Plerixafor

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Plerixafor

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  • For more information, please download leaflet.

    • NEOFOR® (PLERIXAFOR) injection is a sterile, preservative-free, clear, colorless to pale yellow, isotonic solution for subcutaneous injection.
    • Each mL of the sterile solution contains 20 mg of PLERIXAFOR.
    • Each single use vial is filled to deliver 1.2 mL of the sterile solution that contains 24 mg of PLERIXAFOR

    1 INDICATIONS AND USAGE

    PLERIXAFOR, a hematopoietic stem cell mobilizer, is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma.

    2 DOSAGE AND ADMINISTRATION

    2.1. Recommended Dosage and Administration PLERIXAFOR therapy should be initiated and supervised by a physician experienced in oncology and/or hematology. The mobilization and apheresis procedures should be performed in collaboration with an oncology-hematology center with acceptable experience in this field and where the monitoring of hematopoietic progenitor cells can be correctly performed. PLERIXAFOR is for subcutaneous injection. Each vial is intended for single use only. Vials should be inspected visually prior to administration and not used if there is particulate matter or discoloration. Since PLERIXAFOR is supplied as a sterile, preservative free formulation, aseptic technique should be followed when transferring the contents of the vial to a suitable syringe for subcutaneous administration. Begin treatment with PLERIXAFOR after the patient has received G-CSF once daily for four days. Administer PLERIXAFOR approximately 11 hours prior to initiation of each apheresis for up to 4 consecutive days. The recommended dose of PLERIXAFOR by subcutaneous injection is based on body weight: 20 mg fixed dose or 0.24 mg/kg of body weight for patients weighing ≤83 kg. 0.24 mg/kg of body weight for patients weighing >83 kg. Use the patient’s actual body weight to calculate the volume of PLERIXAFOR to be administered. Each vial delivers 1.2 mL of 20 mg/mL solution, and the volume to be administered to patients should be calculated from the following equation: 0.012 × patient’s actual body w eight (in kg) = volume to be administered (in mL) In clinical studies, PLERIXAFOR dose has been calculated based on actual body weight in patients up to 175% of ideal body weight. PLERIXAFOR dose and treatment of patients weighing more than 175% of ideal body weight have not been investigated. Based on increasing exposure with increasing body weight, the PLERIXAFOR dose should not exceed 40 mg/day.

    3 CONTRAINDICATIONS

    History of hypersensitivity to PLERIXAFOR. Anaphylactic shock has occurred with use of PLERIXAFOR.

    4 USE IN SPECIAL POPULATIONS

      4.1. Pregnancy:

      Pregnancy Risk Factor: D

      PLERIXAFOR may cause fetal harm when administered to a pregnant woman. Plerixafor is teratogenic in animals. There are no adequate and well-controlled studies in pregnant women. Women of childbearing potential should be advised to avoid pregnancy during treatment. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

      4.2. NURSING MOTHERS:

      It is not known whether PLERIXAFOR is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from PLERIXAFOR, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

  • For more information, please download leaflet.

    • NEOFOR® (PLERIXAFOR) injection is a sterile, preservative-free, clear, colorless to pale yellow, isotonic solution for subcutaneous injection.
    • Each mL of the sterile solution contains 20 mg of PLERIXAFOR.
    • Each single use vial is filled to deliver 1.2 mL of the sterile solution that contains 24 mg of PLERIXAFOR

    1 INDICATIONS AND USAGE

    PLERIXAFOR, a hematopoietic stem cell mobilizer, is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma.

    2 DOSAGE AND ADMINISTRATION

    2.1. Recommended Dosage and Administration PLERIXAFOR therapy should be initiated and supervised by a physician experienced in oncology and/or hematology. The mobilization and apheresis procedures should be performed in collaboration with an oncology-hematology center with acceptable experience in this field and where the monitoring of hematopoietic progenitor cells can be correctly performed. PLERIXAFOR is for subcutaneous injection. Each vial is intended for single use only. Vials should be inspected visually prior to administration and not used if there is particulate matter or discoloration. Since PLERIXAFOR is supplied as a sterile, preservative free formulation, aseptic technique should be followed when transferring the contents of the vial to a suitable syringe for subcutaneous administration. Begin treatment with PLERIXAFOR after the patient has received G-CSF once daily for four days. Administer PLERIXAFOR approximately 11 hours prior to initiation of each apheresis for up to 4 consecutive days. The recommended dose of PLERIXAFOR by subcutaneous injection is based on body weight: 20 mg fixed dose or 0.24 mg/kg of body weight for patients weighing ≤83 kg. 0.24 mg/kg of body weight for patients weighing >83 kg. Use the patient’s actual body weight to calculate the volume of PLERIXAFOR to be administered. Each vial delivers 1.2 mL of 20 mg/mL solution, and the volume to be administered to patients should be calculated from the following equation: 0.012 × patient’s actual body w eight (in kg) = volume to be administered (in mL) In clinical studies, PLERIXAFOR dose has been calculated based on actual body weight in patients up to 175% of ideal body weight. PLERIXAFOR dose and treatment of patients weighing more than 175% of ideal body weight have not been investigated. Based on increasing exposure with increasing body weight, the PLERIXAFOR dose should not exceed 40 mg/day.

    3 CONTRAINDICATIONS

    History of hypersensitivity to PLERIXAFOR. Anaphylactic shock has occurred with use of PLERIXAFOR.

    4 USE IN SPECIAL POPULATIONS

      4.1. Pregnancy:

      Pregnancy Risk Factor: D

      PLERIXAFOR may cause fetal harm when administered to a pregnant woman. Plerixafor is teratogenic in animals. There are no adequate and well-controlled studies in pregnant women. Women of childbearing potential should be advised to avoid pregnancy during treatment. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

      4.2. NURSING MOTHERS:

      It is not known whether PLERIXAFOR is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from PLERIXAFOR, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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