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  • Yondelis
    / Janssen


    Active Ingredient
    Trabectedin 1 mg/vial

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 1 mg

    partial basket chart 22931 25014

    Related information


    Dosage

    All patients must be premedicated with corticosteroids such as dexamethasone 20 mg intravenously, 30 minutes before each Yondelis infusion; not only as anti-emetic prophylaxis, but also because it appears to provide hepatoprotective effects. Additional anti-emetics may be administered as needed.
    The following criteria are required to allow treatment with Yondelis: 
    Absolute neutrophil count (ANC) ≥ 1,500/mm³, Platelet count ≥ 100,000/mm³, Haemoglobin ≥ 9 g/dl- Bilirubin ≤ upper limit of normal (ULN)
    Alkaline phosphatase of non-osseous origin ≤ 2.5 x ULN (consider hepatic isoenzymes 5-nucleotidase or GGT, to distinguish if the elevation could be osseous in origin). Albumin ≥ 25 g/l, Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 x ULN, Creatinine clearance ≥ 30 ml/min. Creatine phosphokinase (CPK) ≤ 2.5 x ULNThe same criteria as above (except if CPK > 2.5 x ULN) must be met prior to initiation of next cycles. Otherwise treatment must be delayed for up to 3 weeks until the criteria are met. If these toxicities persist beyond 3 weeks, treatment discontinuation should be considered. Additional monitoring of haematological and biochemical parameters [bilirubin, alkaline phosphatase, aminotransferases (AST and ALT) and CPK] should occur weekly during the first two cycles of therapy, and at least once between treatments in subsequent cycles.
    The same dose should be given for all cycles provided that no grade 3-4 toxicities are seen and that the patient fulfils the re-treatment criteria.
    See prescribing information for full details.


    Indications

    Treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.


    Contra-Indications

    Hypersensitivity to trabectedin or to any of the excipients. Concurrent serious or uncontrolled infection. Lactation. Combination with yellow fever vaccine.


    Special Precautions

    The following criteria are required to allow treatment: Absolute neutrophil count (ANC)> 1,500/mm3; platelet count> 100,000/mm3; bilirubin< upper limit of normal (ULN); alkaline phosphatase 25 g/l; alanine aminotransferase (ALT) and aspartate aminotransferase (AST)< 2.5 x ULN; creatinine clearance>30 ml/min; creatine phosphokinase (CPK)< 2.5 x ULN; hemoglobin> 9 g/dl.
    The same criteria as above must be met prior to re-treatment. Otherwise treatment must be delayed for up to 3 weeks until the criteria are met. Additional monitoring of hematological parameters bilirubin, alkaline phosphatase, aminotransferases and CPK should occur weekly during the first two cycles of therapy, and at least once between treatments in subsequent cycles. Prior to re-treatment, patients must fulfil the baseline criteria defined above. If any of the following events occur at any time between cycles, the dose must be reduced one level. See prescribing information for full details.
    Duration of treatment: In clinical trials, there were no pre-defined limits to the number of cycles administered. No cumulative toxicities have been observed in patients treated with multiple cycles.
    Pediatric patients: The safety and efficacy have not yet been established. Elderly patients: No specific studies in elderly patients have been performed. No relevant differences in the safety profile were seen in this patient population. Impaired hepatic function: No studies with the proposed regimen have been conducted in patients with liver dysfunction. However, special caution is advised and dose adjustments may be necessary in these patients since systemic exposure is probably increased and the risk of hepatotoxicity might be increased. Patients with elevated bilirubin must not be treated.
    Impaired renal function: Studies including patients with renal insufficiency (creatinine clearance < 30 ml/min) have not been conducted and therefore Yondelis must not be used in this patient population.
    See prescribing information for full details.


    Side Effects

    Most frequent adverse reactions: Neutropenia, thrombocytopenia, anemia. AST/ALT increases, hyperbilirubinemia.
    See prescribing information for full details.


    Drug interactions

    CYP3A4 inhibitors (e.g. ketoconazole, fluconazole ritonavir, clarithromycin or aprepitant), potent CYP3A4 inducers (e.g. rifampicin, phenorbarbital, Saint John’s Wort). Alcohol consumption must be avoided during treatment.


    Pregnancy and Lactation

    Pregnancy: No sufficient clinical data on exposed pregnancies are available. However, based on its known mechanism of action, trabectedin may cause serious birth defects when administered during pregnancy. Trabectedin should not be used during pregnancy unless clearly necessary. If it is used during pregnancy, the patient must be informed of the potential risk to the foetus and be monitored carefully. If trabectedin is used at the end of pregnancy, potential adverse reactions should be monitored carefully in the newborns.
    Fertility: Men who are fertile and women of childbearing potential must use effective contraception during treatment and 3 months thereafter for women and immediately inform the treating physician if a pregnancy occurs and 5 months after treatment for men. Trabectedin can have genotoxic effects. Advice on conservation of sperm should be sought prior to treatment because of the possibility of irreversible infertility due to therapy with Yondelis. If pregnancy occurs during treatment genetic counseling should be considered. Genetic counseling is also recommended for patients wishing to have children after therapy.
    Lactation: It is not known whether trabectedin is excreted in human milk. The excretion of trabectedin in milk has not been studied in animals. Breast-feeding is contraindicated during treatment and 3 months thereafter.


    Overdose

    There is limited data on the effects of trabectedin overdose. The major anticipated toxicities are gastrointestinal, bone marrow suppression and hepatic toxicity. There is no specific antidote for trabectedin currently available. In the event of an overdose, patients should be closely monitored and symptomatic supportive care measures instituted as required.


    Manufacturer
    Janssen Pharmaceutica, Beerse, Belgium
    Licence holder
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