Common adverse reaction:
The most common adverse reactions (at least 10 %) reported in patients who received plerixafor in conjunction with G-CSF regardless of causality and more frequently with plerixafor than placebo during HSC mobilization and apheresis were diarrhea, nausea, fatigue, injection-site reactions, headache, arthralgia, dizziness, and vomiting.
Adverse reactions (5% or more):
See Table 2.
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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 plerixafor and in 1 % of patients receiving placebo. No complications or clinical symptoms of leukostasis were observed.
In the randomized studies, 34 % of patients with NHL or multiple myeloma had mild to moderate injection-site reactions at the site of subcutaneous administration of plerixafor. These included erythema, hematoma, hemorrhage, induration, inflammation, irritation, pain, paresthesia, pruritus, rash, swelling, and urticaria.
Other adverse reactions (less than 5 %):
Other adverse reactions that occurred in less than 5 % of patients but were reported as related to plerixafor during HSC mobilization and apheresis included abdominal pain, hyperhidrosis, abdominal distention, dry mouth, erythema, stomach discomfort, malaise, hypoesthesia oral, constipation, dyspepsia, and musculoskeletal pain.
Other adverse reactions (less than 1 %):
Mild to moderate systemic reactions were observed in less than 1% of patients approximately 30 minutes after plerixafor administration. Reactions included 1 or more of the following: urticaria (n = 2), periorbital swelling (n = 2), dyspnea (n = 1), or hypoxia (n = 1). Symptoms generally responded to treatments (eg, antihistamines, corticosteroids, hydration or supplemental oxygen) or resolved spontaneously.
Vasovagal reactions, orthostatic hypotension, and/or syncope can occur following subcutaneous injections. In plerixafor oncology and healthy volunteer clinical studies, less than 1% of subjects experienced vasovagal reactions following subcutaneous administration of plerixafor doses of 0.24 mg/kg or less. The majority of these events occurred within 1 hour of plerixafor administration. Because of the potential for these reactions, appropriate precautions.