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Drug overview for REBYOTA (fecal microbiota, live-jslm):
Generic name: fecal microbiota, live-jslm
Drug class: Fecal Microbiota Therapies
Therapeutic class: Gastrointestinal Therapy Agents
Fecal microbiota, live-jslm is a fecal microbiota suspension.
No enhanced Uses information available for this drug.
Generic name: fecal microbiota, live-jslm
Drug class: Fecal Microbiota Therapies
Therapeutic class: Gastrointestinal Therapy Agents
Fecal microbiota, live-jslm is a fecal microbiota suspension.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for REBYOTA (fecal microbiota, live-jslm) have been approved by the FDA:
Indications:
Recurrent Clostridioides difficile infection
Professional Synonyms:
None.
Indications:
Recurrent Clostridioides difficile infection
Professional Synonyms:
None.
The following dosing information is available for REBYOTA (fecal microbiota, live-jslm):
It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
*For rectal administration only.
*Prior to use, thaw fecal microbiota, live-jslm completely by placing the carton in a refrigerator, 2degreesC to 8degreesC (36degreesF to 46degreesF), for approximately 24 hours. The carton may be stored in the refrigerator at 2degreesC to 8degreesC (36degreesF to 46degreesF) and used within 5 days, including thawing time. DO NOT thaw using a heat source such as a microwave or hot water.
*Administer fecal microbiota, live-jslm 24 to 72 hours after the last dose of antibiotics for CDI.
*Administer a single dose of 150 mL rectally.
*Consult the full prescribing information for additional information on preparation and administration of fecal microbiota, live-jslm.
*For rectal administration only.
*Prior to use, thaw fecal microbiota, live-jslm completely by placing the carton in a refrigerator, 2degreesC to 8degreesC (36degreesF to 46degreesF), for approximately 24 hours. The carton may be stored in the refrigerator at 2degreesC to 8degreesC (36degreesF to 46degreesF) and used within 5 days, including thawing time. DO NOT thaw using a heat source such as a microwave or hot water.
*Administer fecal microbiota, live-jslm 24 to 72 hours after the last dose of antibiotics for CDI.
*Administer a single dose of 150 mL rectally.
*Consult the full prescribing information for additional information on preparation and administration of fecal microbiota, live-jslm.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| REBYOTA RECTAL SUSPENSION | Maintenance | Adults insert 150 milliliters by rectal route once |
No generic dosing information available.
The following drug interaction information is available for REBYOTA (fecal microbiota, live-jslm):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Fecal Microbiota/Antibiotics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Fecal microbiota is a suspension of live bacteria, which may be compromised by concurrent use of antibiotics.(1) CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota. Antibacterial treatment should be completed for 24 to 72 hours before initiating treatment with fecal microbiota. Do not use antibiotics for up to 8 weeks after fecal microbiota.(1) DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota. |
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There are 0 moderate interactions.
The following contraindication information is available for REBYOTA (fecal microbiota, live-jslm):
Drug contraindication overview.
*Severe allergic reactions (e.g. anaphylaxis) to any component of fecal microbiota, live-jslm.
*Severe allergic reactions (e.g. anaphylaxis) to any component of fecal microbiota, live-jslm.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for REBYOTA (fecal microbiota, live-jslm):
Adverse reaction overview.
The most commonly reported (>=3%) adverse reactions occurring in adults following a single dose of fecal microbiota, live-jslm were abdominal pain, (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%).
The most commonly reported (>=3%) adverse reactions occurring in adults following a single dose of fecal microbiota, live-jslm were abdominal pain, (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%).
There are 0 severe adverse reactions.
There are 5 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Diarrhea |
Abdominal distension Flatulence Nausea |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for REBYOTA (fecal microbiota, live-jslm):
Safety and effectiveness of fecal microbiota, live-jslm in individuals younger than 18 years of age have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Fecal microbiota, live-jslm is not absorbed systemically following rectal administration, and maternal use is not expected to result in fetal exposure to the drug.
Fecal microbiota, live-jslm is not absorbed systemically by the mother following rectal administration, and breastfeeding is not expected to result in exposure of the child to fecal microbiota, live-jslm.
Of the 978 adults who received fecal microbiota, live-jslm, 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 fecal microbiota, live-jslm are not sufficient to determine if adults 65 years of age and older respond differently than younger adults.
The following prioritized warning is available for REBYOTA (fecal microbiota, live-jslm):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for REBYOTA (fecal microbiota, live-jslm)'s list of indications:
| Recurrent clostridioides difficile infection | |
| A04.71 | Enterocolitis due to clostridium difficile, recurrent |
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