Cholera vaccine

Active immunization against cholera is indicated only for individuals traveling to or residing in countries where cholera is endemic or epidemic.

Cholera vaccine is used for active immunization against cholera. Field studies carried out in endemic cholera areas have shown cholera vaccines to be approximately 50% effective in reducing incidence of disease and for only 3 to 6 months. Use of cholera vaccine does not prevent transmission of infection.

Local reactions manifested by erythema, induration, pain, and tenderness at the site of injection occur in most recipients, and such local reactions may persist for a few days.

Recipients frequently develop malaise, headache, and mild-to-moderate temperature elevations which may persist for 1 to 2 days. 1,4

Read the entire FDA prescribing information for Cholera Vaccine (Cholera Vaccine)

There are no dosage adjustments provided in the manufacturer's labeling.

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; Chlortetracycline; 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; Nitrofurazone; Oxychlorosene; Povidone-Iodine (Topical); RifAXIMin; Silver Nitrate; Sulfacetamide (Ophthalmic); Sulfacetamide (Topical); Taurolidine; 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

Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

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. Higher doses of methotrexate should be avoided. Consider therapy modification

Ocrelizumab: May enhance the adverse/toxic effect of Vaccines (Live). Ocrelizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Rabies Immune Globulin (Human): May diminish the therapeutic effect of Vaccines (Live). Management: Avoid administering the measles vaccine within 4 months after administration of rabies immune globulin. Avoid administering other live vaccines within 3 months after administration of rabies immune globulin. 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

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 (ACIP [Kroger 2017]).

Disease-related concerns:

• 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. Defer 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) (ACIP [Kroger 2017]).

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 (ACIP [Kroger 2017]).

Special populations:

• Altered immunocompetence: Severely immunocompromised patients (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) generally should not receive live vaccines; safety and effectiveness have not been established and immunocompromised patients may have a reduced response to vaccination or may have an adverse event secondary to replication. (ACIP [Kroger 2017]). Live vaccines should be administered ≥4 weeks prior to planned immunosuppression and avoided within 2 weeks of immunosuppression when feasible; live, attenuated vaccines should not be administered for at least 3 months after immunosuppressive therapy (IDSA [Rubin 2014]).

Other warnings/precautions:

• 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 (ACIP [Kroger 2017]).

• Transmission of virus: Bacteria 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's bacteria 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).

One dose, orally, a minimum of 10 days before potential exposure to cholera

Comments:
-Effectiveness has not been established in persons living in cholera-affected areas.
-Effectiveness has not been established in persons with pre-existing immunity from exposure to V. cholerae or receipt of a cholera vaccine.
-This vaccine has not been shown to protect against V. cholerae serogroup O139 or other non-O1 serogroups.

Use: Active immunization against disease caused by Vibrio cholerae serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas.

Data not available

Animal studies are unavailable. There are no controlled data in human pregnancy. Maternal cholera disease is associated with adverse pregnancy outcomes including fetal death. There is a registry that monitors pregnancy outcomes in women exposed to this vaccine during pregnancy. To enroll in or obtain information about the registry, please call PaxVax at 1-800-533-5899. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The manufacturer makes no recommendation regarding use during pregnancy. US FDA pregnancy category: Not assigned Comments: -This vaccine is not absorbed systemically, and maternal use is not expected to expose the fetus. -The vaccine strain may be shed in the stool for at least 7 days, with potential transmission from the mother to infant during vaginal delivery.

• Look for anything that concerns you, such as signs of a severe allergic reaction, very high fever, or unusual behavior.
• Signs of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness. These would usually start within a few minutes to a few hours after the vaccination.

• If you think it is a severe allergic reaction or other emergency that can't wait, call 9-1-1 and get to the nearest hospital. Otherwise, call your clinic.
• Afterward, the reaction should be reported to the ''Vaccine Adverse Event Reporting System'' (VAERS). Your doctor should file this report, or you can do it yourself through the VAERS web site at http://www.vaers.hhs.gov, or by calling 1-800-822-7967.

VAERS does not give medical advice.