Common Side Effects of Entyvio
Entyvio (vedolizumab), used for ulcerative colitis and Crohn's disease, most often causes upper respiratory tract infections (13% of patients), nasopharyngitis (13%), and headache (12%). Other frequent effects include nausea (11%), pyrexia (10%), upper abdominal pain (7%), fatigue (6%), and cough (6%). These typically occur during induction and maintenance phases.[1][2]
Serious Side Effects and Warnings
Rare but serious risks include progressive multifocal leukoencephalopathy (PML), a brain infection from JC virus (cases reported post-approval), and infusion-related reactions like bronchospasm or anaphylaxis. It carries a boxed warning for PML. Liver injury, severe infections (e.g., tuberculosis), and increased malignancy risk are also possible. Monitor for hypersensitivity and vaccinate against infections before starting.[1][2][3]
Side Effects During Pregnancy and Breastfeeding
No adequate data on use in pregnancy; animal studies show no direct harm, but risks to the fetus from maternal IBD are possible. It passes into breast milk in low amounts; weigh benefits against risks, as effects on infants are unknown.[1][3]
How Long Do Side Effects Last?
Most common effects like infections or headache resolve within days to weeks. Infusion reactions happen during or soon after administration and may need slowing or stopping the infusion. PML symptoms can persist or worsen if untreated.[2][3]
Differences in Side Effects for Ulcerative Colitis vs. Crohn's
Profiles are similar overall, but Crohn's patients report slightly higher rates of fatigue (8% vs. 3%) and influenza (5% vs. 3%). No major differences in serious risks like PML.[2]
Managing Side Effects
Report infections or neurological symptoms immediately. Premedicate with antihistamines or steroids for reactions. Regular liver tests and TB screening are standard. Discontinue if PML is suspected.[1][3]
[1]: Entyvio Prescribing Information (FDA)
[2]: Clinical Studies Data (GEMINI Trials)
[3]: Drugs.com - Entyvio Side Effects