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  • Entyvio
    / Takeda


    Active Ingredient
    Vedolizumab 300 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 300 mg

    partial basket chart 66601 5585

    Related information


    Dosage

    Ulcerative colitis: The recommended dose regimen of vedolizumab 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.
    Therapy for patients with ulcerative colitis should be discontinued if no evidence of therapeutic benefit is observed by week 10. Some patients who have experienced a decrease in their response may benefit from an increase in dosing frequency to vedolizumab 300 mg every four weeks. In patients who have responded to treatment with vedolizumab 300 mg, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
    Retreatment: If therapy is interrupted and there is a need to restart treatment with vedolizumab 300 mg, dosing at every four weeks may be considered. The treatment interruption period in clinical trials extended up to one year. Efficacy was regained with no evident increase in adverse reactions or infusion-related reactions during retreatment with vedolizumab.
    Crohn’s disease: The recommended dose regimen of vedolizumab 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.
    Patients with Crohn’s disease, who have not shown a response may benefit from a dose of Entyvio at week 10. Therapy should be continued every eight weeks from week 14 in responding patients. Therapy for patients with Crohn’s disease should be discontinued if no evidence of therapeutic benefit is observed by week 14. Some patients who have experienced a decrease in their response may benefit from an increase in dosing frequency to vedolizumab 300 mg every four weeks. In patients who have responded to treatment with vedolizumab, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
    Retreatment: If therapy is interrupted and there is a need to restart treatment with vedolizumab 300 mg, dosing at every four weeks may be considered. The treatment interruption period in clinical trials extended up to one year. Efficacy was regained with no evident increase in adverse reactions or infusion-related reactions during retreatment with vedolizumab.
    Elderly patients: No dose adjustment is required in elderly patients. Population pharmacokinetic analyses showed no effect of age.
    Patients with renal or hepatic impairment: Vedolizumab 300  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: Vedolizumab 300 is for intravenous use only. It is to be reconstituted and further diluted prior to intravenous administration.
    Vedolizumab 300 is administered as an intravenous infusion over 30 minutes. Patients should be monitored during and after infusion.
    See prescribing information for full details.


    Indications

    Ulcerative colitis: This drug 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: 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.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.
    Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML).


    Special Precautions

    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 vedolizumab. All patients should be observed continuously during each infusion. For the first two 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.
    Infusion-related reactions: In clinical studies, infusion-related reactions (IRR) and hypersensitivity reactions have been reported, with the majority being mild to moderate in severity. If a severe IRR, anaphylactic reaction, or other severe reaction occurs, administration of vedolizumab must be discontinued immediately and appropriate treatment initiated (e.g., epinephrine and antihistamines).
    Infections: Vedolizumab is a gut-selective integrin antagonist with no identified systemic immunosuppressive activity.
    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.
    Induction of remission in Crohn’s disease: Induction of remission in Crohn’s disease may take up to 14 weeks in some patients. The reasons for this are not fully known and are possibly related to the mechanism of action.
    See prescribing information for full details.


    Side Effects

    Nasopharyngitis, bronchitis, gastroenteritis, upper respiratory tract infection, influenza, sinusitis, pharyngitis, headache, paraesthesia, hypertension, oropharyngeal pain, nasal congestion, cough, anal abscess, anal fissure, nausea, dyspepsia, constipation, abdominal distension, flatulence, haemorrhoids, rash, pruritus, eczema, erythema, night sweats, acne, arthralgia, muscle spasms, back pain, muscular weakness, fatigue, pain in the extremity, pyrexia.
    See prescribing information for full details.


    Drug interactions

    No interaction studies have been performed. Vedolizumab has been studied in adult ulcerative colitis and Crohn’s disease patients with concomitant administration of corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, and methotrexate), and aminosalicylates. Population pharmacokinetic analyses suggest that co-administration of such agents did not have a clinically meaningful effect on vedolizumab pharmacokinetics. The effect of vedolizumab on the pharmacokinetics of commonly co-administered medicinal compounds has not been studied.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are limited amount of data from the use of vedolizumab in pregnant women. As a precautionary measure, it is preferable to avoid the use of Entyvio during pregnancy unless the benefits clearly outweigh any potential risk to both the mother and foetus.
    Breast-feeding: Vedolizumab has been detected in human milk. The effect of vedolizumab on infants is unknown. The use of vedolizumab in lactating women should take into account the benefit of therapy to the mother and potential risks to the infant.
    See prescribing information for full details.               


    Overdose

    Doses up to 10 mg/kg (approximately 2.5 times the recommended dose) have been administered in clinical trials. No dose-limiting toxicity was seen in clinical trials.
    See prescribing information for full details.


    Important notes

    Compatibility: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
    Storage: Store in a refrigerator (2°C-8°C). Keep the vial in the outer carton in order to protect from light. This drug should be at room temperature (20°C -25°C) when reconstituted.
    Effects on ability to drive and use machines: Vedolizumab has minor influence on the ability to drive and use machines, as dizziness has been reported in a small number of patients.
    See prescribing information for full details.            


    Manufacturer
    Takeda Pharma A/S, Denmark
    Licence holder
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