Adult Dosing

Crohn Disease, Ulcerative Colitis

• Induction dose 300 mg IV at weeks 0, 2, and 6 and then every q8 weeks thereafter
• Discontinue therapy in patients who show no evidence of therapeutic benefit by Week 14

Note:

• Administer vedolizumab as an IV infusion over 30 minutes. Do not administer as an intravenous push or bolus
• Before initiating treatment with vedolizumab, all patients should be brought up to date with all immunizations according to current immunization guidelines
• Do not freeze. Discard any unused portion of the infusion solution
• Refer package insert for reconstitution and dilution instructions

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Moderate-to-severe ulcerative colitis in patients with inadequate response to 1 or more standard therapies such as corticosteroids, immunomodulators, or TNF blockers
• Moderate-to-severe Crohn disease in patients with inadequate response to 1 or more standard therapies such as corticosteroids, immunomodulators, or TNF blockers

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Allergic reactions, including dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have been occurring with vedolizumab. If a hypersensitivity reaction occurs, discontinue administration and initiate appropriate therapy
• Increased risk for developing infections such as upper respiratory and nasal mucosa has been reported with vedolizumab. Serious infections such as anal abscess, sepsis, tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis and cytomegaloviral colitis has also been reported with vedolizumab
• Increases risk of progressive multifocal leukoencephalopathy (PML) which usually leads to death or severe disability. Cases of PML have been reported in patients who were treated with natalizumab alone as well as in patients who were recently or concomitantly treated with immunomodulators or immunosuppressants
• Therapy may increase the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability
• Elevations of transaminase and/or bilirubin in patients receiving vedolizumab have been reported. Consider discontinuation of the drug in patients with jaundice or other evidence of significant liver injury

Pregnancy Category:B

Breastfeeding: Safety unknown. Manufacturer advises caution

• CNS: Headache
• NEURO: Progressive multifocal leukoencephalopathy (PML)
• GI: Nausea
• HEPA: Liver injury
• DERM: rash, Pruritus
• EENT: Nasopharyngitis, sinusitis, oropharyngeal pain
• RESP: Upper respiratory tract infection, cough, bronchitis
• MUSC: Arthralgia, back pain
• MISC: Infections, pyrexia, fatigue, influenza, pain in extremities
• LOCAL: Infusion-related reactions

• Recombinant humanized monoclonal antibody that binds specifically to the alpha-4-subunit of alpha-4-beta-7 integrin; prevents leukocyte-endothelial adhesion and leukocyte extravasation in the gut-tropic T cells
• Metabolism: Unknown
• Excretion: Unknown
• Half-Life: 25 days

US Trade Name(s)

• Entyvio

US Availability

Entyvio

• INJ: 300 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Allergy & Immunology

Antibodies; Monoclonal (Immunosuppressive)

Gastrointestinal

Antibodies; Monoclonal (Immunosuppressive)