or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.upadacitinibSerious - Use Alternative (1)upadacitinib decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.valrubicinMonitor Closely (1)valrubicin, cholera vaccine. immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.vancomycinSerious - Use Alternative (1)vancomycin, cholera vaccine. pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of cholera vaccine with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer cholera vaccine to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.vandetanibMonitor Closely (1)vandetanib decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.vemurafenibMonitor Closely (1)vemurafenib decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.venetoclaxMonitor Closely (1)venetoclax decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.voclosporinSerious - Use Alternative (1)voclosporin decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Immunosuppressants also increase risk of infection with concomitant live vaccines. Avoid live vaccines for at least 3 months after immunosuppressants.vorinostatMonitor Closely (1)vorinostat decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine. >10% Adults aged 18-45 years Mild headache (18.9%) Mild tiredness (18.7%) Loose stools (13.9%) Mild nausea/vomiting (13.3%) Mild abdominal pain (12.1%) Moderate tiredness (12%) Decreased appetite, mild (11.7%) Children aged 12 to <18 years Mild headache (34.5%) Mild tiredness (31.5%) Mild abdominal pain (28.5%) Decreased appetite, mild (23.6%) Mild nausea (17%) Loose stools (11.5%) Children aged 6 to <12 years Mild abdominal pain (23.6%) Mild tiredness (22.3%) Mild headache (19.1%) Decreased appetite, mild (12.7%) Mild nausea (12.1%) Moderate tiredness (12.1%) Children aged 2 to <6 years Mild tiredness (19.2%) Mild abdominal pain (14.4%) Moderate tiredness (11.6%) Decreased appetite, mild (12.3%) 1-10% Adults aged 18-45 years Moderate headache (9.6%) Moderate abdominal pain (6.2%) Moderate nausea/vomiting (4.7%) Decreased appetite, moderate (4.4%) Children aged 12 to <18 years Moderate headache (9.7%) Moderate tiredness (8.5%) Moderate abdominal pain (8.5%) Decreased appetite, moderate (5.5%) Moderate nausea (4.8%) Mild vomiting (3.6%) Moderate vomiting (1.2%) Children aged 6 to <12 years Moderate headache (5.7%) Loose stools (5.5%) Moderate abdominal pain (3.8%) Mild vomiting (2.5%) Severe fever (2.5%) Decreased appetite, mild (1.9%) Mild nausea (1.9%) Moderate vomiting (1.9%) Children aged 2 to <6 years Mild headache (6.8%) Decreased appetite, moderate (6.8%) Mild nausea (6.2%) Moderate abdominal pain (2.7%) Moderate headache (2.1%) Mild vomiting (1.4%) 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 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 childPregnancy 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. Mechanism of Action Vaccine contains live attenuated cholera bacteria that replicate in the gastrointestinal tract of the recipient to provide immunity 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 (41-72º; 5-22ºC) bottled water (ie, purified, spring, or sparkling) into a clean, disposable cup; do not use tap/faucet water, nonpurified bottled water, other beverages, or other liquids Cut top off buffer component packet; empty buffer component packet contents into cup; effervescence will occur Using a disposable stirrer, stir until buffer component completely dissolves; for children younger than 6 years, discard half of the buffer solution Cut top off active component packet; empty active component packet contents (lyophilized V cholerae CVD 103-HgR) into 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; active component may not dissolve completely Must be consumed within 15 minutes of reconstitution; recipient should drink the full contents of cup (ie, 50 mL or 100 mL) at once Some residue may remain in the cup and should be discarded with the cup NOTE: If 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) No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions 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. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. 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