Effective and Safe
Drug-Free CIC Treatment
Vibrant is indicated for the treatment of adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month.
First of its kind mechanism of action
Vibrant uses gentle vibrations to stimulate the colon mechanically, causing a local effect on natural peristalsis.
The colon’s biological clock appears to be altered in patients with chronic idiopathic constipation
Vibrant’s timed stimulation is optimized to deliver vibrations based on these alterations, which helps the colon contract mechanically in synch with its biological clock.
Efficacy and Safety of the Non-Pharmaceutical Vibrant® System for Chronic Idiopathic Constipation (CIC):
Randomized, double-blind, multicenter, placebo-controlled, phase III trial
Conclusions
The Vibrant System significantly improved stool frequency, other bowel and abdominal symptoms and quality of life in patients with CIC. These benefits were seen soon after the initiation of therapy and were sustained with no significan’t adverse events.
Vibrant provides a novel, non-pharmacological, intraluminal therapy which is efficacious, safe and well tolerated in patients with CIC.
What do your colleagues think about the phase 3 clinical results?
Vibrant should not be used if your patient
- Has a history of complicated/obstructive diverticular disease
- Has a history of intestinal or colonic obstruction, or suspected intestinal obstruction.
- Currently has clinical evidence of significant gastroparesis
- Has a history of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if the subject has been treated and is in remission), and/or anal fissures and fistulas.
- Has a history of Zenker’s diverticulum, dysphagia, esophageal stricture, eosinophilic esophagitis or achalasia
- Is pregnant or lactating
Adverse Events / Side Effects:
Potential adverse events associated with the use of this device may include abdominal pain, abdominal distension, abdominal discomfort, vomiting, nausea, blood in stool, diarrhea, flatulence and proctalgia. In rare cases, obstruction may occur.
Note the safety and effectiveness of the Vibrant System for long-term use in the indicated population, i.e., for more than 8 weeks, has not been evaluated.
Warnings:
- The Vibrant Capsule is MR unsafe. The device has not been evaluated for safety and compatibility in the MR (magnetic resonance) environment. It has not been tested for heating, migration, or image artifact in the MR (magnetic resonance) environment. If patient requires an MRI, verify capsule expulsion via abdominal X-ray before undergoing an MRI examination.
- The capsule should be kept away from implants such as pacemakers, defibrillators, nerve stimulators, and other devices that could be affected by proximity to a DC (direct current) magnetic field.
- Vibrant Capsules must be stored in a safe place, out of the reach of children and/or infants.
- If a child has accidentally swallowed an unused Vibrant capsule, he/she should be brought immediately to a hospital.
- The Vibrant Capsule is magnetic resonance (MR) unsafe. If an MRI is required, verify that no Capsules are currently in your body via abdominal X-ray before undergoing an MRI examination.
Currently, Vibrant is available with a cash option of
$89/month
How to prescribe
Select Vibrant in your EHR
* For a new patient – select code 60009-0189-82
* For a monthly refill – select code 60009-0189-80
Please make sure you include in the prescription notes the patient’s ICD-10 diagnosis code(s) as well as any previous use of prescribed constipation medications.
How to choose Carepoint in your EHR
* Search by zip code – 60173
* Verify address of pharmacy prior to sending prescription - 9 E. Commerce Drive, Schaumburg, IL
* Add to favorites for convenience
How to choose Carepoint in your EHR
* Search by zip code – 60173
* Verify address of pharmacy prior to sending prescription - 9 E. Commerce Drive, Schaumburg, IL
* Add to favorites for convenience
| Product Name | Vibrant Starter Kit |
|---|---|
| NDC | 60009-0189-82 |
| Indication | Treatment of chronic idiopathic constipation |
| Dosage Form | Capsule |
| Dispense Quantity | 1 |
| Dispense Unit | 1 ea Box |
| Number of supply in one box | 1 Pod, 20 Capsules |
| Days Supply | 30 days |
| SIG | As directed by a physician. Orally ingested up to 5 times per week. The capsules should be taken once daily, on any of the 5 days out of the week, shortly before going to sleep |
| Notes to Pharmacist | Relevant ICD-10 Code for CIC and examples of previous medications tried and failed for treatment may streamline Prior Authorization Process |
| Specialty Pharmacy | Carepoint Pharmacy 9 E. Commerce Drive Schaumburg, IL 60173 (855) 237-9112 |
Example Dosing Screenshot:
| Product Name | Vibrant Capsule (Refill) |
|---|---|
| NDC | 60009-0189-80 |
| Indication | Treatment of chronic idiopathic constipation |
| Dosage Form | Capsule |
| Dispense Quantity | 20 |
| Dispense Unit | Capsule |
| Number of supply in one box | 20 Capsules |
| Days Supply | 30 days |
| SIG | As directed by a physician. Orally ingested up to 5 times per week. The capsules should be taken once daily, on any of the 5 days out of the week, shortly before going to sleep |
| Notes to Pharmacist | Relevant ICD-10 Code for CIC and examples of previous medications tried and failed for treatment may streamline Prior Authorization Process |
| Specialty Pharmacy | Carepoint Pharmacy 9 E. Commerce Drive Schaumburg, IL 60173 (855) 237-9112 |
Example Dosing Screenshot:
If you can’t find Vibrant in your EHR or have questions, email us at [email protected]
Using Vibrant is simple!
1. Activate
The patient places the capsule in the pod for an automatic activation
2. Ingest
The patient swallows the capsule with a glass of water
3. Monitor
The patient follows & monitors the treatment using Vibrant app, for best experience