The ordering process for REBYOTA
is streamlined to integrate efficiently into your operational workflow.
WAYS TO ORDER REBYOTA
There are multiple ways to obtain REBYOTA for your patients. Running a benefits verification is the best way to confirm any
payer-dependent requirements.
You can:
- Order as little as a single box of REBYOTA on demand for your patient
- Pre-order and store REBYOTA in an ultra-cold freezer at your site
What you need to know to set up your account and order REBYOTA
- Specialty distributors (SD)
- REBYOTA @ HOME
- Specialty Pharmacies (SP)
- Direct Purchase
Specialty distributors (SD)
SPECIALTY DISTRIBUTOR ACCOUNT SET UP
This step is only needed if you don’t have an in-network specialty distributor account currently set up:
Prior to ordering REBYOTA for your patients, you will need to ensure you have an SD account within our network. We have provided a couple steps to get you started.
Identify which specialty distributor you would like to use within the network
The SD network account set up information chart below contains the specific contact information you will need to begin the process with your preferred SD.
- Each SD has its own application process, turnaround time, and list of documentation that is needed to submit an order
- Address verification may be required
SPECIALTY DISTRIBUTOR ACCOUNT SET UP INFORMATION
Besse
Tel: 1-800-543-2111
Email: accountsetup@besse.com
Online portal: www.besse.com/create-an-account
Cardinal Health™
Metro Medical™
Tel: 1-800-768-2002
Email: customersvc@cardinalhealth.com
Online ordering portal: www.metromedicalorder.com
- Visit www.metromedical.com. On the first screen, click on “Request information or set up an account” in the red box
- Fill out the form and someone will contact you
- If you have any questions during account registration, customers can call customer service at: 800-768-2002
Cardinal Specialty
Tel: 1-866-677-4844
Online Portal*: www.cardinalhealth.com/en/solutions/specialty-distribution/ordering/creating-an-account.html
*Online portal is for hospitals and pharmacies only; physician offices must call to initiate an account.
CuraScript
Tel: 1-877-599-7748
Email: ssatservice@curascript.com
McKesson Medical-
Surgical, Inc
Tel: 1-800-422-0280
Email: Contact Supply Manager through Help Desk for Tech support with the form
Hours of Operations to contact with questions: 8:00 AM –8:00PM ET
Website to complete application: https://mms.mckesson.com/
Click on BECOME A CUSTOMER link and complete form
Estimated time frame/duration for account set-up from submission of COMPLETE paperwork to being able to order. Varies based on size of practice and length of time it takes for sales team to connect with potential customer.
McKesson Specialty
McKesson Plasma and Biologics
Email: MPBOnboarding@mckesson.com
McKesson Specialty Health
Email: onboarding2@mckesson.com
Optum Frontier
Therapies
Tel: 1-833-754-6457
Email: oft_specialtydistribution@optum.com
ORDER REBYOTA
Once you have set up your account with your preferred SD, you can order REBYOTA. First-time orders may take an additional
1-2 days to process; subsequent orders will be shipped within the timeframes below.
When ordering REBYOTA from a specialty distributor, please keep in mind:
- Orders placed on Monday–Thursday before 3:00 PM ET should arrive by 10:30 AM local time the following day*
- Orders placed Friday by 3:00 PM ET should arrive Tuesday by 10:30 AM in the local time zone*
- Ferring has worked with SDs on extended payment terms. Inquire with your SD
*Delivery times are subject to change if the shipping company experiences unforeseen delays.
SPECIALTY DISTRIBUTOR ordering INFORMATION
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 Health™
Metro Medical™
Tel: 1-800-768-2002
Email: customersvc@cardinalhealth.com
Online Ordering Portal: www.metromedicalorder.com
Cardinal Specialty
Tel: 1-855-855-0708
Hours: Monday–Friday, 8:00 AM–7:00 PM ET
CuraScript
Tel: 1-877-599-7748
Fax: 1-888-227-8158
Email: ssatservice@curascript.com
Hours: Monday–Friday, 8:30 AM–5:30 PM ET
McKesson Medical-
Surgical, Inc
Tel: 1-855-571-2100
Email: MMSPCCustomerService@mckesson.com
Ordering Portal (if exists) for web-based ordering: https://mms.mckesson.com/
Hours of Operations to accept orders: 8:00 AM-8:00 PM ET Customer Service
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
Optum Frontier
Therapies
Tel: 1-833-754-6457
Email: oft_specialtydistribution@optum.com
RECEIVING REBYOTA
When you order from an SD, REBYOTA will arrive in an orange box.
