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Entyvio is a brand name for Vedolizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ulcerative colitis 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. Crohn’s disease Entyvio is…
Verbatim from this product's EMA label. Tap a section to expand.
4). Patients should be given the package leaflet. 3 Posology Ulcerative colitis The recommended dose regimen of intravenous vedolizumab is 300 mg administered by intravenous infusion at 0, 2 and 6 weeks and then every 8 weeks thereafter.
1). Some patients who have experienced a decrease in their response may benefit from an increase in dosing frequency to intravenous vedolizumab 300 mg every 4 weeks. In patients who have responded to treatment with vedolizumab, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
1). The treatment interruption period in clinical trials extended up to 1 year. 8). Crohn’s disease The recommended dose regimen of intravenous vedolizumab is 300 mg administered by intravenous infusion at 0, 2 and 6 weeks and then every 8 weeks thereafter.
4). Therapy should be continued every 8 weeks from week 14 in responding patients. 1). Some patients who have experienced a decrease in their response may benefit from an increase in dosing frequency to intravenous vedolizumab 300 mg every 4 weeks.
In patients who have responded to treatment with vedolizumab, corticosteroids may be reduced and/or discontinued in accordance with standard of care. 1). The treatment interruption period in clinical trials extended up to 1 year. 8). Pouchitis The recommended dose regimen of intravenous vedolizumab is 300 mg administered by intravenous infusion at 0, 2 and 6 weeks and then every 8 weeks thereafter.
1). Discontinuation of treatment should be considered if no evidence of therapeutic benefit is observed by 14 weeks of treatment with vedolizumab. Retreatment There are no retreatment data available in patients with pouchitis. 4 Special populations Elderly patients No dose adjustment is required in elderly patients.
2). Patients with renal or hepatic impairment Vedolizumab has not been studied in these patient populations. No dose recommendations can be made. Paediatric population The safety and efficacy of vedolizumab in children aged 0 to 17 years old have not been established.
No data are available. Method of administration Entyvio 300 mg powder for concentrate for solution for infusion is for intravenous use only. It is to be reconstituted and further diluted prior to intravenous administration. Entyvio 300 mg powder for concentrate for solution for infusion is administered as an intravenous infusion over 30 minutes.
Summary of the safety profile The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection, bronchitis, influenza and sinusitis), headache, nausea, pyrexia, fatigue, cough, arthralgia.
Infusion related reactions (with symptoms such as dyspnoea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate) have also been reported in patients treated with vedolizumab. 8 Tabulated list of adverse reactions The following listing of adverse reactions is based on clinical trial and post marketing experience and is displayed by system organ class.
Within the system organ classes, adverse reactions are listed under headings of the following frequency categories: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), very rare (< 1/10 000) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1. 4). No individual Preferred Term reported as an IRR occurred at a rate above 1%. The majority of IRRs were mild or moderate in intensity and < 1% resulted in discontinuation of study treatment.
Observed IRRs generally resolved with no or minimal intervention following the infusion. Most infusion related reactions occurred within the first 2 hours. Of those patients who had infusion related reactions, those dosed with intravenous vedolizumab had more infusion related reactions with in the first 2 hours as compared to placebo patients with infusion related reactions.
Most infusion related reactions were not serious and occurred during the infusion or within the first hour after infusion is completed. One serious adverse reaction of IRR was reported in a Crohn’s disease patient during the second infusion (symptoms reported were dyspnoea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate) and was successfully managed with discontinuation of infusion and treatment with antihistamine and intravenous hydrocortisone.
Intravenous vedolizumab should be administered in a healthcare setting equipped to allow management of acute hypersensitivity reactions including anaphylaxis, if they occur. Appropriate monitoring and medical support measures should be available for immediate use when administering intravenous vedolizumab.
All patients should be observed continuously during each infusion. For the first 2 infusions, they should also be observed for approximately 2 hours following completion of the infusion for signs and symptoms of acute hypersensitivity reactions.
For all subsequent infusions, patients should be observed for approximately 1 hour following completion of the infusion. Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
8). Hypersensitivity reactions were also reported in patients switching from subcutaneous to intravenous formulation. 3). If a mild to moderate IRR occurs, the infusion rate can be slowed or interrupted and appropriate treatment initiated.
