Plerixafor 24 mg/1.2mL Injection, Solution, 1 vial
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Hematopoietic Stem Cell Mobilizer class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Plerixafor injection is used along with a granulocyte-colony stimulating factor (G-CSF) medication such as filgrastim (Neupogen) or pegfilgrastim (Neulasta) to prepare the blood for an autologous stem cell transplant (procedure in which certain blood cells are removed from the body and then returned to the body after chemotherapy and/or radiation) in patients with non-Hodgkin's lymphoma (NHL; cancer that begins in a type of white blood cells that normally fights infection) or multiple myeloma (a type of cancer of the bone marrow). Plerixafor injection is in a class of medications called hemato...
Read the full MedlinePlus article ↗- Think of your bone marrow as a warehouse where stem cells are stored and locked in place. Plerixafor is like a key that unlocks those cells and releases them into your bloodstream,...
- What exactly does Plerixafor Injection do, and why do I need it?
- Filgrastim and plerixafor work together as a team. Filgrastim starts the process of stimulating stem cell production over those first 4 days, and then plerixafor comes in to give a...
- Why do I have to take filgrastim shots for 4 days before starting plerixafor?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
-
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Mozobil 24 mg/1.2mL 00024-5862-01 | Sanofi-Aventis | 1 vial | — | AP | FDA listed | — |
| Plerixafor 20 mg/mL 25021-0416-01 | Sagent | 1 vial | — | AP | FDA listed | — |
| Plerixafor 24 mg/1.2mL 31722-0373-31 | Camber | 1 vial | — | AP | FDA listed | — |
| Plerixafor 24 mg/1.2mL 43598-0308-23 | Dr. | 1 vial | — | AP | FDA listed | — |
| Plerixafor 24 mg/1.2mL 55150-0356-01 | Eugia | 1 vial | — | AP | FDA listed | — |
| Plerixafor 24 mg/1.2mL 65219-0284-12 | Fresenius | 1 vial | — | AP | FDA listed | — |
| Plerixafor 24 mg/1.2mLthis 68083-0155-01 | Gland | 1 vial | — | AP | FDA listed | — |
| plerixafor 24 mg/1.2mL 70121-1694-02 | Amneal | 1 vial | — | AP | FDA listed | — |
| Plerixafor 24 mg/1.2mL 70710-1208-01 | Zydus | 1 vial | — | — | FDA listed | — |
| Plerixafor 24 mg/1.2mL 70771-1776-01 | Zydus | 1 vial | — | — | FDA listed | — |
| Plerixafor 24 mg/1.2mL 71288-0155-01 | Meitheal | 1 vial | — | AP | FDA listed | — |
| Plerixafor 24 mg/1.2mL 72162-2642-02 | Bryant | 1 vial | — | AP | FDA listed | — |
| Plerixafor 24 mg/1.2mL 72205-0249-01 | Novadoz | 1 vial | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 68083-0155-01 You're viewing this | 1 VIAL in 1 CARTON (68083-155-01) / 1.2 mL in 1 VIAL | 2024-05-03 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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.
⏱️ Dosage and Administration ▾
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.
( 2.3 )
2.1Recommended Dosage and Administration Begin treatment with Plerixafor Injection after the patient has received filgrastim once daily for 4 days [see Dosage and Administration ( 2.2 )]. Administer Plerixafor Injection approximately 11 hours prior to initiation of each apheresis for up to 4 consecutive days. The recommended dose of Plerixafor Injection by subcutaneous injection is based on body weight: • 20 mg fixed dose or 0.24 mg/kg of body weight for patients weighing ess than or equal to 83 kg. [see Clinical Pharmacology ( 12.3 )] • 0.24 mg/kg of body weight for patients weighing greater than 83 kg.
Use the patient’s actual body weight to calculate the volume of Plerixafor Injection to be administered. Each vial delivers 1.2 mL of 20 mg/mL solution, and the volume to be administered to patients should be calculated from the following equation: 0.012 × patient’s actual body weight (in kg) = volume to be administered (in mL) In clinical studies, Plerixafor Injection dose has been calculated based on actual body weight in patients up to 175% of ideal body weight. Plerixafor Injection dose and treatment of patients weighing more than 175% of ideal body weight have not been investigated.
Based on increasing exposure with increasing body weight, the Plerixafor Injection dose should not exceed 40 mg/day [see Clinical Pharmacology ( 12.3 )]. Vials should be inspected visually for particulate matter and discoloration prior to administration and should not be used if there is particulate matter or if the solution is discolored. Discard unused portion.