REBYOTA contains live microorganisms; it is important to follow proper storage requirements:
- REBYOTA can stay in the unopened orange shipper box up to 5 days from date on box
- If the seal from the box is unopened, REBYOTA must be moved to the appropriate freezer or refrigerator based on thawing time needed
- Follow unpacking instructions printed on the orange shipper box for storage and thawing requirements
- AEROSAFE will facilitate box returns with a phone call 1-2 days after receipt – Tel: 1-585-328-2140
Learn how you can unpack both the REBYOTA Product Carton(s) and Administration Set(s)
REBYOTA @ HOME
REBYOTA @ HOME
- Offer your patients in-home administration with consideration to:
- Location constraints
- Physical limitations
- Administrative obstacles
- REBYOTA @ Home manages the process from start to finish
- In-home health nurses, available in
all 50 states, coordinate
administration
INITIATE REBYOTA @ HOME
- Fill out form to begin a benefits
verification and fax completed form
directly to REBYOTA @ Home - Chartwell Pharmacy
Tel: 1-412-804-8554
Fax: 1-412-920-1828
Hours: Monday-Friday, 9:00 AM-5:00 PM ET
WHAT TO EXPECT AFTER INITIATING ENROLLMENT
Whether your patient is approved, denied, or if additional information is needed, the REBYOTA@ Home team will be in touch with you and your patient to discuss insurance coverage and to coordinate scheduling administration.
- If a patient is not covered, our team will work with your office to determine the best option for them
- You will receive a notification fax once the administration appointment is set
- All supplies are provided by the in-home nurse (eg, chucks)
REBYOTA @ Home Administration
Watch this video to see how the
in-home nurse will administer
REBYOTA in the convenience of
your patient’s home.
Specialty Pharmacies (SP)
REBYOTA may be dispensed via specialty pharmacies
There may be payer-dependent requirements—running a benefits verification is the best way to confirm.
Please work with your SP on logistics, handling, and their specific returns and replacement policies.
SPECIALTY PHARMACY ORDERING INFORMATION
- Fill out our Patient Enrollment form to begin benefits verification and fax completed form directly to your selected SP
- Review the roadmap to help guide the SP workflow and prescription referral process, if needed
- Optum Frontier:
Tel: 1-855-768-9727
Fax: 1-866-991-9929
Hours: Monday-Friday, 8:00 AM-9:00 PM ET - Accredo:
Tel: 1-866-759-1557
Fax: 1-888-454-8488
Hours: Monday-Friday, 9:00 AM-11:00 PM ET
When ordering from an SP, REBYOTA may not arrive in an ultra cold shipper box (orange AEROSAFE shipper). If it is not in an ultra cold shipper box, you must move REBYOTA to the appropriate location (freezer or refrigerator), per product instructions and thawing needs.
Direct Purchase
To inquire about a direct purchase option via credit card,
please call 1-888-FERRING (1-888-337-7464)
Returns/Replacement goods policy:
- If a patient misses the appointment and the thawed REBYOTA cannot be used, Ferring will offer zero-cost
replacement for the product purchased directly through Ferring - For complete return/replacement policies and procedures, please call 1-888-FERRING (1-888-337-7464)
Returns/Replacement goods policy:
- If a patient misses the appointment and the thawed REBYOTA cannot be used, Ferring will offer zero-cost
replacement for the product purchased through a REBYOTA SD - For complete return/replacement policies and procedures, please contact your site of product procurement
For any product questions or to inquire about a direct purchase option,
please call 1-877-REBYOTA
(1-877-732-9682)
For any product questions please call
1-888-FERRING (1-888-337-7464)
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
ACCESS REBYOTA
Access information and support tools for REBYOTA including coding, billing, reimbursement, and financial assistance.
Why Rebyota
Answers to REBYOTA questions including, safety, patient expectations, and more.
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
1-800-332-1088.
Please click here for full Prescribing Information.