plerixafor (plerixafor) instructions
Common name: plerixafor
Trade name: Mozobil
Full names: Mozobil, plerixafor, plerixafor, plerixafor, plerixafor
Indications:
For the treatment of adults with multiple myeloma or non-Hodgkin lymphoma.
Usage and dosage:
Combined treatment with G-CSF (Granulocyte Colony Stimulating Factor), once a day, for up to 4 consecutive days.
The corresponding dose corresponds to actual body weight: 0.24mg/kg, maximum dose: 40mg/day.
Renal impairment (creatinine clearance ≤50mL/min): 0.16mg/kg, maximum dose: 27mg/day.
For subcutaneous injection.
Adverse reactions:
Anaphylactic shock and allergic reactions, tumor cell mobilization in leukemia patients, increased circulating leukocytes, thrombocytopenia, tumor cell mobilization, gastrointestinal discomfort, fatigue, injection site reactions, headache, joint pain, dizziness, splenomegaly, vasovagal reactions
Contraindications:
Contraindicated for those allergic to any component of plerixafor.
Precautions:
Anaphylactic Shock and Anaphylaxis: Severe hypersensitivity reactions, including anaphylaxis, life-threatening clinically significant hypotension and shock have occurred in patients treated with plerixafor. Observe patients for allergic symptoms during and for at least 30 minutes after plerixafor administration until clinical stabilization at the end of each dose. Plerixafor should be used only if personnel and treatments are immediately available to treat anaphylaxis and other hypersensitivity reactions. In clinical studies, less than 1% of patients experienced mild or moderate allergic reactions within approximately 30 minutes of plerixafor administration.
Mobilization of tumor cells in patients with leukemia: In order to mobilize HSC (hepatic stellate cells), plerixafor may cause mobilization of leukemia cells and subsequent contamination of the collected materials. Therefore, plerixafor is not recommended for HSC (hepatic stellate cell) mobilization and collection from leukemia patients.
Hematology effects: increased leukocytes and decreased platelets.
Splenomegaly and Rupture: Increases in absolute and relative weight of the spleen associated with extramedullary hematopoiesis were observed following prolonged (2-4 weeks) daily administration of Mozobil in rats at doses approximately 4 times the recommended human dose based on body surface area. The effect of Mozobil on patients' spleen size has not been clearly evaluated in clinical studies. Cases of Mozobil combined with growth factor G-CSF to treat splenic enlargement or rupture have been reported. To evaluate the spleen integrity of patients with Mozobil combined with G-CSF for the treatment of left upper quadrant pain or scapular or shoulder pain.
Fetal toxicity: Pregnant women may harm the fetus when using this product. Plerixafor has teratogenic effects in animals. There are no adequate and well-controlled studies on the use of this product in pregnant women. It is recommended that women of childbearing potential use effective contraception during administration of this product. If this drug is used during pregnancy, or if pregnancy occurs while the patient is taking this drug, the patient should be informed of the potential harm to the fetus.
QT/QTc prolongation: There is no QT/QTc (time limit from Q wave to T wave) prolongation effect of this product when the single dose reaches 0.40 mg/kg. In a randomized, double-blind, crossover study, 48 subjects received a single subcutaneous injection of plerixafor (0.24 mg/kg and 0.40 mg/kg) and placebo. The peak concentration of this product at 0.40 mg/kg is approximately 1.8 times the peak concentration after a single subcutaneous dose of 0.24 mg/kg.
Effects on the ability to drive and operate machinery: This product may affect the ability to drive and operate machinery. Some patients experience dizziness, fatigue, or vasovagal reactions; therefore, caution should be used when driving and operating machinery.
Storage:
The allowable temperature range is 15-30℃.
Mechanism of action:
Plerixafor is an inhibitor of the chemokine receptor CXCR4, blocking the binding of CXCR4 to its cognate ligand (stromal cell-derived factor-1a, SDF-1a). Research suggests that SDF-1a and CXCR4 play a role in the directional movement and homing of human HSCs to the bone marrow. Once in the bone marrow, stem cell CXCR4 helps these cells localize to the bone marrow stroma either directly through SDF-1a or by inducing other adhesion factors. Plerixafor causes leukocytosis and an increase in the number of hematopoietic progenitor cells in the circulation in mice, dogs, and humans. In a canine transplant model, CD34 cells mobilized by plerixafor were capable of engraftment and regeneration for years.
Safety and Efficacy: In the pivotal clinical study of Plerixafor Injection, 59% of NHL patients receiving the combination of Mozobil and G-CSF were treated with a target number of at least 5 million stem cells/Kg collected by body weight in 4 or fewer apheresis sessions, compared with 20% of patients receiving placebo. The average number of days to reach target cell number was 3 days in the Mozobil treatment group and was not evaluated in the placebo group. Seventy-two percent of MM patients receiving Mozobil in combination with G-CSF aimed to collect a target number of at least 6 million stem cells/kg of body weight in 2 or fewer apheresis sessions, compared with 28% of patients receiving placebo. The average number of days to reach target cell numbers was 1 day in the Mozobil treatment group and 4 days in the placebo group.
.jpeg)