(KOL er a vak SEEN)
- Vaccine, Live (Bacterial)
Contains live attenuated cholera bacteria that replicate in the gastrointestinal tract of the recipient. Immune mechanisms conferring protection against cholera following receipt of cholera vaccine have not been determined.
Efficacy: In a study of adults 18 to 45 years of age, the efficacy against the occurrence of moderate to severe diarrhea was 90.3% at 10 days post-vaccination and 79.5% at 3 months post-vaccination.
Oral: No systemic absorption.
Use: Labeled Indications
Cholera prevention: Active immunization against disease caused by Vibrio cholerae serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas
Limitations of use: Effectiveness has not been established in persons living in cholera-affected areas or in persons who have preexisting immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. Has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.
History of severe allergic reaction (eg, anaphylaxis) to any component of the formulation or to a previous dose of any cholera vaccine
Cholera prevention: Oral: 100 mL (single dose) administered ≥10 days prior to potential cholera exposure.
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer’s labeling.
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer’s labeling.
Prepare and administer in a health care setting equipped to dispose of medical waste. Complete reconstitution within 15 minutes of removing the carton from the freezer. Pour 100 mL of cold or room temperature purified bottled water into a clean, disposable cup. Do not use tap water, non-purified bottled water, other beverages, or other liquids. Empty buffer component packet contents into cup; stir until completely dissolved. Effervescence will occur. Add the active component packet contents into the cup containing the buffer solution; stir for at least 30 seconds and until active component disperses to form a slightly cloudy suspension (may not dissolve completely and may contain some white particulates). Note: If packets are reconstituted in the improper order, the vaccine must be discarded.
Oral: Avoid eating or drinking for 60 minutes before or after oral ingestion. Consume vaccine within 15 minutes of reconstitution; drink full contents of the cup at once.
Store buffer and active component packets frozen at -25°C to -15°C (-13°F to 5°F). Protect from light and moisture. Packets should not be out of frozen storage for more than 15 minutes prior to reconstitution; when out of frozen storage, packets should not be exposed to temperatures above 27°C (80°F).
Antibiotics: May diminish the therapeutic effect of Cholera Vaccine. Exceptions: Acetic Acid (Otic); Acetic Acid (Topical); Aluminum Acetate; Azithromycin (Ophthalmic); Aztreonam (Oral Inhalation); Bacitracin (Ophthalmic); Bacitracin (Topical); Benzoin; Ciprofloxacin (Ophthalmic); Clindamycin (Topical); Dapsone (Topical); Erythromycin (Ophthalmic); Erythromycin (Topical); Fidaxomicin; Framycetin; Fusidic Acid (Ophthalmic); Fusidic Acid (Topical); Gatifloxacin; Gentamicin (Ophthalmic); Gentamicin (Topical); Gentian Violet; Hexachlorophene; Mafenide; MetroNIDAZOLE (Topical); Mupirocin; Neomycin; Oxychlorosene; Povidone-Iodine (Topical); RifAXIMin; Silver Nitrate; Sulfacetamide (Ophthalmic); Sulfacetamide (Topical); Tobramycin (Ophthalmic). Avoid combination
AzaTHIOprine: May enhance the adverse/toxic effect of Vaccines (Live). AzaTHIOprine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose azathioprine (3 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of azathioprine should be avoided. Consider therapy modification
Belimumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination
Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided. Consider therapy modification
Daclizumab: May enhance the adverse/toxic effect of Vaccines (Live). Daclizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination
Dimethyl Fumarate: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live). Management: Canadian labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. U.S. labeling does not mention this. Consider therapy modification
Fingolimod: May enhance the adverse/toxic effect of Vaccines (Live). Vaccinal infections may develop. Fingolimod may diminish the therapeutic effect of Vaccines (Live). Avoid combination
Immune Globulins: May diminish the therapeutic effect of Vaccines (Live). Management: Consult full interaction monograph for dose interval recommendations. This interaction does not apply to oral Ty21a typhoid vaccine or others listed as exceptions. Consider therapy modification
Immunosuppressants: May enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: AzaTHIOprine; Beclomethasone (Oral Inhalation); Betamethasone (Systemic); Budesonide (Systemic); Corticotropin; Cortisone; Cytarabine (Liposomal); Deflazacort; Dexamethasone (Systemic); Fludrocortisone; Fluticasone (Oral Inhalation); Hydrocortisone (Systemic); Leflunomide; Mercaptopurine; Methotrexate; MethylPREDNISolone; PrednisoLONE (Systemic); PredniSONE; Triamcinolone (Systemic). Avoid combination
Leflunomide: May enhance the adverse/toxic effect of Vaccines (Live). Leflunomide may diminish the therapeutic effect of Vaccines (Live). Management: The ACIP guidelines state that live-attenuated vaccines should generally be avoided for at least 3 months after cessation of immunosuppressant therapy. However, the ACR does not recommend avoiding live vaccines in patients being treated with leflunomide. Consider therapy modification
Mercaptopurine: May enhance the adverse/toxic effect of Vaccines (Live). Mercaptopurine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose 6-mercaptopurine (1.5 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of mercaptopurine should be avoided. Consider therapy modification
Methotrexate: May enhance the adverse/toxic effect of Vaccines (Live). Methotrexate may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose methotrexate (0.4 mg/kg/week or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of methotrexate should be avoided. Consider therapy modification
Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: If a parenteral live vaccine has been recently administered, a scheduled PPD skin test should not be administered for at least 4-6 weeks following the administration of the vaccine. Consider therapy modification
Venetoclax: May enhance the adverse/toxic effect of Vaccines (Live). Venetoclax may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live, attenuated vaccines before, during, or after (prior to B-cell recovery) venetoclax treatment. Avoid combination
Central nervous system: Fatigue (31%), headache (29%)
Gastrointestinal: Abdominal pain (19%), nausea and vomiting (18%)
1% to 10%: Gastrointestinal: Diarrhea (4%)
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (NCIRD/ACIP 2011).
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Consider deferring administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (NCIRD/ACIP 2011).
Concurrent drug therapy issues:
• Vaccines: In order to maximize vaccination rates, the Advisory Committee on Immunization Practices (ACIP) recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible (NCIRD/ACIP 2011).
• Altered immunocompetence: Use with caution in severely immunocompromised patients (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); safety and effectiveness have not been established and immunocompromised patients may have a reduced response to vaccination (NCIRD/ACIP 2011); live vaccines should be administered ≥4 weeks prior to planned immunosuppression and avoided within 2 weeks of immunosuppression when feasible (IDSA [Rubin 2014]).
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (NCIRD/ACIP 2011).
• Transmission of virus: Virus may be shed in the stool of the recipient for at least a week. For ≥14 days following vaccination, recipient should wash their hands thoroughly after using the bathroom and before preparing or handling food. The manufacturer recommends caution when considering use in individuals with close contact to immunocompromised persons.
The cholera vaccine is not systemically absorbed following maternal oral administration and is not expected to result in fetal exposure. Following administration, the vaccine may be shed in the maternal stool for ≥7 days, potentially exposing the newborn to the vaccine strain during vaginal delivery. Maternal cholera infection is associated with adverse pregnancy outcomes, including fetal death.
Health care providers are encouraged to enroll women exposed to the cholera vaccine during pregnancy in the Pregnancy Registry (800-533-5899).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience loss of strength and energy, headache, abdominal pain, nausea, vomiting, lack of appetite, or diarrhea (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.