Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark, medinfoEMEA@takeda.com
Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.
Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.
Treatment should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of ulcerative colitis or Crohn’s disease (see section 4.4). Patients should be given the package leaflet.
The recommended dose regimen of subcutaneous vedolizumab as a maintenance treatment, following at least 2 intravenous infusions, is 108 mg administered by subcutaneous injection once every 2 weeks. The first subcutaneous dose should be administered in place of the next scheduled intravenous dose and every 2 weeks thereafter.
For the intravenous dose regimen, see section 4.2 of the Entyvio 300 mg powder for concentrate for solution for infusion SmPC.
Insufficient data are available to determine if patients who experience a decrease in response on maintenance treatment with subcutaneous vedolizumab would benefit from an increase in dosing frequency.
There are no data on transition of patients from subcutaneous vedolizumab to intravenous vedolizumab during maintenance treatment.
In patients who have responded to treatment with vedolizumab, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
If treatment with subcutaneous vedolizumab is interrupted or if a patient misses a scheduled dose(s) of subcutaneous vedolizumab, patient should be advised to inject the next subcutaneous dose as soon as possible and then every 2 weeks thereafter. The treatment interruption period in clinical trials extended up to 46 weeks with no evident increase in adverse reactions or injection site reactions during re-initiation of treatment with subcutaneous vedolizumab (see section 4.8).
No dose adjustment is required in elderly patients. Population pharmacokinetic analyses showed no effect of age (see section 5.2).
Vedolizumab has not been studied in these patient populations. No dose recommendations can be made.
The safety and efficacy of vedolizumab in children aged 0 to 17 years old have not been established.
No data are available.
Entyvio solution for injection (in a pre-filled syringe or a pre-filled pen) is for subcutaneous injection only.
After proper training on correct subcutaneous injection technique, a patient or caregiver may inject with subcutaneous vedolizumab if their physician determines it is appropriate. Comprehensive instructions for administration using the pre-filled syringe or the pre-filled pen are given in the respective package leaflet.
For further instructions on preparation and special precautions for handling, see section 6.6.
Doses up to 10 mg/kg (approximately 2.5 times the recommended dose) have been administered intravenously in clinical trials. No dose-limiting toxicity was seen in clinical trials.
24 months.
Store in a refrigerator (2°C-8°C). Keep the pre-filled syringes or pre-filled pens in the outer carton in order to protect from light.
Do not freeze.
If needed, a single pre-filled syringe or pre-filled pen can be left out of the refrigerator protected from light at room temperature (up to 25°C) for up to 7 days. Do not use the pre-filled syringe or pre-filled pen if left out of the refrigerator for more than 7 days.
Entyvio 108 mg solution for injection in pre-filled syringe:
Solution for injection in a Type I glass 1 mL syringe with a fixed 27 gauge thin wall, 1.27 cm needle.
The syringe has a rubber needle cover encased in a plastic shell and rubber stopper.
The subcutaneous vedolizumab pre-filled syringe is a single dose, disposable drug delivery system with manual injection operation. Each pre-filled syringe is equipped with a safety device that activates to extend and lock a guard over the needle once the injection is completed.
Packs of 1 or 2 pre-filled syringes, and multipacks of 6 (6 packs of 1) pre-filled syringes.
Entyvio 108 mg solution for injection in pre-filled pen:
Solution for injection in a pre-filled pen in a Type I glass 1 mL syringe and a fixed 27 gauge thin wall, 1.27 cm needle. The syringe has a rubber needle cover encased in a plastic shell and rubber stopper.
The subcutaneous vedolizumab pre-filled pen is a single dose, disposable drug delivery system with mechanical injection operation. Each pre-filled pen is equipped with an automated needle shield to extend and lock over the needle once the device is removed from the injection site.
Packs of 1 or 2 pre-filled pens, and multipacks of 6 (6 packs of 1) pre-filled pens.
Not all pack sizes may be marketed.
Instructions for administration:
After removing the pre-filled syringe or pre-filled pen from the refrigerator, wait 30 minutes before injecting to allow the solution to reach room temperature.
Do not leave the pre-filled syringe or pre-filled pen in direct sunlight.
Do not freeze. Do not use if it has been frozen.
Inspect the solution visually for particulate matter and discoloration prior to administration. The solution should be colourless to yellow. Do not use pre-filled syringe or pre-filled pen with visible particulate matter or discoloration.
Each pre-filled syringe or pre-filled pen is for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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