Ziextenzo

Generic name: pegfilgrastim
Brand names: Fulphila, Neulasta, Neulasta Onpro Kit, Nyvepria, Udenyca, Ziextenzo
Drug class: Colony stimulating factors

Medically reviewed by A Ras MD.

What is Ziextenzo?

Ziextenzo is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.

Description

Pegfilgrastim-bmez is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim-bmez, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-bmez is approximately 39 kD.

ZIEXTENZO for manual subcutaneous injection is supplied in 0.6 mL prefilled syringes. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL).

The delivered 0.6 mL dose from the prefilled syringe for manual subcutaneous injection contains 6 mg pegfilgrastim-bmez (based on protein weight) in a sterile, clear, colorless to slightly yellowish, preservative-free solution (pH 4.0, sodium hydroxide may be added as necessary to adjust pH) containing acetic acid (0.36 mg), polysorbate 20 (0.02 mg), sorbitol (30 mg), and Water for Injection, USP.

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.

Who should not use Ziextenzo?

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

What should I tell my healthcare provider before using Ziextenzo?

Before you receive Ziextenzo, tell your healthcare provider 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 (made from latex). You should not inject Ziextenzo using the prefilled syringe if you have latex allergies.
are pregnant or plan to become pregnant. It is not known if Ziextenzo will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if Ziextenzo passes into your breast milk.

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

How should I use Ziextenzo?

Ziextenzo is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed Instructions for use that comes with your Ziextenzo for information on how to prepare and inject a dose of Ziextenzo.
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 to 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 healthcare provider about when you should give your next dose.

What are the possible side effects of Ziextenzo?

Ziextenzo may cause serious side effects, including:

Spleen Rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider 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 healthcare provider or get emergency help 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 can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using Ziextenzo and call your healthcare provider or get emergency medical help right away.
Sickle cell crises. You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive Ziextenzo. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
Kidney injury (glomerulonephritis). Ziextenzo can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
- swelling of your face or ankles
- blood in your urine or dark colored urin
- you urinate less than usual
Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with Ziextenzo.
Capillary Leak Syndrome. Ziextenzo can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have 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 (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received pegfilgrastim. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.

The most common side effects of Ziextenzo are pain in the bones, arms, and legs. These are not all the possible side effects of Ziextenzo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Ziextenzo

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information guide. Do not use Ziextenzo for a condition for which it was not prescribed. Do not give Ziextenzo to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Ziextenzo that is written for health professionals.

How should I store Ziextenzo?

Store Ziextenzo in the refrigerator between 36°F to 46°F (2°C to 8°C).
Take Ziextenzo out of the refrigerator for at least 15 to 30 minutes before use and allow it to reach room temperature before preparing an injection.
Avoid freezing. If Ziextenzo is accidently frozen, allow the prefilled syringe to thaw in the refrigerator before injecting.
Do not use a Ziextenzo 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 from light or physical damage.
Do not shake the prefilled syringe.
Throw away (dispose of) any Ziextenzo that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 72 hours.

Keep the Ziextenzo prefilled syringe out of the reach of children.

What are the ingredients in Ziextenzo?

Active ingredient: pegfilgrastim-bmez

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

Label

ZIEXTENZO 6 MG/0.6 ML CARTON

NDC 61314-866-01
ZiextenzoTM6 mg/0.6 mL
(pegfilgrastim-bmez)
Injection
For subcutaneous use only
One Time Use Only
One single-dose prefilled syringe with needle guard
6 mg/0.6 mL
Pegylated Recombinant Methionyl Human Granulocyte Colony-
Stimulating Factor (PEG-r-metHuG-CSF) derived from E coli
No Preservative.
Caution: The Needle Cap contains Natural Rubber Latex Which May Cause
Allergic Reactions.
Rx Only
SANDOZ
A Novartis Division

SRC: NLM .

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