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  • Azacitidine Teva
    / Abic


    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 45713

    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. Premedicate patients for nausea and vomiting.
    Obtain complete blood counts, liver chemistries and serum creatinine prior to the first dose.
    Subsequent Treatment Cycles: Repeat cycles 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 Monitoring  for hematologic response and renal toxicities, and delay or reduction of  dosage if necessary: See prescribing information for full details.
    Dosage Adjustment Based on Serum Electrolytes and Renal Toxicity: See prescribing information for full details.
    Instructions for preparation of solution for Intravenous, subcutaneous administration: See prescribing information for full details.


    Indications

    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

    Hypersensitivity to the active substance or to any of its excipients.
    Patients with advanced malignant hepatic tumors.


    Special Precautions

    Anemia, Neutropenia and Thrombocytopenia: Azacitidine 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.
    Monitor liver chemistries prior to initiation of therapy and with each cycle.
    Safety and effectiveness of azacitidine 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 non MDS 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. Monitor serum creatinine and electrolytes prior to initiation of therapy and with each cycle. If unexplained
    reductions in serum bicarbonate <20 mEq/L or elevations of BUN or serum creatinine occur, reduce or hold the dose.
    Patients with renal impairment may be at increased risk for renal toxicity. Also, azacitidine and its metabolites are primarily excreted by the kidney. Therefore, monitor these patients closely for toxicity.
    Tumor Lysis Syndrome: Azacitidine 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, azacitidine 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 azacitidine. Men should be advised to not father a child while receiving treatment with azacitidine.
    Special information on the inactive ingredients: This medicine contains less than 1 mmol (23 mg) sodium per vial, that is to say essentially ‘sodium-free’.
    See prescribing information for full details.


    Side Effects

    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.
    There is a difference in types of adverse drug reactions depending on the  route of administration.
    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: There are no data on the use of azacitidine in pregnant women.
    LactationThere is no information regarding the presence of azacitidine in human milk.
    See prescribing information for full details.


    Overdose

    One case of overdose with azacitidine 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 azacitidine overdosage.


    Manufacturer
    Teva Pharmaceutical Industries Ltd, Israel
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