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DRUGS & SUPPLEMENTS
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Typhivax
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Typhivax uses
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Dosage and administration
- How supplied
- References
INDICATIONS AND USAGE
Typhivax vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is approved for use in persons two years of age or older.
Immunization with Typhivax vaccine should occur at least two weeks prior to expected exposure to S typhi.
Typhivax vaccine is not indicated for routine immunization of individuals in the United States (US). (14)
Selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with S typhi. (14)
Typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as Africa, Asia, and Central and South America where there is a recognized risk of exposure to S typhi. Current CDC advisories should be consulted with regard to specific locales. Vaccination is particularly recommended for travelers who will have prolonged exposure to potentially contaminated food and water. However, even travelers who have been vaccinated should use caution in selecting food and water. (15)
There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disaster or in persons attending rural summer camps. (14)
An optimal reimmunization schedule has not been established. Reimmunization every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time.
For recommended primary immunization and reimmunization see DOSAGE AND ADMINISTRATION section.
Typhivax vaccine should not be used to treat a patient with typhoid fever or a chronic typhoid carrier.
CONTRAINDICATIONS
Typhivax VACCINE IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF HYPERSENSITIVITY TO ANY COMPONENT OF THIS VACCINE.
WARNINGS
Allergic reactions have been reported rarely in the post-marketing experience.
The safety and immunogenicity of Typhivax vaccine in children under two years of age has not been established. As with other polysaccharide vaccines, the antibody response may be inadequate. The decision whether to vaccinate children under 2 years of age depends upon the risk incurred by the child on the basis of the epidemiological context.
Typhivax vaccine provides protection against the risk of infection related to Typhivax, but gives no protection against Salmonella paratyphi A or B, non-S typhi species of Salmonella enterica serovar Typhi, or other bacteria that cause enteric disease.
If the vaccine is used in persons deficient in producing antibodies, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy, the expected immune response may not be obtained. This includes patients with asymptomatic or symptomatic HIV-infection, severe combined immunodeficiency, hypogammaglobulinemia, or agammaglobulinemia; altered immune states due to diseases such as leukemia, lymphoma, or generalized malignancy; or an immune system compromised by treatment with corticosteroids, alkylating drugs, antimetabolites or radiation. (16)
As with any vaccine, vaccination with Typhivax vaccine may not protect 100% of individuals.
PRECAUTIONS
General
Care is to be taken by the health-care provider for the safe and effective use of Typhivax vaccine.
EPINEPHRINE INJECTION MUST BE IMMEDIATELY AVAILABLE FOLLOWING IMMUNIZATION SHOULD AN ANAPHYLACTIC OR OTHER ALLERGIC REACTIONS OCCUR DUE TO ANY COMPONENT OF THE VACCINE.
Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient's history with respect to possible hypersensitivity to the vaccine or similar vaccines.
Acute infection or febrile illness may be reason for delaying use of Typhivax vaccine except when, in the opinion of the physician, withholding the vaccine entails a greater risk.
Syncope (fainting) has been reported following vaccination with Typhivax. Procedures should be in place to prevent falling injury and manage syncopal reactions.
A separate, sterile syringe and needle or a sterile disposable unit must be used for each patient to prevent the transmission of infectious agents from person to person. Needles should not be recapped and should be properly disposed.
Do not administer intravenously.
Safety and immunogenicity data from controlled trials are not available for Typhivax vaccine following previous immunization with whole-cell typhoid or live, oral typhoid vaccine.
INFORMATION FOR VACCINE RECIPIENTS OR PARENTS/GUARDIANS
Before administration, healthcare providers should inform patients, parents or guardians of the benefits and risks of immunization with Typhivax vaccine.
Prior to administration of Typhivax vaccine, healthcare providers should ask patients, parents and guardians about the recent health status of the patient to be immunized.
Typhivax vaccine is indicated in persons traveling to endemic or epidemic areas. Current CDC advisories should be consulted with regard to specific locales.
Travelers should take all necessary precautions to avoid contact with or ingestion of contaminated food and water.
One dose of vaccine should be given at least 2 weeks prior to expected exposure.
