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  • Neulastim
    / Amgen


    Active Ingredient
    Pegfilgrastim 6 mg / 0.6 ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe (solution for injection)

    1 X 6 mg / 0.6 ml (10 mg/ml)

    partial basket chart 71231 14442

    Related information


    Dosage

    Neulastim therapy should be initiated and supervised by physicians experienced in oncology and/or hematology.
    Posology: One 6 mg dose (a single pre-filled syringe) of Neulastim is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
    Method of administration: Neulastim is injected subcutaneously. The injections should be given into the thigh, abdomen or upper arm.
    Pediatric population: The safety and efficacy of Neulastim in children has not yet been established.
    Patients with renal impairment: No dose change is recommended in patients with renal impairment, including those with end-stage renal disease.


    Indications

    Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy, given at intervals of 14 days or more, for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    The safety and efficacy of Neulastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukemia, and in patients with secondary AML; therefore, it should not be used in such patients. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukemia from AML.
    The safety and efficacy of Neulastim have not been investigated in patients receiving high dose chemotherapy. This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
    Pulmonary adverse events: Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk. The onset of pulmonary signs such as cough, fever, and dyspnea in association with radiological signs of
    pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS). In such circumstances Neulastim should be discontinued at the discretion of the physician and the appropriate treatment given.
    Capillary leak syndrome: Capillary leak syndrome has been reported after granulocyte-colony stimulating factor administration and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.
    Splenomegaly and splenic rupture: Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim. Therefore, spleen size
    should be carefully monitored (e.g., clinical examination, ultrasound). A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain.
    Thrombocytopenia and anemia: Treatment with Neulastim alone does not preclude thrombocytopenia and anemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule. Regular monitoring of platelet count and hematocrit is recommended. Special care should be taken when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia.
    Sickle cell anemia: Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell trait or sickle cell disease. Therefore, physicians should use caution when prescribing Neulastim in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicine with splenic enlargement and vaso-occlusive crisis.
    Hypersensitivity: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with Neulastim. Permanently discontinue Neulastim in patients with clinically significant hypersensitivity. Do not administer Neulastim to patients with a history of hypersensitivity to pegfilgrastim or filgrastim. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days.
    Stevens-Johnson syndrome: Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment. If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time.
    See prescribing information for full details.


    Side Effects

    The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common [≥ 1/100 to < 1/10]). Bone pain was generally of mild to moderate severity, transient and could be controlled in most patients with standard analgesics.
    Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnea, erythema, flushing, and hypotension occurred on initial or subsequent treatment with Neulastim (uncommon [≥ 1/1,000 to < 1/100]). Serious allergic reactions, including anaphylaxis can occur in patients receiving Neulastim (uncommon).
    Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon (≥ 1/1,000 to < 1/100) in cancer patients undergoing chemotherapy following administration of granulocyte-colony stimulating factors.
    Splenomegaly, generally asymptomatic, is uncommon.
    Splenic rupture including some fatal cases is uncommonly reported following administration of pegfilgrastim.
    Uncommon pulmonary adverse reactions including interstitial pneumonia, pulmonary edema, pulmonary infiltrates and pulmonary fibrosis have been reported. Uncommonly, cases have resulted in respiratory failure or ARDS, which may be fatal.
    Isolated cases of sickle cell crises have been reported in patients with sickle cell trait or sickle cell disease (uncommon in sickle cell patients).
    See prescribing information for full details.


    Drug interactions

    Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ Neulastim should be administered at least 24 hours after administration of cytotoxic chemotherapy. In clinical trials, Neulastim has been safely administered 14 days before chemotherapy. Concomitant use of Neulastim with any chemotherapy agent has not been evaluated in patients. In animal models concomitant administration of Neulastim and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
    Possible interactions with other hematopoietic growth factors and cytokines have not been specifically investigated in clinical trials.
    The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated. There is no evidence that such an interaction would be harmful.
    The safety and efficacy of Neulastim have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
    Specific interaction or metabolism studies have not been performed; however, clinical trials have not indicated an interaction of Neulastim with any other medicinal products.


    Pregnancy and Lactation

    Pregnancy: There are no or limited amount of data from the use of pegfilgrastim in pregnant women. Neulastim is not recommended during pregnancy and in women of childbearing potential not using contraception.
    Lactation: There is insufficient information on the excretion of Pegfilgrastim/ metabolites in human milk, a risk to the newborns/ infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Neulastim therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
    See prescribing information for full details.      


    Overdose

    Single doses of 300 μg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions. The adverse events were similar to those in subjects receiving lower doses of pegfilgrastim.


    Important notes

    Storage: Store in a refrigerator  (2°C – 8°C). Pegfilgrastim may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours. Pegfilgrastim left at room temperature for more than 72 hours should be discarded. Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Pegfilgrastim. Keep the container in the outer carton, in order to protect from light.


    Manufacturer
    Amgen Europe B.V., Breda, Netherlands.
    Licence holder
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