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Vedolizumab

Also known as: Entyvio, Entyvio Pen, Entyvio

Integrin Receptor AntagonistIntegrin Receptor Antagonists

Route: Subcutaneous, Intravenous

2 interactions on record

Vedolizumab has 2 known drug interactions based on U.S. FDA drug labeling data. 2 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Etanercept, Natalizumab. Patients taking Vedolizumab should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 2
Major: 2

Major (2)

Vedolizumab + Etanercept— Concomitant use increases risk of infections. Avoid concurrent use.
Vedolizumab + Natalizumab— 7 DRUG INTERACTIONS 7.1 Natalizumab Products Because of the potential for increased risk of PML and other infections, av…

Vedolizumab + Etanercept⚠️Major

Concomitant use increases risk of infections. Avoid concurrent use.

Vedolizumab + Natalizumab⚠️Major

7 DRUG INTERACTIONS 7.1 Natalizumab Products Because of the potential for increased risk of PML and other infections, avoid the concomitant use of ENTYVIO with natalizumab products.

Contraindications

4 CONTRAINDICATIONS ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients (such as dyspnea, bronchospasm, urticaria, flushing, rash and increased heart rate) [see Warnings and Precautions (5.1) ] . Patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby ENTYVIO Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not reliably identified an ENTYVIO-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data ) . There are risks to the mother and the fetus associated with inflammatory bowel disease in pregnancy (see Clinical Considerations ) . No fetal harm was observed in animal reproduction studies with intravenous administration of vedolizumab to rabbits and monkeys at dose levels 20 times the recommended human dosage (see Data ) . The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and miscarriage is 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and Embryo/Fetal Risk Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (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. Fetal/Neonatal Adverse Reactions 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 unknown. Data Human Data The vedolizumab pregnancy exposure registry conducted by OTIS/MotherToBaby study in the United States and Canada collected prospective observational data between 2015 and 2022 to assess th

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.