Ziextenzo

Ziextenzo is used to reduce infection risk from low white blood cell counts caused by chemotherapy in adults and children (newborn and older) with non-myeloid cancers. It is also used for acute radiation syndrome, based on animal studies, as human trials weren't feasible.

Ziextenzo (pegfilgrastim-bmez) is a colony-stimulating factor that works by binding to specific receptors on blood-forming (hematopoietic) cells, triggering those cells to multiply, mature, and become fully functional. This improves white blood cell counts in people undergoing chemotherapy.

Ziextenzo (pegfilgrastim-bmez) was FDA-approved on January 31, 2002, and is a biosimilar to Neulasta. Other Neulasta biosimilars include Armlupeg, Ennumo, Fulphila, Fylnetra, Nyvepria, Stimufend, and Udenyca.

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

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 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.

Common side effects

The most common side effects of Ziextenzo are pain in the bones, arms, and legs.

Serious side effects

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. Allergic 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 in people with sickle cell disorder. You may have a severe sickle cell crisis, which could lead to death. Call your healthcare provider right away if you have symptoms of sickle cell crisis, such as pain or difficulty breathing.
• Kidney injury. Call your healthcare provider right away if you develop swelling of your face or ankles, blood in your urine or dark colored urine, or you urinate less than usual.
• Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood count during treatment with Ziextenzo.
• Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood count during treatment with Ziextenzo. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Ziextenzo.
• Capillary leak syndrome (CLS). Ziextenzo can cause fluid to leak from blood vessels into your body's tissues. CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop 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, or a general feeling of tiredness.
• Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). If you have breast cancer or lung 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 a blood cancer called AML. Call your healthcare provider if you develop any symptoms of MDS and AML, including tiredness, fever, or easy bruising or bleeding.
• Inflammation of the aorta (aortitis). Inflammation of the aorta, the large blood vessel that carries blood from the heart to the body, has happened in people who receive pegfilgrastim products. Tell your healthcare provider if you develop fever, stomach (abdominal) pain, feeling tired, or back pain.

Pegfilgrastim products, such as Ziextenzo, can increase bone marrow activity. This may temporarily show up as abnormal results on bone imaging scans. Tell your healthcare provider that you are receiving Ziextenzo.

These are not all the possible side effects of Ziextenzo. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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 come with your Ziextenzo for information on how to prepare and inject a dose of Ziextenzo using the single-dose prefilled syringe.
• You and your caregiver will be shown how to prepare and inject Ziextenzo using the single-dose prefilled syringe before you use it.
• You should not inject a dose of Ziextenzo to children weighing less than 99 pounds (45 kg) from a 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.
• If you inject too much Ziextenzo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

• Store Ziextenzo in the refrigerator between 36°F and 46°F (2°C and 8°C).
• Avoid freezing. If Ziextenzo is accidentally 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 it from light or physical damage.
• Do not shake Ziextenzo.
• Take Ziextenzo out of the refrigerator at least 15 to 30 minutes before use and allow it to reach room temperature, 68°F to 77°F (20°C to 25°C), before preparing an injection.
• Throw away (dispose of) any Ziextenzo that has been left at temperatures between 68°F and 95°F (20°C and 35°C) for more than 120 hours.

Keep out of the reach of children.

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.

Ziextenzo (pregfilgrastim-bmez) is manufactured by Sandoz Inc, Princeton, NJ 08540, US License No. 2003.

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Ziextenzo.

Neulasta (pegfilgrastim) - Amgen Inc.

View Neulasta information in detail.

Neulasta Onpro (pegfilgrastim) - Amgen Inc.

View Neulasta Onpro information in detail.

Neulasta, Neulasta Onpro biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

Armlupeg (pegfilgrastim-unne) - Lupin Limited (Biotech Division)

View Armlupeg information in detail.

Ennumo (pegfilgrastim-pccg) - Accord BioPharma Inc.

Ennumo

Fulphila (pegfilgrastim-jmdb) - Biocon Biologics Inc.

View Fulphila information in detail.

Fylnetra (pegfilgrastim-pbbk) - Kashiv BioSciences, LLC

View Fylnetra information in detail.

Nyvepria (pegfilgrastim-apgf) - Hospira Inc., a Pfizer Company

View Nyvepria information in detail.

Stimufend (pegfilgrastim-fpgk) - Fresenius Kabi USA, LLC

View Stimufend information in detail.

Udenyca (pegfilgrastim-cbqv) - Accord BioPharma Inc.

View Udenyca information in detail.

Udenyca Onbody (pegfilgrastim-cbqv) - Accord BioPharma Inc.

View Udenyca Onbody information in detail.

Ziextenzo (pegfilgrastim-bmez) - Sandoz Inc.