Pegfilgrastim

What it is and how it works

Mechanism of Action Pegfilgrastim products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

Indications

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. • Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). Limitations of Use ZIEXTENZO is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Patients with Cancer Receiving Myelosuppressive Chemotherapy ZIEXTENZO is indicated in adults and pediatric patients aged newborn and older 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 .

Dosage and administration (summary)

Patients with cancer receiving myelosuppressive chemotherapy • For adult patients of any weight and pediatric patients weighing 45 kg and greater, the recommended dosage is 6 mg subcutaneously once per chemotherapy cycle. • Do not administer between 14 days before and 24 hours after administration of chemotherapy. Patients acutely exposed to myelosuppressive doses of radiation • For adults of any weight and pediatric patients weighing 45 kg and greater, the recommended dosage is two doses, 6 mg each, subcutaneously one week apart. Administer the first dose as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation, and a second dose one week after.

Contraindications

is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis . In patients with a history of serious hypersensitivity reaction to pegfilgrastim products or filgrastim products.

Warnings and precautions

• Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. • Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue ZIEXTENZO in patients with ARDS. • Serious hypersensitivity reactions, including anaphylaxis: Permanently discontinue ZIEXTENZO in patients with serious hypersensitivity reactions. • Fatal sickle cell crises: Discontinue ZIEXTENZO if sickle cell crisis occurs.

Pregnancy

Pregnancy Risk Summary Although available data with pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products.

Storage and supply

single-dose prefilled syringe for manual use ZIEXTENZO injection is a clear, colorless to slightly yellowish solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim-bmez, supplied with a 29-gauge, 1/2-inch needle with an UltraSafe Passive TM Needle Guard.

Source: Pegfilgrastim-Bmez (Ziextenzo) — US FDA prescribing information, 2026-05-14, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.