Neulasta (Pegfilgrastim)

(peg fil gra' stim)

Pegfilgrastim is 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 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 comes as a solution (liquid) in prefilled injection syringes and in a pre-filled automatic injection device (On-body Injector) to inject subcutaneously (under the skin). If you are using pegfilgrastim 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 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. Pegfilgrastim may be given to you by a nurse or other healthcare provider, or you may be told to inject the medication at home. If you will be injecting pegfilgrastim at home, follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use pegfilgrastim exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. If you will be injecting pegfilgrastim yourself, a healthcare provider will show you how to inject the medication. Be sure that you understand these directions. Ask your healthcare provider if you have any questions about where on your body you should inject pegfilgrastim, how to give the injection, or how to dispose of used needles and syringes after you inject the medication. If your pegfilgrastim comes in a pre-filled automatic injection device (On-body Injector), 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 On-Body Injector was applied to your skin), the dose of pegfilgrastim will be automatically injected over 45 minutes. When you have the pegfilgrastim pre-filled automatic injection device (On-body Injector) in place;

• you should have a caregiver with you the first time you receive a dose of pegfilgrastim or anytime the On-body injector is applied to the back of your arm.
• you will need to monitor the 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 filgrastim and for 1 hour afterwards.
• 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 On-Body Injector.
• you should make sure that you keep the 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 On-body Injector is applied to your body and before you receive your dose of pegfilgrastim.
• you should immediately remove the 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 On-body Injector device 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 On-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 On-body Injector device.
• you should avoid hot tubs, whirlpools, saunas, and direct sunlight.
• you should avoid using lotions, oils, creams, and cleansers on your skin near the On-body Injector device.

Carefully read the manufacturer's instructions to learn about the On-Body Injector. Follow these directions carefully. Ask your doctor or pharmacist if you have questions about the On-Body Injector. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before using pegfilgrastim,
• tell your doctor and pharmacist if you are allergic to pegfilgrastim, filgrastim (Neupogen), medications that are made using the bacteria E. coli, or any other medications. Ask your pharmacist if you do not know if a medication you are allergic to is made using E. coli. Also tell your doctor if you or the person who will be injecting pegfilgrastim for you is allergic to latex or acrylic adhesives.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention lithium (Eskalith, Lithobid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you are being treated with radiation therapy,or if you have or have ever had cancer of the blood or bone marrow, an enlarged spleen (an organ located under the ribs that is needed to clean the blood and fight infection), 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. 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 breast-feeding. If you become pregnant while using pegfilgrastim, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using pegfilgrastim.
• you should know that pegfilgrastim 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 pegfilgrastim at home, talk to your doctor about what you should do if you forget to inject the medication on schedule.

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

• redness, swelling, bruising, itching or a lump in the area where the medication was injected
• bone, joint, or muscle pain
• headache
• weakness
• constipation
• vomiting

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
• wheezing
• dizziness
• fainting
• sweating
• hives
• rash
• itching
• swelling of the face or around the mouth or eyes, stomach, feet, ankles, or lower legs
• decreased urination
• dark brown or bloody urine
• tiredness

Pegfilgrastim 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 in the refrigerator but do not freeze it. 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 may be kept at room temperature for up to 48 hours but 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 (http://goo.gl/c4Rm4p) 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. http://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 pegfilgrastim. Before having a bone imaging study, tell your doctor and the technician that you are using pegfilgrastim. 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.