Vaxchora

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

Cholera vaccine is usually given orally (by mouth) as a single dose. This vaccine is a powder that is mixed with water before you take it. You will receive this mixture in a clinic or other healthcare setting.

This vaccine should be taken on an empty stomach, at least 1 hour before or 1 hour after eating.

Follow your doctor's instructions about receiving a booster dose if needed.

The timing of this vaccination is very important for it to be effective. For best protection against cholera, this vaccine should be given at least 10 days before you travel to a cholera-affected area.

Because this is a live vaccine, small amounts of live cholera bacteria can pass into your stools for 7 days or longer after you take the cholera vaccine dose. During this time there is a chance that you could pass on the bacteria to another person who has not been vaccinated. Avoid coming into contact with anyone who has a weak immune system.

For at least 2 weeks after you receive cholera vaccine, wash your hands often, especially after using the restroom or handling food.

While traveling in a cholera-affected area, avoid drinking water or soft drinks that are not from sealed bottles or cans. Avoid ice cubes that were not made from bottled water. Use bottled water while brushing your teeth, and when preparing food or cleaning areas where food is prepared and served.

If bottled water is not available, follow the guidelines of the World Health Organization, or the Centers for Disease Control and Prevention, about disinfecting water from a tap or other source.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Since cholera vaccine is given as a one time vaccine, you are not likely to be on a dosing schedule.

For at least 2 weeks after you you receive this vaccine, wash your hands often, especially after using the restroom or handling food.

Avoid eating or drinking anything for at least 1 hour before or 1 hour after taking this vaccine.

For at least 7 days after you receive this vaccine, live cholera bacteria can pass into your feces (bowel movements). During this time, avoid allowing your body fluids to come into contact with your hands or other surfaces. Avoid coming into contact with anyone who has a weak immune system.

Tell your doctor about all the medicines you have used within the past 14 days, especially:

• an antibiotic; or

• chloroquine.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

• an oral, nasal, inhaled, or injectable steroid medicine;

• medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders; or

• medicines to treat or prevent organ transplant rejection.

If you are using any of these medications, you may not be able to receive cholera vaccine, or may need to wait until the other treatments are finished.

This list is not complete. Other drugs may interact with cholera vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Prevention of Cholera Infection

Prevention of disease caused by V. cholerae serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas.1

Cholera is an acute, intestinal infection caused by toxigenic V. cholerae and may be associated with sudden onset of profuse watery diarrhea and rapid progression to volume depletion, severe dehydration, hypovolemic shock, and death.3 5 7 8 11 115 Many individuals with V. cholerae infection are asymptomatic or have only mild to moderate disease;7 8 11 10–20% of infected individuals develop severe disease and potentially fatal dehydration.7 Transmitted principally by ingestion of water and/or food contaminated with feces from individuals with V. cholera infection and generally occurs in countries that lack clean drinking water or proper sanitation.5 7 8 11 115 Although more than 200 V. cholerae serogroups identified,11 only toxigenic strains of V. cholerae serogroups O1 and O139 have been associated with cholera epidemics; serogroup O1 is the leading cause of cholera worldwide.3 8 11 115

Cholera is uncommon in US, but endemic in approximately 50–60 countries, principally in less well-developed areas of the world that have poor sanitation and primitive water systems (e.g., areas of Africa, South and Southeast Asia, the Caribbean).3 5 7 9 11 115 In 2015, 172,454 cases (including 1304 fatalities) were reported in 42 different countries.8 9 However, many cases unreported and it has been estimated that up to 3–4 million cholera cases (up to 95,000–143,000 fatalities) may occur annually worldwide.3 8 9 11 Large cholera epidemic began in Haiti in 2010 following a devastating earthquake;9 115 CDC states cholera likely to persist at endemic levels in Haiti for the foreseeable future and sporadic cases may continue be associated with travel to and from Caribbean countries, including Haiti, the Dominican Republic, and Cuba.5 115

During 2001–2013, there were 123 confirmed cases of cholera in the US in individuals who had been traveling abroad.115 Risk of acquiring cholera is highest in those traveling to countries where cholera is endemic or epidemic, and is especially high in travelers who drink untreated water, eat raw or poorly cooked food (especially seafood), or do not follow proper hygiene recommendations while in cholera endemic or outbreak settings.115 Individuals at increased risk for poor clinical outcome if infected with toxigenic V. cholerae include those without rapid access to medical care and rehydration therapy; those with certain chronic medical conditions (e.g., immunosuppression, cardiovascular disease, renal disease); those with low gastric acidity related to antacid therapy, partial gastrectomy, or other causes; those with blood type O; and pregnant women.3 11

For US travelers, the US Public Health Service Advisory Committee on Immunization Practices (ACIP) recommends cholera vaccine live oral for adults 18 through 64 years of age who will be at increased risk of exposure to toxigenic V. cholerae O1 because they will be traveling to areas with active cholera transmission.3 4 These areas are defined as a province, state, or other administrative subdivision within a country with endemic or epidemic cholera caused by toxigenic V. cholerae O1.3 4 This includes areas that have had cholera activity within the past year and are prone to recurrence of cholera epidemics;3 does not include areas with only rare imported or sporadic cholera cases.3

ACIP states that routine use of cholera vaccine is not recommended for most travelers from the US since the majority do not visit areas with active cholera transmission and, therefore, are at low risk of exposure to toxigenic V. cholerae.3 4

Efficacy for prevention of cholera not established in individuals living in cholera-affected areas or in individuals who have preexisting immunity because of previous exposure to V. cholerae or previous vaccination with a cholera vaccine.1

Has not been shown to provide protection against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.1

All travelers to cholera-affected areas should follow safe food and water precautions and proper sanitation and personal hygiene measures, regardless of vaccination status.3 7 8 9 115 If severe diarrhea develops, traveler should seek prompt medical attention, particularly fluid replacement therapy.3

The most recent information regarding geographic areas where cholera is actively being transmitted and additional information on vaccination and other precautions for prevention of cholera are available from CDC at and .4 115

In the U.S.

