cholera vaccine (Rx)

Brand and Other Names:Vaxchora
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & 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)

CDC ACIP recommendations

  • Recommended for adult travelers (aged 18–64 yr) from the United States to an area of active cholera transmission
  • Duration of protection conferred by the primary dose beyond the evaluated 3-month period is unknown
  • There is no recommendation for use of booster doses at this time
  • MMWR; May 12, 2017/66(18);482-485

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

<18 years: Safety and efficacy not established

≥65 years: Safety and efficacy not established

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Interactions

Interaction Checker

and cholera vaccine

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      Serious - Use Alternative

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          Minor

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            Adverse 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%)

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            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

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            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.

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            Pharmacology

            Mechanism of Action

            Vaccine contains live attenuated cholera bacteria that replicate in the gastrointestinal tract of the recipient to provide immunity

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            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)

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.