Reimmunization consisting of a single-dose for US travelers every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time. (14)
As part of the child's or adult's immunization record, the date, lot number, and manufacturer of the vaccine administered should be recorded. (17)
DRUG INTERACTIONS
There are no known interactions of Typhivax vaccine with drugs or foods.
Concomitant Vaccine Administration
Typhivax was concomitantly administered with Menactra vaccine in individuals 18 through 55 years of age.
No studies have been conducted in the US to evaluate interactions or immunological interference between the concurrent use of Typhivax vaccine and drugs (including antibiotics and antimalarial drugs), immune globulins or other vaccines (including common travelers vaccines such as tetanus, poliomyelitis, hepatitis A, and yellow fever).
Typhivax vaccine must not be mixed with any vaccine in the same syringe. Separate injection sites should be used in case of concomitant administration.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
Typhivax vaccine has not been evaluated for its carcinogenic potential, mutagenic potential or impairment of fertility.
PREGNANCY CATEGORY C
Animal reproduction studies have not been conducted with Typhivax vaccine. It is not known whether Typhivax vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Typhivax vaccine should be given to a pregnant woman only if clearly needed.
When possible, delaying vaccination until the second or third trimester to minimize the possibility of teratogenicity is a reasonable precaution. (18)
NURSING MOTHERS
It is not known whether Typhivax vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Typhivax vaccine is administered to a nursing woman.
There is no data on the use of this product in nursing mothers.
PEDIATRIC USE
Safety and effectiveness of Typhivax vaccine have been established in children 2 years of age and older. (10) (11) FOR CHILDREN BELOW THE AGE OF 2 YEARS, SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED.
ADVERSE REACTIONS
Adverse event information is derived from clinical trials and worldwide post-marketing experience.
DATA FROM CLINICAL TRIALS
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates.
Safety of Typhivax vaccine, the US licensed liquid formulation, has been assessed in clinical trials in more than 4,000 subjects both in countries of high and low endemicity. In addition, the safety of the lyophilized formulation has been assessed in more than 6,000 individuals. The adverse reactions were predominately minor and transient local reactions. Local reactions such as injection site pain, erythema, and induration almost always resolved within 48 hours of vaccination. Elevated oral temperature, above 38°C, was observed in approximately 1% of vaccinees in all studies. No serious or life-threatening systemic events were reported in these clinical trials. (10) (11)
Adverse reactions from two trials evaluating Typhivax vaccine lots in the US (18- to 40-year-old adults) are summarized in Table 3. No severe or unusual side effects were observed. Most subjects reported pain and/or tenderness (pain upon direct pressure). Local adverse experiences were generally limited to the first 48 hours. (10) (11)
| REACTION | Trial 1 Placebo N = 54 | Trial 1 Typhivax vaccine N = 54 (1 Lot) | Trial 2 Typhivax vaccine N = 98 (2 Lots combined) |
|---|---|---|---|
| Local | |||
| Tenderness | 7 (13.0%) | 53 (98.0%) | 95 (96.9%) |
| Pain | 4 (7.4%) | 22 (40.7%) | 26 (26.5%) |
| Induration | 0 | 8 (14.8%) | 5 (5.1%) |
| Erythema | 0 | 2 (3.7%) | 5 (5.1%) |
| Systemic | |||
| Malaise | 8 (14.8%) | 13 (24.0%) | 4 (4.1%) |
| Headache | 7 (13.0%) | 11 (20.4%) | 16 (16.3%) |
| Myalgia | 0 | 4 (7.4%) | 3 (3.1%) |
| Nausea | 2 (3.7%) | 1 (1.9%) | 8 (8.2%) |
| Diarrhea | 2 (3.7%) | 0 | 3 (3.1%) |
| Feverish (subjective) | 0 | 6 (11.1%) | 3 (3.1%) |
| Fever ≥100°F | 0 | 1 (1.9%) | 0 |
| Vomiting | 0 | 1 (1.9%) | 0 |
No studies were conducted in US children. Adverse reactions from a trial in Indonesia in children one to twelve years of age are summarized in Table 4. (10) (11) No severe or unusual side effects were observed.
