DAUNOXOME 50mg Infusion

    DAUNOXOME 50mg

    Daunorubicin

    Category: Infusion

    Manufacturer: ALMAC PHARMA Services Limited, UK

    Uses of DAUNOXOME: - Blood cancer Acute leukaemia, AIDS-related Kaposi's sarcoma Heart failure. Pregnancy, lactation.
    Cytotoxic Chemotherapy
    Daunorubicin forms a stable complex with DNA and interferes with the nucleic acid synthesis. It is a cell-cycle nonspecific agent, but its cytotoxic effects are mostly marked in the S-phase. It also has immunosuppressant and antibacterial effects.
    How to use Daunorubicin: Your doctor or nurse will give you this medicine. Kindly do not self administer. Administration: IV Preparation Reconstitute 20 mg vial with 4 mL SWI to a final concentration of 5 mg/mL IV Administration Vesicant, never administer IM or SC IVP: desired dose is withdrawn into a syringe containing 10-15 mL NS, then injected over 2-3 min into the tubing or sidearm of a freely flowing IV infusion of NS or D5W Has also been diluted in 100 mL of D5W or NS & infused over 30-45 min Flush with 5-10 mL of IV solution before & after drug administration Adult Dose: Acute Nonlymphocytic Leukemia In combination with cytarabine 100 mg/m²/day IV for 7 days first course, for 5 days subsequent courses <60 years old: 45 mg/m² IVP days 1, 2, 3 first course; days 1, 2 subsequent courses >60 years old: 30 mg/m² IVP days 1, 2, 3 first course; days 1, 2 subsequent courses Acute Lymphocytic Leukemia 45 mg/m² IVP days 1, 2, 3 Hepatic Impairment < 1.2 mg/dL serum bilirubin: Dose adjustment not necessary 1.2-3 mg/dL serum bilirubin: 75% of regular dose > 3 mg/dL serum bilirubin: 50% of regular dose Child Dose: Acute Nonlymphocytic Leukemia <2 years old or <0.5 m² BSA: 1 mg/kg IVP qWeek >2 years old or >0.5 m² BSA: 25 mg/m² IVP qWeek Acute Lymphocytic Leukemia <2 years old or <0.5 m² BSA: 1 mg/kg IVP qWeek >2 years old or >0.5 m² BSA: 25 mg/m² IVP qWeek Renal Dose: Renal Impairment >3 mg/dL serum creatinine: Administer 50% regular dose
    Increased risk of cardiotoxicity when used with cyclophosphamide. Increased risk of hepatic toxicity when used with hepatotoxic drugs e.g. high-dose methotrexate. Potentially Fatal: Immunisation with live vaccines is not recommended. Concurrent radiation may lead to increased radiation reaction.
    Heart failure. Pregnancy, lactation.
    Common - Nausea - Vomiting - Low blood platelets - Ulcer - Abdominal pain - Loss of appetite - Decreased white blood cell count - Hair loss - Fever - Decreased blood cells (red cells, white cells, and platelets) - Fatigue - Anemia (low number of red blood cells) - Chills - Diarrhea - Mucosal inflammation - Febrile neutropenia - Stomatitis (Inflammation of the mouth) - Breathing problems >10% Nausea,Vomiting,Arrhythmias,Discoloration of urine,Alopecia 1-10% Injection site skin flare,Hyperuricemia,GI ulceration,Diarrhea <1% Arrythmia,Cardiomyopathy,Bilirubin increased,Pruritus,Urticaria Frequency Not Defined Fever,CHF,Flushing,Stomatitis,Myelosuppression,Rash,Hyperpigmentation of previously radiated areas,Transverse pigmentation of fingernails and toenails,Fertility impairment Potentially Fatal: Bone marrow suppression, cardiac toxicity, cardiomyopathy and congestive heart failure.
    Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
    Precaution: Regular blood count and ECG monitoring; elderly, children. Hepatic or renal impairment may increase risk of toxicity. Pre-existing cardiac disease and previous treatment with doxorubicin. Myocardial toxicity leading to potentially fatal congestive heart failure may occur during therapy or mth to yr after therapy cessation. Incidence of myocardial toxicity increases after total cumulative dose exceeds 400-550 mg/m2 in adults, 300 mg/m2 in children >2 yr, or 10 mg/kg in children <2 yr. Risk of severe myelosuppression leading to infection or haemorrhage. Lactation: excretion in milk unknown/not recommended
    Severe myelosupression, cardiotoxicity with or without transient reversible ECG changes leading to CHF. Treatment is supportive and symptomatic.
    Store unopened vials in the refrigerator, 2°-8°C. Contains no preservatives. Discard unused portions. Protect from light. If Daunorubicin contacts the skin or mucosae, the area should be washed thoroughly with soap and water. Procedures for proper handling and disposal of anticancer drugs should be considered.
    Cytotoxic Chemotherapy
    Daunorubicin forms a stable complex with DNA and interferes with the nucleic acid synthesis. It is a cell-cycle nonspecific agent, but its cytotoxic effects are mostly marked in the S-phase. It also has immunosuppressant and antibacterial effects.
    Pregnancy Category: D Lactation: excretion in milk unknown/not recommended
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