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Ixiaro

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Ixiaro

Ixiaro

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Preventing and Managing Allergic Vaccine Reactions

IXIARO (japanese encephalitis vaccine) contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals [See DESCRIPTION]. Appropriate medical care should be readily available in case of anaphylactic reaction.

Limitations of Vaccine Effectiveness

Vaccinees who receive only one dose of IXIARO (japanese encephalitis vaccine) may have a suboptimal response and may therefore incur higher risk if exposed to JEV compared to vaccinees who receive both doses. Vaccination with IXIARO (japanese encephalitis vaccine) may not result in protection in all cases. IXIARO (japanese encephalitis vaccine) will not protect against encephalitis caused by viruses/pathogens other than JEV.

The full duration of protection following immunization is not known [See Clinical Studies]. There are no data regarding timing or efficacy of booster immunization.

Altered Immunocompetence

There are no safety or efficacy data regarding the use of IXIARO (japanese encephalitis vaccine) in immunocompromised individuals. Immunocompromised individuals may have a diminished immune response to IXIARO (japanese encephalitis vaccine) .

Patient Counseling Information

Counseling by the Health Care Provider

Question the vaccine recipient about reactions to previous vaccines, and inform the vaccine recipient of the benefits and risks of IXIARO (japanese encephalitis vaccine) .

Current U.S. and international advisories should be consulted regarding prevalence of Japanese encephalitis in specific locations. Counsel persons traveling to epidemic and endemic areas that IXIARO (japanese encephalitis vaccine) may not fully protect everyone who gets the vaccine and that personal precautions should be taken to reduce exposure to mosquito bites (adequate clothing, use of repellents, mosquito nets). When educating vaccine recipients regarding the potential side effects, explain that IXIARO (japanese encephalitis vaccine) contains formalin-inactivated JEV particles and is, therefore, non-infectious.

Give the required vaccination information to the vaccine recipient, and provide an opportunity to discuss any questions or concerns.

Instruct the vaccine recipient to report any adverse reactions to their health care provider.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

IXIARO (japanese encephalitis vaccine) has not been evaluated for carcinogenic or mutagenic potential. IXIARO (japanese encephalitis vaccine) was found to have no effect on fertility of female rats at intramuscular doses of up to 300-fold excess relative to the projected human dose (on a mg/kg basis) administered prior to and after mating [See Use in Specific Populations]. The effect of IXIARO (japanese encephalitis vaccine) on male fertility has not been evaluated.

Use In Specific Populations

Pregnancy

Pregnancy category B. Reproduction studies have been performed in female rats at doses approximately 300-fold excess relative to the projected human dose (on a mg/kg basis) and have revealed no evidence of impaired fertility or harm to the fetus due to IXIARO (japanese encephalitis vaccine) . There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, IXIARO (japanese encephalitis vaccine) should be used during pregnancy only if clearly needed.

The effect of IXIARO (japanese encephalitis vaccine) vaccine on embryo-fetal and pre-weaning development was evaluated in a developmental toxicity study using pregnant rats. One group of rats was administered IXIARO (japanese encephalitis vaccine) twice prior to gestation and once during the period of organogenesis (gestation Day 6). A second group of pregnant rats was administered IXIARO (japanese encephalitis vaccine) once prior to gestation and once during the period of organogenesis (gestation Day 6). IXIARO (japanese encephalitis vaccine) was administered at 0.5 mL/rat/occasion (approximately 300-fold excess relative to the projected human dose on a mg/kg basis), by intramuscular injection. No adverse effects on mating, fertility, pregnancy, parturition, lactation, embryo-fetal or pre-weaning development were observed. There was a statistically significant finding of incomplete ossification in a few fetuses derived from the second group of pregnant rats. However, there are no data to suggest that this finding is vaccine related. There were no vaccine-related fetal malformations or other evidence of teratogenesis noted in this study.

Nursing Mothers

It is not known whether this vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if IXIARO (japanese encephalitis vaccine) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of IXIARO (japanese encephalitis vaccine) in a pediatric population ( < 17 years of age) has not been established.

Geriatric Use

Clinical studies of IXIARO (japanese encephalitis vaccine) did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. The limited dataset from the pivotal efficacy study2 is as follows: in subjects ≥ 65 years of age who received IXIARO (japanese encephalitis vaccine) per protocol (N=24), seroconversion rate was 95.8% and geometric mean titer was 255.2.

In subjects ≥ 65 years of age who had been vaccinated in any of five trials1, 2, 3, 4, 5 included in a pooled dataset (N=161), adverse events were reported in 61.9 % (73/118) of subjects in the IXIARO (japanese encephalitis vaccine) group, 57.7% (15/26) in the JE-VAX group, and 70.6% (12/17) in the control [PBS + Al(OH)3] group. Five serious adverse events (SAE) were reported. Four subjects (3.4%) who received IXIARO (japanese encephalitis vaccine) , no subjects who received JE-VAX, and one subject (5.9%) who received the control [PBS + Al(OH)3] experienced a SAE. The serious adverse events occurring in the IXIARO (japanese encephalitis vaccine) group were as follows: one case each of rectal hemorrhage, pancreatic adenocarcinoma, breast cancer, and one death in a subject with metastatic lung adenocarcinoma, which occurred four months after the subject completed the two-dose regimen.

REFERENCES

1. Clinical study referred to as NCT00605085 in the National Library of Medicine clinical trial database, also referred to as study IC51-302 in the Biologics License Application.

2. Clinical study referred to as NCT00604708 in the National Library of Medicine clinical trial database, also referred to as study IC51-301 in the Biologics License Application.

3. Clinical study referred to as NCT00596271 in the National Library of Medicine clinical trial database, also referred to as study IC51-308 in the Biologics License Application.

4. Clinical study referred to as NCT00595790 in the National Library of Medicine clinical trial database, also referred to as study IC51-304 in the Biologics License Application.

5. Clinical study referred to as NCT00594958 in the National Library of Medicine clinical trial database, also referred to as study IC51-309 in the Biologics License Application.

Last reviewed on RxList: 3/11/2010
This monograph has been modified to include the generic and brand name in many instances.

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