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Drug overview for VOWST (fecal microbiota spores, live-brpk):
Generic name: fecal microbiota spores, live-brpk
Drug class: Fecal Microbiota Therapies
Therapeutic class: Gastrointestinal Therapy Agents
Fecal microbiota spores, live-brpk is a bacterial spore suspension in capsules prepared from human fecal matter sourced from qualified donors.
No enhanced Uses information available for this drug.
Generic name: fecal microbiota spores, live-brpk
Drug class: Fecal Microbiota Therapies
Therapeutic class: Gastrointestinal Therapy Agents
Fecal microbiota spores, live-brpk is a bacterial spore suspension in capsules prepared from human fecal matter sourced from qualified donors.
No enhanced Uses information available for this drug.
DRUG IMAGES
VOWST CAPSULE
The following indications for VOWST (fecal microbiota spores, live-brpk) have been approved by the FDA:
Indications:
Adjunct therapy to prevent Clostridioides difficile infection (CDI) recurrence
Professional Synonyms:
Adjunct therapy to prevent Clostridium difficile infection (CDI) recurrence
Indications:
Adjunct therapy to prevent Clostridioides difficile infection (CDI) recurrence
Professional Synonyms:
Adjunct therapy to prevent Clostridium difficile infection (CDI) recurrence
The following dosing information is available for VOWST (fecal microbiota spores, live-brpk):
It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
For oral administration only.
Prior to taking the first dose, complete antibacterial treatment for recurrent CDI 2 to 4 days before initiating treatment with fecal microbiota spores, live-brpk.
Drink 296 mL (10 oz) of magnesium citrate on the day before and at least 8 hours prior to taking the first dose of fecal microbiota spores, live-brpk. In clinical studies, participants with impaired kidney function received polyethylene glycol electrolyte solution (250 mL GoLYTELY, not approved for this use).
Do not eat or drink, except for small amount of water, for at least 8 hours prior to taking the first dose.
The dosage of fecal microbiota spores, live-brpk is 4 capsules taken orally once daily for 3 consecutive days.
Take each dose (4 capsules) on an empty stomach prior to the first meal of the day.
For oral administration only.
Prior to taking the first dose, complete antibacterial treatment for recurrent CDI 2 to 4 days before initiating treatment with fecal microbiota spores, live-brpk.
Drink 296 mL (10 oz) of magnesium citrate on the day before and at least 8 hours prior to taking the first dose of fecal microbiota spores, live-brpk. In clinical studies, participants with impaired kidney function received polyethylene glycol electrolyte solution (250 mL GoLYTELY, not approved for this use).
Do not eat or drink, except for small amount of water, for at least 8 hours prior to taking the first dose.
The dosage of fecal microbiota spores, live-brpk is 4 capsules taken orally once daily for 3 consecutive days.
Take each dose (4 capsules) on an empty stomach prior to the first meal of the day.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| VOWST CAPSULE | Maintenance | Adults take 4 capsules by oral route once daily for 3 days |
No generic dosing information available.
The following drug interaction information is available for VOWST (fecal microbiota spores, live-brpk):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Fecal Microbiota Spores/Antibiotics SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Fecal microbiota spores is a suspension of live bacterial spores, which may be compromised by concurrent use of antibiotics.(1) CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota spores.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota spores. Antibacterial treatment should be completed for 2 to 4 days before initiating treatment with fecal microbiota spores.(1) DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota spores. |
AMIKACIN SULFATE, AMOXICILLIN, AMOXICILLIN-CLAVULANATE POT ER, AMOXICILLIN-CLAVULANATE POTASS, AMPICILLIN SODIUM, AMPICILLIN TRIHYDRATE, AMPICILLIN-SULBACTAM, ARIKAYCE, AUGMENTIN, AUGMENTIN ES-600, AVIDOXY, AVIDOXY DK, AVYCAZ, AZITHROMYCIN, AZTREONAM, BACITRACIN, BACTRIM, BACTRIM DS, BAXDELA, BENZODOX 30, BENZODOX 60, BETHKIS, BICILLIN C-R, BICILLIN L-A, CAYSTON, CEFACLOR, CEFACLOR ER, CEFADROXIL, CEFAZOLIN SODIUM, CEFAZOLIN SODIUM-0.9% NACL, CEFAZOLIN SODIUM-DEXTROSE, CEFAZOLIN SODIUM-STERILE WATER, CEFAZOLIN-D5W, CEFDINIR, CEFEPIME, CEFEPIME HCL, CEFEPIME-DEXTROSE, CEFIXIME, CEFOTAN, CEFOTAXIME SODIUM, CEFOTETAN, CEFOXITIN, CEFOXITIN SODIUM, CEFPODOXIME PROXETIL, CEFPROZIL, CEFTAROLINE FOSAMIL, CEFTAZIDIME, CEFTRIAXONE, CEFUROXIME, CEFUROXIME SODIUM, CEPHALEXIN, CIPRO, CIPROFLOXACIN, CIPROFLOXACIN HCL, CIPROFLOXACIN-D5W, CLARITHROMYCIN, CLARITHROMYCIN ER, CLEOCIN HCL, CLEOCIN PEDIATRIC, CLEOCIN PHOSPHATE, CLINDAMYCIN (PEDIATRIC), CLINDAMYCIN