Cladribine

  • Leudribine

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  • For more information, please download leaflet.

    • The brand name of your medication is LEUDRIBINE® and the generic name is Cladribine.
    • LEUDRIBINE® is in a class of medications called "Antimetabolite”, which interfere with cancer cell growth and prevent cancer to spread in body.
    • LEUDRIBINE® is available in 10mg/10mL dosage form.

    1 Why is LEUDRIBINE® prescribed?

    LEUDRIBINE® solution for injection is used alone or with other medications to treat Specific king of Leukemia, called Hairy cell leukemia.

    2 How is injection solution of LEUDRIBINE® given?

    • LEUDRIBINE® is usually given as an injection at your doctor's office, hospital, or clinic. LEUDRIBINE® is injected into a vein through an IV (infusion) by healthcare providers in 7 days. This medication would be administrated by a set of non–DEHP.
    • Number of 7-days injections and interval between these injections will be decided by your physician.
    • If you feel any inching, pain or swelling in injection-site during infusion, tell your nurse immediately. If the drug gets a way to your skin, wash your skin with Soap and water carefully.
    • Also, your doctor may prescribe some medicines in order to reduce certain side effects of LEUDRIBINE®

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

    • LEUDRIBINE® can lower number of blood cells. It’s necessary to have regular blood tests during treatment.
    • As LEUDRIBINE® can lower the number of blood cells, protect yourself from injury, bleeding and infection. Considering these points is recommended:
    • Wash your hands often with soup and water.
    • Try to avoid contact with people who have colds, flu or infections.
    • You may bleed more easily. Be careful and avoid injury.
    • Use a soft toothbrush and an electric razor.
    • LEUDRIBINE® can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces.
    • Avoid taking live-vaccines during treatment with LEUDRIBINE®. Avoid coming into contact with anyone who has recently received a live vaccine. If it is not possible, wear a mask and cover your nose and mouth. Some of These vaccines are MMR (Munps Measles Rubella), Poliovirus Oral Vaccine, Chickenpox Vaccine and Typhoid Vaccine.
    • Talk with your doctor before using products that have aspirin, blood thinners, garlic, ginseng, ginkgo, ibuprofen, pain killers, or vitamin E and similar products. These medications may increase the risk of bleeding with LEUDRIBINE® concomitant use.

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

    • LEUDRIBINE® can cause severe or life threatening allergic reactions that required immediate medical intervention. So tell your doctor immediately if you have these symptoms.
    • Tell your doctor right away if you experience fever, swelling of gum, mouth sores, wound on your skin, signs of flue or influenza. They can be signs of a lowering of white blood cells.
    • Tell your doctor right away if you develop any unusual bleeding (bleeding from gums, nose, Anal or vaginal bleeding). These can be sign of lowering of blood platelets.
    • Tell your doctor if you have blood in your stool or you have very dark stool. These can be sign of bleeding in your digestive track.
    • Tell your doctor right away if you experience back pain, little urinating or blood in urine. These can be signs of kidney problems
    • Tell your doctor right away if you develop signs of infection including fever (temperature higher than 38 C), shivering, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, wound that will not heal, or anal itching or pain.
    • Tell your doctor right away if you experience any signs tingling, numbness or pain in the hands or feet. These can be signs of sensory or peripheral nerves damage.
    • Tell your doctor right away if you experience any signs of irregularity in heart beat or breasth shortage. These could be signs of heart-lung problems.
    • Call your doctor at once if you have any of these signs:
    • • Feel dizzy in your head

      • Tingling around your mouth

      • Redness, swallow or itching on your skin.

    5 What is the storage condition of LEUDRIBINE®?

    Store LEUDRIBINE® before opening in refrigerator, between 2-8°C and away from light before dilution (keep in original outer carton).

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

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

    Freezing does not effect on quality of LEUDRIBINE®. If solution has been frigid, keep it in room temperature until it becomes liquid. In this case, product can be use till end of expiration date if keep it in refrigerator (2-8°C).

  • For more information, please download leaflet.

    • LEUDRIBINE® Injection, is a synthetic antineoplastic agent for continuous intravenous infusion. It is a clear, colorless, sterile, preservative-free, isotonic solution.
    • LEUDRIBINE® injection, is available in single-dose vials containing 10 mg (1 mg/mL) of CLADRIBINE, a chlorinated purine nucleoside analog.
    • Each milliliter of LEUDRIBINE® injection, contains 1 mg of the active ingredient and 9 mg (0.15 mEq) of sodium chloride as an inactive ingredient.

    1 INDICATIONS AND USAGE

    Hairy Cell Leukemia (HCL):

    CLADRIBINE Injection (LEUDRIBINE®), is indicated for the treatment of active Hairy Cell Leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia or disease-related symptoms.

    2 DOSAGE AND ADMINISTRATION

    The recommended dose and schedule of CLADRIBINE injection for active Hairy Cell Leukemia is as a single course given by continuous infusion for seven consecutive days at a dose of 0.09 mg/kg/day. Deviations from this dosage regimen are not advised.

    If the patient does not respond to the initial course of CLADRIBINE injection for Hairy Cell Leukemia, it is unlikely that they will benefit from additional courses. Physicians should consider delaying or discontinuing the drug if neurotoxicity or renal toxicity occurs. Specific risk factors predisposing to increased toxicity from CLADRIBINE injection have not been defined. In view of the known toxicities of agents of this class, it would be prudent to proceed carefully in patients with known or suspected renal insufficiency or severe bone marrow impairment of any etiology. Patients should be monitored closely for hematologic and non-hematologic toxicity.

    3 PREPARATION AND ADMINISTRATION OF INTRAVENOUS SOLUTIONS:

    CLADRIBINE injection must be diluted with the designated diluent prior to administration. Since the drug product does not contain any antimicrobial preservative or bacteriostatic agent, aseptic technique and proper environmental precautions must be observed in preparation of CLADRIBINE injection solutions.

    4 STABILITY:

    When stored in refrigerated conditions between 2° to 8°C (36° to 46°F) and protected from light, unopened vials of CLADRIBINE injection are stable until the expiration date indicated on the package. Freezing does not adversely affect the solution. If freezing occurs, thaw naturally to room temperature. DO NOT heat or microwave. Once thawed, the vial of CLADRIBINE injection is stable until expiry if refrigerated. DO NOT refreeze. Once diluted, because of possible microbial contamination during dilution, it is advisable to use the admixture immediately and discard unused portions.

    5 COMPATIBILITY:

    Solutions containing CLADRIBINE injection should not be mixed with other intravenous drugs or additives or infused simultaneously via a common intravenous line, since compatibility testing has not been performed.

    6 CONTRAINDICATIONS:

    CLADRIBINE Injection is contraindicated in those patients who are hypersensitive to this drug or any of its components.

    7 USE IN SPECIAL POPULATIONS

      7.1. Pregnancy:

      Pregnancy Risk Factor: D

      Pregnancy Implications: Teratogenic effects and fetal mortality were observed in animal reproduction studies. CLADRIBINE may cause fetal harm if administered during pregnancy. Women of reproductive potential should use highly effective contraception during treatment.

      7.2. NURSING MOTHERS:

      Lactation Excretion in breast milk unknown/ not recommended. Breast-Feeding Considerations: Due to the potential for serious adverse reactions in the nursing infant, the decision to discontinue CLADRIBINE or to discontinue breast-feeding should take into account the importance of treatment to the mother.

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