The recommended dosage of Viberzi in adults is 100 mg twice daily, taken with food.
What Drugs, Substances, or Supplements Interact with Viberzi?
Viberzi may interact with cyclosporine, gemfibrozil, antiretrovirals, rifampin, eltrombopag, ciprofloxacin, gemfibrozil, fluconazole, clarithromycin, paroxetine, bupropion, alosetron, anticholinergics, opioids, rosuvastatin, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, or tacrolimus. Tell your doctor all medications and supplements you use.
Viberzi During Pregnancy or Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before taking this drug. It is unknown if Viberzi passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Viberzi (eluxadoline) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Viberzi Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop taking eluxadoline and call your doctor at once if you have:
new or worsening stomach pain (may be severe);
nausea and vomiting;
severe constipation;
constipation lasting longer than 4 days; or
severe pain in your upper stomach spreading to your back.
Side effects may be more likely in older adults.
Common side effects may include:
constipation;
nausea; or
stomach pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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 Clinical Studies]. Data described below represent pooled data compared to placebo across the
randomized trials.
Pancreatitis
Cases of pancreatitis, not associated with sphincter of Oddi spasm, were reported in 2/807
(0.2%) of patients receiving 75 mg and 3/1032 (0.3%) of patients receiving 100 mg VIBERZI
twice daily in clinical trials. Of these 5 cases, 3 were associated with excessive alcohol intake,
one was associated with biliary sludge, and in one case the patient discontinued VIBERZI 2
weeks prior to the onset of symptoms. All pancreatic events resolved with lipase normalization
upon discontinuation of VIBERZI, with 80% (4/5) resolving within 1 week of treatment
discontinuation. The case of sphincter of Oddi spasm-induced pancreatitis resolved within 24
hours of discontinuation.
Sphincter Of Oddi Spasm
In clinical trials, sphincter of Oddi spasm occurred in 0.2% (2/807) of patients receiving 75 mg
and 0.8% (8/1032) of patients receiving 100 mg VIBERZI twice daily.
Among patients receiving 75 mg, 1/807 (0.1%) patient experienced a sphincter of Oddi
spasm presenting with abdominal pain but with lipase elevation less than 3 times the
upper limit of normal (ULN) and 1/ 807 (0.1%) patient experienced a sphincter of Oddi
spasm manifested as elevated hepatic enzymes associated with abdominal pain
Among patients receiving 100 mg, 1/1032 (0.1%) patient experienced a sphincter of Oddi
spasm manifested as pancreatitis and 7/1032 (0.7%) patients experienced sphincter of
Oddi spasm manifested as elevated hepatic enzymes associated with abdominal pain
Of those patients who experienced a sphincter of Oddi spasm, 80% (8/10) reported their first
onset of symptoms within the first week of treatment. The case of sphincter of Oddi spasminduced
pancreatitis occurred within minutes of taking the first dose of VIBERZI. No cases of
sphincter of Oddi spasm occurred greater than 1 month after treatment onset. All events resolved
upon discontinuation of VIBERZI, with symptoms typically improved by the following day.
Common Adverse Reactions
Table 1 provides the incidence of common adverse reactions reported in > 2% of IBS-D patients
in either VIBERZI treatment group and at an incidence greater than in the placebo group.
Table 1: Common* Adverse Reactions in the Placebo-Controlled Studies in IBS-D
Patients
Adverse Reactions
VIBERZI
100 mg twice daily
(N= 1032)
%
VIBERZI
75 mg twice daily
(N=807)
%
Placebo
(N=975)
%
Constipation
8
7
2
Nausea
7
8
5
Abdominal Pain**
7
6
4
Upper Respiratory Tract Infection
5
3
4
Vomiting
4
4
1
Nasopharyngitis
3
4
3
Abdominal Distention
3
3
2
Bronchitis
3
3
2
Dizziness
3
3
2
Flatulence
3
3
2
Rash***
3
3
2
Increased ALT
3
2
1
Fatigue
2
3
2
Viral gastroenteritis
1
3
2
* Reported in > 2% of VIBERZI-treated patients at either dose and at an incidence greater than in placebo-treated
patients
**"Abdominal Pain" term includes: abdominal pain, abdominal pain lower, and abdominal pain upper
*** "Rash" term includes: dermatitis, dermatitis allergic, rash, rash erythematous, rash generalized, rash maculopapular,
rash papular, rash pruritic, urticaria, and idiopathic urticaria
Constipation was the most commonly reported adverse reaction in VIBERZI-treated patients in
these trials. Approximately 50% of constipation events occurred within the first 2 weeks of
treatment while the majority occurred within the first 3 months of therapy. Rates of severe
constipation were less than 1% in patients receiving 75 mg and 100 mg VIBERZI. Similar rates
of constipation occurred between the active and placebo arms beyond 3 months of treatment.
Adverse Reactions Leading To Discontinuation
Eight percent of patients treated with 75 mg, 8% of patients treated with 100 mg VIBERZI and
4% 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.
Less Common Adverse Reactions
Adverse reactions that were reported in ≤ 2% of VIBERZI-treated patients are listed below by
body system.
Gastrointestinal: gastroesophageal reflux disease General Disorders and administration site conditions: feeling drunk Investigations: increased AST Nervous system: sedation, somnolence Psychiatric disorders: euphoric mood Respiratory: asthma, bronchospasm, respiratory failure, wheezing
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 to reliably estimate their frequency or establish a causal relationship to drug
exposure.
Hypersensitivity: anaphylaxis, angioedema (e.g. swollen face and throat), dyspnea, throat
tightness, and chest pain/tightness [see WARNINGS AND PRECAUTIONS].
&Copy; Viberzi Patient Information is supplied by Cerner Multum, Inc. and Viberzi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
