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NYVEPRIA Adverse Reactions (pegfilgrastim-apgf)


The following clinically significant 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)]
Thrombocytopenia [see Warnings and Precautions (5.7)]
Capillary Leak Syndrome [see Warnings and Precautions (5.8)]
Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.9)]
Myelodysplastic Syndrome [see Warnings and Precautions (5.10)]
Acute Myeloid Leukemia [see Warnings and Precautions (5.10)]
Aortitis [see Warnings and Precautions (5.11)]

6.1 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Pegfilgrastim clinical trials safety data are based upon 932 patients receiving pegfilgrastim 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 pegfilgrastim 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 2 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 pegfilgrastim (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.

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
(N = 461)
Pegfilgrastim 6 mg SC on Day 2
(N = 467)

Musculoskeletal and connective tissue disorders

  Bone pain



  Pain in extremity




In clinical studies, leukocytosis (WBC counts >100 × 109/L) was observed in less than 1% of 932 patients with non-myeloid malignancies receiving pegfilgrastim. No complications attributable to leukocytosis were reported in clinical studies.

6.2 Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing 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 in the studies described below with the incidence of antibodies in other studies or to other pegfilgrastim products may be misleading.

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.

6.3 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of pegfilgrastim products. 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.

Splenic rupture and splenomegaly (enlarged spleen) [see Warnings and Precautions (5.1)]
Acute respiratory distress syndrome (ARDS) [see Warnings and Precautions (5.2)]
Allergic reactions/hypersensitivity, including anaphylaxis, skin rash, urticaria, generalized erythema, and flushing [see Warnings and Precautions (5.3)]
Sickle cell crisis [see Warnings and Precautions (5.4)]
Glomerulonephritis [see Warnings and Precautions (5.5)]
Leukocytosis [see Warnings and Precautions (5.6)]
Thrombocytopenia [see Warnings and Precautions (5.7)]
Capillary Leak Syndrome [see Warnings and Precautions (5.8)]
Injection site reactions
Sweet's syndrome (acute febrile neutrophilic dermatosis), cutaneous vasculitis
Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with breast and lung cancer receiving chemotherapy and/or radiotherapy [see Warnings and Precautions (5.10)]
Aortitis [see Warnings and Precautions (5.11)]
Alveolar hemorrhage
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