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  • TEVIMBRA
    / BeiGene Pharmaceuticals Israel Ltd.


    Active Ingredient
    tislelizumab 100 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Concentrate for solution for infusion

    100 mg/10 ml

    not in the basket chart 63052 24838

    Related information


    Dosage

    The recommended dose of Tevimbra is 200 mg administered by intravenous infusion once every 3 weeks.
    Treatment must be initiated and supervised by physicians experienced in the treatment of cancer.


    Indications

    Oesophageal squamous cell carcinoma (OSCC)
    Monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients


    Special Precautions

    Patient Card
    Patients treated with this medical product must be given the Patient Card to be informed about the risks of immune-related adverse reactions during therapy.
    Immune-related adverse reactions
    Immune-related adverse reactions have been reported, including fatal cases, during treatment with tislelizumab. The majority of these events improved with interruption of tislelizumab, administration of corticosteroids and/or supportive care. Immune-related adverse reactions have also been reported after the last dose of tislelizumab. Immune-related adverse reactions affecting more than one body system can occur simultaneously.
    For suspected immune-related adverse reactions, adequate evaluation to confirm aetiology or exclude alternative aetiologies, including infection, should be ensured. Based on the severity of the adverse reaction, tislelizumab should be withheld and corticosteroids administered. Based on limited data from clinical studies, administration of other systemic immunosuppressants can be considered in patients whose immune-related adverse reactions are not controlled with corticosteroid use. Upon improvement to grade ≤1, corticosteroid taper should be initiated and continued over at least 1 month.
    Immune-related skin reactions
    Cases of severe cutaneous adverse reactions (SCARs) including erythema multiforme (EM), StevensJohnson Syndrome (SJS) and Toxic epidermal necrolysis (TEN), some of them with fatal outcome, have been reported in patients receiving tislelizumab. Patients should be monitored for signs or symptoms of SCARs (e.g. a prodrome of fever, flu-like symptoms, mucosal lesions or progressive skin rash) and other causes should be excluded. For suspected SCAR, tislelizumab should be withheld and the patient should be referred to specialised care for assessment and treatment. If SCAR is confirmed, tislelizumab should be permanently discontinued.
    Thyroid disorders
    Thyroid disorders, including thyroiditis, hypothyroidism and hyperthyroidism, have been reported in patients treated with tislelizumab. Patients should be monitored (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) for changes in thyroid function and clinical signs and symptoms of thyroid disorders. Hypothyroidism may be managed with HRT without treatment interruption and without corticosteroids. Hyperthyroidism may be managed symptomatically
    Adrenal insufficiency
    Adrenal insufficiency has been reported in patients treated with tislelizumab. Patients should be monitored for signs and symptoms of adrenal insufficiency. Monitoring of adrenal function and hormone levels should be considered. Corticosteroids and HRT should be administered as clinically indicated.
    Hypophysitis
    Hypophysitis has been reported in patients treated with tislelizumab. Patients should be monitored for signs and symptoms of hypophysitis/hypopituitarism. Monitoring of pituitary function and hormone levels should be considered. Corticosteroids and HRT should be administered as clinically indicated.
    Type 1 diabetes mellitus
    Type 1 diabetes mellitus, including diabetic ketoacidosis, has been reported in patients treated with tislelizumab. Patients should be monitored for hyperglycaemia and other signs and symptoms of diabetes. Insulin should be administered for type 1 diabetes. In patients with severe hyperglycaemia or ketoacidosis (grade ≥3), tislelizumab should be withheld and anti-hyperglycaemic treatment should be administered. Treatment with tislelizumab may be resumed when metabolic control is achieved.
    Other immune-related adverse reactions
    Other clinically important immune-related adverse reactions were reported with tislelizumab. Patients with other immune-related adverse reactions should be managed according to the treatment modifications.
    Solid organ transplant rejection
    Solid organ transplant rejection has been reported in the post-marketing setting in patients treated with PD-1 inhibitors. Treatment with tislelizumab may increase the risk of rejection in solid organ transplant recipients. The benefit of treatment with tislelizumab versus the risk of possible organ rejection should be considered in these patients.
    Infusion-related reactions

     

    Severe infusion-related reactions (grade 3 or higher) have been reported in patients receiving tislelizumab as a single agent. Patients should be monitored for signs and symptoms of infusion-related reactions.
    See prescribing information for full details.


    Side Effects

    Common: pneumonia, thrombocytopenia, neutropenia, lymphopenia, hyperthyroidism, thyroiditis, hyperglycaemia, hyponatraemia, hypokalaemia, hypertension, dyspnoea, pneumonitis, nausea, diarrhea, stomatitis, hepatitis, arthralgia, myalgia, blood alkaline phosphatase increased, blood creatinine increased.
    Very common: anaemia, hypothyroidism, cough, rash, pruritus, fatigue, decreased appetite, aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased.
    See prescribing information for full details.


    Drug interactions

    Tislelizumab is a humanised monoclonal antibody, cleared from the circulation through catabolism. As such, formal pharmacokinetic interaction studies have not been conducted. As monoclonal antibodies are not metabolised by cytochrome P450 (CYP) enzymes or other drug-metabolising enzymes, inhibition or induction of these enzymes by co-administered medicinal products is not anticipated to affect the pharmacokinetics of tislelizumab. The use of systemic corticosteroids and other immunosuppressants at baseline, before starting tislelizumab, except for physiological doses of systemic corticosteroid (10 mg/day prednisone or equivalent), should be avoided because of their potential interference with the pharmacodynamic activity and efficacy. However, systemic corticosteroids and other immunosuppressants can be used after starting tislelizumab to treat immune-related adverse reactions.


    Pregnancy and Lactation

    Women of childbearing potential should use effective contraception (methods that result in less than 1% pregnancy rates) during treatment and for at least 4 months following the last dose of tislelizumab.
    Pregnancy: There are no available data on the use of tislelizumab in pregnant women. Based on its mechanism of action, tislelizumab can cause foetal harm when administered to a pregnant woman. Human IgG4 (immunoglobulins) are known to cross the placental barrier. Therefore, tislelizumab, being an IgG4 variant, has the potential to be transmitted from the mother to the developing foetus. Tislelizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with tislelizumab.
    Lactation
    : It is unknown whether tislelizumab is excreted in human milk. Its effects on breast-fed newborns/infants and on milk production are also unknown. Because of the potential for serious adverse drug reactions in breast-fed newborns/infants from this medical drug, women should be advised not to breast-feed during treatment and for at least 4 months after the last dose.


    Overdose

    There is no information on overdose with tislelizumab. In case of overdose, patients should be closely monitored for signs or symptoms of adverse drug reactions, and appropriate symptomatic treatment instituted immediately.


    Manufacturer
    BEIGENE SWITZERLAND GMBH, SWITZERLAND
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