Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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 )] Allergies to Acrylics [see Warnings and Precautions ( 5.4 )] Use in Patients with Sickle Cell Disorders [see Warnings and Precautions ( 5.5 )] Glomerulonephritis [see Warnings and Precautions ( 5.6 )] Leukocytosis [see Warnings and Precautions ( 5.7 )] Thrombocytopenia [see Warnings and Precautions ( 5.8 )] Capillary Leak Syndrome [see Warnings and Precautions ( 5.9 )] Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions ( 5.10 )] Myelodysplastic syndrome [see Warnings and Precautions ( 5.11 )] Acute myeloid leukemia [see Warnings and Precautions ( 5.11 )] Aortitis [see Warnings and Precautions ( 5.13 )] Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma at 1-866-941-7875 or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch 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 with rates in the clinical trials of another drug and may not reflect the rates observed in clinical 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/m 2 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.
5 WARNINGS AND PRECAUTIONS Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture ( 5.1 ) Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress.
Discontinue UDENYCA in patients with ARDS.
( 5.2 ) Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA in patients with serious allergic reactions.
( 5.3 ) The on-body injector for UDENYCA uses acrylic adhesives.
For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.
Like all medications, Udenyca can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: