The ordering process for REBYOTA
is streamlined to integrate efficiently into your operational workflow.
HOW TO ORDER REBYOTA
There are multiple ways to order.
REBYOTA is available through a network of specialty distributors (SDs) and specialty pharmacies. A current list of distributor names and phone numbers is included below.
Specialty Distributors
When ordering REBYOTA from a specialty distributor, please keep in mind:
- Orders placed on Monday–Thursday before 3:00 PM ET will arrive by 10:30 AM local time the following day
- Orders placed Friday by 3:00 PM ET will arrive Tuesday by 10:30 AM in the local time zone
- Orders outside of this standard window are available upon request, including Saturday or Monday delivery
- Ferring has worked with SDs on extended payment terms. Inquire with your SD
CuraScript
Tel: 1-877-900-9223
Hours: Monday–Thursday, 9:00 AM–7:00 PM ET and Friday, 9:00 AM–6:30 PM ET
Besse
Tel: 1-800-543-2111
Hours: Monday–Thursday, 8:00 AM–7:00 PM ET and Friday, 8:00 AM–5:00 PM ET
Cardinal Specialty
Tel: 1-855-855-0708
Hours: Monday–Friday, 8:00 AM–7:00 PM ET
McKesson Specialty
McKesson Plasma and Biologics
Tel: 1-877-625-2566
Fax: 888-752-7626
Email: mpborders@mckesson.com
Online Ordering Portal: connect.mckesson.com
Hours: 9:00 AM–7:30 PM ET
McKesson Specialty Health
Tel: 1-855-477-9800
Fax: 800-800-5673
Email: mshcustomercare-mspl@mckesson.com
Online Ordering Portal: mscs.mckesson.com
Hours: 8:00 AM–8:00 PM ET
REBYOTA may be dispensed via specialty pharmacies
- Optum Frontier Therapies. Tel: 1-855-768-9727. Hours: 24/7
- Accredo.
- For prescription related questions please call: 1-866-759-1557
- For customer service related questions please call: 1-877-626-1511
For any product questions or to inquire about a direct purchase option via credit card, please call 1-877-REBYOTA (1-877-732-9682)
For any product questions or to inquire about a direct purchase option,
please call 1-877-REBYOTA (1-877-732-9682)
REBYOTA PRODUCTION INFORMATION
NDC#
55566-9800-2
How supplied
REBYOTA and the administration set are shipped together in a box. Each box may contain up to 6 cartons of REBYOTA and up to 6 administration sets. Each carton of REBYOTA (NDC 55566-9800-2) contains a single dose.
Storage and
handling
REBYOTA contains live microorganisms. It is important to follow the storage requirements.
Upon Receipt: Store the REBYOTA carton in an ultracold freezer (-60°C to -90°C, -76°F to -130°F). Alternatively, store in a refrigerator (2°C to 8°C, 36°F to 46°F) for up to 5 days (including thaw time). Do not refreeze REBYOTA after thawing. Store the administration set at 10°C to 34°C (50°F to 93°F). DO NOT store the administration set in the freezer.
Before Using: Prior to use, thaw REBYOTA completely by placing carton in a refrigerator (2°C to 8°C, 36°F to 46°F) for approximately 24 hours. Do not refreeze REBYOTA after thawing. Dispose of all components in medical waste.
Carton size
Product box: 9 7/16” x 5 6/16” x 1”
Tube kit box: 9 7/16” x 5 6/16” x 1”
Combined: 18 14/16” x 5 12/16” x 2”
Carton weight
Product: 0.264 kg each
Admin Set: 0.09 kg each
REBYOTA Support and Reimbursement
Support for providers as well as patients.
Why Rebyota
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IMPORTANT SAFETY INFORMATION
INDICATION
REBYOTA (fecal microbiota, live – jslm) is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.
Limitation of Use
REBYOTA is not indicated for treatment of CDI.
IMPORTANT SAFETY INFORMATION
Contraindications
Do not administer REBYOTA to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any of the known product components.
Warnings and Precautions
Transmissible infectious agents
Because REBYOTA is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. Any infection suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Ferring Pharmaceuticals Inc.
Management of acute allergic reactions
Appropriate medical treatment must be immediately available in the event an acute anaphylactic reaction occurs following administration of REBYOTA.
Potential presence of food allergens
REBYOTA is manufactured from human fecal material and may contain food allergens. The potential for REBYOTA to cause adverse reactions due to food allergens is unknown.
Adverse Reactions
The most commonly reported (≥3%) adverse reactions occurring in adults following a single dose of REBYOTA were abdominal pain (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%).
Use in Specific Populations
Pediatric Use
Safety and efficacy of REBYOTA in patients below 18 years of age have not been established.
Geriatric Use
Of the 978 adults who received REBYOTA, 48.8% were 65 years of age and over (n=477), and 25.7% were 75 years of age and over (n=251). Data from clinical studies of REBYOTA are not sufficient to determine if adults 65 years of age and older respond differently than younger adults.
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch, or call
1-800-FDA-1088.
Please click here for full Prescribing Information.