Plerixafor (Mozobil)

Trade Name : Mozobil

sanofi-aventis U.S. LLC

SOLUTION

Strength 24 mg/1.2mL

PLERIXAFOR Hematopoietic Stem Cell Mobilizer [EPC],Increased Hematopoietic Stem Cell Mobilization [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Plerixafor (Mozobil) which is also known as Mozobil and Manufactured by sanofi-aventis U.S. LLC. It is available in strength of 24 mg/1.2mL per ml. Read more

Plerixafor (Mozobil) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

Mozobil 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).
Mozobil, a hematopoietic stem cell mobilizer, 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 and multiple myeloma. ()

No data

Initiate Mozobil treatment after the patient has received G-CSF once daily for 4 days. ()
Repeat Mozobil dose up to 4 consecutive days. ()
Dose based on patient weight tttttttttn
Administer by subcutaneous injection approximately 11 hours prior to initiation of apheresis. ()
Renal impairment:u00a0 If creatinine clearance isu00a0u226450 mL/min, decrease dose by one-third to 0.16 mg/kg. ()

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. ()

Mozobil is contraindicated in patients with a history of hypersensitivity to plerixafor . Anaphylactic shock has occurred with use of Mozobil. tttttt

History of hypersensitivity to Mozobil. ()

No data

Anaphylactic Shock and Serious Hypersensitivity Reactions have occurred. Monitor patients during and after completion of Mozobil administration. ()
Tumor Cell Mobilization in Leukemia Patients: Mozobil may mobilize leukemic cells and should not be used in leukemia patients. ()
Hematologic Effects: Increased circulating leukocytes and decreased platelet counts have been observed. u00a0Monitor blood cell counts and platelet counts during Mozobil use. ()
Potential for Tumor Cell Mobilization:u00a0 Tumor cells may be released from marrow during HSC mobilization with Mozobil and G-CSF.u00a0 Effect of reinfusion of tumor cells is unknown. ()
Splenic Rupture: Evaluate patients who report left upper abdominal and/or scapular or shoulder pain. ()
Embryo-Fetal Toxicity: Can cause fetal harm. Advise women not to become pregnant when taking Mozobil.u00a0 (,)

The following clinically significant adverse reactions are discussed elsewhere in the labeling:
Most common adverse reactions (u226510%):u00a0diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness, and vomiting. ()

Lactation: Advise not to breastfeed. ()

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.

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 24u00a0mg 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.u00a0
Plerixafor is a hematopoietic stem cell mobilizer with a chemical name 1,4-Bis((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzene.u00a0 It has the molecular formula CHN. The molecular weight of plerixafor is 502.79 g/mol. The structural formula is provided in .
Figure 1: Structural Formula
Plerixafor is a white to off-white crystalline solid.u00a0It is hygroscopic. Plerixafor has a typical melting point of 131.5u00b0C. The partition coefficient of plerixafor between 1-octanol and pH 7 aqueous buffer is <0.1.

No data

Carcinogenicity studies with plerixafor have not been conducted.
Plerixafor was not genotoxic in an bacterial mutation assay (Ames test in ), an chromosomal aberration test using V79 Chinese hamster cells, or an bone marrow micronucleus test in rats after subcutaneous doses up to 25 mg/kg (150 mg/m).
The effect of plerixafor on human fertility is unknown.u00a0The effect of plerixafor on male or female fertility was not studied in designated reproductive toxicology studies.u00a0The staging of spermatogenesis measured in a 28-day repeated dose toxicity study in rats revealed no abnormalities considered to be related to plerixafor.u00a0No histopathological evidence of toxicity to male or female reproductive organs was observed in 28-day repeated dose toxicity studies.

The efficacy and safety of Mozobil in conjunction with G-CSF 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).u00a0Patients were randomized to receive either Mozobil 0.24 mg/kg or placebo on each evening prior to apheresis. Patients received daily morning doses of G-CSF 10 micrograms/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 29u201375) and 58 years (range 22u201375) 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 (28u201375) 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 G-CSF collected u22655 u00d7 10 CD34+ cells/kg from the peripheral blood in four or fewer apheresis sessions, compared with 20% of patients who were mobilized with placebo and G-CSF (p <0.001). Other CD34+ cell mobilization outcomes showed similar findings (Table 5).u00a0
The median number of days to reach u22655 u00d7 10 CD34+ cells/kg was 3 days for the Mozobil group and not evaluable for the placebo group.u00a0Table 6 presents the proportion of patients who achieved u22655 u00d7 10 CD34+ cells/kg by apheresis day.
In Study 2, 72% of MM patients who were mobilized with Mozobil and G-CSF collected u22656 u00d7 10 CD34+ cells/kg from the peripheral blood in two or fewer apheresis sessions, compared with 34% of patients who were mobilized with placebo and G-CSF (p <0.001). Other CD34+ cell mobilization outcomes showed similar findings (Table 7).u00a0
The median number of days to reach u22656 u00d7 10 CD34+ cells/kg was 1 day for the Mozobil group and 4 days for the placebo group.u00a0Table 8 presents the proportion of patients who achieved u22656 u00d7 10 CD34+ cells/kg by apheresis day.
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.

Mozobil (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: 0024-5862-01
Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0Cu201330u00b0C (59u00b0Fu201386u00b0F). [see USP Controlled Room Temperature]

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 painu00a0.
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 of reproductive potential to use effective contraceptive methods during Mozobil use and for 1 week following the last dose .
Advise women not to breastfeed during treatment with Mozobil and for 1 week following the last dose .

Genzyme CorporationCambridge, MA 02142A SANOFI COMPANY
u00a92019 Genzyme Corporation. All rights reserved. Mozobil is a registered trademark of Genzyme Corporation.

Carton contains one vial of
Mozobiln (plerixafor injection)
24 mg/1.2 mL
For single use only
Rx only
See package insertfor dosageand administration
genzyme

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Plerixafor (Mozobil)

Trade Name : Mozobil

SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Plerixafor (Mozobil)

Trade Name : Mozobil

SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

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you’re looking for?