Data from FDA - Curated by Toby Galbraith - Last updated 21 April 2017

Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

VAXCHORA is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. VAXCHORA is approved for use in
adults 18 through 64 years of age traveling to cholera-affected areas. (1)

Limitations of Use:
• The effectiveness of VAXCHORA has not been established in persons living in cholera-affected areas. (1.1)
• The effectiveness of VAXCHORA has not been established in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. (1.1)
• VAXCHORA has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups. (1.1)

Full Prescribing information

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Advisory information

contraindications

Severe allergic reaction (e.g., anaphylaxis) to any ingredient of VAXCHORA or to a previous dose of any cholera vaccine. (4)

Special warnings and precautions
• The safety and effectiveness of VAXCHORA have not been established in immunocompromised persons. (5.1)
• VAXCHORA may be shed in the stool of recipients for at least 7 days.
There is a potential for transmission of the vaccine strain to nonvaccinated close contacts (e.g., household contacts). Use caution when considering whether to administer VAXCHORA to individuals with immunocompromised close contacts. (5.2)
Adverse reactions
The most common adverse reactions (incidence > 3%) were tiredness (30%), headache (28%), abdominal pain (18%), nausea/vomiting (17%), lack of appetite (16%) and diarrhea (4%). (6)

Usage information

Dosing and administration
• For oral administration only.
• Prepare and administer VAXCHORA in a healthcare setting equipped to dispose of medical waste. (2.3)
• Prepare VAXCHORA by reconstituting the buffer component in 100 milliliters (mL) of purified bottled water; then add the active component (lyophilized V. cholerae CVD 103-HgR). (2.3) After preparation, a single dose of VAXCHORA is 100 mL. (3)
• Instruct recipients to avoid eating or drinking for 60 minutes before or after oral ingestion of VAXCHORA. (2.2)
• Administer VAXCHORA a minimum of 10 days before potential exposure to cholera. (2.1)

Interactions

Avoid concomitant administration of VAXCHORA with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer VAXCHORA to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination. (7.2)

Immune responses to VAXCHORA may be diminished when VAXCHORA is administered concomitantly with chloroquine. Administer VAXCHORA at least 10 days before beginning antimalarial prophylaxis with chloroquine.(7.2)

More information

Category Value
Authorisation number BLA125597
Orphan designation No
Product NDC 70460-001
Date First Approved 03-10-2016
Marketing authorisation holder PaxVax Bermuda Ltd.

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