Vaxchora Vaccine (cholera vaccine, live)
Cholera Vaccine Oral Suspension, Reconstituted, Oral (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Cholera vaccine is commercially available in the US as an oral live, attenuated bacterial vaccine containing Vibrio cholerae (V. cholerae) strain CVD 103-HgR derived from V. cholerae serogroup O1. Cholera vaccine live oral is used to stimulate active immunity against V. cholerae serogroup O1. This is the only cholera vaccine available in the US; other types of oral cholera vaccines may be available in other countries.
Cholera vaccine live oral contains live, attenuated Vibrio cholerae(V. cholerae) strain CVD 103-HgR and is used to stimulate active immunity to V. cholerae serogroup O1.
The V. cholerae CVD 103-HgR vaccine strain is constructed from the V. cholerae serogroup O1 classical Inaba strain 569B by deleting the catalytic domain sequence of the toxigenic cholera toxin A subunit gene (ctxA), which prevents the vaccine strain from synthesizing active cholera toxin. The vaccine strain remains able to synthesize the nontoxic, immunogenic cholera toxin B subunit gene (ctxB). In addition, a unique phenotypic marker is inserted into the hemolysin gene locus (hylA) to enable differentiation of the vaccine strain from wild-type V. cholerae serogroup O1.
The V. cholerae CVD 103-HgR vaccine strain is grown in a medium consisting of casamino acids, yeast extract, mineral salts, and an anti-foaming agent; the vaccine strain is collected by filtration and is diafiltered and concentrated.
The bacteria are concentrated by ultrafiltration before addition of a stabilization solution containing ascorbic acid (an antioxidant), Hy-Case SF (hydrolyzed casein (a protein derived from cow's milk), a cryoprotectant), and sucrose (a cryoprotectant). The stabilized bacteria are lyophilized, milled, and blended with anhydrous lactose (a bulking agent). The active component blend is filled into packets.
The buffer component is manufactured by blending together sodium bicarbonate (a gastric acid neutralizer), sodium carbonate (a buffer), ascorbic acid (a buffer and water chlorine neutralizer), and anhydrous lactose (a manufacturing flow aid). The buffer component blend is filled into packets.
Following oral administration of cholera vaccine live oral, the live, attenuated V. cholerae CVD 103-HgR vaccine strain replicates in the GI tract and induces a local mucosal immune response in the small intestine. The exact immunologic mechanism by which cholera vaccine live oral provides protection against V. cholerae serogroup O1 has not been determined, but is thought to be related to immune responses at the intestinal mucosal surface. Because intestinal immunity cannot be easily measured in clinical trials, serum vibriocidal antibodies have been used as a surrogate marker to indicate an immune response to cholera vaccine live oral.
In studies in adults 18-45 years of age, serum vibriocidal antibody was detected within 10 days following a single dose of cholera vaccine live oral and approximately 90-94% of vaccinees seroconverted after a single vaccine dose. Seroconversion in these studies was defined as a 4-fold or greater increase in serum vibriocidal antibody titers from baseline to day 10 after vaccination. The seroconversion rate in adults 46-64 years of age appears to be similar to that in adults 18-45 years of age.
The seroconversion rate in pediatric patients 2-17 years of age was 98.5% after a single dose.
Cholera vaccine live oral is not absorbed systemically following oral administration. Approximately 11% of adults who receive a single dose of cholera vaccine live oral shed the vaccine strain of V. cholerae in their stools for at least 7 days after the vaccine dose.
USES: This vaccine is used to help prevent cholera infection. People can get cholera by eating food or drinking water that has been contaminated. This vaccine is recommended for people who are traveling to areas where this infection is common.
This vaccine contains live bacteria that have been weakened. It works by increasing the body's natural defense (immunity) against the bacteria. Vaccines may not fully protect everyone who receives them.
While traveling, you should still avoid contaminated food or water (such as by drinking only bottled or boiled water, eating only fully cooked food). Ask your health care professional for more details.
Generic name: cholera vaccine, live
Pronunciation: (KOL-er-a)
Drug class: Cholera Vaccine
Therapeutic class: Biologicals
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Vaxchora Vaccine
Indications
The following indications are listed for Vaxchora Vaccine:
- Cholera Vaccination
Also known as: Active Immunization Against Vibrio Cholerae, Active Immunization For The Prevention Of Cholera, Cholera Prevention, Cholera Prophylaxis.
Dosing
No dosing information is available for this tab.
