Udenyca

Last updated on RxList: 6/18/2021
Udenyca Side Effects Center

What Is Udenyca?

Udenyca (pegfilgrastim-cbqv) is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

What Are Side Effects of Udenyca?

Common side effects of Udenyca include:

  • bone pain and pain in the extremities.

Dosage for Udenyca

The dose of Udenyca for patients with cancer receiving myelosuppressive chemotherapy is 6 mg administered subcutaneously once per chemotherapy cycle.

What Drugs, Substances, or Supplements Interact with Udenyca?

Udenyca may interact with other drugs. Tell your doctor all medications and supplements you use.

Udenyca During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Udenyca; it is unknown how it would affect a fetus. It is unknown if Udenyca passes into breast milk. Other filgrastim products are secreted poorly into breast milk, and filgrastim products are not orally absorbed by neonates. Consult your doctor before breastfeeding.

Additional Information

Our Udenyca (pegfilgrastim-cbqv) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

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Udenyca Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, skin rash, sweating, warmth or tingly feeling; dizziness, fast heartbeats; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Capillary leak syndrome is a rare but serious side effect of pegfilgrastim. Call your doctor right away if you have signs of this condition, which may include: decreased urination, tiredness, dizziness or light-headed feeling, trouble breathing, and sudden swelling, puffiness, or feeling of fullness.

Call your doctor at once if you have:

  • sudden or severe pain in your left upper stomach spreading up to your shoulder;
  • sudden and severe pain in your chest, stomach, or back;
  • severe or ongoing pain anywhere in your body;
  • fever, tiredness;
  • shortness of breath, rapid breathing;
  • pale skin, easy bruising, unusual bleeding;
  • bruising, swelling, or a hard lump where the medicine was injected; or
  • kidney problems--little or no urination, pink or dark urine, swelling in your face or lower legs.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • bone pain; or
  • pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Udenyca (Pegfilgrastim-cbqv Injection)

Udenyca Professional Information

SIDE EFFECTS

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]
  • Glomerulonephritis [see WARNINGS AND PRECAUTIONS]
  • Leukocytosis [see WARNINGS AND PRECAUTIONS]
  • Thrombocytopenia [see WARNINGS AND PRECAUTIONS]
  • Capillary Leak Syndrome [see WARNINGS AND PRECAUTIONS]
  • Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see WARNINGS AND PRECAUTIONS]
  • Myelodysplastic syndrome [see WARNINGS AND PRECAUTIONS]
  • Acute myeloid leukemia [see WARNINGS AND PRECAUTIONS]
  • Aortitis [see WARNINGS AND PRECAUTIONS]

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/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
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

In clinical studies, leukocytosis (WBC counts > 100 x 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.

Immunogenicity

As with all therapeutic proteins, there is a 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.

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]
  • Acute respiratory distress syndrome (ARDS) [see WARNINGS AND PRECAUTIONS].
  • Allergic reactions/hypersensitivity, including anaphylaxis, skin rash, urticaria, generalized erythema and flushing [see WARNINGS AND PRECAUTIONS]
  • Sickle cell crisis [see WARNINGS AND PRECAUTIONS]
  • Glomerulonephritis [see WARNINGS AND PRECAUTIONS]
  • Leukocytosis [see WARNINGS AND PRECAUTIONS]
  • Thrombocytopenia [see WARNINGS AND PRECAUTIONS]
  • Capillary leak syndrome [see WARNINGS AND PRECAUTIONS]
  • 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]
  • Aortitis [see WARNINGS AND PRECAUTIONS]
  • Alveolar hemorrhage

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Udenyca (Pegfilgrastim-cbqv Injection)

© Udenyca Patient Information is supplied by Cerner Multum, Inc. and Udenyca Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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