Plerixafor
Generic Name: plerixafor
Brand Names:
Plerixafor
11 DESCRIPTION Plerixafor injection, USP is a sterile, preservative-free, clear, colorless to pale-yellow, isotonic solution for subcutaneous injection. Each mL of the sterile solution contains 20 mg of plerixafor, USP. Each single-dose vial is filled to deliver 1.2 mL of the sterile solution that contains 24 mg of plerixafor and 5.9 mg of sodium chloride in Water for Injection adjusted to a pH of 6.0 to 7.5 with hydrochloric acid and with sodium hydroxide, if required.
Overview
11 DESCRIPTION Plerixafor injection, USP is a sterile, preservative-free, clear, colorless to pale-yellow, isotonic solution for subcutaneous injection. Each mL of the sterile solution contains 20 mg of plerixafor, USP. Each single-dose vial is filled to deliver 1.2 mL of the sterile solution that contains 24 mg of plerixafor and 5.9 mg of sodium chloride in Water for Injection adjusted to a pH of 6.0 to 7.5 with hydrochloric acid and with sodium hydroxide, if required.
Uses
1 INDICATIONS AND USAGE 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. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION • Initiate plerixafor injection treatment after the patient has received filgrastim once daily for 4 days. ( 2.1 ) • Repeat plerixafor injection dose up to 4 consecutive days. ( 2.1 ) • 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. ( 2.1 ) • greater than 83 kg: select dose based on 0.24 mg/kg actual body weight. ( 2.1 ) • Administer by subcutaneous injection approximately 11 hours prior to initiation of apheresis. ( 2.1 ) • Renal impairment: If creatinine clearance is ≤50 mL/min, decrease dose by one-third to 0.16 mg/kg.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: • Anaphylactic shock and hypersensitivity reactions [see Warnings and Precautions (5.1) ] • Potential for tumor cell mobilization in leukemia patients [see Warnings and Precautions (5.2) ] • Increased circulating leukocytes and decreased platelet counts [see Warnings and Precautions (5.3) ] • Potential for tumor cell mobilization [see Warnings and Precautions (5.4) ] • Splenic enlargement [see Warnings and Precautions (5.5) ] Most common adverse reactions (≥10%): diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness, and vomiting.
Warnings
5 WARNINGS AND PRECAUTIONS • 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. 4 CONTRAINDICATIONS Plerixafor injection 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 )
Pregnancy
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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Plerixafor injection USP, 24 mg/1.2 mL (20 mg/mL) is a sterile, preservative-free, clear, colorless to pale yellow solution supplied in a 2 mL clear glass single-dose vial. NDC Number: 31722-373-31 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Discard unused portion.
Frequently Asked Questions
What is Plerixafor used for?▼
1 INDICATIONS AND USAGE 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. ( 1 )
What are the side effects of Plerixafor?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: • Anaphylactic shock and hypersensitivity reactions [see Warnings and Precautions (5.1) ] • Potential for tumor cell mobilization in leukemia patients [see Warnings and Precautions (5.2) ] • Increased circulating leukocytes and decreased platelet counts [see Warnings and Precautions (5.3) ] • Potential for tumor cell mobilization [see Warnings and Precautions (5.4) ] • Splenic enlargement [see Warnings and Precautions (5.5) ] Most common adverse reactions (≥10%): diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness, and vomiting.
Can I take Plerixafor during pregnancy?▼
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.
What are the important warnings for Plerixafor?▼
5 WARNINGS AND PRECAUTIONS • 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. 4 CONTRAINDICATIONS Plerixafor injection 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.