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Ziextenzo

Last reviewed on RxList: 11/13/2019
Ziextenzo Side Effects Center

Last reviewed on RxList 11/13/2019

What Is Ziextenzo?

Ziextenzo (pegfilgrastim-bmez) 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. Ziextenzo is biosimilar to Neulasta (pegfilgrastim).

What Are Side Effects of Ziextenzo?

Side effects of Ziextenzo include:

  • bone pain and
  • pain in the extremities

Dosage for Ziextenzo

The dosage of Ziextenzo for patients with cancer receiving myelosuppressive chemotherapy is 6 mg administered subcutaneously once per chemotherapy cycle. Weight-based dosing is used for pediatric patients weighing less than 45 kg.

Ziextenzo In Children

The safety and effectiveness of Ziextenzo has been established in pediatric patients. No overall differences in safety were identified between adult and pediatric patients based on postmarketing surveillance and review of the scientific literature.

What Drugs, Substances, or Supplements Interact with Ziextenzo?

Ziextenzo may interact with other medicines.

Tell your doctor all medications and supplements you use.

Ziextenzo During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Ziextenzo; it is unknown how it would affect a fetus. It is unknown if Ziextenzo passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Ziextenzo (pegfilgrastim-bmez) 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.

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.

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Ziextenzo 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]
  • Capillary Leak Syndrome [see WARNINGS AND PRECAUTIONS]
  • Potential for Tumor Growth Stimulatory Effects on Malignant Cells [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 notreflect the rates 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 patientsreceived 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 studyin patients with metastatic or non-metastatic breast cancer receiving docetaxel 100 mg/m² every 21 days (Study3). 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 reportedin clinical studies.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation ishighly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence ofantibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, includingassay methodology, sample handling, timing of sample collection, concomitant medications, and underlyingdisease. For these reasons, comparison of the incidence of antibodies in the studies described below with theincidence 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 detectionfor this assay is 500 ng/mL. Pre-existing binding antibodies were detected in approximately 6% (51/849) ofpatients 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 ofneutralizing 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]
  • Capillary Leak Syndrome [see WARNINGS AND PRECAUTIONS]
  • Injection site reactions
  • Sweet's syndrome (acute febrile neutrophilic dermatosis), cutaneous vasculitis
  • Aortitis [see WARNINGS AND PRECAUTIONS]
  • Alveolar hemorrhage

Read the entire FDA prescribing information for Ziextenzo (Pegfilgrastim-bmez Injection)

Related Resources for Ziextenzo

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

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