mozobil
Pharmaranks rates Mozobil 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Mozobil (Plerixafor) is a hematopoietic stem cell mobilizer used to treat Non-Hodgkin Lymphoma, Multiple Myeloma.
Plerixafor · by Genzyme
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Plerixafor
- Drug class
- Hematopoietic Stem Cell Mobilizer
- Form
- Injectable
- Strength
- Plerixafor 24MG/1.2ML (20MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- non-hodgkin lymphoma, multiple myeloma
- Manufacturer
- Genzyme
- FDA application
- NDA022311
What is Mozobil?
From the FDA label:Mozobil (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((1,4,8,11-tetraazacyclotetradecan-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. Figure 1: Structural Formula
How to use
Initiate Mozobil treatment after the patient has received filgrastim once daily for 4 days. ( 2.1 ) Repeat Mozobil 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 ) 2.1 Recommended Dosage and Administration Begin treatment with Mozobil after the patient has received filgrastim once daily for 4 days [see Dosage and Administration (2.2) ] . Administer Mozobil approximately 11 hours prior to initiation of each apheresis for up to 4 consecutive days. The recommended dose of Mozobil by subcutaneous injection is based on body weight: 20 mg fixed dose or 0.24 mg/kg of body weight for patients weighing less 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 Mozobil 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…
Side effects
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. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-877-4MOZOBIL or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 Mozobil in conjunction with filgrastim regardless of causality and more frequent with Mozobil than placebo during HSC mobilization and apheresis were diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia,…
Warnings
Important safety information
Anaphylactic Shock and Serious Hypersensitivity Reactions have occurred. Monitor patients during and after completion of Mozobil administration. ( 5.1 ) Tumor Cell Mobilization in Leukemia Patients: Mozobil 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 Mozobil use. ( 5.3 ) Potential for Tumor Cell Mobilization: Tumor cells may be released from marrow during HSC mobilization with Mozobil 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 Mozobil. ( 5.6 , 8.1 ) 5.1 Anaphylactic 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 Mozobil [see Adverse Reactions (6.2) ] . Observe patients for signs and symptoms of hypersensitivity during and after Mozobil administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Mozobil 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 Mozobil administration in less than 1% of patients [see Adverse Reactions (6.1) ] . 5.2 Tumor Cell Mobilization in Leukemia Patients For the purpose of HSC mobilization, Mozobil may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, Mozobil is not intended for HSC mobilization and harvest in patients with leukemia. 5.3 Hematologic Effects Leukocytosis Administration of Mozobil in conjunction with filgrastim increases circulating leukocytes as well as HSC populations. Monitor white blood cell counts during Mozobil use [see Adverse Reactions (6.1) ] . Thrombocytopenia Thrombocytopenia has been observed in patients receiving Mozobil. Monitor platelet counts in all patients who receive Mozobil and then undergo apheresis. 5.4 Potential for Tumor Cell Mobilization When Mozobil 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. 5.5 Splenic 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 Mozobil 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 Mozobil in conjunction with filgrastim. Evaluate individuals receiving Mozobil in combination with filgrastim who report left upper abdominal pain and/or scapular or shoulder pain for splenic integrity. 5.6 Embryo-Fetal Toxicity Based on findings from animal reproduction studies, Mozobil 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 alterations to growth at exposures approximately 10 times the exposure at the recommended human dose. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use an effective form of contraception during treatment with Mozobil and for one week after the final dose [see Use in Specific Populations (8.1) ] .
Who should not take Mozobil
Mozobil is contraindicated in patients with a history of hypersensitivity to plerixafor [see Warnings and Precautions (5.1) ] . Anaphylactic shock has occurred with use of Mozobil. History of hypersensitivity to Mozobil. ( 4 )
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Drug class
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Mozobil treat?
- Mozobil (Plerixafor) may be used to treat non-hodgkin lymphoma, multiple myeloma, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Mozobil rated?
- pharmaranks gives Mozobil a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Mozobil?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Mozobil. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Mozobil?
- Mozobil is marketed by Genzyme. You can see Genzyme's full profile, rating, and other products on pharmaranks.
- Is Mozobil a brand-name or generic drug?
- Mozobil is a brand-name product with the active ingredient Plerixafor.
- Is Mozobil available over the counter?
- No. Mozobil is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Mozobil come in?
- Mozobil is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Mozobil?
- Mozobil is classified as hematopoietic stem cell mobilizer, per the FDA's Established Pharmacologic Class.
- Is Mozobil FDA-registered?
- Mozobil is on record with the U.S. FDA under application number NDA022311. You can verify this on its official FDA label.
- Has Mozobil been recalled by the FDA?
- Yes. Mozobil has 2 recorded FDA recall events in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Mozobil safe?
- There's no single safe-or-not verdict. pharmaranks gives Mozobil a recall-safety score of 72/100, based on its FDA recall history (2 recorded recall events) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Mozobil?
- Mozobil's side effects are taken directly from its FDA label. From the label: 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 circulati… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about PLERIXAFOR
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 794 reports naming PLERIXAFOR — the active ingredient in Mozobil, and the FDA flagged 85% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- febrile neutropenia106 reports
- mucosal inflammation61 reports
- pyrexia59 reports
- plasma cell myeloma54 reports
- thrombocytopenia47 reports
- diarrhoea46 reports
- neutropenia44 reports
- nausea43 reports
Read these as a signal, not a rate. A report does not mean PLERIXAFOR caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 27, 2026.
Reviews
No reviews yet. Be the first to write one.
People also viewed
blenrep
Belantamab Mafodotin-Blmf
empliciti
Elotuzumab
gleostine
Lomustine
purinethol
Mercaptopurine
revlimid
Lenalidomide
sarclisa escena
Isatuximab-Irfc
Compare Mozobil head-to-head
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
mozobil
72/100