June 28, 2016
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Ixiaro

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Ixiaro




Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypersensitivity Reactions

IXIARO 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

Vaccination with IXIARO may not protect all individuals.

Altered Immunocompetence

Immunocompromised individuals may have a diminished immune response to IXIARO.

Patient Counseling Information

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

Consult current U.S. and international advisories regarding prevalence of Japanese encephalitis in specific locations. Advise the parent, guardian, or recipient that IXIARO 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).

Give the parent, guardian, or recipient the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization, and inquire about previous reactions to vaccines.

Inform the parent, guardian, or recipient of the importance of completing the immunization series.

Instruct the parent, guardian, or recipient to immediately report any signs and/or symptoms of a severe adverse reaction, including anaphylaxis (difficulty breathing, wheezing, weakness or fast heart beat, hives).

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

IXIARO has not been evaluated for carcinogenic or mutagenic potential. IXIARO 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 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. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, IXIARO should be used during pregnancy only if clearly needed.

The effect of IXIARO 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 twice prior to gestation and once during the period of organogenesis (gestation Day 6). A second group of pregnant rats was administered IXIARO once prior to gestation and once during the period of organogenesis (gestation Day 6). IXIARO 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.

Healthcare practitioners are encouraged to report inadvertent use in pregnant women to the distributor, Intercell USA Inc. at 844-349-4276 (8443-IXIARO)

Nursing Mothers

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

Pediatric Use

Safety and effectiveness of IXIARO have not been established in infants younger than 2 months of age [See ADVERSE REACTIONS and Clinical Studies].

Geriatric Use

Clinical studies of IXIARO did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. In a study that included 24 subjects ≥ 65 years of age who received IXIARO per protocol (Study 5)5, the proportion of these subjects achieving a JEV neutralizing antibody titer ≥ 1:10 at 28 days after the second dose of IXIARO was 95.8% (geometric mean titer: 255.2).

In subjects 65 years of age and older who had been vaccinated in any of five trials4 ,5 ,6 ,7 ,8 included in a pooled dataset (N=161), adverse events were reported in 61.9% (73/118) of subjects in the IXIARO group, 57.7% (15/26) in the JE-VAX group, and 70.6% (12/17) in the control [PBS + Al(OH)3] group. Serious adverse events (SAE) were experienced by four subjects (3.4%) who received IXIARO, no subjects who received JE-VAX, and one subject (5.9%) who received the control [PBS + Al(OH)3]. The SAEs occurring in the IXIARO 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.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/6/2016

Warnings
Precautions

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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