Ziextenzo (pegfilgrastim-bmez)

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 urine
  • 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.

Patients With Cancer Receiving Myelosuppressive Chemotherapy

The recommended dosage of Ziextenzo is a single subcutaneous injection of 6 mg administered once perchemotherapy cycle. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Do notadminister Ziextenzo between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

Administration

• Ziextenzo is administered subcutaneously via a single-dose prefilled syringe for manual use.
• Prior to use, remove the carton from the refrigerator and allow the Ziextenzo prefilled syringe to reach roomtemperature for a minimum of 15-30 minutes. Discard any prefilled syringe left at room temperature for greater than 120 hours.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Ziextenzo is supplied as a clear and colorless toslightly yellowish solution. Do not administer Ziextenzo if discoloration or particulates are observed.
• The needle cap on the prefilled syringes contains dry natural rubber (derived from latex) which may cause allergic reactions; persons with latex allergies should not administer these products.

Pediatric Patients Weighing Less Than 45 kg

• The Ziextenzo prefilled syringe is not designed to allow for 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. Refer to Table 1.

Table 1: Dosing of Ziextenzo for pediatric patients weighing less than 45 kg

• Although available data with Ziextenzo or 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 fetaloutcomes, there are available data from published studies in pregnant women exposed to filgrastim products.
• These studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• There are no data on the presence of pegfilgrastim products in human milk, the effects on the breastfed child, orthe effects on milk production.
• Other filgrastim products are secreted poorly into breast milk, and filgrastimproducts are not absorbed orally by neonates.
• The developmental and health benefits of breastfeeding should beconsidered along with the mother's clinical need for Ziextenzo and any potential adverse effects on thebreastfed child from Ziextenzo or from the underlying maternal condition.