Label: VAXCHORA- cholera vaccine, live, oral kit

  • Category: VACCINE LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated February 7, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use VAXCHORA safely and effectively. See full prescribing information for VAXCHORA. VAXCHORA® (Cholera Vaccine, Live, Oral) Suspension ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    VAXCHORA is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in persons 2 through 64 years of age traveling to cholera-affected areas.   1.1 ...
  • 2 DOSAGE AND ADMINISTRATION
    For oral administration only. 2.1 Dose and Schedule - Administer a single oral dose of VAXCHORA a minimum of 10 days before potential exposure to cholera. The safety and effectiveness of ...
  • 3 DOSAGE FORMS AND STRENGTHS
    VAXCHORA is a suspension for oral administration. Before reconstitution, each dose of VAXCHORA is supplied as a foil packet of buffer and an accompanying foil packet of the active component ...
  • 4 CONTRAINDICATIONS
    Do not use in persons who have a history of severe allergic reaction (e.g., anaphylaxis) to any ingredient of VAXCHORA or to a previous dose of any cholera vaccine [see Description (11)].
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Altered Immunocompetence - The safety and effectiveness of VAXCHORA have not been established in immunocompromised persons [see Immunocompromised Individuals (8.6)]. 5.2 Shedding and ...
  • 6 ADVERSE REACTIONS
    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a vaccine cannot be directly compared to rates in the clinical trials ...
  • 7 DRUG INTERACTIONS
    7.1 Food and Drink - Avoid food or drink for 60 minutes before and after vaccine administration [see Restrictions on Eating and Drinking (2.2)]. 7.2 Concomitant Vaccines or ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - VAXCHORA is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. Clinical ...
  • 11 DESCRIPTION
    VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR. CVD 103-HgR was constructed from ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - VAXCHORA contains live attenuated cholera bacteria that replicate in the gastrointestinal tract of the recipient. Immune mechanisms conferring protection against ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - VAXCHORA has not been evaluated for the potential to cause carcinogenicity or genotoxicity, or to impair fertility.
  • 14 CLINICAL STUDIES
    14.1 Efficacy Against V. cholerae Challenge - Study 2 was a randomized, double-blind, saline placebo-controlled V. cholerae challenge study conducted in the US. Subjects 18 through 45 years of ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - VAXCHORA is supplied as shown in Table 8. The contents of both packets are reconstituted with bottled water (purified, spring, or sparkling [carbonated]), to form one oral ...
  • 17 PATIENT COUNSELING INFORMATION
    Prior to administration of this vaccine, the health care professional should inform the individual of the following: • Advise vaccine recipients to exercise caution regarding food and water ...
  • PRINCIPAL DISPLAY PANEL - Carton
    Carton - NDC 50632-015-02 - STORE REFRIGERATED - Use After Reconstitution - Cholera Vaccine, Live, Oral - Vaxchora® Contents: Single-dose Active Packet (4x108 to 2x109 CFU of - Vibrio cholerae ...
  • PRINCIPAL DISPLAY PANEL - Buffer and Active Packets
    BUFFER COMPONENT - OF VAXCHORA® (Cholera Vaccine, Live, Oral) 1 - Packet 1 of 2. USE FIRST. Contents (Single-Dose): Buffer - Directions: Add entire contents - of Packet 1 to 100 mL of ...
  • INGREDIENTS AND APPEARANCE
    Product Information