Ziextenzo (pegfilgrastim-bmez) for Neutropenia

ZIEXTENZO is a man-made form of G-CSF or granulocyte colony-stimulating factor. G-CSF stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.

ZIEXTENZO is 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.

• Do not take ZIEXTENZO if you have had a serious allergic reaction to pegfilgrastim products or filgrastim products.

• ZIEXTENZO should not be used for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Before you receive ZIEXTENZO, tell your doctor about all of your medical conditions, including if you:

• have a sickle cell disorder.

• have kidney problems.

• are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber. You should not inject ZIEXTENZO using the prefilled syringe if you have latex allergies.

• are pregnant or planning to become pregnant. It is not known if ZIEXTENZO can harm your unborn baby.

• are breastfeeding or planning to breastfeed. It is not known if ZIEXTENZO can pass into your breast milk.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• ZIEXTENZO is given as an injection under your skin by a doctor.

• You and your caregiver will be shown how to prepare and inject ZIEXTENZO before you use it.

• You should not inject a dose of ZIEXTENZO into children weighing less than 45 kg from a ZIEXTENZO prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the ZIEXTENZO prefilled syringe.

• If you are receiving ZIEXTENZO because you are also receiving chemotherapy, the last dose of ZIEXTENZO should be injected at least 14 days before and 24 hours after your dose of chemotherapy.

• If you miss a dose of ZIEXTENZO, talk to your doctor about when you should give your next dose.

The recommended dosage of ZIEXTENZO is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. Do not administer ZIEXTENZO between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

The ZIEXTENZO prefilled syringe does not allow direct administration of doses less than 0.6 mL (6 mg). The syringe does not bear graduation marks, which are necessary to accurately measure doses of ZIEXTENZO less than 0.6 mL (6 mg) for direct administration to patients. Thus, the direct administration to patients requiring dosing of less than 0.6 mL (6 mg) is not recommended due to the potential for dosing errors.

• 10 – 20 kg
  • ZIEXTENZO Dose: 1.5 mg
  • Volume to Administer: 0.15 mL

• 21 – 30 kg
  • ZIEXTENZO Dose: 2.5 mg
  • Volume to Administer: 0.25 mL

• 31 – 44 kg
  • ZIEXTENZO Dose: 4 mg
  • Volume to Administer: 0.4 mL

For pediatric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of ZIEXTENZO

• Spleen rupture: Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your doctor right away if you have pain in the left upper stomach area or your left shoulder.

• A serious lung problem called Acute Respiratory Distress Syndrome (ARDS): Call your doctor right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.

• Serious allergic reactions: ZIEXTENZO may cause serious allergic reactions. These reactions can cause shortness of breath, wheezing, a rash over your whole body, dizziness, swelling around your mouth or eyes, sweating, and fast heart rate. If you have any of these symptoms, stop using ZIEXTENZO and call your doctor right away.

• Sickle cell crises: You may get a serious sickle cell crisis, which could lead to death if you have a sickle cell disorder and receive ZIEXTENZO. Call your doctor right away if you have symptoms of sickle cell crisis such as difficulty breathing or pain.

• Kidney injury (glomerulonephritis): ZIEXTENZO can cause kidney injury. Call your doctor right away if you develop any of the following symptoms.
  • swelling of your face or ankles
  • blood in your urine or dark-colored urine
  • you urinate less than usual

• Increased white blood cell count (leukocytosis): Your doctor will check your blood during treatment with ZIEXTENZO.

• Decreased platelet count (thrombocytopenia): Your doctor will check your blood during treatment with ZIEXTENZO. Tell your doctor if you have unusual bleeding or bruising during treatment with ZIEXTENZO.

• Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes.

• Myelodysplastic syndrome and acute myeloid leukemia: If you have lung cancer or breast cancer, when ZIEXTENZO is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called MDS or myelodysplastic syndrome or a blood cancer called AML or acute myeloid leukemia. Symptoms of MDS and AML may include fever, tiredness, and easy bruising or bleeding. Call your doctor if you develop these symptoms during treatment with ZIEXTENZO.

• Capillary Leak Syndrome (CLS): ZIEXTENZO can cause fluid to leak from blood vessels into your body’s tissues. This condition is called CLS or Capillary Leak Syndrome. CLS can cause symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:
  • swelling or puffiness and are urinating less than usual
  • trouble breathing
  • swelling of your stomach area (abdomen) and feeling of fullness
  • dizziness or feeling faint
  • a general feeling of tiredness

• Inflammation of the aorta (aortitis): Inflammation of the aorta has been reported in patients who received pegfilgrastim products. Symptoms may include fever, feeling tired, abdominal pain, and back pain. Call your doctor if you experience these symptoms.

• Store ZIEXTENZO in the refrigerator between 2°C to 8°C.

• Do not freeze.

• Do not use the prefilled syringe that has been frozen more than 1 time. Use a new ZIEXTENZO prefilled syringe.

• Keep the prefilled syringe in the original carton to protect it from light or physical damage.

• Do not shake the prefilled syringe.

• Take ZIEXTENZO out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.

• Throw away any ZIEXTENZO that has been left at room temperature, 68°F to 77°F, for more than 15 days.

• Keep the ZIEXTENZO prefilled syringe out of the reach of children

Active ingredient: pegfilgrastim-bmez
Inactive ingredients: polysorbate 20, acetic acid, sorbitol, and Water for Injection. Sodium hydroxide may be added as necessary to adjust pH.