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Clinical Trial Experience

The following serious adverse reactions are discussed elsewhere in the labeling:

• Potential for tumor cell mobilization in leukemia patients [see WARNINGS AND PRECAUTIONS]
• Increased circulating leukocytes and decreased platelet counts [see WARNINGS AND PRECAUTIONS]
• Potential for splenic enlargement [see WARNINGS AND PRECAUTIONS]

The most common adverse reactions ( > 10%) reported in patients who received Mozobil (plerixafor injection) in conjunction with G-CSF regardless of causality and more frequent with Mozobil (plerixafor injection) than placebo during HSC mobilization and apheresis were diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness, and vomiting.

Safety data for Mozobil (plerixafor injection) in combination with G-CSF were obtained from two randomized placebo-controlled studies (301 patients) and 10 uncontrolled studies (242 patients). Patients were primarily treated with Mozobil (plerixafor injection) at daily doses of 0.24 mg/kg SC. Median exposure to Mozobil (plerixafor injection) 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 (plerixafor injection) and G-CSF group and 292 patients were treated in the placebo and G-CSF group. Patients received daily morning doses of G-CSF 10 micrograms/kg for 4 days prior to the first dose of Mozobil (plerixafor injection) 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 (plerixafor injection) regardless of causality and were more frequent with Mozobil (plerixafor injection) than placebo during HSC mobilization and apheresis are shown in Table 2.

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.

Table 2: Adverse Reactions in ≥ 5% of Non-Hodgkin's Lymphoma and Multiple Myeloma Patients Receiving Mozobil (plerixafor injection) and More Frequent than Placebo During HSC Mobilization and Apheresis

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 (plerixafor injection) . These included erythema, hematoma, hemorrhage, induration, inflammation, irritation, pain, paresthesia, pruritus, rash, swelling, and urticaria.

Mild to moderate systemic reactions were observed in less than 1% of patients approximately 30 min after Mozobil (plerixafor injection) administration. Events included 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 (plerixafor injection) oncology and healthy volunteer clinical studies, less than 1% of subjects experienced vasovagal reactions following subcutaneous administration of Mozobil (plerixafor injection) doses ≤ 0.24 mg/kg. The majority of these events occurred within 1 hour of Mozobil (plerixafor injection) 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 (plerixafor injection) during HSC mobilization and apheresis included abdominal pain, hyperhidrosis, abdominal distention, dry mouth, erythema, stomach discomfort, malaise, hypoesthesia oral, constipation, dyspepsia, and musculoskeletal pain.

Based on in vitro data, plerixafor is not a substrate, inhibitor or inducer of human cytochrome P450 isozymes. Plerixafor is not likely to be implicated in in vivo drug-drug interactions involving cytochrome P450s. At concentrations similar to what are seen clinically, plerixafor did not act as a substrate or inhibitor of P-glycoprotein in an in vitro study. [see CLINICAL PHARMACOLOGY]

Last reviewed on RxList: 7/13/2010
This monograph has been modified to include the generic and brand name in many instances.