2.2Recommended Concomitant Medications Administer daily morning doses of filgrastim 10 mcg/kg for 4 days prior to the first evening dose of Plerixafor Injection and on each day prior to apheresis [see Clinical Studies ( 14 )].
2.3Dose Modifications in Renal Impairment In patients with moderate and severe renal impairment (estimated creatinine clearance (CL CR ) less than or equal to 50 mL/min), reduce the dose of Plerixafor Injection by one-third based on body weight category as shown in Table 1. If CL CR is less than or equal to 50 mL/min the dose should not exceed 27 mg/day, as the mg/kg based dosage results in increased plerixafor exposure with increasing body weight [see Clinical Pharmacology ( 12.3 )]. Similar systemic exposure is predicted if the dose is reduced by one-third in patients with moderate and severe renal impairment compared with subjects with normal renal function [see Clinical Pharmacology ( 12.3 )].
Table 1: Recommended Dosage of Plerixafor Injection in Patients with Renal Impairment Estimated Creatinine Clearance (mL/min) Dose Body Weight less than or equal to 83 kg Body Weight greater than 83 kg and less than 160 kg greater than 50 20 mg or 0.24 mg/kg once daily 0.24 mg/kg once daily (not to exceed 40 mg/day) less than or equal to 50 13 mg or 0.16 mg/kg once daily 0.16 mg/kg once daily (not to exceed 27 mg/day) The following (Cockroft-Gault) formula may be used to estimate CL CR : Males: Creatinine clearance (mL/min) = weight (kg) X (140 – age in years) 72 × serum creatinine (mg/dL) Females: Creatinine clearance (mL/min) = 0.85 × value calculated for males There is insufficient information to make dosage recommendations in patients on hemodialysis.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 24 mg/1.2 mL (20 mg/mL) sterile, clear, colorless to pale-yellow solution in a single-dose vial. • Injection: 24 mg/1.2 mL (20 mg/mL) in a single-dose vial.
⛔ Contraindications ▾
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 Injection. • History of hypersensitivity to Plerixafor Injection.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Anaphylactic shock and Serious Hypersensitivity Reactions have occurred. Monitor patients during and after completion of Plerixafor Injection administration. ( 5.1 ) • Tumor Cell Mobilization in Leukemia Patients: Plerixafor Injection 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 Injection use. ( 5.3 ) • Potential for Tumor Cell Mobilization: Tumor cells may be released from marrow during HSC mobilization with Plerixafor Injection 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 Injection. ( 5.6 , 8.1 )
5.1Anaphylactic 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 Injection [see Adverse Reactions ( 6.2 )] . Observe patients for signs and symptoms of hypersensitivity during and after Plerixafor Injection administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Plerixafor Injection 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 Injection administration in less than 1% of patients [see Adverse Reactions ( 6.1 )] .
5.2Tumor Cell Mobilization in Leukemia Patients For the purpose of HSC mobilization, Plerixafor Injection may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, Plerixafor Injection is not intended for HSC mobilization and harvest in patients with leukemia.
5.3Hematologic Effects Leukocytosis Administration of Plerixafor Injection in conjunction with filgrastim increases circulating leukocytes as well as HSC populations. Monitor white blood cell counts during Plerixafor Injection use [see Adverse Reactions ( 6.1 )]. Thrombocytopenia Thrombocytopenia has been observed in patients receiving Plerixafor Injection.
Monitor platelet counts in all patients who receive Plerixafor Injection and then undergo apheresis.
5.4Potential for Tumor Cell Mobilization When Plerixafor Injection 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.
5.5Splenic Enlargement and Rupture Higher absolute and relative spleen weights associated with extramedullary hematopoiesis were observed following prolonged (2 to 4 weeks) daily plerixafor SC administration in rats at doses approximately 4-fold higher than the recommended human dose based on body surface area. The effect of Plerixafor Injection on spleen size in patients was not specifically evaluated in clinical studies. Cases of splenic enlargement and/or rupture have been reported following the administration of Plerixafor Injection in conjunction with filgrastim.
Evaluate individuals receiving Plerixafor Injection in combination with filgrastim who report left upper abdominal pain and/or scapular or shoulder pain for splenic integrity.
5.6Embryo-Fetal Toxicity Based on findings from animal reproduction studies, Plerixafor Injection can cause fetal harm when administered to a pregnant woman. Plerixafor administration to pregnant rats during organogenesis resulted in embryo-fetal mortality, structural abnormalities, and alteration…
🤒 Adverse Reactions ▾
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.
