Celstemx 24mg Injection

Plerixafor is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM). Plerixafor, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Anaphylactic Shock and Serious Hypersensitivity Reactions have occurred. Monitor patients during and after completion of Plerixafor administration. Tumor Cell Mobilization in Leukemia Patients: Plerixafor may mobilize leukemic cells and should not be used in leukemia patients. Hematologic Effects: Increased circulating leukocytes and decreased platelet counts have been observed. Monitor blood cell counts and platelet counts during Plerixafor use. Potential for Tumor Cell Mobilization: Tumor cells may be released from marrow during HSC mobilization with Plerixafor and filgrastim. Effect of reinfusion of tumor cells is unknown. Splenic Rupture: Evaluate patients who report left upper abdominal and/or scapular or shoulder pain. Embryo-Fetal Toxicity: Can cause fetal harm. Advise women not to become pregnant when taking Plerixafor. Anaphylactic Shock and Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening with clinically significant hypotension and shock have occurred in patients receiving Plerixafor. Observe patients for signs and symptoms of hypersensitivity during and after Plerixafor administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Plerixafor when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. In clinical studies, mild or moderate allergic reactions occurred within approximately 30 minutes after Plerixafor administration in less than 1% of patients. Tumor Cell Mobilization in Leukemia Patients For the purpose of HSC mobilization, Plerixafor may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, Plerixafor is not intended for HSC mobilization and harvest in patients with leukemia. Hematologic Effects Leukocytosis Administration of Plerixafor in conjunction with filgrastim increases circulating leukocytes as well as HSC populations. Monitor white blood cell counts during Plerixafor use. Thrombocytopenia has been observed in patients receiving Plerixafor. Monitor platelet counts in all patients who receive Plerixafor and then undergo apheresis. Potential for Tumor Cell Mobilization When Plerixafor is used in combination with filgrastim for HSC mobilization‚ tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are discussed elsewhere in the labeling: Anaphylactic shock and hypersensitivity reactions Potential for tumor cell mobilization in leukemia patients Increased circulating leukocytes and decreased platelet counts Potential for tumor cell mobilization Splenic enlargement Most common adverse reactions (≥10%): diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness, and vomiting. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (≥10%) reported in patients who received Plerixafor in conjunction with filgrastim regardless of causality and more frequent with Plerixafor than placebo during HSC mobilization and apheresis were diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness, and vomiting. Safety data for Plerixafor in combination with filgrastim were obtained from two randomized placebo-controlled studies (301 patients) and 10 uncontrolled studies (242 patients). Patients were primarily treated with Plerixafor at daily doses of 0.24 mg/kg SC. Median exposure to Plerixafor in these studies was 2 days (range 1 to 7 days). In the two randomized studies in patients with NHL and MM, a total of 301 patients were treated in the Plerixafor and filgrastim group and 292 patients were treated in the placebo and filgrastim group. Patients received daily morning doses of filgrastim 10 mcg/kg for 4 days prior to the first dose of Plerixafor 0.24 mg/kg SC or placebo and on each morning prior to apheresis. The adverse reactions that occurred in ≥5% of the patients who received Plerixafor regardless of causality and were more frequent with Plerixafor than placebo during HSC mobilization and apheresis are shown in Table 2. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.