Plerixafor Vivanta
Generic CXCR4 Antagonist for Haematopoietic Stem Cell Mobilisation
Quick Facts About Plerixafor Vivanta
Key Takeaways About Plerixafor Vivanta
- Generic version of plerixafor: Plerixafor Vivanta is a bioequivalent generic formulation of the originator medicine Mozobil and delivers the same active ingredient at identical concentration (20 mg/ml)
- Used together with G-CSF: Plerixafor Vivanta is always administered in combination with G-CSF to maximise mobilisation of CD34+ stem cells from bone marrow into the peripheral blood for apheresis collection
- For poor mobilisers: Indicated for patients with lymphoma or multiple myeloma who cannot mobilise sufficient stem cells with G-CSF alone prior to autologous stem cell transplantation
- Rapid onset: Stem cell mobilisation begins within 4–9 hours of injection, with peak CD34+ cell counts observed 9–14 hours after the subcutaneous dose – perfectly timed for next-morning apheresis
- Hospital administration only: Given as a subcutaneous injection by healthcare professionals in a hospital or transplant centre, typically 6–11 hours before each apheresis session for 2–4 consecutive days
What Is Plerixafor Vivanta and What Is It Used For?
Plerixafor Vivanta is a generic CXCR4 chemokine receptor antagonist that mobilises haematopoietic stem cells from the bone marrow into the peripheral blood. Used in combination with G-CSF, it facilitates stem cell collection (apheresis) before autologous stem cell transplantation in patients with lymphoma, multiple myeloma, or certain paediatric solid tumours.
Haematopoietic stem cell transplantation (HSCT) is a potentially curative treatment for several haematological malignancies, including non-Hodgkin lymphoma, Hodgkin lymphoma, and multiple myeloma. In an autologous transplant, the patient's own haematopoietic stem cells are collected, the patient receives high-dose chemotherapy (sometimes with radiotherapy) to eradicate residual malignant cells, and the stored stem cells are then reinfused to reconstitute the bone marrow and restore normal blood cell production. The critical prerequisite for this entire process is successful stem cell mobilisation – the movement of enough CD34+ haematopoietic stem cells from the bone marrow into the peripheral blood so they can be harvested.
Traditionally, G-CSF (granulocyte colony-stimulating factor, sold as filgrastim, lenograstim, or pegfilgrastim) has been the standard mobilisation agent. G-CSF stimulates the bone marrow to produce more myeloid cells and stem cells and gradually releases them into the circulation over 4–5 days. However, an estimated 15–40% of patients – those with heavy prior chemotherapy exposure, advanced age, previous radiotherapy, or certain disease characteristics – fail to achieve adequate CD34+ cell yields with G-CSF monotherapy. These "poor mobilisers" historically faced delayed or cancelled transplants, multiple apheresis sessions, or invasive bone marrow harvest procedures.
Plerixafor Vivanta addresses this limitation through a fundamentally different and complementary mechanism of action. The active substance, plerixafor, is a small-molecule bicyclam compound that acts as a selective, reversible antagonist of the CXCR4 chemokine receptor. Under normal physiological conditions, stromal cell-derived factor-1 alpha (SDF-1α, also known as CXCL12) is produced by bone marrow stromal cells and binds to the CXCR4 receptor on haematopoietic stem cells, effectively tethering these cells within the bone marrow niche. By competitively blocking the SDF-1α/CXCR4 interaction, plerixafor releases stem cells from their bone marrow anchors, causing a rapid and clinically significant surge of circulating CD34+ cells within hours of administration.
When G-CSF and plerixafor are combined, they exhibit pharmacodynamic synergy. G-CSF gradually expands the total stem cell pool and initiates slow release over several days, while plerixafor provides an acute, high-magnitude mobilisation boost in the hours immediately preceding apheresis. Landmark Phase III randomised controlled trials (DiPersio et al., 2009; Micallef et al., 2009) demonstrated that plerixafor plus G-CSF significantly increased the proportion of patients reaching the minimum CD34+ cell target (≥2 × 106 cells/kg) compared with placebo plus G-CSF – converting many previously unsuccessful mobilisers into candidates for autologous transplantation.
Plerixafor Vivanta delivers this same clinical benefit at a typically lower cost than the originator product Mozobil. Regulatory approval for generic plerixafor products (including Plerixafor Vivanta, Plerixafor Teva and Plerixafor Accord) followed the expiry of the originator's regulatory exclusivity and data protection period. Generic approvals require demonstration of bioequivalence, pharmaceutical quality, and identical active ingredient, strength, dosage form, and route of administration to the reference product.