To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 864-879-9994 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical 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 Injection in conjunction with filgrastim regardless of causality and more frequent with Plerixafor Injection than placebo during HSC mobilization and apheresis were diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness, and vomiting.
Safety data for Plerixafor Injection 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 Injection at daily doses of 0.24 mg/kg SC. Median exposure to Plerixafor Injection 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 Injection 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 Injection 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 Injection regardless of causality and were more frequent with Plerixafor Injection than placebo during HSC mobilization and apheresis are shown in Table 2.
Table 2: Adverse Reactions in ≥ 5% of Non-Hodgkin’s Lymphoma and Multiple Myeloma Patients Receiving Plerixafor Injection and More Frequent than Placebo during HSC Mobilization and Apheresis Percent of Patients (%) Plerixafor Injection and Filgrastim (n = 301) Placebo and Filgrastim (n = 292) All Grades a Grade 3 Grade 4 All Grades Grade 3 Grade 4 Gastrointestinal disorders Diarrhea 37 < 1 0 17 0 0 Nausea 34 1 0 22 0 0 Vomiting 10 < 1 0 6 0 0 Flatulence 7 0 0 3 0 0 General disorders and administration site conditions Injection site reactions 34 0 0 10 0 0 Fatigue 27 0 0 25 0 0 Musculoskeletal and connective tissue disorders Arthralgia 13 0 0 12 0 0 Nervous system disorders Headache 22 < 1 0 21 1 0 Dizziness 11 0 0 6 0 0 Psychiatric disorders Insomnia 7 0 0 5 0 0 a Grades based on criteria from the World Health Organization (WHO) In the randomized studies, 34% of patients with NHL or MM had mild to moderate injection site reactions at the site of subcutaneous administration of Plerixafor Injection.
These included erythema, hematoma, hemorrhage, induration, inflammation, irritation, pain, paresthesia, pruritus, rash, swelling, and urticaria. Mild to moderate allergic reactions were observed in less than 1% of patients within approximately 30 min after Plerixafor Injection administration, including one or more of the following: urticaria (n = 2), periorbital swelling (n = 2), dyspnea (n = 1) or hypoxia (n = 1). Symptoms generally responded to treatments (e.g., antihistamines, corticosteroids, hydration or supp…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 )
8.1Pregnancy Risk Summary Limited available data with Plerixafor Injection 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 Injection [see Warnings and Precautions ( 5.6 ) ]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
The background risk of major birth defects and miscarriages for the indicated population is unknown. Data Animal Data Plerixafor administered to pregnant rats induced embryo-fetal toxicity, including fetal death, increased resorptions and post-implantation loss, decreased fetal weights, anophthalmia, shortened digits, cardiac interventricular septal defect, ringed aorta, globular heart, hydrocephaly, dilatation of olfactory ventricles, and retarded skeletal development. Embryo-fetal toxicities occurred mainly at a dose of 90 mg/m 2 (approximately 10 times the recommended human dose of 0.24 mg/kg when compared on a mg/m 2 basis).
8.2Lactation Risk Summary There are no data on the presence of plerixafor in human milk, the effect on the breastfed child, or the effect on milk production. Because of the potential serious adverse reactions in the breastfed child, advise females that breastfeeding is not recommended during treatment with Plerixafor Injection and for one week after the final dose.
8.3Females and Males of Reproductive Potential Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating Plerixafor Injection [see Use in Specific Populations ( 8.1 )]. Contraception Females Plerixafor Injection can cause embryo-fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1 )]. Advise females of reproductive potential to use effective contraception during treatment with Plerixafor Injection and for one week after the final dose.
Males Males treated with Plerixafor Injection should use effective contraception during treatment and for one week after cessation of treatment.
8.4Pediatric Use The safety and effectiveness of Plerixafor Injection have not been established in pediatric patients. Effectiveness was not demonstrated in a single phase 1/2 randomized, open-label, comparative study of Plerixafor Injection plus standard regimens for mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation. Forty-five pediatric patients ages 1 to <17 years with solid tumors or lymphoma were randomized 2:1 to Plerixafor Injection in addition to standard mobilization regimens (N=30) or standard mobilization regimens alone (N=15) (comparator arm).
No new safety signals were observed in pediatric patients in this trial. The day prior to the first apheresis, median peripheral blood CD34+ counts were 35 × 10 6 cells/L in the comparator arm and 15 × 10 6 cells/L in the Plerixafor Injection arm. On the day of the first apheresis, median peripheral blood CD34+ counts were 64 × 10 6 cells/L in the comparator arm and 77 × 10 6 cells/L in the Plerixafor Injection arm.
