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  • Mylotarg
    / Pfizer


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 4.5 mg

    partial basket chart

    Related information


    Dosage

    Premedication and Special Considerations: Premedicate adults with acetaminophen 650 mg orally and diphenhydramine 50 mg orally or intravenously 1 hour prior to Gemtuzumab ozogamicin dosing and 1 mg/kg methylprednisolone or an equivalent dose of an alternative corticosteroid within 30 minutes prior to infusion of Gemtuzumab Ozogamicin . Premedicate children with acetaminophen 15 mg/kg (maximum of 650 mg), diphenhydramine 1 mg/kg (maximum of 50 mg), and 1 mg/kg methylprednisolone orally or intravenously; additional doses of acetaminophen and diphenhydramine may be administered every 4 hours after the initial pretreatment dose.
    Repeat with the same dose of methylprednisolone or an equivalent corticosteroid for any sign of an infusion reaction, such as fever, chills, hypotension, or dyspnea during the infusion or within 4 hours afterwards.
    Use appropriate measures to prevent tumor lysis syndrome.
    For patients with hyperleukocytosis (leukocyte count greater than or equal to 30 Gi/L), cytoreduction is recommended prior to administration of Gemtuzumab Ozogamicin.
    Recommended Dosage
    Newly-Diagnosed De Novo CD33-positive AML (combination regimen): A treatment course including Gemtuzumab ozogamicin in combination therapy for adults with newly-diagnosed de novo CD33-positive AML consists of 1 induction cycle and 2 consolidation cycles. For the induction cycle, the recommended dose of Gemtuzumab ozogamicin is 3 mg/m² (up to one 5 mg vial) on Days 1, 4 and 7 in combination with daunorubicin and cytarabine. For patients requiring a second induction cycle, do NOT administer Gemtuzumab Ozogamicin  during the second induction cycle.
    For the consolidation cycles, the recommended dose of Gemtuzumab Ozogamicin  is 3 mg/m2 on Day 1 (up to one 5 mg vial) in combination with daunorubicin and cytarabine.
    Newly-Diagnosed CD33-positive AML (single-agent regimen): A treatment course of Gemtuzumab Ozogamicin  as a single agent for adults with newly-diagnosed CD33-positive AML consists of 1 cycle of induction and up to 8 cycles of continuation therapy.
    For the induction cycle, the recommended dose of Gemtuzumab Ozogamicin  is 6 mg/m² (not limited to one 5 mg vial) as a single agent on Day 1, and 3 mg/m² (not limited to one 5 mg vial) on Day 8.
    For continuation, the recommended dose of Gemtuzumab ozogamicin is 2 mg/m2 (not limited to one 5 mg vial) as a single agent on Day 1 every 4 weeks.
    Relapsed or Refractory CD33-positive AML (single-agent regimen): The recommended dose of Gemtuzumab Ozogamicin  as a single agent for treatment of relapsed or refractory CD33-positive AML is 3 mg/m² (up to one 5 mg vial) on Days 1, 4 and 7. Treatment in the relapsed or refractory setting consists of a single course of Gemtuzumab Ozogamicin.
    For dosage modifications for toxicities: See prescribing information for full details.


    Indications

    Newly-Diagnosed CD33-positive Acute Myeloid Leukemia (AML): MYLOTARG is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults.
    Relapsed or Refractory CD33-positive AML: MYLOTARG is indicated for the treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older.


    Contra-Indications

    Hypersensitivity to active substance or to any of its excipients.


    Special Precautions

    Hepatotoxicity, Including Veno-occlusive Liver Disease (VOD): Hepatotoxicity, including life-threatening and sometimes fatal hepatic VOD events, have been reported in patients receiving this drug  as a single agent or as part of a combination chemotherapy regimen.
    Infusion-Related Reactions (Including Anaphylaxis): Life-threatening or fatal infusion related-reactions can occur during or within 24 hours following infusion of this drug.
    Signs and symptoms of infusion-related reactions may include fever, chills, hypotension, tachycardia, hypoxia and respiratory failure.
    Hemorrhage: This medication is myelosuppressive and can cause fatal or life-threatening hemorrhage due to prolonged thrombocytopenia.
    QT Interval Prolongation: QT interval prolongation has been observed in patients treated with other drugs containing calicheamicin. When administering this drug to patients who have a history of or predisposition for QTc prolongation, who are taking medicinal products that are known to prolong QT interval, and in patients with electrolyte disturbances, obtain electrocardiograms (ECGs) and electrolytes prior to the start of treatment and as needed during administration.
    Use in AML with Adverse-Risk Cytogenetics: For patients being treated with this drug in combination with daunorubicin and cytarabine for newly-diagnosed de novo AML, when cytogenetics testing results become available consider whether the potential benefit of continuing treatment with this medication outweighs the risks for the individual patient.
    Embryo-Fetal Toxicity: Based on its mechanism of action and findings from animal studies, Gemtuzumab ozogamicin can cause embryo-fetal harm when administered to a pregnant woman. In animal studies, gemtuzumab ozogamicin caused embryo-fetal toxicity, starting at a dose that was approximately 0.4 times the exposure in patients at the maximum recommended dose, based on the area under the concentration-time curve (AUC). Advise females of reproductive potential to use effective contraception during treatment with Gemtuzumab ozogamicin and for at least 6 months after the final dose of Gemtuzumab ozogamicin.
    See prescribing information for full details.


    Side Effects

    Hepatotoxicity including Veno-occlusive Liver Disease, infusion-related reactions, hemorrhage.
    See prescribing information for full details.


    Drug interactions

    No clinical drug interaction studies have been performed.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Advise females of reproductive potential to avoid becoming pregnant while receiving this drug. Advise females of reproductive potential to use effective contraception during treatment with this medication and for at least 6 months after the last dose.
    LactationThere are no data on the presence of gemtuzumab ozogamicin or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
    See prescribing information for full details.


    Manufacturer
    Pharmacia & Upjohn Company, USA
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