HCL, CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE-D5W, CLINDAMYCIN-0.9% NACL, COLISTIMETHATE, COLY-MYCIN M PARENTERAL, CONTEPO, CYCLOSERINE, DALBAVANCIN HCL, DALVANCE, DAPTOMYCIN, DAPTOMYCIN-0.9% NACL, DEMECLOCYCLINE HCL, DICLOXACILLIN SODIUM, DIFICID, DORYX, DORYX MPC, DOXY 100, DOXYCYCLINE HYCLATE, DOXYCYCLINE IR-DR, DOXYCYCLINE MONOHYDRATE, E.E.S. 200, E.E.S. 400, EMBLAVEO, EMROSI, ERTAPENEM, ERY-TAB, ERYPED 200, ERYPED 400, ERYTHROCIN LACTOBIONATE, ERYTHROCIN STEARATE, ERYTHROMYCIN, ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN LACTOBIONATE, ETHAMBUTOL HCL, EXTENCILLINE, FETROJA, FIDAXOMICIN, FIRVANQ, FOSFOMYCIN TROMETHAMINE, FURADANTIN, GENTAMICIN SULFATE, GENTAMICIN SULFATE IN NS, IMIPENEM-CILASTATIN SODIUM, ISONIAZID, KIMYRSA, KITABIS PAK, LENTOCILIN S, LEVOFLOXACIN, LEVOFLOXACIN-D5W, LINCOCIN, LINCOMYCIN HCL, LINEZOLID, LINEZOLID-0.9% NACL, LINEZOLID-D5W, MACROBID, MB CAPS, ME-NAPHOS-MB-HYO 1, MEROPENEM, MEROPENEM-0.9% NACL, METHENAMINE HIPPURATE, METHENAMINE MANDELATE, MINOCIN, MINOCYCLINE ER, MINOCYCLINE HCL, MINOCYCLINE HCL ER, MONDOXYNE NL, MORGIDOX, MOXATAG, MOXIFLOXACIN, MOXIFLOXACIN HCL, NAFCILLIN, NAFCILLIN SODIUM, NEOMYCIN SULFATE, NITROFURANTOIN, NITROFURANTOIN MONO-MACRO, NUZYRA, OFLOXACIN, ORACEA, ORBACTIV, ORLYNVAH, OXACILLIN, OXACILLIN SODIUM, PENICILLIN G POTASSIUM, PENICILLIN G SODIUM, PENICILLIN GK-ISO-OSM DEXTROSE, PENICILLIN V POTASSIUM, PFIZERPEN, PIPERACILLIN-TAZOBACTAM, PIVYA, POLYMYXIN B SULFATE, PRETOMANID, PRIFTIN, PRIMAXIN, PRIMSOL, PYRAZINAMIDE, RECARBRIO, RIFABUTIN, RIFADIN, RIFAMPIN, RIFAPENTINE, SEYSARA, SIRTURO, SIVEXTRO, STREPTOMYCIN SULFATE, SULBACTAM (XACDURO), SULFADIAZINE, SULFAMETHOXAZOLE-TRIMETHOPRIM, SULFATRIM, TARGADOX, TAZICEF, TEFLARO, TETRACYCLINE HCL, TIGECYCLINE, TOBI, TOBI PODHALER, TOBRAMYCIN, TOBRAMYCIN SULFATE, TRIMETHOPRIM, TYGACIL, TYZAVAN, UNASYN, URELLE, URETRON D-S, URIBEL TABS, URIMAR-T, URNEVA, URO-MP, URO-SP, UROGESIC-BLUE, URYL, VABOMERE, VANCOCIN HCL, VANCOMYCIN, VANCOMYCIN HCL, VANCOMYCIN HCL-0.9% NACL, VANCOMYCIN HCL-D5W, VIBATIV, XACDURO, XENLETA, XERAVA, XIFAXAN, XIMINO, ZEMDRI, ZERBAXA, ZEVTERA, ZITHROMAX, ZITHROMAX TRI-PAK, ZOSYN, ZYVOX |
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for VOWST (fecal microbiota spores, live-brpk):
Drug contraindication overview.
*None.
*None.
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 VOWST (fecal microbiota spores, live-brpk):
Adverse reaction overview.
Most common adverse reactions (reported in >=5% of participants) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%) and diarrhea (10.0%).
Most common adverse reactions (reported in >=5% of participants) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%) and diarrhea (10.0%).
There are 0 severe adverse reactions.
There are 7 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abdominal distension Chills Constipation Diarrhea Fatigue |
Flatulence Nausea |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for VOWST (fecal microbiota spores, live-brpk):
The safety and effectiveness of fecal microbiota spores, live-brpk 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 |
All pregnancies have a background risk of major birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no data on use of fecal microbiota spores, live-brpk in pregnant individuals. Developmental toxicity studies in animals have not been conducted with fecal microbiota spores, live-brpk.
general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no data on use of fecal microbiota spores, live-brpk in pregnant individuals. Developmental toxicity studies in animals have not been conducted with fecal microbiota spores, live-brpk.
It is not known whether fecal microbiota spores, live-brpk is excreted in human milk. Data are not available to assess the effects of fecal microbiota spores, live-brpk on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for fecal microbiota spores, live-brpk and any other potential adverse effects on the breastfed child from fecal microbiota spores, live-brpk or from the underlying maternal condition.
Of the 349 adults who received fecal microbiota spores, live-brpk, 52.4% were >=65 years of age (n=183), and 28.1% were >=75 years of age (n=98). Data from clinical studies of fecal microbiota spores, live-brpk are not sufficient to determine if adults >=65 years of age respond differently than younger adults.
The following prioritized warning is available for VOWST (fecal microbiota spores, live-brpk):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for VOWST (fecal microbiota spores, live-brpk)'s list of indications:
| Adjunct therapy to prevent CDI recurrence | |
| A04.7 | Enterocolitis due to clostridium difficile |
| A04.71 | Enterocolitis due to clostridium difficile, recurrent |
| A04.72 | Enterocolitis due to clostridium difficile, not specified as recurrent |
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