Cholera vaccine live oral is administered as an oral suspension.
Vaccine recipients should be instructed to avoid eating or drinking for 60 minutes before and after ingestion of cholera vaccine live oral. Cholera vaccine live oral is provided by the manufacturer in a single-dose carton that contains a foil packet of lyophilized live, attenuated Vibrio cholerae (V. cholerae) CVD 103-HgR (active component) and a foil packet of dry powder buffer (buffer component). These 2 components must be reconstituted and mixed together according to the manufacturer's instructions to provide an oral suspension containing cholera vaccine live oral.
Following reconstitution, if desired, no more than 4 g (1 teaspoon) of sucrose (table sugar) or no more than 1 g (1/4 teaspoon) of non-flavored stevia sweeteners may be added and stirred into the suspension. Do not add any other sweeteners or medicinal flavorings as this can reduce the effectiveness of the vaccine. If sucrose and non-flavored stevia are added, administer the final oral suspension containing cholera vaccine live oral within 30 minutes after preparation. If sugar or sweetener has not been added, administer the final oral suspension within 4 hours of reconstitution at room temperature (~21degreesC). Ensure the entire contents of the cup (100 mL) is swallowed at one time.
The packets containing the active component and buffer component should be stored in the original carton, refrigerated at 2-8degreesC, and protected from light and moisture. Packages may be stored at 9-25degreesC for no more than 24 hours prior to reconstitution.
Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune responses in vaccinees. All vaccines should be inspected upon delivery and monitored during storage to ensure that the appropriate temperature is maintained. Vaccine that has been mishandled or has not been stored at the recommended temperature should not be administered. If there are concerns about mishandling, the manufacturer or state or local health departments should be contacted for guidance on whether the vaccine is usable.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
Cholera Vaccine Live/Selected Antibiotics
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Antibiotics with activity against Vibrio cholerae may attenuate the immunization response to the live cholera vaccine.(1)
CLINICAL EFFECTS: Concurrent or recent antibiotic use may make the cholera vaccine ineffective.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of live cholera vaccine states that it should not be administered to patients who have received antibiotics within 14 days prior to vaccination.(1) If antimalarial prophylaxis with chloroquine is required, administer the live cholera vaccine at least 10 days before beginning chloroquine.(1) Antibiotics linked to this monograph are: macrolides, quinolones, tetracyclines, ampicillin, cefprozil, chloramphenicol, furazolidone, sulfamethoxazole-trimethoprim, and sulfametrole-trimethoprim.(2,3)
DISCUSSION: Antibiotics with activity against Vibrio cholerae may attenuate the immunization response to the live cholera vaccine, rendering the vaccine ineffective.
Live Vaccines/Bevacizumab
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Systemic bevacizumab suppresses the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines. Immune response to vaccines may be decreased during periods of immunocompromise.(1)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1)
PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency. Intravitreal injections of small doses of bevacizumab for macular degeneration or macular edema are not expected to suppress immune function.
PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) Intravitreal injections of small doses of bevacizumab for macular degeneration or macular edema are not expected to suppress immune function. For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1)
DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)
Live Vaccines/Rebisufligene Etisparvovec
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Rebisufligene etisparvovec therapy may suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines. Immune response to vaccines may be decreased during periods of immunocompromise.(1)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1) The vaccine may result in illness.(1,2)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The US manufacturer of rebisufligene etisparvovec states that vaccines should be avoided 30 days prior to rebisufligene etisparvovec administration.(1)
DISCUSSION: Rebisufligene etisparvovec therapy may pose a risk for vaccine-derived infections and decrease the effectiveness of vaccines.(1)
Live Vaccines/Vusolimogene Oderparepvec
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: The interaction potential of live virus vaccines with vusolimogene oderparepvec is unknown.
CLINICAL EFFECTS: Concurrent administration of live vaccines with vusolimogene oderparepvec may alter the effectiveness or toxicities of either agent.
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of vusolimogene oderparepvec states that vaccines containing live attenuated viruses should be avoided during vusolimogene oderparepvec therapy.(2) Patients should be advised that their cancer gene therapy may be delayed due to administration of vaccines.(3)
DISCUSSION: The concomitant use of live attenuated vaccines and vusolimogene oderparepvec has not been evaluated. The manufacturer's recommendation is based on vaccine guidance used in clinical trials.(2)
Live Vaccines; Live Bcg/Selected Immunosuppressive Agents
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: A variety of disease modifying agents suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(2)
PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.
PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) Patients who receive anti-B cell therapies should not receive live vaccines for at least 6 months after such therapies due to a prolonged duration of immunosuppression. An exception is the Zoster vaccine, which can be given at least 1 month after receipt of anti-B cell therapies.(1) The US manufacturer of abatacept states live vaccines should not be given during or for up to 3 months after discontinuation of abatacept.(2) The US manufacturer of live BCG for intravesicular treatment of bladder cancer states use is contraindicated in immunosuppressed patients.(3) The US manufacturer of daclizumab states live vaccines are not recommended during and for up to 4 months after discontinuation of treatment.(4) The US manufacturer of guselkumab states that live vaccines should be avoided during treatment with guselkumab.(5) The US manufacturer of inebilizumab-cdon states that live vaccines are not recommended during treatment and after discontinuation until B-cell repletion. Administer all live vaccinations at least 4 weeks prior to initiation of inebilizumab-cdon.(6) The US manufacturer of ocrelizumab states that live vaccines are not recommended during treatment and until B-cell repletion occurs after discontinuation of therapy. Administer all live vaccines at least 4 weeks prior to initiation of ocrelizumab.(7) The US manufacturer of ozanimod states that live vaccines should be avoided during and for up to 3 months after discontinuation of ozanimod.(8) The US manufacturer of siponimod states that live vaccines are not recommended during treatment and for up to 4 weeks after discontinuation of treatment.(9) The US manufacturer of ustekinumab states BCG vaccines should not be given in the year prior to, during, or the year after ustekinumab therapy.(10) The US manufacturer of satralizumab-mwge states that live vaccines are not recommended during treatment and should be administered at least four weeks prior to initiation of satralizumab-mwge.(11) The US manufacturer of ublituximab-xiiy states that live vaccines are not recommended during treatment and until B-cell recovery. Live vaccines should be administered at least 4 weeks prior to initiation of ublituximab-xiiy.(12) The US manufacturer of etrasimod states that live vaccines should be avoided during and for 5 weeks after treatment. Live vaccines should be administered at least 4 weeks prior to initiation of etrasimod.(13) The US manufacturer of emapalumab-lzsg states that live vaccines should not be administered to patients receiving emapalumab-lzsg and for at least 4 weeks after the last dose of emapalumab-lzsg. The safety of immunization with live vaccines during or following emapalumab-lzsg therapy has not been studied.(14) The US manufacturer of sibeprenlimab-szsi states live vaccines should not be given within 30 days prior to initiation or during treatment with sibeprenlimab-szsi.(15)
DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)
Vaccines/Pariglasgene Brecaparvovec
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines. The mechanism is not known.(1)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The US manufacturer of pariglasgene brecaparvovec states that vaccines should be avoided for 1 month prior to pariglasgene brecaparvovec administration.(1)
DISCUSSION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines.(1)
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Live Vaccines/Brensocatib
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Brensocatib may suppress the immune system by inhibiting dipeptidyl peptidase-1 (DPP-1). Brensocatib prevents the activation of neutrophil serine proteases (NSPs) during neutrophil maturation in the bone marrow.(1) Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines. Immune response to vaccines may be decreased during periods of immunocompromise.(2)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained. The vaccine may result in illness. Immune response to live vaccines may be decreased during periods of immunocompromise.(2)
PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.
PATIENT MANAGEMENT: The coadministration of live vaccines and brensocatib should be avoided.(1) The Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live-attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(2)
DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(2) The concomitant use of live attenuated vaccines and brensocatib has not been evaluated. Brensocatib may suppress the immune system by inhibiting dipeptidyl peptidase-1 (DPP-1).(1)
Live Vaccines/Leniolisib
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Leniolisib modifies the immune system. Immune response to live vaccines may be decreased during treatment with leniolisib.(1)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1)
PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.
PATIENT MANAGEMENT: The manufacturer of leniolisib states live, attenuated vaccinations may be less effective if administered during leniolisib treatment.(1)
DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1)
Live Vaccines/Methotrexate (Low Strength Injection, Oral)
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: A variety of disease modifying agents such as methotrexate suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines. Immune response to vaccines may be decreased during periods of immunocompromise.(1)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1)
PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.
PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) CDC recommendations for zoster vaccine state it may be administered to patients receiving methotrexate if the dose is < or = to 0.4 mg/kg/week for treatment of rheumatoid arthritis, psoriasis, inflammatory bowel disease or other conditions.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1)
DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)
Live Vaccines/Systemic Corticosteroids; Corticotropin (Acth)
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Corticosteroids and corticotropin suppress the immune system. In severely immunocompromised patients, virus replication after administration of live, attenuated-virus vaccines can be enhanced and/or the immune response to the vaccine may be decreased.(1)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1)
PREDISPOSING FACTORS: Patients receiving immunosuppressive doses of corticosteroids or corticotropin for equal to or greater than 14 consecutive days.(1)
PATIENT MANAGEMENT: The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are severely immunosuppressed, including those who are receiving or have received high-dose, systemic steroids for greater than or equal to 14 consecutive days. Live vaccines should be deferred for at least 1 month after discontinuation of high-dose systemic steroids administered for 14 consecutive days. When initiating immunosuppressives doses of corticosteroids, wait 4 weeks after a live vaccines is administered. However, if patients require therapy for chronic inflammatory conditions, do not delay therapy due to past vaccines. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued.(1) The US manufacturer of corticotropin(2) and triamcinolone(3) and the Australian manufacturer of dexamethasone(4) state that administration of live or live-attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids or corticotropin. The manufacturer of deflazacort states that live or live-attenuated vaccines should be administered at least 4 to 6 weeks prior to initiation of therapy with deflazacort.(5)
DISCUSSION: Many clinicians consider a dose equivalent to either 2 mg/kg of body weight or a total of 20 mg/day of prednisone as sufficiently immunosuppressive to raise safety concerns about live-virus vaccines.(1) Immunization procedures may be undertaken in patients receiving corticosteroids when the therapy is short term (less than 2 weeks); low to moderate dose; long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administered topically (skin or eyes), by aerosol, or by intra-articular, bursal, or tendon injection.(1) Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1)
Live Vaccines/Tuberculin Testing
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Measles infection and severe acute and chronic infections may induce an anergic state resulting in a false-negative tuberculin test. The live measles vaccine, as well as other live vaccines (e.g. smallpox, varicella, yellow fever) theoretically may also suppress response to tuberculin testing, though the degree of suppression may be less than that expected from acute infection with wild-type virus.(1-4)
CLINICAL EFFECTS: Tuberculin testing that is performed more than one day but less than 28 days after administration of a live vaccine may result in a false negative tuberculin response. Tuberculin testing may be administered simultaneously with live vaccines.(1-4)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The CDC states that live vaccines (e.g. MMR and varicella) and tuberculin testing may be administered within one day of each other at separate administration sites. If it has been more than one day since tuberculin testing has been administered, the live vaccine can be given at any interval after the tuberculin test. However, if the live vaccine has been administered more than one day previously and tuberculin testing is indicated, tuberculin testing should be deferred for at least 4-6 weeks.(1-4)
DISCUSSION: Suppression of response to tuberculin testing has been observed following measles infection, live measles vaccination, and live smallpox vaccination. The degree of suppression after live virus vaccination is likely to be less than that from an acute infection with wild-type virus. There is no data on suppression of response to tuberculin testing with other live vaccines. In the absence of data, the CDC recommends tuberculin testing within one day that a live vaccine is administered. Otherwise the tuberculin test should be deferred for at least 4-6 weeks.(1-4)
Live Vaccines; Live Bcg/Hydroxyurea
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Hydroxyurea may suppress the immune system.(1) Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(2)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(2) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(3)
PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies), treatments (e.g. radiation) and cytotoxic drugs may all increase the magnitude of immunodeficiency.
PATIENT MANAGEMENT: Recommendations for administration of live vaccines in patients on hydroxyurea are dependent on the indication. The US manufacturers of hydroxyurea recommend avoiding live vaccine use in patients taking hydroxyurea. Evaluate hematologic status prior to and during treatment with hydroxyurea. Provide supportive care and modify the dose or discontinue hydroxyurea as needed.(1) The Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued.(2) The ACIP recommendations state that routine vaccinations patients with secondary immunodeficiency such as sickle cell disease are likely effective. Live viral and bacterial vaccines are contraindicated in patients with generalized malignant neoplasm, immunosuppressive, or radiation therapy, depending on immune status.(4)
DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(2) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(2) A multicenter, randomized, double-blind, placebo-controlled trial in infants and young children with sickle cell disease (BABY HUG) studied the response to pneumococcal and measles, mumps, and rubella vaccines in patients using hydroxyurea. The authors concluded that hydroxyurea does not appear to have significant deleterious effects on the immune function of infants and children with sickle cell disease. Additional assessments of lymphocyte parameters of hydroxyurea-treated children may be warranted. No changes in current immunization schedules are recommended; however, for endemic disease or epidemics, adherence to accelerated immunization schedules for the measles, mumps, and rubella vaccine should be reinforced.(5)
Live Vaccines; Live Bcg/Teplizumab
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Teplizumab may cause lymphopenia and suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1,2)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained. The vaccine may result in illness.(1,2) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(3)
PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.
