About

This information supports the use of the Entyvio (vedolizumab) Dosing Calculator. The tool is designed for healthcare professionals to visualize the standard dosing schedules for adult patients with Ulcerative Colitis or Crohn's Disease, covering both intravenous (IV) induction/maintenance and subcutaneous (SC) maintenance therapy. It serves as an educational resource and does not replace clinical judgment or the official prescribing information.

Outputs

Upon calculation, the tool generates a detailed dosing schedule table with the following columns:

• Dose #: The sequential number of each administration.
• Phase: Indicates whether the dose is part of the 'Induction' or 'Maintenance' phase.
• Week: The treatment week corresponding to each dose (e.g., Week 0, Week 2).
• Calculated Date: The projected calendar date for the administration. Dates for subsequent doses can be adjusted, and the schedule will update accordingly.
• Dose/Route: The specific dose and route of administration (e.g., 300 mg IV, 108 mg SC).

How to Use

To generate a dosing schedule, follow these steps:

1. Select Patient Condition: Choose either Ulcerative Colitis or Crohn's Disease.
2. Select Formulation: Choose between Intravenous (IV) or Subcutaneous (SC) administration. The start date label will update based on this selection.
3. Enter Start Date:
   • For IV therapy, this is the date of the first 300 mg IV induction dose.
   • For SC therapy, this is the date of the first 108 mg SC injection, which typically occurs at Week 6 after initiating treatment with IV induction.
4. Calculate: Click the "Calculate Schedule" button to view the results. You can add more maintenance doses to the schedule as needed.

Dosing Overview

The calculator follows the standard dosing regimens for adults:

• Intravenous (IV) Administration: The recommended dosage is 300 mg administered by intravenous infusion at Week 0, Week 2, and Week 6, followed by a maintenance dose of 300 mg IV every 8 weeks thereafter.
• Subcutaneous (SC) Administration: For maintenance therapy, after completing at least two IV induction infusions, the recommended dosage is 108 mg administered by subcutaneous injection every 2 weeks. The first SC dose is typically administered at the time of the next scheduled IV infusion (Week 6).

Switching

Patients on Entyvio IV maintenance therapy may be switched to Entyvio SC maintenance therapy. The switch occurs by administering the first subcutaneous dose at the time of the next scheduled intravenous infusion and continuing with a 108 mg SC injection every 2 weeks thereafter. This tool models the SC schedule starting from the first injection date.

Missed Dose

If a maintenance dose is missed, instruct the patient to take their dose as soon as possible and then resume dosing at the recommended interval. For IV infusions, the schedule should be adjusted accordingly. For SC injections, the patient should resume the every-2-week schedule from the date of the most recent injection. Always consult the full prescribing information for specific guidance.

Safety Alerts

Vedolizumab is associated with important safety considerations. These include an increased risk of infections, infusion-related reactions, hypersensitivity reactions, and liver injury. Progressive Multifocal Leukoencephalopathy (PML) has been reported in patients treated with other integrin receptor antagonists. A causal relationship between vedolizumab and PML has not been established. This tool is not a substitute for a thorough review of the product's full prescribing information and safety data.

FAQ

References

• ENTYVIO® (vedolizumab) Prescribing Information. Takeda Pharmaceuticals America, Inc. FDA.gov.
• ENTYVIO® (vedolizumab) for injection, for intravenous use & for subcutaneous use - Official HCP Site. EntyvioHCP.com.
• Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369(8):699-710. DOI: 10.1056/NEJMoa1215734.
• Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013;369(8):711-721. DOI: 10.1056/NEJMoa1215739.