Approved Indications
Plerixafor Vivanta is approved for the following indications, always in combination with G-CSF:
- Adults with lymphoma or multiple myeloma: To enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients whose cells mobilise poorly
- Paediatric patients aged 1 year to under 18 years: With lymphoma or solid malignant tumours, for mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation, when cells mobilise poorly
What Plerixafor Vivanta Is Not Used For
Plerixafor Vivanta is not indicated for, and should not be used for:
- Stem cell mobilisation in patients with any form of leukaemia (acute myeloid leukaemia, acute lymphoblastic leukaemia, chronic myeloid leukaemia, chronic lymphocytic leukaemia) – due to the theoretical risk of mobilising leukaemic blasts into the circulation
- Allogeneic donor mobilisation outside of approved labelling (use in healthy donors has been studied in research settings but is not a standard approved indication in all regions)
- Treatment of WHIM syndrome or other conditions outside the approved indications (although plerixafor is being studied for rare conditions such as WHIM syndrome under different brand names)
- Self-administration outside the context of a supervised transplant mobilisation programme
A generic medicine contains the same active ingredient at the same strength as the originator, in the same pharmaceutical form, and with the same route of administration. Regulatory authorities (such as the European Medicines Agency and national regulators) require bioequivalence studies showing that the generic delivers the active drug to the bloodstream in the same amount and at the same rate as the originator. Clinical outcomes are therefore equivalent. Generic medicines typically cost less because the manufacturer does not need to repeat the original research and development work. For patients and healthcare systems, this means equal clinical benefit at lower cost, improving access to essential treatments.
What Should You Know Before Using Plerixafor Vivanta?
Before receiving Plerixafor Vivanta, inform your doctor about all medical conditions, particularly heart problems, kidney disease, high white blood cell counts, low platelet counts, previous hypersensitivity reactions, or any history of leukaemia. Plerixafor Vivanta should not be used in patients with leukaemia or known hypersensitivity to plerixafor.
Contraindications
You should not receive Plerixafor Vivanta if any of the following apply:
- Known hypersensitivity to plerixafor or any excipient – allergic reactions, including anaphylaxis, have been reported with plerixafor products
- Leukaemia: Plerixafor should not be used for stem cell mobilisation in patients with leukaemia, as mobilisation of leukaemic cells into the peripheral blood could theoretically increase circulating tumour burden and complicate downstream processing of the collected product
Warnings and Precautions
Discuss the following conditions and risk factors with your doctor or haematologist before starting Plerixafor Vivanta:
- Cardiovascular risk factors: In pivotal clinical trials, uncommon cases of myocardial infarction occurred in patients receiving plerixafor plus G-CSF who had pre-existing cardiac risk factors. Patients should be assessed for cardiac risk and monitored throughout treatment. Report any chest pain, pressure, tightness, shortness of breath, or radiating arm or jaw pain immediately
- Renal impairment: Plerixafor is primarily excreted unchanged by the kidneys. If you have moderate to severe renal impairment (creatinine clearance ≤50 ml/min), your doctor will reduce the dose by one-third. There is limited experience in patients on haemodialysis or with a creatinine clearance below 20 ml/min
- Leukocytosis: Both G-CSF and plerixafor elevate circulating white blood cells. Your white blood cell count will be monitored regularly during the mobilisation period. If the count exceeds 100 × 109/L on any day, your physician may consider discontinuing treatment, as extremely high counts may be associated with hyperviscosity-related symptoms
- Thrombocytopenia: Low platelet counts have been associated with apheresis and with plerixafor. Platelet counts should be monitored before and during mobilisation, particularly during repeated apheresis sessions
- Splenic effects: G-CSF alone or with plerixafor has been associated with splenic enlargement and, rarely, splenic rupture. Patients should report left upper abdominal pain, shoulder tip pain, or signs of internal bleeding immediately
- Vasovagal reactions and orthostatic hypotension: Transient episodes of dizziness, lightheadedness, or fainting have been reported within one hour after injection. Patients with a history of vasovagal reactions should inform their team so appropriate precautions can be taken (lying flat during and after injection, monitored environment)
- Potential for tumour cell mobilisation: There is a theoretical concern that plerixafor could mobilise malignant cells along with haematopoietic stem cells in patients with lymphoma or multiple myeloma. The clinical significance of this is not fully established, and data from long-term follow-up studies have not shown worse outcomes
Rash, hives, swelling of the face, eyes, lips, tongue, or throat, difficulty breathing or swallowing, severe dizziness, collapse or loss of consciousness shortly after an injection – these may indicate a serious allergic reaction (anaphylaxis). Also seek urgent care for chest pain, pressure or tightness, severe upper-left abdominal pain (possible splenic enlargement or rupture), sudden severe headache, or persistent vomiting.
Pregnancy and Breastfeeding
Plerixafor Vivanta should not be used during pregnancy. There is no controlled clinical experience with plerixafor in pregnant women. Animal reproductive studies have demonstrated embryo-foetal toxicity including teratogenicity (structural malformations), increased post-implantation loss, and reduced foetal weight at plasma exposures similar to or above the maximum recommended human dose. Based on the mechanism of action and animal data, plerixafor can cause foetal harm if administered during pregnancy.
Women of childbearing potential must use effective contraception during treatment with Plerixafor Vivanta and for at least one week after the last dose. Before starting treatment, pregnancy should be excluded in women of reproductive potential. Men with female partners of reproductive potential should also use adequate contraception during and after treatment according to local guidance.