• Vaxchora

Available Dosage Forms:

• Powder for Suspension
• Suspension

Therapeutic Class: Vaccine

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of cholera vaccine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of cholera vaccine in the geriatric population. Safety and efficacy have not been established.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use this vaccine or change some of the other medicines you take.

• Thiotepa

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adalimumab
• Alemtuzumab
• Amikacin
• Amoxicillin
• Ampicillin
• Antithymocyte Globulin Rabbit
• Azanidazole
• Azithromycin
• Aztreonam
• Bacampicillin
• Balofloxacin
• Bendamustine
• Benznidazole
• Besifloxacin
• Bortezomib
• Bosutinib
• Brodalumab
• Cabazitaxel
• Capecitabine
• Capreomycin
• Carboplatin
• Carfilzomib
• Carmustine
• Cefaclor
• Cefadroxil
• Cefamandole
• Cefatrizine
• Cefazolin
• Cefdinir
• Cefditoren
• Cefepime
• Cefetamet
• Cefixime
• Cefmenoxime
• Cefodizime
• Cefonicid
• Cefoperazone
• Ceforanide
• Cefotaxime
• Cefotetan
• Cefotiam
• Cefoxitin
• Cefpirome
• Cefpodoxime
• Cefprozil
• Ceftaroline Fosamil
• Ceftazidime
• Cefteram Pivoxil
• Ceftezole
• Ceftibuten
• Ceftizoxime
• Ceftobiprole
• Ceftolozane
• Ceftriaxone
• Cefuroxime
• Cephalexin
• Cephaloridine
• Cephalothin
• Cephapirin
• Cephradine
• Chlorambucil
• Chloramphenicol
• Chlortetracycline
• Cinoxacin
• Ciprofloxacin
• Cisplatin
• Cladribine
• Clarithromycin
• Clindamycin
• Clofarabine
• Cloxacillin
• Colistimethate Sodium
• Colistin
• Cyclophosphamide
• Cytarabine
• Cytarabine Liposome
• Dacarbazine
• Dalbavancin
• Dalfopristin
• Dasatinib
• Daunorubicin
• Daunorubicin Citrate Liposome
• Delamanid
• Demeclocycline
• Dibekacin
• Dicloxacillin
• Dirithromycin
• Docetaxel
• Doripenem
• Doxorubicin
• Doxycycline
• Dupilumab
• Enoxacin
• Epirubicin
• Ertapenem
• Erythromycin
• Etoposide
• Everolimus
• Fidaxomicin
• Fludarabine
• Flumequine
• Fluorouracil
• Fosfomycin
• Framycetin
• Furazolidone
• Fusidic Acid
• Gatifloxacin
• Gemcitabine
• Gemifloxacin
• Gemtuzumab Ozogamicin
• Gentamicin
• Guselkumab
• Hydroxyurea
• Idarubicin
• Ifosfamide
• Imatinib
• Imipenem
• Interferon Alfa
• Irinotecan
• Irinotecan Liposome
• Isepamicin
• Isoconazole
• Josamycin
• Kanamycin
• Levofloxacin
• Lincomycin
• Linezolid
• Lomefloxacin
• Lomustine
• Lymecycline
• Mechlorethamine
• Melphalan
• Mepartricin
• Mercaptopurine
• Meropenem
• Methacycline
• Methicillin
• Methotrexate
• Metronidazole
• Minocycline
• Miokamycin
• Mitomycin
• Mitoxantrone
• Moxalactam
• Moxifloxacin
• Nadifloxacin
• Nafcillin
• Nalidixic Acid
• Nelarabine
• Netilmicin
• Nilotinib
• Nimorazole
• Nitrofurantoin
• Norfloxacin
• Ofatumumab
• Ofloxacin
• Oleandomycin
• Oritavancin
• Ornidazole
• Oxacillin
• Oxaliplatin
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Paromomycin
• Pazufloxacin
• Pefloxacin
• Pemetrexed
• Penicillin G
• Penicillin G Benzathine
• Penicillin G Procaine
• Penicillin G Sodium
• Penicillin V
• Penicillin V Potassium
• Pentostatin
• Pipemidic Acid
• Piperacillin
• Ponatinib
• Procarbazine
• Proguanil
• Prulifloxacin
• Pyrimethamine
• Quinupristin
• Rifabutin
• Rifampin
• Rifapentine
• Rifaximin
• Rituximab
• Rokitamycin
• Rolitetracycline
• Rosoxacin
• Roxithromycin
• Rufloxacin
• Sarilumab
• Secnidazole
• Sisomicin
• Sparfloxacin
• Spiramycin
• Streptomycin
• Sulfamethoxazole
• Sultamicillin
• Tedizolid Phosphate
• Teicoplanin
• Telavancin
• Telithromycin
• Temocillin
• Temozolomide
• Teniposide
• Tetracycline
• Tigecycline
• Tobramycin
• Tocilizumab
• Topotecan
• Tositumomab
• Trimethoprim
• Vancomycin
• Vinblastine
• Vinorelbine
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Weak immune system (eg, cancer, AIDS)—Use with caution. May make these conditions worse.

Use Vaxchora as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take before travel to cholera-affected areas as you have been told by your doctor. If you have questions, talk with your doctor or pharmacist.
• Take by mouth only.
• Your doctor will give this medicine.
• Do not eat or drink anything within 60 minutes before or after taking Vaxchora.

What do I do if I miss a dose?

• Call your doctor to find out what to do.