플레릭사포르

Plerixafor injection 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 injection, 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.

Plerixafor is contraindicated in patients with a history of hypersensitivity to plerixafor [see Warnings and Precautions (5.1)]. Anaphylactic shock has occurred with use of plerixafor. History of hypersensitivity to plerixafor. (4)

Anaphylactic Shock and Serious Hypersensitivity Reactions have occurred. Monitor patients during and after completion of plerixafor administration. (5.1) Tumor Cell Mobilization in Leukemia Patients: Plerixafor may mobilize leukemic cells and should not be used in leukemia patients. (5.2) Hematologic Effects: Increased circulating leukocytes and decreased platelet counts have been observed. Monitor blood cell counts and platelet counts during plerixafor use. (5.3) 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. (5.4) Splenic Rupture: Evaluate patients who report left upper abdominal and/or scapular or shoulder pain. (5.5) Embryo-Fetal Toxicity: Can cause fetal harm. Advise women not to become pregnant when taking plerixafor. ( 5.6 , 8.1 ) 5.1 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 [see Adverse Reactions (6.2)]. 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 …

8.1 Pregnancy Risk Summary Limited available data with plerixafor use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, subcutaneous administration of plerixafor to pregnant rats during organogenesis at doses 10-times the maximum recommended human doses resulted in embryo-fetal mortality, structural abnormalities, and alterations to growth [see Data] . Advise pregnant women of the potential risk to the fetus. Advise women of reproductive potential to avoid becoming pregnant while receiving treatment with plerixafor [ see Warnings and Precautions (5.6) ] . In the U.S. general population, the estimated …