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  • Bortez Teva
    / Abic


    Active Ingredient
    Bortezomib 3.5 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 3.5 mg

    partial basket chart 40331

    Dosage

    General Dosing Guidelines: The recommended starting dose of Bortezomib is 1.3mg/m², may be administered intravenously at a concentration of 1 mg/mL, or subcutaneously at a concentration of 2.5 mg/mL .When administered intravenously, the drug  is administered as a 3 to 5 second bolus intravenous injection.
    Because each route of administration has a different reconstituted concentration, caution should be used when calculating the volume to be administered.
    This medication is for intravenous or subcutaneous use only.
    This agent  must not be administered by any other route. Intrathecal administration has resulted in death.
    Dosage in Previously Untreated Multiple Myeloma: Bortezomib is administered in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles as shown in Table 1 at the attached doctor’s leaflet. In Cycles 1-4, Bortezomib is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29 and 32). In Cycles 5-9, Bortez Teva 3.5mg is administered once weekly (days 1, 8, 22 and 29).
    At least 72 hours should elapse between consecutive doses of Bortezomib.
    Dose must be individualized to prevent overdose.
    Dose Regimen for Patients with Previously Untreated Multyple Myeloma, Dose Modification Guidelines for Combination Therapy with Bortezomib, Melphalan and Prednisone, Dose Adjustments During Treatment for Patients with Previously Untreated Mantle Cell, Dosage in Relapsed Multiple Myeloma and Relapsed Mantle Cell Lymphoma: See prescribing information for full details.


    Indications

    Treatment of patients with multiple myeloma.
    Treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
    Bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for hematopoietic stem cell transplantation.


    Contra-Indications

    Bortezomib is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol. Reactions have included anaphylactic reactions.
    Bortezomib is contraindicated in acute diffuse infiltrative pulmonary and pericardial disease. When bortezomib is given in combination with other medicinal products, refer to their physician insert for additional contraindications.
    Bortezomib is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of bortezomib.


    Special Precautions

    There have been fatal cases of inadvertent intrathecal administration of bortezomib.
    This medication is authorized for intravenous or subcutaneous use only.
    Peripheral Neuropathy: Bortezomib treatment causes a peripheral neuropathy that is predominantly sensory.
    However, cases of severe sensory and motor peripheral neuropathy have been reported. Patients with pre-existing symptoms (numbness, pain or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may experience worsening peripheral neuropathy (including ≥Grade 3) during treatment with bortezomib. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness.
    Hypotension: The incidence of hypotension (postural, orthostatic, and hypotension NOS) was 8%. These events are observed throughout therapy. Caution should be used when treating patients with a history of syncope, patients receiving medications known to be associated with hypotension, and patients who are dehydrated. Management of orthostatic/postural hypotension may include adjustment of antihypertensive medications, hydration, and administration of mineralocorticoids and/or sympathomimetics.
    Cardiac Toxicity: Acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have occurred during bortezomib therapy, including reports in patients with no risk factors for decreased left ventricular ejection fraction. Fluid retention may be a  redisposing factor for signs and symptoms of heart failure. Patients with risk factors for, or existing heart disease should be closely monitored.
    Pulmonary Toxicity: There have been reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration, lung and Acute Respiratory Distress Syndrome (ARDS) in patients receiving bortezomib. Some of these events have been fatal. A pre-treatment chest radiograph is recommended to serve as a baseline for potential post-treatment pulmonary changes.
    Posterior Reversible Encephalopathy Syndrome (PRES): Posterior Reversible Encephalopathy Syndrome (PRES; formerly termed Reversible Posterior Leukoencephalopathy Syndrome (RPLS)) has occurred in patients receiving bortezomib. PRES is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. Brain imaging, preferably MRI (Magnetic Resonance Imaging), is used to confirm the diagnosis. In patients developing PRES, discontinue bortezomib. The safety of reinitiating bortezomib therapy in patients previously experiencing PRES is not known.
    Gastrointestinal Toxicity: Bortezomib treatment can cause nausea, diarrhea, constipation, and vomiting Ileus can occur. Fluid and electrolyte replacement should be administered to prevent dehydration. Interrupt bortezomib for severe symptoms.
    Thrombocytopenia/Neutropenia: Bortezomib is associated with thrombocytopenia and neutropenia that follow a cyclical pattern with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle. The cyclical pattern of platelet and neutrophil decreases and recovery remain consistent in the studies of multiple myeloma and mantle cell lymphoma, with no evidence of cumulative thrombocytopenia or neutropenia in the treatment regimens studied.
    See prescribing information for full details.


    Side Effects

    Peripheral neuropathy, hypotension, cardiac toxicity, pulmonary toxicity, posterior reversible encephalopathy syndrome (pres), gastrointestinal toxicity, thrombocytopenia/neutropenia, tumor lysis syndrome, hepatic toxicity.
    See prescribing information for full details.


    Drug interactions

    Bortezomib is a substrate of cytochrome P450 enzyme 3A4, 2C19 and 1A2.
    CYP3A4 Inhibitors: Co-administration of ketoconazole, a strong CYP3A4 inhibitor, increased the exposure of bortezomib by 35% in 12 patients. Monitor patients for signs of bortezomib toxicity and consider a bortezomib dose reduction if bortezomib must be given in combination with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir).
    CYP3A4 Inducers: Co-administration of rifampin, a strong CYP3A4 inducer, is expected to decrease the exposure of bortezomib by at least 45%. Because the drug interaction study (n=6) was not designed to exert the maximum effect of rifampin on bortezomib PK, decreases greater than 45% may occur. Efficacy may be reduced when bortezomib is used in combination with strong CYP3A4 inducers; therefore, concomitant use of strong CYP3A4 inducers is not recommended in patients receiving bortezomib (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital).
    St. John’s Wort (Hypericum perforatum) may decrease bortezomib exposure unpredictably and should be avoided.
    Melphalan-Prednisone: Co-administration of melphalan-prednisone increased the exposure of bortezomib by 17% in 21 patients. However, this increase is unlikely to be clinically relevant.
    Please refer to the license holder for further details.


    Pregnancy and Lactation

    Pregnancy: Bortezomib may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women.
    LactationIt is not known whether bortezomib is excreted in human milk.
    See prescribing information for full details. 


    Overdose

    See prescribing information for full details.


    Manufacturer
    S.C. Sindan-Pharma S.R.L., Romania
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