Breastfeeding should be discontinued during treatment with Plerixafor Vivanta. It is unknown whether plerixafor or its metabolites are excreted in human milk. Given the potential for serious adverse effects in breastfed infants, a decision must be made to either discontinue breastfeeding or to discontinue the medicine, weighing the importance of treatment to the mother.
Fertility
The effects of plerixafor on human fertility are unknown. In animal studies, no direct effects on male or female fertility endpoints were demonstrated at clinically relevant doses. However, given that Plerixafor Vivanta is typically administered as part of a mobilisation programme that precedes high-dose chemotherapy and transplantation – both of which can significantly impair fertility – patients of reproductive age should be counselled about fertility preservation options (sperm banking, oocyte or embryo cryopreservation) before the entire transplant treatment pathway begins.
Driving and Operating Machinery
Plerixafor Vivanta can cause dizziness, fatigue, or vasovagal reactions. Patients should not drive or operate machinery if they experience these effects. Since Plerixafor Vivanta is administered in a hospital or outpatient apheresis setting and patients are typically undergoing a demanding treatment course, they should arrange transportation to and from appointments and avoid driving during the active mobilisation and collection period.
Excipients of Note
Plerixafor Vivanta contains less than 1 mmol sodium (23 mg) per dose, which is considered essentially sodium-free and compatible with a low-sodium diet. The formulation does not contain preservatives, lactose, or other excipients commonly associated with hypersensitivity. Full excipient information is available in the product labelling supplied with each vial.
How Does Plerixafor Vivanta Interact with Other Drugs?
Plerixafor has a favourable drug interaction profile because it is not metabolised by cytochrome P450 enzymes and is not a substrate or inhibitor of P-glycoprotein. Its main interaction is the intended synergistic combination with G-CSF. Always inform your transplant team of every medicine and supplement you are taking.
The pharmacokinetic profile of plerixafor is relatively simple and predictable. The drug is absorbed rapidly after subcutaneous injection (peak plasma concentrations within 30–60 minutes), has a moderate volume of distribution, is minimally protein-bound, and is not significantly metabolised by the hepatic cytochrome P450 (CYP) enzyme system. Approximately 70% of the administered dose is excreted unchanged in the urine within 24 hours. This metabolic profile means that clinically significant drug-drug interactions mediated by CYP enzyme induction or inhibition are unlikely.
Because renal excretion is the predominant route of elimination, concurrent use of drugs that significantly affect renal function (particularly nephrotoxic medicines) could theoretically reduce plerixafor clearance and increase its exposure. In patients receiving nephrotoxic agents, baseline and ongoing renal function monitoring is recommended, and the plerixafor dose should be reduced if creatinine clearance falls below 50 ml/min regardless of cause.
The mandatory co-administration of plerixafor with G-CSF deserves particular attention. This is not an "interaction" in the negative sense but rather the intended therapeutic combination. G-CSF and plerixafor act additively to raise circulating white blood cell counts; clinicians must monitor total white blood cell and CD34+ counts to optimise the timing of apheresis and to avoid excessive leukocytosis. Both drugs can cause bone pain (a G-CSF-predominant effect) and transient blood count abnormalities.
Key Drug Interactions
| Drug or Class | Category | Clinical Effect | Recommendation |
|---|---|---|---|
| G-CSF (filgrastim, lenograstim, pegfilgrastim) | Colony-stimulating factor (required combination) | Synergistic mobilisation of CD34+ stem cells; additive leukocytosis and bone pain | Required combination – this is the intended clinical use. Monitor WBC and CD34+ counts; time apheresis to 6–11 hours after plerixafor dose |
| Nephrotoxic agents | Aminoglycosides, amphotericin B, high-dose NSAIDs, certain antivirals, radiographic contrast | May reduce renal clearance of plerixafor, increasing exposure and potentially adverse effects | Monitor serum creatinine and eGFR; reduce plerixafor dose by one-third if CrCl ≤50 ml/min |
| Chemo-mobilisation regimens | Cyclophosphamide, etoposide, ifosfamide, cytarabine | Chemotherapy-based mobilisation may be combined with G-CSF and plerixafor in selected patients | Timing, dose, and sequence must be coordinated by the transplant team; heightened monitoring for cytopenias and infections |
| Anticoagulants (heparin, LMWH, warfarin, DOACs) | Anticoagulant therapy | Apheresis uses anticoagulation in the extracorporeal circuit; systemic anticoagulants may combine with plerixafor-related thrombocytopenia to increase bleeding risk | Review anticoagulation plan with transplant team; monitor platelet counts daily during mobilisation |
| CYP substrates (general) | Diverse pharmacology | No clinically significant interactions expected; plerixafor is not a substrate, inhibitor or inducer of major CYP enzymes | No dose adjustment required; routine pharmacovigilance |
| P-glycoprotein substrates | Various (digoxin, dabigatran, some oncology drugs) | Plerixafor is not a substrate or inhibitor of P-glycoprotein in vitro | No specific dose adjustment; monitor per standard clinical practice |
Herbal Products and Supplements
There are no formally studied interactions between plerixafor and common herbal products or dietary supplements. However, because Plerixafor Vivanta is used in patients preparing for high-dose chemotherapy and transplantation, it is essential to disclose all supplements (including St John's wort, echinacea, vitamin E, fish oil, turmeric, and herbal immune-modulators) to the transplant team. Some supplements can affect platelet function, liver enzymes, or drug metabolism of other components of the conditioning regimen and are often discontinued before the mobilisation and conditioning phases for safety.
No formal drug-drug interaction studies have been conducted with plerixafor beyond the mandatory co-administration with G-CSF. In vitro studies indicate that plerixafor is neither a substrate nor an inhibitor of any major CYP450 isoenzyme, and it is not a substrate for P-glycoprotein. The primary route of elimination is renal, with approximately 70% of the dose excreted unchanged in urine within 24 hours. Drugs that compete for renal tubular secretion could theoretically interact with plerixafor, but this has not been observed in clinical practice. For all generic plerixafor products including Plerixafor Vivanta, the interaction profile is identical to that of the originator product.
What Is the Correct Dosage of Plerixafor Vivanta?
The recommended dose of Plerixafor Vivanta for adults is 0.24 mg/kg body weight per day (or a fixed 20 mg dose in patients weighing up to approximately 83 kg), given as a subcutaneous injection 6–11 hours before each apheresis session. The dose is reduced by one-third in moderate to severe renal impairment. Treatment typically lasts 2–4 consecutive days (maximum 7 days).
Plerixafor Vivanta is always used as part of a structured mobilisation regimen in combination with G-CSF. The mobilisation schedule is coordinated by a haematology or transplant centre. G-CSF (typically filgrastim at 10 µg/kg/day) is initiated first, usually for four consecutive mornings, to expand and begin mobilising the stem cell pool. On the evening of the fourth day, the first dose of Plerixafor Vivanta is administered, timed 6–11 hours before the planned apheresis session the following morning. This cycle is repeated daily until sufficient CD34+ cells have been collected for transplantation.
Adults
Standard Adult Dosage
Dose: 0.24 mg/kg body weight per day (body weight measured within one week of first dose); alternatively, a fixed 20 mg dose may be used for patients up to approximately 83 kg
Route: Subcutaneous injection, typically into the upper arm, abdomen, or thigh
Timing: 6 to 11 hours before the start of each apheresis session (typically administered in the evening, apheresis the next morning)
Duration: 2–4 consecutive days, up to a maximum of 7 days or until the CD34+ collection target is achieved
Maximum daily dose: 40 mg/day in patients with normal renal function
Notes: Body weight should be measured within one week before the first dose and used for all subsequent dose calculations.
Renal Impairment (Creatinine Clearance ≤50 ml/min)
Dose: Reduced to 0.16 mg/kg body weight per day (one-third dose reduction)
Route: Subcutaneous injection
Maximum daily dose: 27 mg/day
Notes: Limited pharmacokinetic data are available for patients with severe renal impairment (CrCl <20 ml/min) or those receiving haemodialysis. Creatinine clearance should be calculated using the Cockcroft-Gault equation or equivalent and reviewed prior to each dose if clinically unstable.
Children (1 Year to Under 18 Years)
Paediatric Dosage
Dose: 0.24 mg/kg body weight per day
Route: Subcutaneous injection
Timing: 6 to 11 hours before apheresis
Duration: 2–4 consecutive days (maximum 7 days)
Notes: Safety and efficacy have not been established in children younger than 1 year. Paediatric dosing is strictly weight-based and should only be prescribed by specialists experienced in paediatric stem cell transplantation. Injection volumes are smaller than adults; careful attention to injection technique in children is required. Reduced doses apply if paediatric patients have impaired renal function.
Elderly Patients
No dose adjustment is recommended for elderly patients based on age alone. However, renal function declines with age, and doses should be adjusted according to creatinine clearance as described above. Elderly patients are also more likely to have cardiovascular comorbidities, and cardiac monitoring during treatment is particularly important. Careful clinical assessment is recommended before starting treatment in patients over 70 years of age or those with multiple comorbidities.
How Is Plerixafor Vivanta Given?
Plerixafor Vivanta is administered by a healthcare professional (doctor or specialised nurse) as a subcutaneous injection. The injection is typically given in the upper arm, the abdomen (at least 5 cm from the umbilicus), or the anterior thigh, with injection sites rotated for multi-day courses to reduce local reactions. The following steps describe the typical mobilisation and collection workflow:
- Days 1–4 (approximately): G-CSF is started at the standard mobilisation dose (filgrastim 10 µg/kg/day, typically in the morning) to begin stem cell pool expansion and initial mobilisation
- Evening of Day 4: Plerixafor Vivanta is given as a subcutaneous injection, 6–11 hours before the planned apheresis session on Day 5 morning. G-CSF is continued the following morning
- Day 5 morning: Peripheral CD34+ counts are checked; if sufficient, apheresis is performed using a cell separator to collect stem cells from the peripheral blood
- Repeat: Steps 2–3 are repeated for up to a total of 4 days (maximum 7 days of plerixafor) until the target CD34+ cell dose is achieved (typically ≥2 × 106 CD34+ cells/kg for a single transplant; ≥5 × 106 CD34+ cells/kg for tandem transplants or optimal engraftment)
- Cell processing and cryopreservation: Collected stem cells are processed and cryopreserved until the patient is ready for conditioning chemotherapy and reinfusion
Missed Dose
Because Plerixafor Vivanta is administered in a supervised hospital or outpatient setting on a strict timing schedule, missed doses are uncommon. If the evening dose is delayed, the timing of the morning apheresis must be re-coordinated to maintain the 6–11 hour interval that ensures optimal peak CD34+ counts at collection. The transplant team will manage any rescheduling and will not administer a "double dose" to compensate for a missed injection.