| REACTIONS | N = 175 |
|---|---|
| Local | |
| Soreness | 23 (13.0%) |
| Pain | 25 (14.3%) |
| Erythema | 12 (6.9%) |
| Induration | 5 (2.9%) |
| Impaired Limb Use | 0 |
| Systemic | |
| Feverishness | 5 (2.9%) |
| Headache | 0 |
| Decreased Activity | 3 (1.7%) |
In the US Reimmunization Study, subjects who had received Typhivax vaccine 27 or 34 months earlier, and subjects who had never previously received a typhoid vaccination, were randomized to placebo or Typhivax vaccine, in a double-blind study. Safety data from the US Reimmunization Study are presented in Table 5. (10) (11) (13) In this study 5/30 (17%) primary immunization subjects and 10/45 (22%) reimmunization subjects had a local reaction. No severe or unusual side effects were observed. Most subjects reported pain and/or tenderness (pain upon direct pressure). Local adverse experiences were generally limited to the first 48 hours. (10) (11) (13)
| REACTION | PLACEBO (N = 32) | FIRST IMMUNIZATION (N = 30) | REIMMUNIZATION (N = 45 |
|---|---|---|---|
| Local | |||
| Tenderness | 2 (6%) | 28 (93%) | 44 (98%) |
| Pain | 1 (3%) | 13 (43%) | 25 (56%) |
| Induration | 0 | 5 (17%) | 8 (18%) |
| Erythema | 0 | 1 (3%) | 5 (11%) |
| Systemic | |||
| Malaise | 1 (3%) | 11 (37%) | 11 (24%) |
| Headache | 5 (16%) | 8 (27%) | 5 (11%) |
| Myalgia | 0 | 2 (7%) | 1 (2%) |
| Nausea | 0 | 1 (3%) | 1 (2%) |
| Diarrhea | 0 | 0 | 1 (2%) |
| Feverish (subjective) | 0 | 3 (10%) | 2 (4%) |
| Fever ≥100°F | 1 (3%) | 0 | 1 (2%) |
| Vomiting | 0 | 0 | 0 |
Solicited Injection Site and Systemic Reactions When Given With Menactra Vaccine
The majority (70%-77%) of solicited injection site reactions at the Typhivax and at the Menactra injection sites were reported as Grade 1 and resolved within 3 days post-vaccination. The most common systemic reactions were headache (41% when Menactra and Typhivax were given concomitantly; 42% when Typhivax was given with Placebo, and 33% when Menactra vaccine was given alone one month after Typhivax vaccination) and fatigue (38% when Menactra vaccine and Typhivax were given concomitantly; 35% when Typhivax was given with Placebo, and 27% when Menactra vaccine was given alone one month after Typhivax vaccination). Fever ≥40.0°C and seizures were not reported.
DATA FROM WORLDWIDE POST-MARKETING EXPERIENCE
In addition to reports in clinical trials, worldwide voluntary adverse events reports received since market introduction of Typhivax vaccine are listed below. This list includes serious events and/or events which were included based on severity, frequency of reporting or a plausible causal connection to Typhivax vaccine. Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to vaccination.
- Gastrointestinal disorders
Nausea, vomiting, diarrhea, abdominal pain
- General disorders and administration site condition
Injection site pain, inflammation, induration, and erythema; lymphadenopathy, fever, asthenia, malaise, flu-like episode
- Immune system disorders
Anaphylaxis, allergic-type reactions such as pruritus, rash, urticaria, angioedema, difficulty breathing, hypotension; serum sickness
- Musculoskeletal and connective tissue disorders
Myalgia, arthralgia, cervical pain
- Nervous system disorders
Syncope with and without convulsions, headache, loss of consciousness, tremor
- Respiratory system disorders
Asthma
Additional Adverse Events
Post-marketing reports of glomerulonephritis, neutropenia, bilateral retinitis, and polyarthritis have been reported in patients who had also received other vaccines; however, a causal relationship has not been established.
REPORTING OF ADVERSE EVENTS
Reporting by parents and patients of all adverse events occurring after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by the health-care provider to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967 or visit the VAERS website at http//www.vaers.org. (17)
Health-care providers also should report these events to the Pharmocovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370, or call 1-800-822-2463.
DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The syringe or vial and its packaging should also be inspected prior to use for evidence of leakage, premature activation of the plunger, or a faulty tip seal. If any of these conditions exists, the vaccine should not be administered.
