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Articles

Safety in lactation: Drugs for chronic bowel disorders

21 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Aminosalicylates for chronic bowel disorders Mesalazine…
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Refrigerated Storage

EntyvioTakeda

Takeda
Entyvio
300 mg 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 current BNF for company contact details.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

30 September 2020
London Medicines Information

EntyvioTakeda

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

Contact Takeda in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

30 September 2020
London Medicines Information

Lactation Safety Information

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
15 September 2019

New Medicines

EntyvioActive pouchitis in adults who have had an inadequate response with, lost response to, or were intolerant to antibiotic therapy

Information

Entyvio
Licence extension / variation
Takeda
Takeda

Development and Regulatory status

Launched
Launched
Phase IV Clinical Trials
March 2022
Mar 22License extension approved in the UK for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy [6].
Jan 22Approved in the EU [5].
Dec 21Recommended for EU approval by CHMP – the extension to the existing indication is “treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy” [4].
Jul 21Has been filed in the EU for antibiotic-refractory pouchitis [3].

Category

A humanised monoclonal antibody that specifically targets α4β7 integrin and inhibits its adhesion to mucosal addressin cell adhesion molecule 1 (MAdCAM-1), thereby demonstrating gut-selective immunomodulatory activity.
Up to 45% of patients who undergo ileal pouch surgery for ulcerative colitis have pouchitis. Metronidazole or ciprofloxacin for two weeks is the first-line therapy. Mesalazine or corticosteroids may be used in acute pouchitis if antibiotics are ineffective. Long-term, low-dose metronidazole or ciprofloxacin are potentially effective for chronic pouchitis [1].
Active pouchitis in adults who have had an inadequate response with, lost response to, or were intolerant to antibiotic therapy
Intravenous infusion

Further information

Yes

Trial or other data

Feb 21Phase IV EARNEST study completes [2].
Oct 16Phase IV EARNEST study to compare the efficacy of vedolizumab intravenous (IV) and placebo in terms of the percentage of participants with chronic or recurrent pouchitis achieving clinically relevant remission starts (NCT02790138). The study will enrol 110 patients. Participants will be randomly assigned to one of the two treatment groups - Vedolizumab 300 mg IV or placebo IV. All participants will receive an intravenous infusion at Day 1, Weeks 2, 6, 14, 22, and 30 along with concomitant antibiotic treatment with ciprofloxacin 500 mg twice daily through Week 4. This multicentre trial will be conducted in North America and Europe, including UK. The overall time to participate in treatment and efficacy assessment of this study is 34 weeks. Participants will make multiple visits to the clinic, plus a final visit 18 weeks after the last dose of study drug for a safety follow-up assessment (up to Week 48). Participants will also participate in a long-term follow-up, by phone after the last dose of study drug up to Week 56. Collection of primary outcome data is due to complete Jun 20 [2].

Evidence based evaluations

EntyvioAcute intestinal graft versus host disease (GvHD) - prevention in patients aged 12 years and older undergoing allogenic haematopoietic stem cell (allo-HSCT) transplantation as treatment for a haematologic malignancy or myeloproliferative disorder

Information

Entyvio
Licence extension / variation
Takeda
Takeda

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

A humanised monoclonal antibody that specifically targets α4β7 integrin and inhibits its adhesion to mucosal addressin cell adhesion molecule 1 (MAdCAM-1), thereby demonstrating gut-selective immunomodulatory activity.
About 35%-50% of hematopoietic stem cell transplant (HSCT) recipients will develop acute Graft versus host disease (GVHD). Given the number of transplants performed, it is estimated that about 5500 patients/year will develop acute GVHD [1].
Acute intestinal graft versus host disease (GvHD) - prevention in patients aged 12 years and older undergoing allogenic haematopoietic stem cell (allo-HSCT) transplantation as treatment for a haematologic malignancy or myeloproliferative disorder
Intravenous infusion