Vivotif-B, US

Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 17 April 2017

Indication(s)

INDICATIONS AND USAGE Vivotif (Typhoid Vaccine Live Oral Ty21a) is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi.

Routine typhoid vaccination is not recommended in the United States of America.

Selective immunization against typhoid fever is recommended for the following groups: 1) travelers to areas in which there is a recognized risk of exposure to S. typhi, 2) persons with intimate exposure (e.g. household contact) to a S. typhi carrier, and 3) microbiology laboratorians who work frequently with S. typhi (7).

There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disasters or in persons attending rural summer camps.

Not all recipients of Vivotif will be fully protected against typhoid fever.

Vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms.

The vaccine will not afford protection against species of Salmonella other than Salmonella typhi or other bacteria that cause enteric disease.

The vaccine is not suitable for treatment of acute infections with S. typhi.

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Advisory information

contraindications

CONTRAINDICATIONS Hypersensitivity to any component of the vaccine or the enteric-coated capsule.

The vaccine should not be administered to persons during an acute febrile illness.

Safety of the vaccine has not been demonstrated in persons deficient in their ability to mount a humoral or cell-mediated immune response, due to either a congenital or acquired immunodeficient state including treatment with immunosuppressive or antimitotic drugs.

The vaccine should not be administered to these persons regardless of benefits.

Special warnings and precautions

PRECAUTIONS General The health care provider should take all necessary precautions to ensure the safe and effective use of the vaccine.

Patients should be questioned about previous reactions to this or similar products.

The previous immunization history of the patient and current antibiotic usage should be obtained by the health care provider.

Information for Patients It is essential that all 4 doses of vaccine be taken at the prescribed alternate day interval to obtain a maximal protective immune response.

Vaccine potency is dependent upon storage under refrigeration [between 2 °C and 8 °C (35.6 °F- 46.4 °F)].

The vaccine should be stored under refrigeration at all times.

It is essential to replace unused vaccine in the refrigerator between doses.

The vaccine capsule should be swallowed approximately 1 hour before a meal with a cold or luke-warm [temperature not to exceed body temperature, e.g., 37 °C (98.6 °F)] drink.

Care should be taken not to chew the vaccine capsule.

The vaccine capsule should be swallowed as soon after placing in the mouth as possible.

Not all recipients of Vivotif (Typhoid Vaccine Live Oral Ty21a) will be fully protected against typhoid fever.

Travelers should take all necessary precautions to avoid contact or ingestion of potentially contaminated food or water.

Several anti-malaria drugs, such as mefloquine, chloroquine and proguanil (not approved for use in US) possess antibacterial activity which may interfere with the immunogenicity of Vivotif.

Clinical results (see Warnings - Drug-Interactions) indicate that mefloquine and chloroquine can be administered together with Vivotif.

Proguanil should be administered only if 10 days or more have elapsed since the final dose of Vivotif was ingested.

Any serious adverse reactions related to the administration of the vaccine should be reported to your health care provider.

You may also report an adverse reaction directly to the Vaccine Adverse Event Reporting System (1-800-822-7967) (20).

Your health care provider should inform you of the benefits and risks of the vaccine, the importance of taking all 4 capsules in the correct schedule, and the importance of proper storage temperature of the capsules.

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals with Vivotif have not been performed to evaluate carcinogenic potential, mutagenic potential or impairment of fertility.

Pregnancy Category C Animal reproduction studies have not been conducted with Vivotif.

It is not known whether Vivotif® can cause fetalharm when administered to pregnant women or can affect reproduction capacity.

Vivotif® should be given to a pregnant woman only if clearly needed.

Nursing Mothers There is no data to warrant the use of this product in nursing mothers.

It is not known if Vivotif is excreted in human milk.

Pediatric Use The safety and efficacy of Vivotif has not been established in children under 6 years of age.

This product is not indicated for use in children under 6 years of age.

Adverse reactions

ADVERSE REACTIONS More than 1.4 million doses of Ty21a have been administered in controlled clinical trials and more than 150 million doses of Vivotif (Typhoid Vaccine Live Oral Ty21a) have been marketed world-wide.

Active surveillance for adverse reactions of enteric-coated capsules was performed in a pilot study (21) and in a subgroup of a large field trial (14) involving a total of 483 individuals receiving three vaccine doses.

The overall symptom rates from both studies when vaccinated with capsules were combined and shown to be: abdominal pain (6.4 %), nausea (5.8 %), headache (4.8 %), fever (3.3 %), diarrhea (2.9 %), vomiting (1.5 %) and skin rash (1.0 %).

Only the incidence of nausea occured at a statistically higher frequency in the vaccinated group as compared to the placebo group (14).

Administration of vaccine doses more than 5-fold higher than the currently recommended dose caused only mild reactions in an open study involving 155 healthy adult males (16).

Post-marketing surveillance has revealed that adverse reactions are infrequent and mild (17).

Adverse reactions reported to the manufacturer during 1991 - 1995, during which time over 60 million doses (capsules) were administered, included: diarrhea (N = 45), abdominal pain (N = 42), nausea (N = 35), fever (N = 34), headache (N = 26), skin rash (N = 26), vomiting (N = 18), or urticaria in the trunk and/or extremities (N = 13).

One isolated, non-fatal anaphylactic shock considered to be an allergic reaction to the vaccine was reported.

Dosing and administration

DOSAGE AND ADMINISTRATION One capsule is to be swallowed approximately 1 hour before a meal with a cold or luke-warm [temperature not to exceed body temperature, e.g., 37 °C (98.6 °F)] drink on alternate days, e.g., days 1, 3, 5 and 7.

Immunization (ingestion of all 4 doses of Vivotif (Typhoid Vaccine Live Oral Ty21a) should be completed at least 1 week prior to potential exposure to S. typhi.

The blister containing the vaccine capsules should be inspected to ensure that the foil seal and capsules are intact.

The vaccine capsule should not be chewed and should be swallowed as soon after placing in the mouth as possible.

A complete immunization schedule is the ingestion of 4 vaccine capsules as described above.

Re-immunization The optimum booster schedule for Vivotif® has not been determined.

Efficacy has been shown to persist for at least 5 years.

Further, there is no experience with Vivotif as a booster in persons previously immunized with parenteral typhoid vaccine.

It is recommended that a re-immunization dose consisting of four vaccine capsules taken on alternate days be given every 5 years under conditions of repeated or continued exposure to typhoid fever (7).

Pregnancy and lactation

Nursing Mothers There is no data to warrant the use of this product in nursing mothers. It is not known if Vivotif is excreted in human milk.

More information

Category	Value
Authorisation number	BLA103123
Orphan designation	No
Product NDC	21695-526
Date Last Revised	18-03-2011
Type	HUMAN PRESCRIPTION DRUG
RXCUI	762598
Marketing authorisation holder	Rebel Distributors Corp

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