Pegfilgrastim injection, pegfilgrastim-cbqv, and pegfilgrastim-jmdb injection are biologic medications (medications made from living organisms). Biosimilar pegfilgrastim-cbqv and pegfilgrastim-jmdb injection are highly similar to pegfilgrastim injection and work the same way as pegfilgrastim injection in the body. Therefore, the term pegfilgrastim injection products will be used to represent these medications in this discussion.
Pegfilgrastim injection products are used to reduce the chance of infection in people who have certain types of cancer and are receiving chemotherapy medications that may decrease the number of neutrophils (a type of blood cell needed to fight infection). Pegfilgrastim injection (Neulasta) 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.
Pegfilgrastim injection products come as a solution (liquid) in prefilled injection syringes to inject subcutaneously (under the skin), and in a prefilled automatic injection device (on-body injector) to apply to the skin. If you are using a pegfilgrastim injection product to decrease the risk of infection during chemotherapy, it is usually given as a single dose for each chemotherapy cycle, no sooner than 24 hours after the last dose of chemotherapy of the cycle is given and more than 14 days before beginning the next chemotherapy cycle. If you are using pegfilgrastim injection because you have been exposed to harmful amounts of radiation, it is usually given as 2 single doses, one week apart. Your doctor will tell you exactly when you should use pegfilgrastim injection products.
Pegfilgrastim injection products may be given to you by a nurse or other healthcare provider, you may be told to inject the medication yourself at home, or you may receive a prefilled automatic injection device by the nurse or healthcare provider that will inject the medication automatically for you at home. If you will be injecting pegfilgrastim injection products yourself at home, or if you receive the prefilled automatic injection device, a healthcare provider will show you how to inject the medication, or how to manage the device. Your healthcare provider will also give you the manufacturer's information for the patient. Ask your healthcare provider to explain any part that you do not understand. Use a pegfilgrastim injection product 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 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 automatic injection device , the device will usually 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 automatic injection device was applied to your skin), the dose of pegfilgrastim solution will be automatically injected subcutaneously over 45 minutes.
When you have the pegfilgrastim prefilled automatic injection device in place;
If the prefilled automatic injection device 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.
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 products,
Unless your doctor tells you otherwise, continue your normal diet.
If you will be injecting a pegfilgrastim injection product at home, talk to your doctor about what you should do if you forget to inject the medication on schedule.
Pegfilgrastim injection products may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
Pegfilgrastim injection products 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 products 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 products (Neulasta prefilled syringe, Udenyca) may be kept at room temperature for up to 48 hours, and pegfilgrastim injection (Fulphila) may be kept at room temperature for up to 72 hours. Pegfilgrastim injection products should be kept away from direct sunlight.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
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 product.
Before having a bone imaging study, tell your doctor and the technician that you are using a pegfilgrastim injection product. Pegfilgrastim may affect the results of this type of study.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: September 15, 2019.