oved, cannot be excluded.
5.9 Aortitis
Aortitis has been reported in patients receiving pegfilgrastim products. It may occur as early as the first week afterstart of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain,malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count).
Consider aortitis in patients who develop these signs and symptoms without known etiology. DiscontinueUDENYCA if aortitis is suspected.
5.10 Nuclear Imaging
Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated withtransient positive bone imaging changes. This should be considered when interpreting bone imaging results.
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
• Splenic Rupture [see Warnings and Precautions (5.1)]
• Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2)]
• Serious Allergic Reactions [see Warnings and Precautions (5.3)]
• Use in Patients with Sickle Cell Disorders [see Warnings and Precautions (5.4)]
• Glomerulonephritis [see Warnings and Precautions (5.5)]
• Leukocytosis [see Warnings and Precautions (5.6)]
• Capillary Leak Syndrome [see Warnings and Precautions (5.7)]
• Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.8)]
• Aortitis [see Warnings and Precautions (5.9)]
• Nuclear Imaging [see Warnings and Precautions (5.10)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinicaltrials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect therates observed in clinical practice.
Pegfilgrastim clinical trials safety data are based upon 932 patients receiving pegfilgrastim in seven randomizedclinical 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 pegfilgrastim after nonmyeloablative cytotoxic chemotherapy. Most patients received a single 100mcg/kg (n = 259) or a single 6 mg (n = 546) dose per chemotherapy cycle over 4 cycles.
The following adverse reaction data in Table 2 are from a randomized, double-blind, placebo-controlled study inpatients with metastatic or non-metastatic breast cancer receiving docetaxel 100 mg/m2 every 21 days (Study 3). Atotal of 928 patients were randomized to receive either 6 mg pegfilgrastim (n = 467) or placebo (n = 461). Thepatients 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.
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.
Table 2. Adverse Reactions with ≥ 5% Higher Incidence in pegfilgrastim Patients Compared to Placebo in
Study 3
Body System
Adverse Reaction
Placebo
(N = 461)
pegfilgrastim 6 mg SC on Day 2
(N = 467)
Musculoskeletal and connective tissue disorders
Bone Pain 26% 31%
Pain in Extremity 4% 9%
Leukocytosis
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