Version May 2024
Cholera prevention:
Primary immunization: Oral: 2 doses given at intervals of ≥1 week and completed at least 1 week prior to trip to endemic/epidemic areas; restart primary immunization schedule if interval between doses >6 weeks.
Booster:
2 to 5 years since last dose: Oral: 1 booster dose.
>5 years since last dose: Oral: Repeat primary immunization schedule.
Patients with ongoing risk (off label): Oral: 1 booster dose every 2 years (NACI 2017).
Enterotoxigenic E. coli diarrhea prevention:
Primary immunization: Oral: 2 doses given at intervals of ≥1 week and completed at least 1 week prior to trip to endemic/epidemic areas; restart primary immunization schedule if interval between doses >6 weeks.
Booster:
3 months to 5 years since last dose: Oral: 1 booster dose.
>5 years since last dose: Oral: Repeat primary immunization schedule.
Patients with ongoing risk (off label): Oral: 1 booster dose every 3 months (NACI 2017).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
Cholera: Oral:
Primary immunization:
Children 2 to <6 years: 3 doses given at intervals of ≥1 week and completed at least 1 week prior to trip to endemic/epidemic areas; restart primary immunization schedule if interval between any doses >6 weeks
Children ≥6 years: Refer to adult dosing.
Booster:
Children 2 to <6 years:
6 months to 5 years since last dose: 1 booster dose
>5 years since last dose: Repeat primary immunization schedule
Patients with ongoing risk (off-label): 1 booster dose every 6 months (NACI 2012)
Children ≥6 years: Refer to adult dosing.
Enterotoxigenic E. coli diarrhea: Oral: Children ≥2 years: Refer to adult dosing.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children, adolescents, and adults.
>10%: Gastrointestinal: Abdominal pain (16%), diarrhea (12%)
1% to 10%:
Gastrointestinal: Nausea (4%), vomiting (3%)
Nervous system: Dizziness (≤1%), headache (≤1%)
Neuromuscular & skeletal: Asthenia (≤1%), myalgia (≤1%)
Miscellaneous: Fever (4%)
<1%:
Cardiovascular: Syncope
Dermatologic: Diaphoresis, skin rash
Endocrine & metabolic: Dehydration
Gastrointestinal: Abdominal cramps, abdominal distress, anorexia, dysgeusia, dyspepsia, flatulence, sore throat
Nervous system: Drowsiness, fatigue, insomnia, malaise, shivering
Neuromuscular & skeletal: Arthralgia
Respiratory: Cough, rhinitis
Postmarketing:
Cardiovascular: Hypertension
Dermatologic: Pruritus, urticaria
Gastrointestinal: Gastroenteritis
Hematologic & oncologic: Lymphadenitis
Hypersensitivity: Angioedema
Nervous system: Chills, pain, paresthesia
Respiratory: Dyspnea, flu-like symptoms, increased bronchial secretions
Hypersensitivity to any component of the formulation or packaging or to formaldehyde; acute gastrointestinal illness or acute febrile illness (excluding minor illnesses such as a mild upper respiratory tract infection)
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 administration (ACIP [Kroger 2021]).
Disease-related concerns:
• Acute illness: Use of travelers' diarrhea and cholera vaccine is contraindicated in patients with acute febrile or acute gastrointestinal illness. In general, vaccines may be administered in patients with mild or moderate acute illness (NACI 2017).
• Cholera infection: Vaccine has not been shown to protect against cholera caused by V. cholerae serogroup O139 or other species of Vibrio.
• HIV: Vaccine may be administered to patients with HIV infection.
Concurrent drug therapy issues:
• Vaccines: In order to maximize vaccination rates, the National Advisory Committee on Immunization recommends simultaneous administration of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. Separate administration of typhoid vaccine (oral) by at least 8 hours (NACI 2017).
Special populations:
• Altered immunocompetence: Consider deferring immunization during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines. Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2021]; IDSA [Rubin 2014]).
Dosage form specific issues:
• Formaldehyde: Some dosage forms may contain trace amounts of formaldehyde.
Other warnings/precautions:
• Antipyretics: Antipyretics have not been shown to prevent febrile seizures. Antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2021]). One study reported that routine prophylactic administration of acetaminophen prior to vaccination to prevent fever decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).
