Ziextenzo

Ziextenzo  is a prescription medication used to stimulate the production of a certain type of white blood cell in order to help prevent infections in people receiving bone marrow transplants or undergoing cancer chemotherapy. Ziextenzo belongs to a group of medications called granulocyte colony-stimulating factors. Ziextenzo is a biosimilar (closely related) product to Neupogen (filgrastim).

This medication comes in an injectable form in prefilled syringes. Ziextenzo injections are given just under the skin (subcutaneously) by a healthcare provider. It can be administered by the patient or a caregiver after training by a healthcare provider.

Common side effects include pain in the bones, arms, and legs.

Ziextendo is a prescription medication used to treat patients with cancer who are receiving myelosuppressive chemotherapy. It is intended to help reduce the risk of infection during chemotherapy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Ziextendo. See the “Ziextendo Precautions” section.

Common side effects of Ziextendo include pain in the bones, arms, and legs.

This is not a complete list of Ziextendo side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been reported by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Ziextenzo 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 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
  • 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.

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

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Ziextenzo, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you receive Ziextenzo, tell your healthcare provider about all of your healthcare 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).
• 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 the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. It is not known if Ziextenzo will harm your unborn baby. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Ziextenzo crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using 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.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended Ziextenzo dosage for patients with cancer receiving myelosuppressive chemotherapy is 6 mg administered subcutaneously once per chemotherapy cycle. Weight-based dosing is used for children who weigh less than 45 kg.

If you take too much Ziextenzo, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• 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.