Instruct patients to stop VIBERZI immediately and seek medical attention if they experience symptoms suggestive of pancreatitis such as new or worsening acute abdominal or epigastric pain radiating to the back or shoulder, with or without nausea and vomiting (see 2 CONTRAINDICATIONS).
, biliary-type pain) in patients taking VIBERZI, especially in patients without a gallbladder. Postmarketing serious adverse reactions of sphincter of Oddi spasm with or without pancreatitis resulting in hospitalization have been reported, primarily in patients without a gallbladder.
Most of the reported cases of sphincter of Oddi spasm occurred within a week of starting treatment with VIBERZI and some developed symptoms after one or two doses. VIBERZI is contraindicated in patients without a gallbladder. Patients with known or suspected sphincter of Oddi disease or dysfunction and/or biliary tract or pancreatic disease, including a history of pancreatitis, must not receive VIBERZI (see 2 CONTRAINDICATIONS).
g. , right upper quadrant] pain), that may radiate to the back or shoulder with or without nausea and vomiting. Do not restart VIBERZI in patients who developed biliary duct obstruction or sphincter of Oddi spasm while taking VIBERZI (see 2 CONTRAINDICATIONS).
4 hours up to 22 hours) after oral administration of VIBERZI. 3 Pharmacokinetics, Special Populations and Conditions). Therefore, VIBERZI is contraindicated in hepatic impaired subjects (see 2 CONTRAINDICATIONS). Hypersensitivity Reactions In post-marketing experience, serious hypersensitivity reactions (including anaphylaxis) have been reported following VIBERZI administration.
Some of these reactions occurred after the first one or two doses of VIBERZI (see