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Vedolizumab

Published
Topics: Allergy and immunologyCCG commissioned new medicinesGastrointestinal disorders · New MedicinesPatent expiriesStability outside the fridgeVedolizumab ·
Contents
  1. dm+d
  2. Refrigerated Storage
    1. Entyvio · Takeda
    2. Entyvio · Takeda
  3. Lactation Safety Information

dm+d

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Refrigerated Storage

EntyvioTakeda

Takeda
Entyvio
300mg powder for concentrate for solution for infusion

Contact Takeda in all cases where a deviation from the recommended storage conditions has occurred. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details and product literature.

17 October 2022
London MI Service

EntyvioTakeda

Takeda
Entyvio
108mg solution for injection in pre-filled pen/syringe

In the event of an inadvertent temperature excursion the following data may be used:
The pre-filled pen/syringe can be left out of the refrigerator in its original carton at room temperature (up to 25 °C) for up to 7 days. Do not use the pre-filled pen/syringe if left out of the refrigerator for more than 7 days.
Contact Takeda in cases where additional stability data is required. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details and product literature.

See above
17 October 2022
London MI Service

Lactation Safety Information

Caution
See summary
Limited published evidence of safety indicates small amounts in breast milk which are likely to be degraded in the infant’s GI tract
Very long half-life increases risk of accumulation in breastfed infants
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
Safety in lactation: Drugs for chronic bowel disorders
15 September 2019
Bibliography