Pegfilgrastim Injection

Pegfilgrastim injection is available as different products that are biologic medications (medications made from living organisms). These biologic products are considered to be "biosimilar" to filgrastim injection which means they work as well and are just as safe to use as pegfilgrastim injection. Pegfilgrastim injection mentioned in the monograph below refers to any of these products.

Pegfilgrastim injection is used to increase white blood cells and decrease the risk of infection in patients receiving chemotherapy for certain types of cancer. Pegfilgrastim injection is also used to increase the chance of survival in people who have been exposed to harmful amounts of radiation, which can cause severe and life-threatening damage to bone marrow. Pegfilgrastim is in a class of medications called colony stimulating factors. It works by helping the body make more neutrophils (a type of blood cell needed to fight infection).

Pegfilgrastim injection comes as a solution (liquid) in prefilled injection syringes and a prefilled autoinjector to inject subcutaneously (under the skin). Some types of pegfilgrastim injection also come in a prefilled on-body injector to apply to the skin.   How often you receive pegfilgrastim injection and the length of your treatment depends on the condition that you have and how well your body responds to the medication. Your doctor will tell you exactly when you should use pegfilgrastim injection.

Pegfilgrastim injection may be given to you by a nurse or other healthcare provider or you may be told to inject the medication yourself at home, or you may receive a prefilled on-body injector by the nurse or healthcare provider that will inject the medication automatically for you at home. If you will be giving pegfilgrastim injection yourself at home, or if you receive the prefilled on-body injector, a healthcare provider will show you how to inject the medication, or how to manage the device. Ask your healthcare provider if you have any questions.

Use pegfilgrastim injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not shake syringes or autoinjectors containing pegfilgrastim solution. Always look at pegfilgrastim solution before injecting. Do not use if the expiration date has passed, or if the pegfilgrastim solution has particles or looks cloudy or discolored.

If your pegfilgrastim solution comes in a prefilled on-body injector, the device will be applied to your abdomen or the back of your arm by a nurse or other healthcare provider the day before you will receive the dose of pegfilgrastim. The next day (approximately 27 hours after the prefilled on-body injector was applied to your skin), the dose of pegfilgrastim solution will be automatically injected subcutaneously.

When you have the pegfilgrastim prefilled on-body injector in place,

• you should have a caregiver with you the first time you receive a dose of pegfilgrastim or anytime the prefilled on-body injector is applied to the back of your arm.
• you will need to monitor the prefilled on-body injector while the entire dose of pegfilgrastim is injected in your body, so you should avoid activities and being in places that may interfere with monitoring while you are receiving the dose of pegfilgrastim and for 1 hour afterward.
• you should not travel, drive a car, or operate machinery 1 hour before and 2 hours after you receive your dose of pegfilgrastim with the prefilled on-body injector (about 26 to 29 hours after it was applied).
• you should make sure that you keep the prefilled on-body injector at least 4 inches away from electric appliances and equipment including cell phones, cordless telephones, and microwave ovens.
• you should avoid airport x-rays and request a manual pat down if you have to travel after the prefilled on-body injector is applied to your body and before you receive your dose of pegfilgrastim.
• you should immediately remove the prefilled on-body injector if you have an allergic reaction while you are receiving your dose of pegfilgrastim by grabbing the edge of the adhesive pad and peeling it off. Call your doctor immediately and get emergency medical treatment.
• you should call your doctor immediately if the prefilled on-body injector comes off of your skin, if the adhesive becomes noticeably wet, if you see dripping from the device, or if the status light flashes red. You should keep the prefilledon-body injector dry for 3 hours before you receive your dose of pegfilgrastim to help you notice if your device starts to leak while you are receiving your dose.
• you should avoid being exposed to medical imaging studies (X-ray scan, MRI, CT scan, ultrasound) or oxygen-rich environments (hyperbaric chambers).
• you should avoid sleeping or applying pressure on the prefilled on-body injector.
• you should avoid hot tubs, whirlpools, saunas, and direct sunlight.
• you should avoid using lotions, oils, creams, and cleansers on your skin near the prefilled on-body injector.

If the prefilled on-body injector flashes red, if the device comes off before the full dose is delivered, or if the adhesive on the device becomes wet or there is leaking, call your doctor right away. You may not have received the full dose of pegfilgrastim, and may need an additional dose.

Use each syringe or vial only once. Even if there is still some solution left in the syringe or vial, do not use it again.

Dispose of used needles, syringes, and devices in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

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

Before using pegfilgrastim injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had cancer of the blood or bone marrow, myelodysplasia (problems with bone marrow cells that may develop into leukemia), or kidney problems.
• tell your doctor if you have sickle cell disease (a blood disease that may cause painful crises, a low number of red blood cells, infection, and damage to the internal organs). If you have sickle cell disease, you may be more likely to have a crisis during your treatment with pegfilgrastim injection. Call your doctor right away if you have a sickle cell crisis during your treatment.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using a pegfilgrastim injection call your doctor.
• you should know that pegfilgrastim injection decreases the risk of infection but does not prevent all infections that may develop during or after chemotherapy. Call your doctor if you develop signs of infection such as fever; chills; rash; sore throat; diarrhea; or redness, swelling, or pain around a cut or sore.

Unless your doctor tells you otherwise, continue your normal diet.

If you will be injecting a pegfilgrastim injection at home, talk to your doctor about what you should do if you forget to inject the medication on schedule.

Pegfilgrastim injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• bone pain
• pain in arms or legs

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• pain in the left upper part of the stomach or the tip of your left shoulder
• fever, shortness of breath, trouble breathing, fast breathing
• swelling of the face, throat, or around the mouth or eyes; hives; rash; itching; trouble swallowing or breathing; rapid heartbeat; or sweating
• swelling of your face or ankles, bloody or dark-colored urine, decreased urination
• unusual bleeding or bruising, fever, or tiredness
• fever, abdominal pain, back pain, headache, neck pain, feeling unwell
• swelling of stomach area or other swelling, decreased urination, trouble breathing, dizziness, tiredness

Pegfilgrastim injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Keep this medication in the carton it came in, tightly closed, and out of reach of children. Store pegfilgrastim injection in the refrigerator but do not freeze them. If you accidentally freeze the medication, you may allow it to thaw in the refrigerator. However, if you freeze the same syringe of medication a second time, you should dispose of that syringe. Pegfilgrastim injection (Neulasta^® prefilled syringe, Udenyca^® prefilled syringe and autoinjector) may be kept at room temperature for up to 48 hours, pegfilgrastim injection (Fulphila^®, Fylnetra^®, Stimufend^®) may be kept at room temperature for up to 72 hours, pegfilgrastim injection (Ziextenzo^®) may be kept at room temperature for up to 5 days, and pegfilgrastim injection (Nyvepria^®) may be kept at room temperature for up to 15 days. Pegfilgrastim injection should be kept away from direct sunlight.

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to a pegfilgrastim injection.

Before having a bone imaging study, tell your doctor and the technician that you are using a pegfilgrastim injection. Pegfilgrastim may affect the results of this type of study.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Armlupeg^®(pegfilgrastim-unne)
• Ennumo^®(pegfilgrastim-pccg)
• Fulphila^®(pegfilgrastim-jmdb)
• Fylnetra^®(pegfilgrastim-pbbk)
• Neulasta^®(pegfilgrastim)
• Nyvepria^®(pegfilgrastim-apgf)
• Stimufend^® (pegfilgrastim-fpgk)
• Udenyca^®(pegfilgrastim-cbqv)
• Ziextenzo (pegfilgrastim-bmez)