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Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 30.04.2022
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Plerixafor® (Plerixafor) injection is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM).
Plerixafor works by helping your bone marrow release stem cells into your bloodstream so they can be collected and transplanted back into the body.
Plerixafor is used in people with non-Hodgkin's lymphoma or multiple myeloma.
Plerixafor may also be used for purposes not listed in this medication guide.
Usual Adult Dose for non-Hodgkin's Lymphoma:
Treatment with Plerixafor should begin after the patient has received G-CSF once daily for four days. Plerixafor should be administered approximately 11 hours prior to initiation of apheresis for up to 4 consecutive days.
The recommended dose of Plerixafor is 0.24 mg/kg body weight by subcutaneous (SC) injection.
The patient's actual body weight should be used to calculate the volume of Plerixafor 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 X patient's actual body weight (in kg) = volume to be administered (in mL)
In clinical studies, Plerixafor dose has been calculated based on actual body weight in patients up to 175% of ideal body weight. The dose of Plerixafor and the 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 dose should not exceed 40 mg/day.
Daily morning doses of G-CSF 10 micrograms/kg for 4 days should be administered prior to the first evening dose of Plerixafor and on each day prior to apheresis.
Usual Adult Dose for Multiple Myeloma:
Treatment with Plerixafor should begin after the patient has received G-CSF once daily for four days. Plerixafor should be administered approximately 11 hours prior to initiation of apheresis for up to 4 consecutive days.
The recommended dose of Plerixafor is 0.24 mg/kg body weight by subcutaneous (SC) injection.
The patient's actual body weight should be used to calculate the volume of Plerixafor 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 X patient's actual body weight (in kg) = volume to be administered (in mL)
In clinical studies, Plerixafor dose has been calculated based on actual body weight in patients up to 175% of ideal body weight. The dose of Plerixafor and the 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 dose should not exceed 40 mg/day.
Daily morning doses of G-CSF 10 micrograms/kg for 4 days should be administered prior to the first evening dose of Plerixafor and on each day prior to apheresis.
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What is the most important information I should know about Plerixafor?
Do not receive Plerixafor without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.
You should not receive this medication if you are allergic to Plerixafor, or if you have leukemia.
Before receiving Plerixafor, tell your doctor if you have kidney disease.
Plerixafor is given as an injection in a hospital or clinic setting. Before receiving Plerixafor, you will be given another medication that will help your bone marrow produce stem cells and certain white blood cells that help support your immune system.
To be sure this medication is not causing harmful effects, your blood will need to be tested often.
Use Plerixafor as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Plerixafor is given as an injection at your doctor's office, hospital, or clinic.
- Do not use Plerixafor if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Plerixafor, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Plerixafor.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Peripheral stem cell mobilization: Mobilization of hematopoietic stem cells (HSCs) for collection and subsequent autologous transplantation (in combination with filgrastim) in patients with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM)
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What other drugs will affect Plerixafor?
Drug/Drug: Based on in vitro studies, Plerixafor is not a substrate, inhibitor or inducer of human cytochrome P-450 enzymes. Formal drug interaction studies have not been conducted.
In clinical studies of patients with NHL, the addition of rituximab to a mobilization regimen of Plerixafor and G-CSF did not impact patient safety or CD34+ cell yield.
Drug/Food: Plerixafor is administered parenterally, and interactions with food and drink are considered unlikely.
Pharmaceutical Incompatibilities: In the absence of compatibility studies, Plerixafor should not be mixed with other medicinal products in the same injection.
Drug/Laboratory Tests: Plerixafor has not been shown to interfere with any routine clinical laboratory tests.
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What are the possible side effects of Plerixafor?
Safety data for Plerixafor in conjunction with G-CSF in oncology patients with lymphoma and multiple myeloma were obtained from 2 placebo-controlled phase III studies and 10 uncontrolled phase II studies in 543 patients. Patients were primarily treated with daily doses of 0.24 mg/kg Plerixafor by SC injection. The exposure to Plerixafor in these studies ranged from 1-7 consecutive days (median=2 days).