For intramuscular use only. Do NOT inject intravenously.
The immunizing dose for adults and children is a single injection of 0.5 mL. The dose for adults is typically given intramuscularly in the deltoid, and the dose for children is given IM either in the deltoid or the anterolateral thigh. The vaccine should not be injected into the gluteal area or areas where there may be a nerve trunk.
A reimmunizing dose is 0.5 mL. Reimmunization consisting of a single dose for US travelers every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time. (14)
The syringe is intended for single use only, must not be reused, and must be disposed of properly and promptly following its use.
The skin at the site of injection first should be cleansed and disinfected. Tear off upper seal of vial cap. Cleanse top of rubber stopper of the vial with a suitable antiseptic and wipe away all excess antiseptic before withdrawing vaccine.
HOW SUPPLIED
Syringe, without needle, 0.5 mL, NDC 49281-790-88. Packaged as NDC 49281-790-51.
Vial, 20 Dose, NDC 49281-790-38. Packaged as NDC 49281-790-20.
STORAGE
Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE.
REFERENCES
- Levine MM, et al. New knowledge on pathogenesis of bacterial enteric infections as applied to vaccine development. Microbiol. Rev. 47: 510-550, 1983
- Levine MM. Typhoid Fever Vaccines. p 333-361. In Vaccines, Plotkin SA, Mortimer EA, eds. W.B. Saunders, 1988
- Levine MM, et al. Typhoid Fever Chapter 5, In: Vaccines and Immunotherapy. Stanley J. Cryz, Jr., Editor. pp 59-72, 1991
- CDC. Summary of Notifiable Diseases, United States 1992. MMWR 41: No. 55, 1993
- Ryan CA, et al. Typhivax infections in the United States, 1975-1984: Increasing Role of Foreign Travel. Rev Infect Dis 11:1-8, 1989
- Woodruff BA, et al. A new look at typhoid vaccination. Information for the practicing physician. JAMA 265: 756-759, 1991
- Ames WR, et al. Age and sex as factors in the development of the typhoid carrier state, and a method for estimating carrier prevalence. Am J Public Health 33: 221-230, 1943
- CDC. Typhoid fever - Skagit County, Washington. MMWR 39: 749-751, 1990
- Acharya IL, et al. Prevention of typhoid fever in Nepal with the Vi capsular polysaccharide of Typhivax. N Engl J Med 317: 1101-1104, 1987
- Unpublished data available from Sanofi Pasteur Inc., compiled 1991
- Unpublished data available from Sanofi Pasteur SA
- Klugman KP, et al. Protective activity of Vi capsular polysaccharide vaccine against typhoid fever. The Lancet, 1165-1169, 1987
- Keitel WA, et al. Clinical and serological responses following primary and booster immunization with Typhivax Vi capsular polysaccharide vaccines. Vaccines 12: 195-199, 1994
- Recommendations of the Immunization Practices Advisory Committee (ACIP). Typhoid Immunization. MMWR 43: No. RR-14, 1994
- CDC. Health Information for International Travel 2001-2002. Atlanta: US Department of Health and Human Services, Public Health Service, 2001
- ACIP: Use of vaccines and immune globulins in persons with altered immunocompetence. MMWR 42: No. RR-4, 1993
- CDC. Vaccine Adverse Event Reporting System - United States. MMWR 39: 730-733, 1990
- ACIP: Update on Adult Immunization. MMWR 40: No. RR-12, 1991
Product Information as of March 2014.
Manufactured by:
Sanofi Pasteur SA
Lyon, France
US Govt License #1724
Distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
1-800-VACCINE (1-800-822-2463)
968190-942501
NDC 49281-790-88
Typh
0.5 mL
Typhoid Vi
Polysaccharide
Vaccine
Typhivax®
IM only
Rx only
Sanofi Pasteur
Typhivax pharmaceutical active ingredients containing related brand and generic drugs:
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Frequently asked Questions
Can i drive or operate heavy machine after consuming Typhivax?Depending on the reaction of the Typhivax after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Typhivax not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Typhivax addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Review
sdrugs.com conducted a study on Typhivax, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Typhivax consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.Visitor reports
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The information was verified by Dr. Rachana Salvi, MD Pharmacology