Viberzi 75 mg/1
Eluxadoline · TABLET, FILM COATED · Allergan, Inc.
Viberzi is a tablet, film coated containing eluxadoline at 75 mg/1, taken oral. Manufactured by Allergan, Inc..
Key Facts
- Brand Name
- Viberzi
- Generic Name
- Eluxadoline
- NDC Code (Product)
61874-075- Manufacturer
- Allergan, Inc.
- Strength
- 75 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- NDA206940
- Drug Class
- mu-Opioid Receptor Agonist [EPC]
- Marketing Start
- 10/01/2015
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D). VIBERZI is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D). ( 1 )
Dosage & Administration
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 dose of VIBERZI [see Adverse Reactions ( 6.1 ) ]. receiving concomitant OATP1B1 inhibitors [see Drug Interactions ( 7 )] . with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment [see Use in Specific Population s ( 8.6 ) ] . with moderate or severe renal impairment (eGFR less than 60 mL/min/1.73 m 2 ); and in patients with end stage renal disease (ESRD) not yet on dialysis (eGFR less than 15 mL/min/1.73 m 2 ) [see Use in Specific Populations ( 8.7 )]. Discontinue VIBERZI in patients who develop severe constipation [see Warnings and Precautions ( 5.4 )] . Instruct patients if they miss a dose, take the next dose at the regular time and not to take 2 doses at the same time to make up for a missed dose. The recommended dosage in adults is 100 mg twice daily taken with food. ( 2 ) The recommended dosage is 75 mg twice daily taken with food in patients: unable to tolerate the 100 mg dose. ( 2 , 6.1 ) receiving concomitant OATP1B1 inhib…
Contraindications
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 [see Warnings and Precautions ( 5.1 , 5.2 )] With known or suspected biliary duct obstruction; or sphincter of Oddi disease or dysfunction. These patients are at increased risk for sphincter of Oddi spasm [see Warnings and Precautions ( 5.1 )]. With 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 [see Warnings and Precautions ( 5.1 )]. With 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 [see Warnings and Precautions ( 5.1 )] . With a known hypersensitivity reaction to VIBERZI [see Warnings and Precautions ( 5.3 )]. With severe hepatic impairment (Child-Pugh Class C). These patients are at risk for significantly increased plasma concentrations of eluxadoline [see Use in Specific Populations ( 8.6 )] With a history of chr…
Drug Interactions
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. Table 2: Established and Other Potentially Clinically Relevant Interactions Affecting VIBERZI OATP1B1 Inhibitors Clinical Impact: Increased exposure to eluxadoline when coadministered with cyclosporine [ see Clinical Pharmacology ( 12.3 ) ] Intervention: Administer VIBERZI at a dose of 75 mg twice daily [see Dosage and Administration ( 2 )] and monitor patients for impaired mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery and for other eluxadoline-related adverse reactions [see Adverse Reactions ( 6.1 )] . Examples: cyclosporine, gemfibrozil, antiretrovirals (atazanavir, lopinavir, ritonavir, saquinavir, tipranavir), rifampin, eltrombopag Drugs that Cause Constipation Clinical Impact: Increased risk for constipation related adverse reactions and potential for constipation related serious adverse reactions Intervention: Avoid use with other drugs that may cause constipation (see below); loperamide may be used occasionally…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions described below and elsewhere in the labeling include: Pancreatitis [see Warnings and Precautions ( 5.1 )] Sphincter of Oddi Spasm [ see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Constipation [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (>5%) are constipation, nausea and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1- 800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial s 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 and may not reflect the rates observed in practice. Over 1700 patients with IBS-D have been treated with 75 or 100 mg of VIBERZI twice daily in controlled trials. Exposures from placebo-controlled clinical trials in adult patients with IBS-D included 1391 exposed for 3 months, 1001 exposed for 6 months and 488 exposed for one year. Demographic characteristics were comparable between the treatment groups [see …
Frequently Asked Questions
What is Viberzi used for?
Viberzi contains Eluxadoline. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Viberzi a controlled substance?
Yes, Viberzi is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Viberzi?
The generic name for Viberzi is Eluxadoline. There are no other listed brand versions of Eluxadoline.
What is the NDC code for Viberzi 75 mg/1?
The NDC (National Drug Code) for Viberzi 75 mg/1 is 61874-075, listed by Allergan, Inc..
Other Viberzi Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)