Overdose
Clinical experience with plerixafor overdose is limited. In a dose-escalation study in healthy volunteers, doses up to 0.48 mg/kg were evaluated; dose-limiting adverse effects included gastrointestinal symptoms (nausea, vomiting, diarrhoea), vasovagal reactions, and orthostatic hypotension. There is no specific antidote for plerixafor. In the event of suspected overdose, the patient should be monitored closely for adverse effects and given appropriate supportive care, including intravenous fluids for hypotension, antiemetics for nausea, and haematologic monitoring for excessive leukocytosis. Given the short half-life (approximately 3–5 hours), effects are expected to resolve within a day.
| Patient Group | Dose | Route | Maximum Daily Dose | Special Considerations |
|---|---|---|---|---|
| Adults (normal renal function) | 0.24 mg/kg/day (or 20 mg fixed if ≤83 kg) | Subcutaneous | 40 mg/day | Weigh patient within 1 week of first dose |
| Adults (CrCl ≤50 ml/min) | 0.16 mg/kg/day | Subcutaneous | 27 mg/day | Monitor renal function; limited data in CrCl <20 ml/min or dialysis |
| Children (1–17 years) | 0.24 mg/kg/day | Subcutaneous | 40 mg/day (clinician-adjusted) | Weight-based dosing; specialist paediatric supervision |
| Elderly (≥65 years) | As per adult dosing | Subcutaneous | 40 mg/day (or adjusted for renal function) | Adjust based on renal function; cardiac monitoring recommended |
What Are the Side Effects of Plerixafor Vivanta?
The most common side effects of Plerixafor Vivanta are gastrointestinal symptoms (diarrhoea, nausea, vomiting), injection site reactions, headache, dizziness and fatigue. Uncommon but serious side effects include allergic reactions (including anaphylaxis), myocardial infarction in patients with cardiac risk factors, and splenic enlargement.
Like all medicines, Plerixafor Vivanta can cause side effects, although not everyone experiences them. The majority of side effects observed in clinical trials were mild to moderate in severity, transient, and did not require treatment discontinuation. It is important to remember that Plerixafor Vivanta is always used together with G-CSF – and often alongside chemotherapy conditioning regimens – so some reported side effects may be attributable to G-CSF, to the underlying malignancy, to previous chemotherapy, or to the apheresis procedure itself rather than to plerixafor directly.
The side effect profile of plerixafor has been well characterised in the pivotal Phase III clinical trials (AMD3100-3101 in non-Hodgkin lymphoma and AMD3100-3102 in multiple myeloma), in post-marketing surveillance by regulatory agencies (EMA EudraVigilance, FDA FAERS), and in real-world registries such as the EBMT and CIBMTR databases. Because Plerixafor Vivanta is bioequivalent to the originator Mozobil, the expected adverse event profile is identical.
The frequency categories below follow the standard MedDRA convention used in European product information.
Very Common (affects more than 1 in 10 people)
- Diarrhoea
- Nausea
- Injection site reactions (redness, irritation, pain, swelling, bruising)
- Anaemia (low red blood cell count, particularly in paediatric patients)
Common (affects up to 1 in 10 people)
- Headache
- Dizziness
- Fatigue, weakness and malaise
- Insomnia and sleep disturbances
- Flatulence (wind)
- Constipation
- Dyspepsia (indigestion)
- Vomiting
- Abdominal pain, discomfort or bloating
- Dry mouth
- Oral hypoaesthesia (numbness or tingling around the mouth)
- Hyperhidrosis (excessive sweating)
- Generalised erythema (skin redness)
- Arthralgia (joint pain)
- Musculoskeletal pain and bone pain (often attributed predominantly to G-CSF)
Uncommon (affects up to 1 in 100 people)
- Hypersensitivity reactions (skin rash, urticaria, periorbital swelling)
- Anaphylactic reactions, including anaphylactic shock
- Abnormal dreams and nightmares
- Myocardial infarction (in patients with pre-existing cardiovascular risk factors)
- Orthostatic hypotension
- Transient sinus tachycardia or palpitations
Rare and Post-Marketing Reports
- Severe gastrointestinal adverse events (severe diarrhoea, severe vomiting, dehydration)
- Splenic enlargement (splenomegaly)
- Splenic rupture (very rare; predominantly associated with G-CSF exposure)
- Vasovagal reactions, including syncope
- Dyspnoea (shortness of breath) and transient hypoxia
- Hyperleukocytosis (WBC >100 × 109/L)
Cardiovascular Risk
In Phase III clinical studies, uncommon cases of myocardial infarction occurred in patients with pre-existing cardiovascular risk factors who received plerixafor plus G-CSF. The causal relationship has not been definitively established, as these patients had significant underlying cardiac disease and were simultaneously receiving G-CSF, which itself can influence cardiovascular physiology through leukocytosis and inflammatory effects. Nevertheless, patients with known cardiac risk factors (hypertension, diabetes, coronary artery disease, prior myocardial infarction, smoking history, dyslipidaemia) should be carefully evaluated before mobilisation and monitored during treatment. Seek immediate medical attention if you experience chest pain, tightness or pressure, shortness of breath, pain radiating to the arm, jaw or back, or sudden onset of nausea with cold sweats.
