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  • Vidaza
    / Neopharm


    Active Ingredient
    Azacitidine 100 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 100 mg

    partial basket chart 83101 22302

    Dosage

    First Treatment Cycle: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m² subcutaneously or intravenously, daily for 7 days. Patients should be premedicated for nausea and vomiting. Complete blood counts, liver chemistries and serum creatinine should be obtained prior to first dose.
    Subsequent Treatment Cycles: Cycles should be repeated every 4 weeks. The dose may be increased to 100 mg/m² if no beneficial effect is seen after 2 treatment cycles and if no toxicity other than nausea and vomiting has occurred. It is recommended that patients be treated for a minimum of 4 to 6 cycles. However, complete or partial response may require additional treatment cycles. Treatment may be continued as long as the patient continues to benefit. Patients should be monitored for hematologic response and renal toxicities, and dosage delay or reduction as described at the prescribing information.
    See prescribing information for full details.


    Indications

    For treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).


    Contra-Indications

    Advanced Malignant Hepatic Tumors: This product is contraindicated in patients with advanced malignant hepatic tumors.
    Hypersensitivity to Azacitidine or Mannitol: This product is contraindicated in patients with a known hypersensitivity to a zacitidine or mannitol.


    Special Precautions

    Anemia, Neutropenia and Thrombocytopenia: This drug causes anemia, neutropenia and thrombocytopenia. Monitor complete blood counts frequently for response and/or toxicity, at a minimum, prior to each dosing cycle. After administration of the recommended dosage for the first cycle, adjust dosage for subsequent cycles based on nadir counts and hematologic response.
    Hepatotoxicity in Patients with Severe Pre-existing Hepatic Impairment: Because azacitidine is potentially hepatotoxic in patients with severe pre-existing hepatic impairment, caution is needed in patients with liver disease. Patients with extensive tumor burden due to metastatic disease have been reported to experience progressive hepatic coma and death during azacitidine treatment, especially in such patients with baseline albumin <30 g/L. Azacitidine is contraindicated in patients with advanced malignant hepatic tumors.
    Safety and effectiveness in patients with MDS and hepatic impairment have not been studied as these patients were excluded from the clinical trials.
    Renal Toxicity: Renal toxicity ranging from elevated serum creatinine to renal failure and death have been reported in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents for nonMDS conditions. In addition, renal tubular acidosis, defined as a fall in serum bicarbonate to <20 mEq/L in association with an alkaline urine and hypokalemia (serum potassium <3 mEq/L) developed in 5 patients with CML treated with azacitidine and etoposide. If unexplained reductions in serum bicarbonate <20 mEq/L or elevations of BUN or serum creatinine occur, the dosage should be reduced or held.
    Patients with renal impairment may be at increased risk for renal toxicity. Also, azacitidine and its metabolites are primarily excreted by the kidney. Therefore, these patients should be closely monitored for toxicity. Patients with MDS and renal impairment were excluded from the clinical studies.
    Tumor Lysis Syndrome: VIDAZA may cause fatal or serious tumor lysis syndrome, including in patients with MDS. Tumor lysis syndrome may occur despite concomitant use of allopurinol. Assess baseline risk and monitor and treat as appropriate.
    Embryo-Fetal Risk: Based on the mechanism of action and findings in animals, VIDAZA can cause fetal harm when administered to a pregnant woman. Azacitidine administered to pregnant rats via a single intraperitoneal (IP) dose approximating 8% of the recommended human daily dose caused fetal death and anomalies.
    Advise females with reproductive potential to avoid pregnancy during treatment with VIDAZA. Men should be advised to not father a child while receiving treatment with VIDAZA.


    Side Effects

    Most Commonly Occurring Adverse Reactions (Subcutaneous or Intravenous
    Route): nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia, ecchymosis.
    The most common adverse reactions by intravenous route also included petechiae, rigors, weakness and hypokalemia.
    Adverse Reactions Most Frequently (>2%) Resulting in Clinical Intervention
    (Subcutaneous or Intravenous Route):
    Discontinuation: leukopenia, thrombocytopenia, neutropenia.
    Dose Held: leukopenia, neutropenia, thrombocytopenia, pyrexia, pneumonia, febrile neutropenia.
    Dose Reduced: leukopenia, neutropenia, thrombocytopenia.
    See prescribing information for full details.


    Drug interactions

    No formal clinical drug interaction studies with azacitidine have been conducted.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Based on its mechanism of action and findings in animals, VIDAZA can cause fetal harm when administered to a pregnant woman.
    Lactation: There is no information regarding the presence of azacitidine in human milk, the effects of VIDAZA on the breastfed infant, or the effects of VIDAZA on milk production.
    Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for azacitidine in animal studies and the potential for serious adverse reactions in nursing infants from VIDAZA, advise patients not to breastfeed during treatment with VIDAZA.
    See prescribing information for full details.


    Overdose

    One case of overdose with VIDAZA was reported during clinical trials. A patient
    experienced diarrhea, nausea, and vomiting after receiving a single intravenous dose of approximately 290 mg/m², almost 4 times the recommended starting dose. The events resolved without sequelae, and the correct dose was resumed the following day. In the event of overdosage, the patient should be monitored with appropriate blood counts and should receive supportive treatment, as necessary. There is no known specific antidote for VIDAZA overdosage.


    Manufacturer
    Celgene International SARL, Switzerland
    Licence holder
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