• Appropriate use: Cholera vaccination: The World Health Organization (WHO) recommends vaccination, in conjunction with other preventive and control strategies (eg, provision of safe water and sanitation efforts), in endemic areas (eg, south and southeast Asia and Africa) and in areas at risk for outbreaks. Vaccination should be targeted at high-risk populations (eg, patients who are pregnant, lactating, infected with HIV) when resources are limited. Reactive vaccination may be considered to control the spread of current outbreaks. In addition, the WHO recommends vaccination for travelers who are at an increased risk for the disease (eg, emergency and relief workers) (WHO 2017).
• 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 2021]).
Not available in the US
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension [vial]:
Dukoral: 31.25 x 109 of each of the following Vibrio cholerae O1 strains: Inaba classic (heat inactivated), Inaba El Tor (formalin inactivated), Ogawa classic (heat inactivated), Ogawa classic (formalin inactivated), and 1 mg recombinant cholera toxin B subunit (rCTB) (3 mL) [may contain trace amounts of formaldehyde; packaged with sachet containing 5.6 g sodium hydrogen carbonate (contains saccharin, raspberry flavor)]
For oral use only; do not administer IM, IV, or SubQ. Oral administration of other medications, vaccines, and consumption of food or drink should be avoided 1 hour before and 1 hour following vaccine administration. Separate administration of typhoid vaccine (oral) by at least 8 hours.
Oral: Administer by mouth in prepared buffer solution (to protect from gastric acidic environment). Oral administration of other medications, vaccines, and consumption of food or drink should be avoided 1 hour before and 1 hour following vaccine administration. Separate administration of typhoid vaccine (oral) by at least 8 hours. Do not administer IM, IV, or SubQ.
Note: Not approved in the United States.
Cholera prevention: Active immunization against cholera in adults and children ≥2 years of age.
Enterotoxigenic E. coli diarrhea prevention: Active immunization against diarrhea caused by heat-labile toxin-producing enterotoxigenic E. coli (LT-ETEC) in adults and children ≥2 years of age.
Note: The Committee to Advise on Tropical Medicine and Travel (CATMAT) and the National Advisory Committee on Immunization do not routinely recommend vaccination with Travelers’ diarrhea and Cholera vaccine for most travelers. Vaccination should be considered after a detailed, travel-related risk assessment to identify those most likely to benefit from vaccination (CATMAT 2015; NACI 2017).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification
Cladribine: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Corticosteroids (Systemic): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Methotrexate: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to methotrexate initiation, if possible. If patients are vaccinated less than 14 days prior to or during methotrexate therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification
Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification
Typhoid Vaccine: May diminish the therapeutic effect of Travelers' Diarrhea and Cholera Vaccine. Management: Separate the dosing of encapsulated oral typhoid vaccine and the oral travelers' diarrhea and cholera vaccine by at least 8 hours. Risk D: Consider therapy modification
Vedolizumab: May diminish the therapeutic effect of Travelers' Diarrhea and Cholera Vaccine. Management: Administer travelers' diarrhea and cholera vaccine prior to initiation of therapy with vedolizumab. Risk D: Consider therapy modification
Food and/or drink may affect efficacy of the vaccine. Management: Avoid food and/or drink 1 hour before and 1 hour following vaccine administration.
Safety and efficacy in pregnant women have not been established; the vaccine is not recommended for use during pregnancy. However, since the vaccine is given orally in an inactivated form, acts locally in the gut, and does not replicate, it may not (in theory) cause a risk to the fetus. Use should only be considered if the potential benefit to the mother outweighs the potential risk to the fetus. Inactivated vaccines have not been shown to cause increased risks to the fetus (ACIP [Kroger 2021]).
The manufacturer states that the vaccine may be given to lactating women.
There is ~1.1 g of sodium per dose of vaccine.
Contains killed V. cholerae O1 bacteria and recombinant cholera toxin B subunit (CTB); the toxin of enterotoxigenic E. coli (ETEC) is structurally, functionally, and immunologically similar to CTB and is neutralized by antibodies against CTB. Vaccine administration induces immunity and an IgA antitoxic and antibacterial response locally within the gastrointestinal tract; immunity is specific to V. cholerae O1 (classical and El Tor biotypes; Inaba and Ogawa serotypes) and ETEC.
Onset of action: ETEC diarrhea and cholera immunity: ~1 week after primary immunization
Duration: ETEC immunity: 3 months after primary immunization; Cholera immunity: Children 2-6 years of age: 6 months after primary immunization; Children ≥6 years and Adults: 2 years after primary immunization
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
