"The U.S. Food and Drug Administration today expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer.
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Splenic Rupture [See WARNINGS AND PRECAUTIONS]
- Acute Respiratory Distress Syndrome [See WARNINGS AND PRECAUTIONS]
- Serious Allergic Reactions [See WARNINGS AND PRECAUTIONS]
- Use in Patients with Sickle Cell Disorders [See WARNINGS AND PRECAUTIONS]
- Potential for Tumor Growth Stimulatory Effects on Malignant Cells [See WARNINGS AND PRECAUTIONS]
The most common adverse reactions occurring in ≥ 5% of patients and with a between-group difference of ≥ 5% higher in the pegfilgrastim arm in placebo controlled clinical trials are bone pain and pain in extremity.
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 with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Neulasta clinical trials safety data are based upon 932 patients receiving Neulasta in seven randomized clinical trials. The population was 21 to 88 years of age and 92% female. The ethnicity was 75% Caucasian, 18% Hispanic, 5% Black, and 1% Asian. Patients with breast (n = 823), lung and thoracic tumors (n = 53) and 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.
The following adverse reaction data in Table 1 are from a randomized, double-blind, placebo-controlled study in patients with metastatic or non-metastatic breast cancer receiving docetaxel 100 mg/m² every 21 days (Study 3). A total of 928 patients were randomized to receive either 6 mg Neulasta (n = 467) or placebo (n = 461). The patients were 21 to 88 years of age and 99% female. The ethnicity was 66% Caucasian, 31% Hispanic, 2% Black, and < 1% Asian, Native American or other.
Bone pain and pain in extremity occurred at a higher incidence in Neulasta-treated patients as compared with placebo-treated patients.
Table 1: Adverse Reactions With ≥ 5% Higher
Incidence in Neulasta Patients Compared to Placebo in Study 3
|System Organ Class
|Neulasta 6 mg SC on Day 2
|Musculoskeletal and connective tissue disorders|
|Pain in extremity||4%||9%|
In clinical studies, leukocytosis (WBC counts > 100 x 109/L) was observed in less than 1% of 932 patients with non-myeloid malignancies receiving Neulasta. No complications attributable to leukocytosis were reported in clinical studies.
As with all therapeutic proteins, there is a potential for immunogenicity. Binding antibodies to pegfilgrastim were detected using a BIAcore assay. The approximate limit of detection for this assay is 500 ng/mL. Pre-existing binding antibodies were detected in approximately 6% (51/849) of patients with metastatic breast cancer. Four of 521 pegfilgrastim-treated subjects who were negative at baseline developed binding antibodies to pegfilgrastim following treatment. None of these 4 patients had evidence of neutralizing antibodies detected using a cell-based bioassay.
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, and the observed incidence of antibody positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Neulasta with the incidence of antibodies to other products may be misleading.
The following adverse reactions have been identified during post approval use of Neulasta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) reported frequency of the reaction, or (3) strength of causal relationship to Neulasta.
Gastro-intestinal disorders: Splenic rupture [see WARNINGS AND PRECAUTIONS]
Blood and lymphatic system disorder: Sickle cell crisis [see WARNINGS AND PRECAUTIONS]
Respiratory, thoracic, and mediastinal disorder: ARDS [see WARNINGS AND PRECAUTIONS]
General disorders and administration site conditions: Injection site reactions
Skin and subcutaneous tissue disorders: Sweet's syndrome, Cutaneous vasculitis
Read the Neulasta (pegfilgrastim) Side Effects Center for a complete guide to possible side effects
No formal drug interaction studies between Neulasta and other drugs have been performed. Increased hematopoietic activity of the bone marrow in response to growth factor therapy may result in transiently positive bone-imaging changes. Consider these findings when interpreting bone-imaging results.
Read the Neulasta Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 6/4/2012
This monograph has been modified to include the generic and brand name in many instances.
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