Finished product reference

Plerixafor

Injection · Parenteral · 20 mg/1mL · 1.2 mL

List code
22412
Pharmacologic class
Hematopoietic Stem Cell Mobilizer

What it is and how it works

Mechanism of Action Plerixafor is an inhibitor of the CXCR4 chemokine receptor and blocks binding of its cognate ligand, stromal cell-derived factor-1α (SDF-1α). SDF-1α and CXCR4 are recognized to play a role in the trafficking and homing of human hematopoietic stem cells (HSCs) to the marrow compartment. Once in the marrow, stem cell CXCR4 can act to help anchor these cells to the marrow matrix, either directly via SDF-1α or through the induction of other adhesion molecules. Treatment with plerixafor resulted in leukocytosis and elevations in circulating hematopoietic progenitor cells in mice, dogs and humans.

Indications

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.

Dosage and administration (summary)

Initiate plerixafor injection treatment after the patient has received filgrastim once daily for 4 days. Repeat plerixafor injection dose up to 4 consecutive days. Dose based on patient weight Less than or equal to 83 kg: 20 mg dose or select dose based on 0.24 mg/kg actual body weight. greater than 83 kg: select dose based on 0.24 mg/kg actual body weight. Administer by subcutaneous injection approximately 11 hours prior to initiation of apheresis. Renal impairment: If creatinine clearance is ≤50 mL/min, decrease dose by one-third to 0.16 mg/kg. Recommended Dosage and Administration Begin treatment with plerixafor injection after the patient has received filgrastim once daily for 4 days .

Contraindications

Plerixafor injection is contraindicated in patients with a history of hypersensitivity to plerixafor . Anaphylactic shock has occurred with use of plerixafor. History of hypersensitivity to plerixafor.

Warnings and precautions

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.

Pregnancy

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 e…

Storage and supply

Plerixafor injection, 24 mg/1.2 mL (20 mg/mL) is a sterile, preservative-free, clear, colorless to pale-yellow solution supplied in a 4 mL clear glass single-dose vial. 24 mg per 1.2 mL (20 mg/mL) Single-Dose Vial Packaged Individually NDC 55150-356-01 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

Source: Plerixafor (Plerixafor) — US FDA prescribing information, 2024-06-28, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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