se.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of Neulasta® cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to Neulasta® use and for approximating rates.
The data described below reflect exposure to Neulasta® in 932 patients. Neulasta® was studied in placebo- and active-controlled trials (n = 467, and n = 465, respectively). The population encompassed an age range of 21 to 88 years. Ninety-two percent of patients were female. The ethnicity of the patients was as follows: 75% Caucasian, 18% Hispanic, 5% Black, and 1% Asian. Patients with solid tumors (breast [n = 823], lung and thoracic tumors [n = 53]) or lymphoma (n = 56) received Neulasta® after nonmyeloablative cytotoxic chemotherapy. Most patients received a single 100 mcg/kg (n = 259) or a single 6 mg (n = 546) dose per chemotherapy cycle over 4 cycles.
In the placebo-controlled trial, bone pain occurred at a higher incidence in Neulasta®-treated patients as compared to placebo-treated patients. The incidence of other commonly reported adverse events were similar in the Neulasta ®- and placebo-treated patients, and were consistent with the underlying cancer diagnosis and its treatment with chemotherapy. The data in Table 2 reflect those adverse events occurring in at least 10% of patients treated with Neulasta® in the placebo-controlled study.
Table 2. Adverse Events Occurring in ≥ 10% * of Patients in the Placebo‑Controlled Study.
|
Events occurring in ≥ 10% of Neulasta ®-treated patients and at a higher incidence as compared to placebo-treated patients.
|
|
Event |
Neulasta® (n = 467) |
Placebo (n = 461) |
|
Alopecia |
48% |
47% |
|
Bone Pain |
31% |
26% |
|
Diarrhea |
29% |
28% |
|
Pyrexia (not including febrile neutropenia) |
23% |
22% |
|
Myalgia |
21% |
18% |
|
Headache |
16% |
14% |
|
Arthralgia |
16% |
13% |
|
Vomiting |
13% |
11% |
|
Asthenia |
13% |
11% |
|
Edema peripheral |
12% |
10% |
|
Constipation |
10% |
6% |
In the active controlled studies, common adverse events occurred at similar rates and severities in both treatment arms (Neulasta®, n = 465; Filgrastim, n = 331). These adverse experiences occurred at rates between 72% and 15% and included: nausea, fatigue, alopecia, diarrhea, vomiting, constipation, fever, anorexia, skeletal pain, headache, taste perversion, dyspepsia, myalgia, insomnia, abdominal pain, arthralgia, generalized weakness, peripheral edema, dizziness, granulocytopenia, stomatitis, mucositis, and neutropen |
