Entyvio
(vedolizumab)Entyvio 300 MG Injection
NO BLACK BOX WARNING
Dosage & administration
drug label
Entyvio prescribing information
financial assistance
Entyvio financial assistance options
Co-pay savings program
commercial only
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Bridge program
commercial only
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Foundation programs
under insured
no insurance
goverment insurance
65+
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patient education
Entyvio patient education
Getting started on Entyvio
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Patient toolkit
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Other resources
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people also ask
Entyvio FAQs
Is there a pregnancy exposure registry for ENTYVIO?Yes, there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ENTYVIO during pregnancy. For more information, you can call 1-877-TAKEDA-7 (1-877-825-3327).
What is the risk of using ENTYVIO during pregnancy?Available pharmacovigilance data, data from the ongoing pregnancy registry, and data from published case reports and cohort studies in pregnant women have not identified an ENTYVIO associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. However, there are risks to the mother and the fetus associated with inflammatory bowel disease in pregnancy. It is important to consider these risks in addition to the benefits of using ENTYVIO.
What are the risks associated with inflammatory bowel disease (IBD) in pregnancy?Published data suggest that the risk of adverse pregnancy outcomes in women with IBD is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth.
Can ENTYVIO affect immune responses in newborns and infants?ENTYVIO administered during pregnancy could affect immune responses in the in utero-exposed newborn and infant. The clinical significance of low levels of ENTYVIO in utero-exposed infants is unknown. The safety of administering live or live-attenuated vaccines in exposed infants is also unknown.
Is it safe to use ENTYVIO while breastfeeding?Data from a clinical lactation study show the presence of vedolizumab (the active ingredient in ENTYVIO) in human milk. Systemic exposure in a breastfed infant is expected to be low because monoclonal antibodies are largely degraded in the gastrointestinal tract. There are no data on the effects of vedolizumab on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ENTYVIO and any potential adverse effects on the breastfed infant from ENTYVIO or from the underlying maternal condition.
Is ENTYVIO safe for use in pediatric patients?Safety and effectiveness of ENTYVIO in pediatric patients have not been established.
Is ENTYVIO safe for use in geriatric patients?Clinical trials of ENTYVIO did not include sufficient numbers of subjects aged 65 and over.
FAQ Data Source