Once the mild or moderate IRR subsides, continue the infusion. 8). 1). 8). Vedolizumab treatment is not to be initiated in patients with active, severe infections until the infections are controlled, and physicians should consider withholding treatment in patients who develop a severe infection while on chronic treatment with vedolizumab.
Caution should be exercised when considering the use of vedolizumab in patients with a controlled chronic severe infection or a history of recurring severe infections. Patients should be monitored closely for infections before, during and after treatment.
3). Before starting treatment with vedolizumab, patients must be screened for tuberculosis according to the local practice. If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis treatment in accordance with local recommendations, before beginning vedolizumab.
1. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). 6.
In patients who received intravenous vedolizumab at weeks 0 and 2 followed by placebo, no increase in the rate of IRR was seen upon retreatment with intravenous vedolizumab after loss of response. 9%) in the placebo group. The individual Preferred Terms included mouth ulceration, swelling, oedema peripheral, chest discomfort, asthenia, acute kidney injury, obstructive airway disorder and flushing.
All events were reported as mild to moderate in intensity, none were considered serious and none resulted in study discontinuation. 70 per patient-year in the placebo-treated patients. The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, sinusitis, and urinary tract infections.
Most patients continued on vedolizumab after the infection resolved. 06 per patient year in placebo-treated patients. Over time, there was no significant increase in the rate of serious infections. 0%) in the vedolizumab group experienced a serious infection of gastroenteritis.
The subject was hospitalized for observation, recovered from the event and completed the study. In controlled and open-label studies (ulcerative colitis and Crohn’s disease) in adults with intravenous vedolizumab, serious infections have been reported, which include tuberculosis, sepsis (some fatal), salmonella sepsis, […]
In patients diagnosed with TB whilst receiving vedolizumab therapy, then vedolizumab therapy should be discontinued until the TB infection has been resolved. Some integrin antagonists and some systemic immunosuppressive agents have been associated with progressive multifocal leukoencephalopathy (PML), which is a rare and often fatal opportunistic infection caused by the John Cunningham (JC) virus.
By binding to the α4β7 integrin expressed on gut-homing lymphocytes, vedolizumab exerts an immunosuppressive effect specific to the gut. Although no systemic immunosuppressive effect was noted in healthy subjects the effects on systemic immune system function in patients with inflammatory bowel disease is not known.
Healthcare professionals should monitor patients on vedolizumab for any new onset or worsening of neurological signs and symptoms and consider neurological referral if they occur. If PML is suspected, treatment with vedolizumab must be withheld; if confirmed, treatment must be permanently discontinued.
Malignancies The risk of malignancy is increased in patients with ulcerative colitis and Crohn’s disease. Immunomodulatory medicinal products may increase the risk of malignancy. Prior and concurrent use of biological products No vedolizumab clinical trial data are available for patients previously treated with natalizumab or rituximab.
Caution should be exercised when considering the use of vedolizumab in these patients. Patients previously exposed to natalizumab should normally wait a minimum of 12 weeks prior to initiating therapy with vedolizumab, unless otherwise indicated by the patient’s clinical condition.
6 No clinical trial data for concomitant use of vedolizumab with biologic immunosuppressants are available. Therefore, the use of vedolizumab in such patients is not recommended. Live and oral vaccines In a placebo-controlled study of healthy volunteers, a single 750 mg dose of vedolizumab did not lower rates of protective immunity to hepatitis B virus in subjects who were vaccinated intramuscularly with 3 doses of recombinant hepatitis B surface antigen.
Vedolizumab-exposed subjects had lower seroconversion rates after receiving a killed, oral cholera vaccine. The impact on other oral and nasal vaccines is unknown. It is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating vedolizumab therapy.
Patients receiving vedolizumab treatment may continue to receive non-live vaccines. There are no data on the secondary transmission of infection by live vaccines in patients receiving vedolizumab. Administration of the influenza vaccine should be by injection in line with routine clinical practice.
Other live vaccines may be administered concurrently with vedolizumab only if the benefits clearly outweigh the risks. Induction of remission in Crohn’s disease […]