Fluquadri Use In Pregnancy & Lactation

Pregnancy: According to WHO, vaccination is especially important for populations who are at a higher risk of serious influenza complications. Therefore, WHO recommends annual vaccination for pregnant women at any stage of pregnancy.
A developmental and reproductive toxicity study has been performed in female rabbits at a dose approximately 20 times the human dose (on a mg/kg basis) and has revealed no evidence of impaired female fertility or harm to the fetus due to FluQuadri. There are, however, no adequate and wellcontrolled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, FluQuadri should be given to a pregnant woman only if clearly needed.
In the developmental and reproductive toxicity study, female rabbits were administered FluQuadri or control saline (each 0.5 mL/dose) by intramuscular injection 24 and 10 days before insemination, and on Days 6, 12, and 27 of gestation. The administration of FluQuadri did not result in systemic maternal toxicity (no adverse clinical signs and no change in body weight or food consumption). In addition, no adverse effects on pregnancy, parturition, lactation, or embryo-fetal or pre-weaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis noted in this study.
Sanofi Pasteur Inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes and newborn health status following vaccination with FluQuadri during pregnancy. Healthcare providers are encouraged to enroll women who receive FluQuadri during pregnancy in Sanofi Pasteur Inc.'s vaccination pregnancy registry.
Nursing Mothers: It is not known whether FluQuadri is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FluQuadri is administered to a nursing woman.