Pegfilgrastim is a man-made version of a certain natural substance made by your body. It is used to help your body make more white blood cells. White blood cells are important to help you fight off infections. Pegfilgrastim is given to people whose ability to make white blood cells is reduced due to chemotherapy. Some brands may also be used to increase white blood cells after exposure to large amounts of radiation.

This monograph is about the following pegfilgrastim products: pegfilgrastim, pegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, pegfilgrastim-fpgk, pegfilgrastim-jmdb, and pegfilgrastim-pbbk.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using pegfilgrastim and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection under the skin as directed by your doctor. For use during chemotherapy, it is usually given once during each chemotherapy cycle. However, it should not be given within 14 days before or 24 hours after chemotherapy. Ask your doctor for specific directions about when to use this medication. For use after radiation exposure, pegfilgrastim is usually given for 2 doses, one week apart.

The dosage and schedule are based on your medical condition and response to treatment. Children's dosage is also based on weight.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Take the medication out of the refrigerator at least 30 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat in the microwave or place it in hot water). Do not shake this medication. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is bruised, tender, red, hard, or that has scars, moles, or stretch marks. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Aching or pain in the bones and muscles may occur. Taking a non-aspirin pain reliever such as acetaminophen may help relieve pain. Ask your doctor or pharmacist for more details. Redness, swelling, itching, or bruising at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• pink/bloody urine
• easy bleeding/bruising
• fever
• fast heartbeat
• purple/red spots on your skin
• back pain

Get medical help right away if you have any very serious side effects, including:

• breathing problems (such as shortness of breath, fast breathing)
• unusual decrease in urination
• unusual tiredness
• swelling/puffiness of the body

Rarely, serious (possibly fatal) damage to the spleen may occur. Get medical help right away if you develop stomach/abdominal pain or shoulder pain.

Rarely, this medication may increase the risk of developing a certain bone marrow disorder (myelodysplastic syndrome-MDS) or blood cancer (acute myeloid leukemia-AML) in people with breast or lung cancer who are receiving chemotherapy/radiation. Ask your doctor for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using pegfilgrastim, tell your doctor or pharmacist if you are allergic to it; or to any pegfilgrastim or filgrastim products; or to eflapegrastim; or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex in the needle cover on the prefilled syringe), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• sickle cell disease
• spleen problems

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication may pass into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Pegfilgrastim is very similar to filgrastim. Do not use a filgrastim product while using a pegfilgrastim product.

This medication may interfere with certain lab tests (such as bone imaging tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, kidney function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store in the refrigerator. Do not freeze or shake. Keep the medication in the original package to protect from light. If the medication is taken out of the refrigerator, use or discard it within the time directed in your product package. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.