Leukocytosis and Haematological Effects
An increase in total white blood cell count is an expected pharmacodynamic effect of both G-CSF and plerixafor. Your transplant team will perform regular blood counts throughout mobilisation. In most patients, the leukocytosis is transient, peaks around the time of optimal apheresis, and resolves within days of completing treatment. If counts become excessively elevated (>100 × 109/L), treatment may be discontinued to mitigate hyperviscosity risk. Thrombocytopenia may also occur due to the combination of plerixafor, G-CSF, and repeated apheresis – platelet counts should be monitored before each collection session, and platelet transfusions should be available if required.
Paraesthesia and Numbness
Tingling sensations (paraesthesia) and numbness, particularly around the mouth (oral hypoaesthesia) or in the extremities, are reported in patients undergoing cancer treatment and stem cell mobilisation. Approximately one in five patients may describe these sensations during mobilisation. Observational data suggest the incidence is not meaningfully increased by adding plerixafor to G-CSF, indicating that paraesthesia is predominantly related to the underlying malignancy, prior chemotherapy-induced neuropathy, or apheresis-related citrate toxicity rather than to plerixafor specifically.
Long-Term Safety
Plerixafor is administered for a short course (typically 2–4 days, maximum 7 days) in the context of a one-time mobilisation event. Long-term safety data from post-marketing registries have not identified delayed or cumulative toxicities attributable to plerixafor exposure. Patients who undergo autologous transplantation after plerixafor-assisted mobilisation experience engraftment kinetics, transplant outcomes, and long-term disease control comparable to those mobilised with G-CSF alone, provided equivalent CD34+ cell doses are reinfused.
Reporting suspected side effects after a medicine has been authorised is important because it allows continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals and patients are encouraged to report suspected adverse reactions through national reporting systems such as the FDA MedWatch programme (United States), the MHRA Yellow Card Scheme (United Kingdom), Health Canada Canada Vigilance Program (Canada), TGA Database of Adverse Event Notifications (Australia), or the EMA EudraVigilance system (European Union). Reporting ensures that any emerging safety signal can be promptly investigated.
How Should You Store Plerixafor Vivanta?
Plerixafor Vivanta should be stored at room temperature (below 30 °C), in its original carton to protect from light, and out of the sight and reach of children. Do not use after the printed expiry date. Once the vial is opened, the solution must be used immediately as it contains no preservatives.
The following storage guidelines apply to Plerixafor Vivanta solution for injection. Full local storage information is included in the package leaflet supplied with each pack.
- Temperature: Store below 30 °C (room temperature). Refrigeration is not required, and freezing should be avoided, as freezing may alter the solution properties
- Light protection: Keep the vial in the outer carton to protect from light until ready for use
- After opening: The solution should be used immediately once the vial has been opened. Plerixafor Vivanta is a single-use product and contains no preservatives – any unused solution remaining in an opened vial must be discarded
- Expiry date: Do not use Plerixafor Vivanta after the expiry date printed on the carton and vial label (expressed as month and year; the product can be used up to the last day of that month)
- Appearance inspection: Before use, visually inspect the solution. It should be clear, colourless to slightly yellow, and free from visible particles or discolouration. Do not use if the solution is discoloured, cloudy, contains visible particles, or if the vial is damaged
- Disposal: Do not dispose of medicines via wastewater, sink, toilet, or household waste. Ask your pharmacist or healthcare facility how to dispose of medicines and used vials or syringes safely. Safe disposal protects the environment and prevents accidental exposure
- Child safety: Keep this medicine out of the sight and reach of children. Used needles and vials must be disposed of in an approved sharps container
- Transport conditions: During transport, the product should remain within the recommended temperature range. Temperature excursions must be documented and assessed by the pharmacy or healthcare facility before the product is administered
In most clinical settings, Plerixafor Vivanta is stored and prepared by the hospital pharmacy or apheresis unit. Storage protocols follow national good manufacturing and pharmacy practice standards. Patients do not typically handle storage themselves, as the medicine is administered in a supervised healthcare environment.
What Does Plerixafor Vivanta Contain?
