pegfilgrastim

What is the most important information I should know about pegfilgrastim?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is pegfilgrastim?

Pegfilgrastim is used to prevent neutropenia (a lack of certain white blood cells) that is caused by receiving chemotherapy.

Pegfilgrastim is a form of a protein that stimulates the growth of white blood cells that help your body fight against infection.

Pegfilgrastim may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using pegfilgrastim?

Tell your doctor if you have ever had:

• sickle cell disorder;
• kidney disease;
• chronic myeloid leukemia;
• radiation treatment;
• myelodysplastic syndrome (also called "preleukemia"); or
• a latex allergy.

Treatment with Fulphila and radiation with or without chemotherapy for breast or lung cancer, you could develop a blood disorder or blood cancer (leukemia). Ask your doctor about this risk.

Tell your doctor if you are pregnant or breastfeeding.

How should I use pegfilgrastim?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Pegfilgrastim should not be given within 14 days before or 24 hours after you receive chemotherapy.

Pegfilgrastim is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

You may need medical tests to help your doctor determine how long to treat you with pegfilgrastim.

Do not use a Neulasta or Udenyca syringe that has been left at room temperature for longer than 48 hours. Do not use a Fulphila or Ziextenzo syringe that has been left at room temperature for longer than 72 hours.

The Neulasta Onpro Injector is a special device placed on the skin that delivers your pegfilgrastim dose at a specific time. You will need to wear the device for 27 hours before the dose begins. The timed dose will then be released from the device slowly over a 45-minute period.

While wearing Neulasta Onpro, you or a caregiver will need to check the device to make sure it is working properly.

Each prefilled syringe or Onpro Injector is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using pegfilgrastim?

When using Neulasta Onpro: Avoid traveling, driving, or operating machinery while wearing the device.

What are the possible side effects of pegfilgrastim?

Capillary leak syndrome is a rare but serious side effect of pegfilgrastim. Call your doctor right away if you have signs of this condition, which may include: decreased urination, tiredness, dizziness or light-headed feeling, trouble breathing, and sudden swelling, puffiness, or feeling of fullness.

• sudden or severe pain in your left upper stomach spreading up to your shoulder;
• sudden and severe pain in your chest, stomach, or back;
• severe or ongoing pain anywhere in your body;
• fever, tiredness;
• shortness of breath, rapid breathing;
• pale skin, easy bruising, unusual bleeding;
• bruising, swelling, or a hard lump where the medicine was injected; or
• kidney problems --little or no urination, pink or dark urine, swelling in your face or lower legs.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• bone pain; or
• pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect pegfilgrastim?

Other drugs may affect pegfilgrastim, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about pegfilgrastim.