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  • Velcade
    / Janssen

    Active Ingredient
    Bortezomib 3.5 mg

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft


    1 X 3.5 mg

    partial basket chart 12925 22260


    Patients with mild hepatic impairment do not require a starting dose adjustment and should be treated per the recommended VELCADE dose. Patients with moderate or severe hepatic impairment should be started on VELCADE at a reduced dose of 0.7 mg/m2 per injection during the first cycle, and a subsequent dose escalation to 1.0 mg/m² or further dose reduction to 0.5 mg/m² may be considered based on patient tolerance.
    See prescribing information for full details.


    For the treatment of patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on the last therapy.


    Hypersensitivity to bortezomib, boron or to any of the excipients. Sever hepatic impairment. Pregnancy and lactation.
    See prescribing information for full details.

    Special Precautions

    Patients with pre-existing symptoms of peripheral neuropathy (numbness, pain or a burning feeling in the feet or hands) may experience worsening during treatment. Patients with a history of syncope, patients receiving medicdbations known to be associated with hypotensions and patients who are dehydrated. Patients with risk factors for or existing heart disease. Patients with renal impairment: No clinical information is available on patients with creatinine clearance values less than 13 ml/minute and patients on hemodialysis. The safety and effectiveness in children have not been established.
    See prescribing information for full details.

    Side Effects

    Asthenic conditions (including fatigue, malaise and weakness), nausea, diarrhea, decreased appetite, constipation, thrombocytopenia, peripheral neuropathy (including peripheral sensory neuropathy and aggravated peripheral neuropathy), pyrexia, vomiting and anemia.
    See prescribing information for full details.

    Drug interactions

    No formal drug interaction studies have been conducted.

    Pregnancy and Lactation

    Pregnancy: Pregnancy Category D [see Special Precautions) Bortezomib was not teratogenic in nonclinical developmental toxicity studies in rats and rabbits at the highest dose tested (0.075 mg/kg; 0.5 mg/m² in the rat and 0.05 mg/kg; 0.6 mg/m² in the rabbit) when administered during organogenesis. These dosages are approximately half the clinical dose of 1.3 mg/m² based on body surface area. Pregnant rabbits given bortezomib during organogenesis at a dose of 0.05 mg/kg (0.6 mg/m²) experienced significant post-implantation loss and decreased number of live fetuses. Live fetuses from these litters also showed significant decreases in fetal weight. The dose is approximately 0.5 times the clinical dose of 1.3 mg/m² based on body surface area. There are no adequate and well-controlled studies in pregnant women. If VELCADE is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus.
    Nursing Mothers: It is not known whether bortezomib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse events in nursing infants from VELCADE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.


    There is no known specific antidote for VELCADE overdose. In humans, fatal outcomes following the administration of more than twice the recommended therapeutic dose have been reported, which were associated with the acute onset of symptomatic hypotension and thrombocytopenia. In the event of an overdose, the patient’s vital signs should be monitored and appropriate supportive care given. Studies in monkeys and dogs showed that intravenous bortezomib as low as 2 times the recommended clinical dose on a mg/m2 basis was associated with increases in heart rate, decreases in contractility, hypotension, and death. In dog studies, a slight increase in the corrected QT interval was observed at doses resulting in death. In monkeys, doses of 3.0 mg/m2 and greater (approximately twice the recommended clinical dose) resulted in hypotension starting at 1 hour post-administration, with progression to death in 12 to 14 hours following drug administration.

    Janssen Pharmaceutica, Beerse, Belgium
    Licence holder