PATIENT MANAGEMENT: The Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live-attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) Vaccination should ideally precede the initiation of teplizumab therapy by 8 weeks. Live vaccines are not recommended within the 8 weeks prior to, during, or for 52 weeks after stopping teplizumab therapy.(2)
DISCUSSION: Vaccinations may be less effective if administered within 8 weeks before, during, and for 52 weeks following teplizumab therapy.(2) Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1)
Moderate Interaction: Assess the risk to the patient and take action as needed.
Vaccines/Hepatitis B Vaccine (Fendrix)
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix and other vaccines.(1)
CLINICAL EFFECTS: It is unknown if concurrent administration of the hepatitis B vaccine Fendrix and other vaccines will affect the efficacy of either vaccine.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The Swedish manufacturer of Fendrix states that since there is no data available for the concurrent administration of Fendrix with other vaccines, the administration of Fendrix and other vaccines should be separated by 2 to 3 weeks.(1)
DISCUSSION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix with other vaccines.(1)
Contraindications
*History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or to a previous dose of any cholera vaccine.
There are no contraindication contraindications for this drug.
- Immunosuppression
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects reported in more than 3% of adults following a single dose of cholera vaccine live oral include tiredness (31%), headache (29%), abdominal pain (19%), nausea/vomiting (18%), lack of appetite (17%), and diarrhea (4%).
Adverse effects reported in pediatric patients 12 to <18 years of age following a single dose of cholera vaccine live oral include headache (45%), tiredness (41%), abdominal pain (38%), lack of appetite (29%), and nausea (22%).
Adverse effects reported in pediatric patients 6 to <12 years of age following a single dose of cholera vaccine live oral include tiredness (35%), abdominal pain (27%), headache (26%), lack of appetite (15%), and nausea (14%).
Adverse effects reported in pediatric patients 2 to <6 years of age following a single dose of cholera vaccine live oral include tiredness (31%), loss of appetite (19%), and abdominal pain (17%).
Rare or Very Rare
- Angioedema
- Lymphadenopathy
Less Frequent
- Acute abdominal pain
- Diarrhea
- Loose stools
- Nausea
- Vomiting
Rare or Very Rare
- Anorexia
- Arthralgia
- Chills
- Cough
- Dehydration
- Dizziness
- Drowsy
- Dysgeusia
- Dyspepsia
- Dyspnea
- Fatigue
- Fever
- Flatulence
- Flu-like symptoms
- Gastroenteritis
- General weakness
- Headache disorder
- Hyperhidrosis
- Hypertension
- Insomnia
- Malaise
- Pain
- Paresthesia
- Pruritus of skin
- Rhinitis
- Skin rash
- Sore throat
- Syncope
- Urticaria
Precautions
No enhanced messaging available.
Safety and efficacy of cholera vaccine live oral have not been established in pediatric patients younger than 2 years of age.
Data are not available to date regarding use of cholera vaccine live oral in pregnant women.
Because cholera vaccine live oral is not absorbed systemically following oral administration, vaccination during pregnancy is not expected to result in fetal exposure to the vaccine.
Clinicians should consider that cholera infection is associated with adverse pregnancy outcomes, including fetal death. Clinicians also should consider that the vaccine strain of V. cholerae may be shed in the stools of vaccinated mothers for at least 7 days after vaccination and there is potential for transmission of the vaccine strain from the mother to the infant during vaginal delivery.
Data are not available to date regarding use of cholera vaccine live oral in nursing women.
Because cholera vaccine live oral is not absorbed systemically following oral administration, vaccination in nursing women is not expected to result in exposure to the vaccine in breast-fed infants.
Cholera vaccine live oral is not indicated in adults 65 years of age or older.
Safety and efficacy of cholera vaccine live oral have not been established in adults 65 years of age or older.
ICD codes
| Code | Type | Description |
|---|---|---|
| Cholera vaccination | ||
| Z23 | ICD10CM | Encounter for immunization |
ICD code information from First Databank (FDB).
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Last reviewed · Source: First Databank (FDB) drug data
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