ENTYVIO PEN (vedolizumab)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Progressive multifocal leukoencephalopathy

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Infection

There are 0 moderate contraindications.

There are 18 severe adverse reactions.

More Frequent	Less Frequent
Influenza	Increased alanine transaminase Increased aspartate transaminase

Rare/Very Rare
Active tuberculosis Acute pancreatitis Anaphylaxis Bacterial sepsis Bronchospastic pulmonary disease Cytomegalovirus disease Hepatitis Hyperbilirubinemia Hypersensitivity drug reaction Hypertension Interstitial lung disease Interstitial pneumonitis Listeriosis Malignancy Progressive multifocal leukoencephalopathy

There are 21 less severe adverse reactions.

More Frequent	Less Frequent
Arthralgia Back pain Bronchitis Cough Fatigue Fever Headache disorder Nausea Pain in extremities Pain in oropharynx Pharyngitis Pruritus of skin Sinusitis Sore throat Upper respiratory infection Urinary tract infection	None.

Rare/Very Rare
Dyspnea Flushing Skin rash Tachycardia Urticaria

Available pharmacovigilance data, pregnancy registry data, and published literature in pregnant women have not reliably identified a vedolizumab-associated risk of major birth defects, spontaneous abortion, or adverse maternal or fetal outcomes. Increased disease activity in women with inflammatory bowel disease may increase the risk of adverse pregnancy outcomes, including preterm delivery, low birth weight, and small size for gestational age at birth. No fetal harm was observed in reproduction studies in rabbits and monkeys at vedolizumab doses of approximately 20 times the recommended human dosage.

Observational data from the Organization of Teratology Information Specialists (OTIC)/MotherToBaby Entyvio(R) Pregnancy Registry, collected between 2015 to 2022, compared pregnant patients with ulcerative colitis or Crohn disease exposed to vedolizumab (n=99) with pregnant patients with these disease states treated with other biologicals (n=76). The percentage of major birth defects among live-born infants in patients treated with vedolizumab was 7.4% compared to 5.6%

in patients treated with other biologicals. No evidence of an increased risk for major structural birth defects was observed. Use of vedolizumab during pregnancy could affect immune responses in neonates and infants exposed to the drug in utero.

The clinical importance of low concentrations of vedolizumab in infants who were exposed to the drug in utero is unknown. The safety of administering live vaccines to infants who were exposed to the drug in utero also is unknown.

Available data suggest that vedolizumab is distributed into human milk in low concentrations. Systemic exposure is expected to be low because of degradation of monoclonal antibodies in the GI tract. The effects on a breast-fed infant are unknown; effects of the drug on milk production also are unknown. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for vedolizumab and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

Clinical studies of vedolizumab did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger adults. However, no overall differences in efficacy or safety were observed between geriatric and younger patients, and other clinical experience revealed no evidence of age-related differences.