Plerixafor exposure, shown as AUC, in pediatric patients aged 12 to 18 years was within the range of values previously observed in adults, while the AUC of plerixafor in pediatric patients aged 2 to 12 years was 67% to 87% of that observed in adults, given the same a…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Limited available data with Plerixafor Injection 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 Injection [see Warnings and Precautions ( 5.6 ) ]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
The background risk of major birth defects and miscarriages for the indicated population is unknown. Data Animal Data Plerixafor administered to pregnant rats induced embryo-fetal toxicity, including fetal death, increased resorptions and post-implantation loss, decreased fetal weights, anophthalmia, shortened digits, cardiac interventricular septal defect, ringed aorta, globular heart, hydrocephaly, dilatation of olfactory ventricles, and retarded skeletal development. Embryo-fetal toxicities occurred mainly at a dose of 90 mg/m 2 (approximately 10 times the recommended human dose of 0.24 mg/kg when compared on a mg/m 2 basis).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of Plerixafor Injection have not been established in pediatric patients. Effectiveness was not demonstrated in a single phase 1/2 randomized, open-label, comparative study of Plerixafor Injection plus standard regimens for mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation. Forty-five pediatric patients ages 1 to <17 years with solid tumors or lymphoma were randomized 2:1 to Plerixafor Injection in addition to standard mobilization regimens (N=30) or standard mobilization regimens alone (N=15) (comparator arm).
No new safety signals were observed in pediatric patients in this trial. The day prior to the first apheresis, median peripheral blood CD34+ counts were 35 × 10 6 cells/L in the comparator arm and 15 × 10 6 cells/L in the Plerixafor Injection arm. On the day of the first apheresis, median peripheral blood CD34+ counts were 64 × 10 6 cells/L in the comparator arm and 77 × 10 6 cells/L in the Plerixafor Injection arm.
Plerixafor exposure, shown as AUC, in pediatric patients aged 12 to 18 years was within the range of values previously observed in adults, while the AUC of plerixafor in pediatric patients aged 2 to 12 years was 67% to 87% of that observed in adults, given the same adult dose (0.24 mg/kg).
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of subjects in controlled clinical studies of Plerixafor Injection, 24% were 65 and over, while 0.8% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Since plerixafor is mainly excreted by the kidney, no dose modifications are necessary in elderly individuals with normal renal function.
In general, care should be taken in dose selection for elderly patients due to the greater frequency of decreased renal function with advanced age. Dosage adjustment in elderly patients with CL CR less than or equal to 50 mL/min is recommended [see Dosage and Administration ( 2.3 ) and Clinical Pharmacology ( 12.3 )].
🆘 Overdosage ▾
10 OVERDOSAGE Based on limited data at doses above the recommended dose of 0.24 mg/kg SC, the frequency of gastrointestinal disorders, vasovagal reactions, orthostatic hypotension, and/or syncope may be higher.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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. CD34+ cells mobilized by plerixafor were capable of engraftment with long-term repopulating capacity up to one year in canine transplantation models.
12.2Pharmacodynamics Data on the fold increase in peripheral blood CD34+ cell count (cells/mcL) by apheresis day were evaluated in two placebo-controlled clinical studies in patients with NHL and MM (Study 1 and Study 2, respectively). The fold increase in CD34+ cell count (cells/mcL) over the 24-hour period starting from the day prior to the first apheresis and ending the next morning just before the first apheresis is summarized in Table 3. During this 24-hour period, a single dose of Plerixafor Injection or placebo was administered 10 to 11 hours prior to apheresis.
Table 3: Fold Increase in Peripheral Blood CD34+ Cell Count Following Pretreatment with Filgrastim and Administration of Plerixafor Study Plerixafor Injection and Filgrastim Placebo and Filgrastim Median Mean (SD) Median Mean (SD) Study 1 5.0 6.1 (5.4) 1.4 1.9 (1.5) Study 2 4.8 6.4 (6.8) 1.7 2.4 (7.3) In pharmacodynamic studies of Plerixafor Injection in healthy volunteers, peak mobilization of CD34+ cells was observed between 6 and 9 hours after administration. In pharmacodynamic studies of Plerixafor Injection in conjunction with filgrastim in healthy volunteers, a sustained elevation in the peripheral blood CD34+ count was observed from 4 to 18 hours after plerixafor administration with a peak CD34+ count between 10 and 14 hours.
