Frequently asked questions about ZIEXTENZO

ZIEXTENZO is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count in patients with certain types of cancer who are receiving chemotherapy that can cause fever and low white blood cell count. ZIEXTENZO is a man-made form of granulocyte colony-stimulating factor (G-CSF), a substance normally produced by the body.

Learn more about ZIEXTENZO

ZIEXTENZO is a prescription medication used to help reduce the chance of infection due to a low white blood cell count in patients with certain types of cancer who are receiving chemotherapy that can cause fever and low white blood cell count.

Do not take ZIEXTENZO if you have had a serious allergic reaction to pegfilgrastim or filgrastim products. Talk to your doctor to see if ZIEXTENZO may be appropriate for you.

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 (derived from latex). You should not take ZIEXTENZO using the prefilled syringe if you have a latex allergy
• 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 are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

While chemotherapy is fighting cancer cells, it can also harm normal cells in the body that divide rapidly. Strong chemotherapy, described as myelosuppressive (my-eh-lo-suh-press-iv), can lower the number of infection-fighting white blood cells (neutrophils) in your body. White blood cells are a key part of your immune system.

Learn more about chemotherapy and infections

A biologic medicine is a complex medication developed by cutting-edge technology. Biologics may consist of sugars, proteins, or nucleic acids, or may be living entities such as cells and tissues. Most biologics are made of a combination of components that are not easily identifiable.

Biologic medicines are complex and therefore are expensive to make. A biosimilar is a medication that has been approved by the FDA as being highly similar to a biologic that is already on the market, but can be produced at a lower cost. "Highly similar" means that a biosimilar has gone through rigorous testing to prove that it works in the same way, offers the same function, and has the same side effects. The more affordable a medicine is, the more people can access it.

Learn more about biosimilars

Biosimilar and generic medications both help reduce the price and increase access to expensive name-brand drugs. Generic medicines contain the same active ingredient as the name-brand product, but it is difficult to make exact copies of biologic drugs because they are generally large, complex molecules produced in living systems. For this reason, a biosimilar is made to be highly similar to its reference product, meaning that it has gone through rigorous testing to prove that it works in the same way, offers the same function, and has the same side effects as its reference product.

The most common side effects of ZIEXTENZO are pain in the bones, arms, and legs. Other possible side effects include:

• Spleen rupture. Your spleen may become enlarged and can rupture while taking ZIEXTENZO. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or left shoulder
• A serious lung problem called acute respiratory distress syndrome (ARDS). Call your healthcare provider or get emergency medical 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 urine, or you urinate less than usual
• Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with ZIEXTENZO
• Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with ZIEXTENZO. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with ZIEXTENZO. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot
• 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
• Myelodysplastic syndrome and acute myeloid leukemia. 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 myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with ZIEXTENZO
• 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

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

No formal drug interaction studies have been conducted. When discussing your treatment options, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The active ingredient in ZIEXTENZO is pegfilgrastim-bmez. The inactive ingredients in ZIEXTENZO are acetic acid, polysorbate 20, sorbitol, and water for injection. Sodium hydroxide may be added as necessary to adjust pH.

• Store ZIEXTENZO in the refrigerator between 36°F to 46°F (2°C to 8°C)
• Take ZIEXTENZO out of the refrigerator at least 15 to 30 minutes before use and allow it to reach room temperature before preparing an injection
• 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 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 95°F (20°C to 35°C), for more than 120 hours

Keep the ZIEXTENZO prefilled syringe out of reach of children.

Sandoz One Source for ZIEXTENZO offers a variety of financial support for patients. The Sandoz One Source Commercial Co-Pay Program for ZIEXTENZO supports eligible,* commercially insured patients with their out-of-pocket co-pay costs for ZIEXTENZO.

Learn about other financial services from Sandoz One Source

_{*Eligibility Requirements: Prescription must be for an approved indication. This program is not health insurance. This program is for insured patients only; cash-paying or uninsured patients are not eligible. Patients are not eligible if prescription for ZIEXTENZO is paid, in whole or in part, by any state or federally funded programs, including but not limited to Medicare (including Part D, even in the coverage gap) or Medicaid, Medigap, VA, DOD, or TRICARE, or private indemnity plans that do not cover prescription drugs, or HMO insurance plans that reimburse the patient for the entire cost of their prescription drugs, or where prohibited by law. Co-Pay Program may apply to out-of-pocket expenses that occurred within 120 days prior to the date of the enrollment. Co-Pay Program may not be combined with any other rebate, coupon, or offer. Co-Pay Program has no cash value. Sandoz reserves the right to rescind, revoke, or amend this offer without further notice.}

For more information about ZIEXTENZO, you can contact your doctor or a Sandoz One Source case manager at 1-844-SANDOZ1 (1-844-726-3691).