Each millilitre of Plerixafor Vivanta solution for injection contains 20 mg of plerixafor as the active ingredient. The other ingredients (excipients) are typically sodium chloride, hydrochloric acid and/or sodium hydroxide for pH adjustment, and water for injections. Refer to the product-specific leaflet for the exact excipient list of your Plerixafor Vivanta pack.
Active Ingredient
The active substance is plerixafor. Each millilitre of solution for injection contains 20 mg of plerixafor. Plerixafor is a synthetic bicyclam compound with the full chemical name 1,1′-[1,4-phenylenebis(methylene)]bis[1,4,8,11-tetraazacyclotetradecane]. It has a molecular formula of C28H54N8 and a molecular weight of 502.78 g/mol. The compound contains two identical 14-membered tetraazamacrocyclic rings joined through a para-phenylene linker, and it binds selectively to the CXCR4 chemokine receptor with high affinity. Because Plerixafor Vivanta is a bioequivalent generic, the active substance is chemically identical to the plerixafor in the originator product Mozobil.
Excipients (Inactive Ingredients)
The excipients in Plerixafor Vivanta are standard pharmaceutical aids used to create a stable, injectable, isotonic solution. They typically include:
- Sodium chloride: Used to make the solution isotonic with body fluids, reducing discomfort on injection
- Hydrochloric acid (concentrated): Used in small amounts for pH adjustment
- Sodium hydroxide: Used in small amounts for pH adjustment
- Water for injections: The solvent for the formulation
Patients with known hypersensitivity to any excipient should not receive Plerixafor Vivanta. The formulation does not contain preservatives, antimicrobials, latex, lactose, gelatin, or animal-derived ingredients. The exact excipient list for your specific Plerixafor Vivanta pack is printed in the package leaflet supplied with the medicine – always check this before use, particularly if you have known allergies.
Appearance and Packaging
Plerixafor Vivanta is supplied as a clear, colourless to slightly yellow sterile solution for injection in a single-use glass vial sealed with a rubber stopper and an aluminium flip-off cap. Each pack contains one vial of concentration 20 mg/ml. The fill volume per vial provides a dose appropriate for a single adult or paediatric administration. The vial is designed for single use only; any portion not used immediately after opening must be discarded.
Manufacturer and Marketing Authorisation
Plerixafor Vivanta is manufactured and distributed under the marketing authorisation of Vivanta. The marketing authorisation holder and contact details for each country are printed on the product carton and the accompanying package leaflet. Generic plerixafor products are available from several pharmaceutical companies including Vivanta, Teva, and Accord Healthcare; all are required to meet the same regulatory standards for quality, safety, and efficacy as the originator Mozobil.
Generic medicines like Plerixafor Vivanta are manufactured to the same Good Manufacturing Practice (GMP) standards as originator products. National regulators (EMA, FDA, MHRA, TGA, Health Canada) inspect manufacturing sites, review stability data, confirm bioequivalence, and verify pharmacovigilance systems before granting approval. Once approved, generics are subject to the same post-marketing surveillance requirements as originator products. This ensures that patients receive consistent, high-quality medicines regardless of which manufacturer produces their specific pack.
Frequently Asked Questions About Plerixafor Vivanta
Plerixafor Vivanta is a generic form of plerixafor used in combination with G-CSF to mobilise haematopoietic (blood-forming) stem cells from the bone marrow into the peripheral bloodstream. These stem cells are then collected through a procedure called apheresis and stored for later reinfusion during autologous stem cell transplantation. It is approved for adults with lymphoma or multiple myeloma who are "poor mobilisers" – meaning G-CSF alone does not release enough stem cells into the blood – and for children aged 1 to under 18 years with lymphoma or solid tumours.
Plerixafor Vivanta is a generic version of the originator medicine Mozobil. Both products contain the same active ingredient (plerixafor) at the same concentration (20 mg/ml), have the same route of administration (subcutaneous injection), and are approved for the same clinical indications. Regulatory authorities have confirmed bioequivalence, meaning that Plerixafor Vivanta delivers the same amount of active drug to the bloodstream in the same time frame as Mozobil. Clinical efficacy and safety are therefore considered equivalent. The main practical differences are the manufacturer, the branding on the packaging, and typically a lower price for the generic product, which can improve access and reduce healthcare costs.
Plerixafor Vivanta works by blocking the CXCR4 chemokine receptor on haematopoietic stem cells. Normally, a signalling protein called SDF-1α (also known as CXCL12) binds to the CXCR4 receptor and anchors stem cells within the bone marrow microenvironment. By blocking this interaction, plerixafor allows the stem cells to detach from the bone marrow stroma and enter the bloodstream, where they can be collected by apheresis. When used together with G-CSF – which has already expanded the total stem cell pool over several days – plerixafor provides an additional acute surge of CD34+ cells into the circulation that coincides with the planned apheresis session.
Plerixafor and G-CSF work through different but complementary mechanisms. G-CSF gradually stimulates the bone marrow to produce more stem cells and slowly releases them into the blood over four to five days. Plerixafor then provides a rapid additional release by blocking the CXCR4 receptor that holds stem cells in the bone marrow. Together, the combination achieves significantly higher stem cell yields than either agent alone, ensuring that enough cells are collected for a successful transplant. Plerixafor alone, without prior G-CSF treatment, would release stem cells already present in the bone marrow but the total yield would be insufficient for transplantation because the stem cell pool has not been expanded.
Plerixafor Vivanta is typically administered by healthcare professionals in a hospital or transplant centre, because it is part of a complex stem cell mobilisation and collection programme that requires close medical supervision, apheresis procedures, and daily blood monitoring. Some healthcare systems allow experienced patients, with training, to self-administer the evening subcutaneous injection at home under the guidance of their transplant team – particularly if they are already comfortable with subcutaneous G-CSF injections. This decision is made individually by the treating physician, taking into account the patient's capability, distance from the hospital, and comfort with the procedure.
If insufficient stem cells are collected despite G-CSF and Plerixafor Vivanta, the collection can be extended for additional apheresis days (up to a total of 7 days of plerixafor exposure). If the CD34+ cell target still cannot be achieved, the transplant team may consider alternative strategies: a repeat mobilisation attempt at a later date using a different regimen (such as chemotherapy-primed mobilisation with G-CSF), a bone marrow harvest under general anaesthesia to collect stem cells directly from the bone marrow, or reassessment of the overall treatment plan. Each option is discussed with the patient based on their clinical situation, disease status, and transplant goals.
Plerixafor Vivanta can be used in patients with kidney problems, but the dose must be adjusted. Because plerixafor is primarily excreted by the kidneys, patients with moderate to severe renal impairment (creatinine clearance ≤50 ml/min) should receive a reduced dose of 0.16 mg/kg/day, with a maximum of 27 mg/day, instead of the standard 0.24 mg/kg/day. There is limited experience in patients with very severe kidney disease (creatinine clearance below 20 ml/min) or those on haemodialysis, so these patients require careful evaluation and close monitoring by the transplant team. Baseline renal function is assessed before mobilisation starts, and creatinine is monitored during treatment.
Plerixafor Vivanta itself does not cause hair loss (alopecia). Hair loss is a well-known side effect of high-dose chemotherapy used in the conditioning regimen before autologous transplantation, but it is not associated with plerixafor or G-CSF mobilisation. Any hair loss experienced by patients undergoing this treatment pathway occurs as a result of the chemotherapy phase, not the mobilisation phase. Patients should discuss expected side effects of their entire treatment plan (mobilisation, conditioning, and transplantation) with their transplant team so they have a complete picture of what to expect.
References
- European Medicines Agency (EMA). Plerixafor – Summary of Product Characteristics and Public Assessment Reports for generic plerixafor products. 2024.
- US Food and Drug Administration (FDA). Mozobil (plerixafor injection) – Prescribing Information. Sanofi Genzyme; current edition. Reference labelling for generic equivalents.
- DiPersio JF, Stadtmauer EA, Nademanee A, et al. Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma. Blood. 2009;113(23):5720–5726.
- DiPersio JF, Micallef IN, Stiff PJ, et al. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. J Clin Oncol. 2009;27(28):4767–4773.
- Duarte RF, Chabannon C, Bernasconi P, et al. Plerixafor for stem cell mobilisation: the European perspective. Bone Marrow Transplant. 2018;53(5):543–551.
- National Institute for Health and Care Excellence (NICE). Technology Appraisal Guidance TA465: Plerixafor for stem cell mobilisation in lymphoma and multiple myeloma. 2017.
- Giralt S, Costa L, Schriber J, et al. Optimizing autologous stem cell mobilization strategies to improve patient outcomes: consensus guidelines and recommendations. Biol Blood Marrow Transplant. 2014;20(3):295–308.
- Hopman RK, DiPersio JF. Advances in stem cell mobilization. Blood Rev. 2014;28(1):31–40.
- Worel N, Apperley JF, Basak GW, et al. EBMT Working Party Recommendations on Stem Cell Mobilisation. Bone Marrow Transplant. 2022;57:1145–1156.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023.
- European Society for Blood and Marrow Transplantation (EBMT). EBMT Handbook: Haematopoietic Stem Cell Transplantation and Cellular Therapies. 8th Edition, 2024.
- British National Formulary (BNF). Plerixafor – Drug Monograph. NICE/BNF; updated 2025.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, a multidisciplinary group of licensed healthcare professionals with expertise in haematology, oncology, clinical pharmacology, and stem cell transplantation. Generic medicines are evaluated with the same scientific rigour as originator products.
iMedic Medical Editorial Team – specialists in haematology and clinical pharmacology with experience in stem cell transplantation, supportive care, and generic medicines policy.
iMedic Medical Review Board – independent panel of medical experts who verify accuracy, completeness, and adherence to international guidelines (EBMT, ASTCT, NICE, EMA, FDA).
This article follows the GRADE evidence framework and is based on systematic reviews, randomised controlled trials, regulatory summaries of product characteristics, and international clinical guidelines. All content is independently produced with no commercial funding or pharmaceutical industry sponsorship. Published: . Last reviewed: .