Azacitidine

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  • For more information, please download leaflet.

    • The brand name of your medication is LEUKAZA® and the generic name is Azacitidine.
    • LEUKAZA® is a nucleoside analogue that interfere with cell growth and prevent cancer spread in body.
    • This medication is a sterile lyophilized powder available in in 1 dose, 100 mg in 1 vial-containing packages.

    1 Why is LEUKAZA® prescribed?

    LEUKAZA® is used to treat a type of Bone marrow cancers like Myelodiplastic syndrome and other blood diseases. LEUKAZA® has been maybe used other diseases which are not mentioned in this leaflet.

    2 How is injection solution of LEUKAZA® given?

    • LEUKAZA® is usually given as an injection at your doctor's office, hospital, or clinic. This medication is injected into a vein through an IV (infusion) by healthcare providers.
    • Before administration of LEUKAZA®, your doctor gives you some medications to prevent nausea and vomiting.
    • If during LEUKAZA® administration, the drug leaks out to your skin, wash your skin immediately.
    • Avoid using this medication, if you find any color change or particle in vial.
    • Keep away this medication and any other part of administration set and needles out of reach of Children and pets, also avoid re-use administration devices of LEUKAZA®.
    • If you missed a dose, contact with your doctor, immediately.
    • IF you have further questions about LEUKAZA®, ask your doctor, pharmacist or other health care professionals.

    3 What special precautions should you follow during your treatment with LEUKAZA®?

    • LEUKAZA® may cause dizziness, faint or drowsiness. The symptoms can be more sever while taking alcohol or some other medication. Avoid driving or other activities which requires concentration.
    • Dizziness and drowsiness following LEUKAZA® administration can become more sever by taking alcohol, hot shower, doing exercise or having fever. For preventing these symptoms, stand up slowly (Especially when you get up in the morning). If you have such symptoms, sit or lay down.
    • Tell your doctor or dentist before you receive any dental care or surgery.
    • LEUKAZA® can lower clotting cells in your blood (Platelets), Avoid activities that may cause injury or bruising. If you see any unusual bleeding (like blood in your stool or dark stool), contact your doctor, immediately.
    • You may be at risk of infection, avoid contact with people who have cold, flu or infections. If you notice any symptom of an infection call your doctor immediately.
    • If you are male patient and taking LEUKAZA®, use birth control methods. For more information, consult with your doctor.
    • If you have diarrhea or sever vomiting, Prevent dehydration. For more instruction about prevention, discuss this issue with your doctor or pharmacist.
    • During treatment with LEUKAZA®, you should take some blood cells exams, liver or kidney function tests. These tests are necessary to monitor your health and side effects of this medication. Ask your doctor about these tests.
    • Using LEUKAZA® for old patients should be with caution. This group of patients are more sensitive to drug’s effects.
    • There should be more caution in using LEUKAZA® in Children. Efficacy and safety of this medication had not been approved in pediatrics.
    • LEUKAZA® can cause harm to the fetus. If you are a woman of childbearing potential, use birth control that you can trust to stop pregnancy while taking this medication.
    • Avoid breastfeeding during treatment with LEUKAZA®. Excretion of this medication in milk is unknown.
    • Do not receive any kind of vaccination without your doctor’s approval while taking LEUKAZA® and after the end of the treatment (at least for three months after completion of treatment).
    • Before taking any vaccine, contact your doctor. Concomitant use of vaccines with LEUKAZA® can cause risk of infection or interfere with vaccine effects.
    • If you have any liver problem, contact your doctor.
    • Keep a list with you of all the medicines you use (including any prescription or nonprescription medicine, herbal preparation and vitamins) and show this list to any doctor or other healthcare provider who treats you. LEUKAZA® may interact with some medications.

    4 What are some side effects that you need to call your doctor about, right away?

    • LEUKAZA® can cause severe or life threatening allergic reactions that required immediate medical intervention. So tell your doctor or contact emergency unit, immediately if you have these symptoms.
    • Tell your doctor right away if you experience fever, shivering, sever sore-throat, otitis, sinusitis, increase in sputum production or any color change, feeling uncomfortable during urination, scars in your mouth or any other lesion that last more than usual, pain or scar in anus. These can be signs of infection.
    • Call your doctor at once if you have:

    • Sever ongoing dizziness or sudden faint
    • severe ongoing vomiting or stomach discomfort
    • severe ongoing diarrhea
    • Sever ongoing constipation
    • Any skin symptoms,
    • Any side effect that has not be resolved or getting worst.

    5 What is the storage condition of LEUKAZA®?

    Store LEUKAZA® at 15-30°C and away from light before opening (keep in original outer carton).

    Reconstituted solution should be used immediately due to the risk of microbial contamination.

    LEUKAZA® should never be used after the expiration date printed on the packaging.

    Reconstitute should be clear, colorless, and free of any particulate matters. If not, avoid using it.

    Keep LEUKAZA® out of reach of children.

  • For more information, please download leaflet.

    • LEUKAZA® (AZACITIDINE for injection) contains azacitidine, which is a pyrimidine nucleoside analog of cytidine.
    • The finished product is supplied in a sterile form for reconstitution as a solution with further dilution for intravenous infusion.
    • Vials of LEUKAZA® contain 100 mg of AZACITIDINE and 100 mg mannitol as a sterile lyophilized powder.

    1 INDICATIONS AND USAGE

    1.1. Myelodysplastic Syndromes (MDS)

    AZACITIDINE is indicated 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).

    2 DOSAGE AND ADMINISTRATION

    2.1. 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.

    2.2. 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.

    3 Preparation of AZACITIDINE:

    AZACITIDINE is a cytotoxic drug. Follow applicable special handling and disposal procedures. The AZACITIDINE vial is single-dose and does not contain any preservatives. Discard unused portions of each vial properly. Do not save any unused portions for later administration.

    4 SOLUTION STABILITY:

    AZACITIDINE reconstituted for intravenous administration may be stored at 25°C (77°F), but administration must be completed within 1 hour of reconstitution.

    5 CONTRAINDICATIONS:

    5.1. Advanced Malignant Hepatic Tumors

    AZACITIDINE is contraindicated in patients with advanced malignant hepatic tumors.

    5.2. Hypersensitivity to AZACITIDINE or Mannitol

    AZACITIDINE is contraindicated in patients with a known hypersensitivity to AZACITIDINE or mannitol.

    6 USE IN SPECIAL POPULATIONS

      6.1. Pregnancy:

      Pregnancy Risk Factor: D

      Pregnancy Implications: Embryotoxicity, fetal death, and fetal abnormalities were observed in animal studies. There are no adequate and well-controlled studies in pregnant women. Women of childbearing potential should be advised to avoid pregnancy during treatment. Verify the pregnancy status of females of reproductive potential prior to initiating AZACITIDINE. In addition, males should be advised to avoid fathering a child while on AZACITIDINE therapy.

      6.2. NURSING MOTHERS:

      Excretion in breast milk unknown/not recommended. There is no information regarding the presence of AZACITIDINE in human milk, the effects of AZACITIDINE on the breastfed infant, or the effects of AZACITIDINE 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 AZACITIDINE, advise patients not to breastfeed during treatment with AZACITIDINE.

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