QT/QTc Prolongation There is no indication of a QT/QTc prolonging effect of Plerixafor Injection in single doses up to 0.40 mg/kg. In a randomized, double-blind, crossover study, 48 healthy subjects were administered a single subcutaneous dose of plerixafor (0.24 mg/kg and 0.40 mg/kg) and placebo. Peak concentrations for 0.40 mg/kg Plerixafor Injection were approximately 1.8-fold higher than the peak concentrations following the 0.24 mg/kg single subcutaneous dose.
12.3Pharmacokinetics The single-dose pharmacokinetics of plerixafor 0.24 mg/kg were evaluated in patients with NHL and MM following pretreatment with filgrastim (10 mcg/kg once daily for 4 consecutive days). Plerixafor exhibits linear kinetics between the 0.04 mg/kg to 0.24 mg/kg dose range. The pharmacokinetics of plerixafor was similar across clinical studies in healthy subjects who received plerixafor alone and NHL and MM patients who received plerixafor in combination with filgrastim.
A population pharmacokinetic analysis incorporated plerixafor data from 63 subjects (NHL patients, MM patients, subjects with varying degrees of renal impairment, and healthy subjects) who received a single SC dose (0.04 mg/kg to 0.24 mg/kg) of plerixafor. A two-compartment disposition model with first order absorption and elimination was found to adequately describe the plerixafor concentration-time profile. Significant relationships between clearance and creatinine clearance (CL CR ), as well as between central volume of distribution and body weight were observed.
The distribution half-life (t 1/2α ) was estimated to be 0.3 hours and the terminal population half-life (t 1/2β ) was 5.3 hours in patients with normal renal function. The population pharmacokinetic analysis showed that the mg/kg-based dosage results in an increased plerixafor exposure (AUC 0-24h ) with increasing body weight. In order to c…
🧬 Mechanism of Action ▾
12.1Mechanism 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. CD34+ cells mobilized by plerixafor were capable of engraftment with long-term repopulating capacity up to one year in canine transplantation models.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Plerixafor injection 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: 68083-155-01 Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Plerixafor Injection 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. 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.
Plerixafor is a hematopoietic stem cell mobilizer with a chemical name 1,4-Bis((1,4,8,11tetraazacyclotetradecan-1-yl)methyl)benzene. It has the molecular formula C 28 H 54 N 8 . The molecular weight of plerixafor is 502.79 g/mol.
The structural formula is provided in Figure 1. Figure 1: Structural Formula Plerixafor is a white to off-white crystalline solid. It is hygroscopic.
Plerixafor has a typical melting point of 131.5 °C. The partition coefficient of plerixafor between 1-octanol and pH 7 aqueous buffer is < 0.1. Plerixafor-SPL-Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients of the potential for anaphylactic reactions, including signs and symptoms such as urticaria, periorbital swelling, dyspnea, or hypoxia during and following Plerixafor Injection and to report these symptoms immediately to a healthcare professional [see Adverse Reactions ( 6.1 ), ( 6.2 )]. Advise patients to contact healthcare professional immediately if they experience left upper abdominal pain and/or scapular or shoulder pain [see Adverse Reactions ( 6.1 ), ( 6.2 )].
Advise patients to inform the healthcare professional immediately if symptoms of vasovagal reactions such as orthostatic hypotension or syncope occur during or shortly after their Plerixafor Injection [see Adverse Reactions ( 6.1 )]. Advise patients who experience itching, rash, or reaction at the site of injection to notify a healthcare professional, as these symptoms have been treated with over-the-counter medications during clinical trials [see Adverse Reactions ( 6.1 )]. Advise patients that Plerixafor Injection may cause gastrointestinal disorders, including diarrhea, nausea, vomiting, flatulence, and abdominal pain.
Patients should be told how to manage specific gastrointestinal disorders and to inform their healthcare professional if severe events occur following Plerixafor Injection [see Adverse Reactions ( 6.1 )]. Advise females of reproductive potential of the potential risk to a fetus. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with Plerixafor Injection [see Warnings and Precautions ( 5.6 ), Use in Specific Populations ( 8.1 )] .
Advise females and males of reproductive potential to use effective contraceptive methods during Plerixafor Injection use and for 1 week following cessation of treatment [see Warnings and Precautions ( 5.6 ) and Use in Specific Populations ( 8.1 )]. Advise women not to breastfeed during treatment with Plerixafor Injection and for 1 week following the last dose [Use in Specific Populations ( 8.2 )] . Manufactured by: Gland Pharma Limited D.P.Pally, Dundigal Post, Hyderabad - 500043, India.
Revised: February 2024