Brand Name
Mozobil
Generic Name
Plerixafor
View Brand Information FDA approval date: September 01, 2013
Classification: Hematopoietic Stem Cell Mobilizer
Form: Injection, Solution
What is Mozobil (Plerixafor)?
Plerixafor injection is indicated in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma or multiple myeloma . Plerixafor injection, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma or multiple myeloma.
Approved To Treat
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Brand Information
Mozobil (PLERIXAFOR)
1INDICATIONS AND USAGE
Mozobil 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).
2DOSAGE FORMS AND STRENGTHS
Injection: 24 mg/1.2 mL (20 mg/mL) sterile, clear, colorless to pale-yellow solution in a single-dose vial.
3CONTRAINDICATIONS
Mozobil is contraindicated in patients with a history of hypersensitivity to plerixafor
4ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed elsewhere in the labeling:
- Anaphylactic shock and hypersensitivity reactions
- Potential for tumor cell mobilization in leukemia patients
- Increased circulating leukocytes and decreased platelet counts
- Potential for tumor cell mobilization
- Splenic enlargement
4.1Clinical 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 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, dizziness, and vomiting.
Safety data for Mozobil 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 Mozobil at daily doses of 0.24 mg/kg SC. Median exposure to Mozobil 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 Mozobil 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 Mozobil 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 Mozobil regardless of causality and were more frequent with Mozobil than placebo during HSC mobilization and apheresis are shown in Table 2.
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 Mozobil. 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 Mozobil 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 supplemental oxygen) or resolved spontaneously.
Vasovagal reactions, orthostatic hypotension, and/or syncope can occur following subcutaneous injections. In Mozobil oncology and healthy volunteer clinical studies, less than 1% of subjects experienced vasovagal reactions following subcutaneous administration of Mozobil doses ≤0.24 mg/kg. The majority of these events occurred within 1 hour of Mozobil administration. Because of the potential for these reactions, appropriate precautions should be taken.
Other adverse reactions in the randomized studies that occurred in <5% of patients but were reported as related to Mozobil during HSC mobilization and apheresis included abdominal pain, hyperhidrosis, abdominal distention, dry mouth, erythema, stomach discomfort, malaise, hypoesthesia oral, constipation, dyspepsia, and musculoskeletal pain.
Hyperleukocytosis: In clinical trials, white blood cell counts of 100,000/mcL or greater were observed, on the day prior to or any day of apheresis, in 7% of patients receiving Mozobil and in 1% of patients receiving placebo. No complications or clinical symptoms of leukostasis were observed.
4.2Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the following adverse reactions have been reported from postmarketing experience with Mozobil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
5OVERDOSAGE
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.
6DESCRIPTION
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
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.
7CLINICAL STUDIES
The efficacy and safety of Mozobil in conjunction with filgrastim in non-Hodgkin's lymphoma (NHL) Study AMD 3100-3101 (referred to as study 1) (NCT00103610) and multiple myeloma (MM) Study AMD 3100-3102 (referred to as study 2) (NCT00103662) were evaluated in two placebo-controlled studies (Studies 1 and 2). Patients were randomized to receive either Mozobil 0.24 mg/kg or placebo on each evening prior to apheresis. Patients received daily morning doses of filgrastim 10 mcg/kg for 4 days prior to the first dose of Mozobil or placebo and on each morning prior to apheresis. Two hundred and ninety-eight (298) NHL patients were included in the primary efficacy analyses for Study 1. The mean age was 55 years (range 29–75) and 58 years (range 22–75) in the Mozobil and placebo groups, respectively, and 93% of subjects were Caucasian. In study 2, 302 patients with MM were included in the primary efficacy analyses. The mean age (58 years) and age range (28–75) were similar in the Mozobil and placebo groups, and 81% of subjects were Caucasian.
In Study 1, 59% of NHL patients who were mobilized with Mozobil and filgrastim collected ≥5 × 10
The median number of days to reach ≥5 × 10
In Study 2, 72% of MM patients who were mobilized with Mozobil and filgrastim collected ≥6 × 10
The median number of days to reach ≥6 × 10
Multiple factors can influence time to engraftment and graft durability following stem cell transplantation. For transplanted patients in the Phase 3 studies, time to neutrophil and platelet engraftment and graft durability were similar across the treatment groups.
8HOW SUPPLIED/STORAGE AND HANDLING
Mozobil
NDC Number: 0024-5862-01
9PATIENT 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 Mozobil injection and to report these symptoms immediately to a healthcare professional
Advise patients to contact healthcare professional immediately if they experience left upper abdominal pain and/or scapular or shoulder pain
Advise patients to inform a healthcare professional immediately if symptoms of vasovagal reactions such as orthostatic hypotension or syncope occur during or shortly after their Mozobil injection
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
Advise patients that Mozobil 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 Mozobil injection
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 Mozobil
Advise females and males of reproductive potential to use effective contraceptive methods during Mozobil use and for 1 week following cessation of treatment
Advise women not to breastfeed during treatment with Mozobil and for 1 week following the last dose
10PRINCIPAL DISPLAY PANEL - 24 mg/1.2 mL Vial Carton
NDC 0024-5862-01
Mozobil
24 mg/1.2 mL
For subcutaneous
One single-dose vial.
Rx only
SANOFI GENZYME
