Zarxio

Zarxio 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. Zarxio belongs to a group of medications called granulocyte colony-stimulating factors. Zarxio is a biosimilar (closely related) product to Neupogen (filgrastim).

This medication comes in an injectable form in prefilled syringes. Zarxio injections can be given by a doctor or nurse by intravenous (IV) infusion or just under the skin (subcutaneously). It can also be administered by the patient or a caregiver after training by a healthcare professional.

Common side effects include back or bone pain, fever, nausea, and vomiting.

Zarxio can cause dizziness. Do not drive or operate heavy machinery until you know how Zarxio affects you.

Zarxio is a prescription medication used to treat patients:

• with cancer who are receiving myelosuppressive chemotherapy
• with acute myeloid leukemia who are receiving induction or consolidation chemotherapy
• with cancer who are undergoing bone marrow transplantation
• who are undergoing autologous peripheral blood progenitor cell collection and therapy
• with severe chronic neutropenia (low number of white blood cells)

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

• Sandoz Inc.

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

Common side effects of Zarxio include:

• fever
• rash
• pain
• cough
• shortness of breath
• nosebleed
• anemia
• diarrhea
• hair loss
• reduced sense of touch or sensation

This is not a complete list of Zarxio 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 Zarxio including the following:

• Enlarged or ruptured spleen. Tell your healthcare provider right away if you have some or all of the following symptoms of enlarged or ruptured spleen:
  • left abdominal or shoulder pain
• Acute respiratory distress syndrome. Tell your healthcare provider right away if you have some or all of the following symptoms of acute respiratory distress syndrome:
  • fever
  • trouble breathing
• Serious allergic reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of a serious allergic reaction:
  • rash
  • shortness of breath
  • wheezing
  • dizziness
  • swelling around your face or eyes
  • fast heartbeat
  • sweating
• Fatal sickle cell crisis
• Capillary leak syndrome. Tell your healthcare provider right away if you have some or all of the following symptoms of capillary leak syndrome:
  • swelling or puffiness in your body or abdomen
  • urinating less often than normal
  • feeling full
  • trouble breathing
  • dizziness or feeling faint
  • tiredness
• Decreased platelet count. Tell your healthcare provider right away if you have some or all of the following symptoms of decreased platelet count:
  • unusual bleeding or bruising

Zarxio can cause dizziness. Do not drive or operate heavy machinery until you know how Zarxio affects you.

Do not take Zarzio if you:

• are allergic to Zarxio or to any of its ingredients
• are allergic to any other granulocyte colony-stimulating factors

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 Zarxio, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Zarxio, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Zarcio or to any of its ingredients
• have sickle cell disorder
• are receiving radiation therapy
• are allergic to latex
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

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

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Zarxio falls into category C. 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. 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 Zarxio 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 Zarxio.

• Zarxio injections can be given by a healthcare provider or nurse by intravenous (IV) infusion or under your skin (subcutaneous injection). Your healthcare provider may decide subcutaneous injections can be given at home by you or your caregiver. If Zarxio is given at home, see the detailed “Instructions for Use” that comes with your Zarxio for information on how to prepare and inject a dose of Zarxio.

• You and your caregiver will be shown how to prepare and inject Zarxio before you use it. Your healthcare provider will tell you how much Zarxio to inject and when to inject it. Do not change your dose unless your doctor tells you to.

• You should not inject a dose of Zarxio less than 0.3 mL (180 mcg) from a Zarxio prefilled syringe. A dose less than 0.3 mL cannot be accurately measured using the Zarxio prefilled syringe. 

• If you are receiving Zarxio because you are also receiving chemotherapy, your dose of Zarxio should be injected at least 24 hours before or 24 hours after your dose of chemotherapy.

• If you miss a dose of Zarxio, talk to your healthcare provider about when you should give your next dose.

• Your healthcare provider will do blood tests before and during treatment with Zarxio to check your blood cell counts and to check you for side effects.

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

The dose your doctor recommends may be based on the following:

• the condition being treated
• your weight
• other medical conditions you have
• how you respond to this medication

The recommended dose and length of therapy of Zarxio varies on the basis of the condition being treated and other medical procedures you are having.

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

• Store Zarxio in the refrigerator. Do not freeze Zarxio.
• Zarxio may be stored at room temperatore for up to 24 hours. Discard Zarxio that has been at room temperature longer than 24 hours.
• Throw away the prefilled syringe after you administer a dose, even if medication is left in the syringe.
• Keep this and all medications out of the reach fo children.