DENGVAXIA(Dengue Tetravalent Vaccine, Live)Suspension for Subcutaneous Injection(七)
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Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxicdrugs and corticosteroids (used in greater than physiologic doses), may reduce the immuneresponse to DENGVAXIA.
7.3 Drug/Laboratory Test Interactions
DENGVAXIA may cause temporary depression of tuberculin purified protein derivative (PPD)test sensitivity, leading to false negative results. Tuberculin testing should be performed beforeDENGVAXIA is administered or at least 1 month following vaccination with DENGVAXIA.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed toDENGVAXIA during pregnancy. Women who receive DENGVAXIA during pregnancy are
encouraged to contact directly, or have their healthcare professional contact, Sanofi Pasteur Inc.
at 1-800-822-2463 (1-800-VACCINE) to enroll in or obtain information about the registry.
Risk Summary
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US generalpopulation, the estimated background risk of major birth defects and miscarriage in clinicallyrecognized pregnancies is 2% to 4% and 15% to 20%, respectively.
No specific studies of DENGVAXIA have been performed among pregnant women. A limitednumber of cases of inadvertent exposure during pregnancy were reported during clinical studies.
Isolated adverse pregnancy outcomes (e.g., stillbirth, intrauterine death, spontaneous abortion,blighted ovum) have been observed for these exposed pregnancies, with similar frequency andnature in the vaccinated individuals compared to the control group, and with risk factorsidentified for all cases. Available data in pregnant women are not sufficient to determine theeffects of DENGVAXIA on pregnancy, embryo-fetal development, parturition and post-nataldevelopment.
In two developmental toxicity studies, the effect of DENGVAXIA on embryo-fetal and postnataldevelopment was eva luated in pregnant rabbits and mice. A developmental toxicity studywas performed in female rabbits given a 5 log10 50% cell culture infectious dose (CCID50) ofDENGVAXIA (full human dose ranging from 4.5 log10 to 6.0 log10 CCID50) by intravenousinjection prior to mating and during gestation. The study revealed no evidence of harm to thefetus due to DENGVAXIA. In another study, female mice were administered a single dose of 5log10 CCID50, 6.5 log10 CCID50 (about 3 times the highest human dose) or 8 log10 CCID50 (about100 times the highest human dose) of DENGVAXIA by intravenous injection during gestation.
Fetal toxicities were observed at maternally toxic doses. [See Animal Data (8.1).]
Clinical Considerations
Disease-associated maternal and/or embryo/fetal riskPregnant women are at increased risk of complications associated with dengue infectioncompared to non-pregnant women.
Pregnant women with dengue may be at increased risk foradverse pregnancy outcomes, including preterm labor and delivery. Vertical transmission ofdengue virus from mothers with viremia at delivery to their infants has been reported.
Fetal/neonatal adverse reactions
Vaccine viremia can occur 7 to 14 days after vaccination with a duration of <7 days [SeePharmacokinetics (12.3).]. The potential for transmission of the vaccine virus from mother to
infant is unknown.
Animal Data
In two developmental toxicity studies, the effect |
