Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The 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%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics, Inc.
at 1-833-246-2566 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of VOWST was evaluated in one Phase 3, randomized, double-blind clinical study (Study 1: NCT03183128) and one Phase 3, open-label clinical study (Study 2: NCT03183141) conducted in the United States and Canada.
Adults with confirmed rCDI were required to have symptoms controlled 48 to 96 hours post-antibacterial treatment to be eligible for enrollment and randomization (1:1) to receive either VOWST or placebo (capsules containing 92 ± 4% glycerol in saline) for 3 consecutive days.
Participants with neutropenia (absolute neutrophil count of <500 cells/mm 3 ), toxic megacolon, or small bowel ileus were excluded from these studies.
A total of 349 adults 18 years of age and older with rCDI were exposed to VOWST across both Study 1 (n=90) and Study 2 (n=259).
Across both Study 1 and Study 2, 99.1% of adults (346/349) received all scheduled doses of VOWST.
5 WARNINGS AND PRECAUTIONS 5.1 Transmissible infectious agents Because VOWST is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents.
Any infection suspected by a healthcare provider possibly to have been transmitted by this product should be reported by the healthcare provider to Aimmune Therapeutics, Inc.
at 1-833-246-
5.2 Potential presence of food allergens VOWST is manufactured from human fecal matter and may contain food allergens.
The potential for VOWST to cause adverse reactions due to food allergens is unknown.
Like all medications, Vowst can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: