Mozobil 24 mg/1.2mL
PLERIXAFOR · INJECTION, SOLUTION · Sanofi-Aventis U.S. LLC
Mozobil is a injection, solution containing plerixafor at 24 mg/1.2mL, taken subcutaneous. Manufactured by Sanofi-Aventis U.S. LLC.
Key Facts
- Brand Name
- Mozobil
- Generic Name
- PLERIXAFOR
- NDC Code (Product)
0024-5862- Manufacturer
- Sanofi-Aventis U.S. LLC
- Strength
- 24 mg/1.2mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA022311
- Drug Class
- Hematopoietic Stem Cell Mobilizer [EPC]
- Marketing Start
- 09/01/2013
Recall History
Sanofi-Aventis U.S. LLC
Labeling: Incorrect or Missing Package Insert
Genzyme Corporation / Genzyme Biosurgery
Labeling: Incorrect or Missing Lot and/or Exp. Date
Full Prescribing Information
Indications & Usage
1 INDICATIONS 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). Mozobil, a hematopoietic stem cell mobilizer, 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 or multiple myeloma. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 bod…
Contraindications
4 CONTRAINDICATIONS 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 )
Adverse Reactions
6 ADVERSE REACTIONS 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 conj…
Frequently Asked Questions
What is Mozobil used for?
Mozobil contains PLERIXAFOR. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Mozobil a controlled substance?
Mozobil is not classified as a controlled substance by the DEA.
What is the generic name for Mozobil?
The generic name for Mozobil is PLERIXAFOR. There are 11 other brand versions of PLERIXAFOR.
What is the NDC code for Mozobil 24 mg/1.2mL?
The NDC (National Drug Code) for Mozobil 24 mg/1.2mL is 0024-5862, listed by Sanofi-Aventis U.S. LLC.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)