In the 2 phase III studies in non-Hodgkin's lymphoma and multiple myeloma patients (AMD3100-3101 and AMD3100-3102, respectively), a total of 301 patients were treated in the Plerixafor and G-CSF group, and 292 patients were treated in the placebo and G-CSF group. Patients received daily morning doses of G-CSF 10 mcg/kg for 4 days prior to the 1st dose of Plerixafor or placebo and on each morning prior to apheresis. Adverse reactions that occurred more frequently with Plerixafor and G-CSF than placebo and G-CSF, and were reported as related in ≥1% of the patients who received Plerixafor, during haematopoietic stem cell mobilisation and apheresis, and prior to chemotherapy/ablative treatment in preparation for transplantation are shown in Table 6. Adverse reactions are listed by system organ class and frequency. Frequencies are defined according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data).
From chemotherapy/ablative treatment in preparation of transplantation through 12 months post-transplantation, no significant differences in the incidence of adverse reactions were observed across treatment groups.
The adverse reactions reported in patients with lymphoma and multiple myeloma who received Plerixafor in the controlled phase III studies and uncontrolled studies, including a phase II study of Plerixafor as monotherapy for haematopoietic stem cell mobilization, are similar. No significant differences in the incidence of adverse reactions were observed for oncology patients by disease, age or gender.
Myocardial Infarction: In clinical studies, 7 of 679 oncology patients experienced myocardial infarctions after haematopoietic stem cell mobilisation with Plerixafor and G-CSF. All events occurred at least 14 days after last Plerixafor administration. Additionally, 2 female oncology patients in the compassionate use programme experienced myocardial infarction following haematopoietic stem cell mobilization with Plerixafor and G-CSF. One of these events occurred 4 days after last Plerixafor administration. Lack of temporal relationship in 8 of 9 patients coupled with the risk profile of patients with myocardial infarction does not suggest Plerixafor confers an independent risk for myocardial infarction in patients who also receive G-CSF.
Hyperleukocytosis: White blood cell counts of >100 x 109/L were observed, on the day prior to or any day of apheresis, in 7% patients receiving Plerixafor and in 1% patients receiving placebo in the phase III studies. No complications or clinical symptoms of leukostasis were observed.
Vasovagal Reactions: In Plerixafor oncology and healthy volunteer clinical studies, <1% of subjects experienced vasovagal reactions (orthostatic hypotension and/or syncope) following SC administration of Plerixafor doses ≤0.24 mg/kg. The majority of these events occurred within 1 hr of Plerixafor administration.
Gastrointestinal Disorders: In Plerixafor clinical studies of oncology patients, there have been rare reports of severe gastrointestinal events including diarrhoea, nausea, vomiting and abdominal pain.
Paresthesiae: Paresthesiae are commonly observed in oncology patients undergoing autologous transplantation following multiple disease interventions. In the placebo-controlled phase III studies, the incidence of paresthesiae was 20.6% and 21.2% in the Plerixafor and placebo groups, respectively.
Elderly Patients: In the 2 placebo-controlled clinical studies of Plerixafor, 24% of patients were ≥65 years. No notable differences in the incidence of adverse reactions were observed in these elderly patients when compared with younger ones.
Each 1.2-mL vial is filled to deliver Plerixafor 24 mg (20 mg/mL). It also contains sodium chloride 5.9 mg in sterile water for injection adjusted to a pH of 6-7.5 with hydrochloric acid and with sodium hydroxide, if required.
Plerixafor is a small-molecule bicyclam derivative that selectively antagonizes the CXCR4 chemokine receptor and blocks binding of its cognate ligand, stromal cell-derived factor-1α (SDF-1α, also known as CXCL12). The mechanism of action of Plerixafor involves interruption of the CXCR4/SDF-1α interaction resulting in mobilization of haematopoietic stem cells (HSCs) positive for cell surface glycoprotein CD34 (CD34+ cells) to the peripheral blood where they can be collected for HSC transplantation. Plerixafor alone has been shown to mobilize CD34+ HSCs into the peripheral blood; this effect is further enhanced when Plerixafor is used in conjunction with granulocyte colony-stimulating factor (G-CSF).