Dosing and uses of Vaxchora (cholera vaccine)
Adult dosage forms and strengths
oral suspension (after reconstitution)
- 100mL (following reconstitution)
- Supplied as a foil packet of buffer and an accompanying foil packet of the active component (lyophilized V cholerae CVD 103-HgR)
Cholera Prevention
Indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults aged 18-64 yr traveling to cholera-affected areas
100 mL PO as a single dose a minimum of 10 days before potential exposure to cholera (see Administration)
Dosing Considerations
Limitations of use
- Effectiveness has not been established in persons living in cholera-affected areas
- Effectiveness has not been established in persons who have preexisting immunity from previous exposure to V cholerae or receipt of a cholera vaccine
- Cholera vaccine has not been shown to protect against disease caused by V cholerae serogroup O139 or other non-O1 serogroups
Pediatric dosage forms and strengths
<18 years: Safety and efficacy not established
Geriatric dosage forms and strengths
≥65 years: Safety and efficacy not established
Vaxchora (cholera vaccine) adverse (side) effects
>10%
Mild headache (18.9%)
Mild tiredness (18.7%)
Mild nausea/vomiting (13.3%)
Mild abdominal pain (12.1%)
Moderate tiredness (12%)
Decreased appetite, mild (11.7%)
1-10%
Moderate headache (9.6%)
Moderate abdominal pain (6.2%)
Moderate nausea/vomiting (4.7%)
Warnings
Contraindications
History of severe allergic reaction (eg, anaphylaxis) to any vaccine ingredient or to a previous dose of any cholera vaccine
Cautions
Safety and effectiveness have not been established in immunocompromised persons
Viral shedding may occur in the stool of recipients for at least 7 days; potential for transmission of the vaccine strain to nonvaccinated close contacts (eg, household contacts); caution when considering whether to administer to individuals with immunocompromised close contacts
Pregnancy
Pregnancy
Not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug
Maternal cholera disease is associated with adverse pregnancy outcomes, including fetal death
Vaccine strain may be shed in the stool of the vaccinated mother for at least 7 days, with a potential for transmission from mother to infant during vaginal delivery
Pregnancy registry: 1-800-533-5899
Lactation
Not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Vaxchora (cholera vaccine)
Mechanism of action
Vaccine contains live attenuated cholera bacteria that replicate in the gastrointestinal tract of the recipient to provide immunity
Administration
Oral Preparation
Reconstitution should be completed within 15 minutes of removing the carton from the freezer (no need to thaw)
Pour 100 mL of cold or room temperature (41ºF-72ºF; 5ºC-22ºC) purified bottled water into a clean, disposable cup; do not use tap water, nonpurified bottled water, other beverages, or other liquids
Use scissors to cut the top off the buffer component packet
Empty buffer component packet contents into cup; effervescence will occur Using a disposable stirrer, stir until the buffer component completely dissolves
Use scissors to cut the top off the active component packet
Empty the active component packet contents (lyophilized V cholerae CVD 103-HgR) into the cup containing the buffer solution
Stir for at least 30 seconds and until active component disperses to form a slightly cloudy suspension that may contain some white particulates; the active component may not dissolve completely
Must be consumed within 15 minutes of reconstitution; the recipient should drink the full contents of the cup at once
Some residue may remain in the cup and should be discarded with the cup
NOTE: If the packets are reconstituted in the improper order, the vaccine must be discarded
Oral Administration
For oral administration only
Instruct patients to avoid eating or drinking for 1 hr before or after oral ingestion
Orally ingested as a single, oral liquid dose of 100 mL at least 10 days before travel to a cholera-affected area
Disposal instructions
- Dispose of the cup, packets, and stirrer according to standard procedures for medical waste
- Inactivate any spilled vaccine and clean any nondisposable equipment used for preparation with 70% isopropyl alcohol or 10% bleach solution
Storage
Store buffer component and active component packets frozen at −13°F to 5°F (−25°C to −15°C)
Protect from light and moisture
Packets do not require thawing prior to reconstitution
Packets should not be out of frozen storage for >15 minutes prior to reconstitution; when out of frozen storage, packets should not be exposed to temperatures >80°F (27°C)
