Neupogen (Filgrastim)

Filgrastim, Filgrastim-sndz, Tbo-filgrastim Injection (fil gra' stim) Granix® Neupogen® Zarxio® Granulocyte Colony-Stimulating Factor G-CSF Recombinant Methionyl Human G-CSF

Filgrastim, filgrastim-sndz, and tbo-filgrastim are used to decrease 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). Filgrastim and filgrastim-sndz are used in people who are undergoing bone marrow transplants, in people who have severe chronic neutropenia (condition in which there are a low number of neutrophils in the blood), and to prepare the blood for leukapheresis (a treatment in which certain blood cells are removed from the body and then returned to the body following chemotherapy). Filgrastim 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 your bone marrow. Filgrastim, filgrastim-sndz, and tbo-filgrastim are in a class of medications called colony-stimulating factors. They work by helping the body make more neutrophils.

Filgrastim comes as a solution (liquid) in vials and prefilled syringes to inject under the skin or into a vein. Filgrastim-sndz comes as a solution (liquid) in prefilled syringes to inject under the skin or into a vein. Tbo-filgrastim comes as a solution (liquid) in prefilled syringes to inject under the skin. It is usually given once a day, but filgrastim and filgrastim-sndz may be given twice a day when it is used to treat severe chronic neutropenia. The length of your treatment depends on the condition that you have and how well your body responds to the medication. If you are using filgrastim, filgrastim-sndz, or tbo-filgrastim to decrease the risk of infection during chemotherapy, you will receive your first dose of the medication at least 24 hours after you receive a dose of chemotherapy, and will continue to receive the medication every day for up to 2 weeks or until your blood cell counts return to normal. If you are using filgrastim or filgrastim-sndz to decrease the risk of infection during a bone marrow transplant, you will receive the medication at least 24 hours after you receive chemotherapy and at least 24 hours after the bone marrow is infused. If you are using filgrastim or filgrastim-sndz to prepare your blood for leukapheresis, you will receive your first dose of filgrastim or filgrastim-sndz at least 4 days before the first leukapheresis and will continue to receive the medication until the last leukapheresis. If you are using filgrastim or filgrastim-sndz to treat severe chronic neutropenia, you may need to use the medication for a long period of time. If you are using filgrastim because you have been exposed to harmful amounts of radiation, your doctor will monitor you carefully and the length of your treatment will depend on how well your body responds to the medication. Do not stop using filgrastim without talking to your doctor. Filgrastim, filgrastim-sndz, or tbo-filgrastim 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 filgrastim, filgrastim-sndz, or tbo-filgrastim at home, inject the medication at about the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use filgrastim, filgrastim-sndz, or tbo-filgrastim 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 filgrastim, filgrastim-sndz, or tbo-filgrastim 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 filgrastim, filgrastim-sndz, or tbo-filgrastim, how to give the injection, what type of syringe to use, or how to dispose of used needles and syringes after you inject the medication. Do not shake vials or syringes containing filgrastim, filgrastim-sndz, or tbo-filgrastim. Vials and syringes that look foamy, cloudy, or discolored should not be used. Your doctor may start you on a low dose of filgrastim or filgrastim-sndz and gradually increase your dose. Your doctor may also decrease your dose, depending on how your body reacts to the medication. If you are using filgrastim or filgrastim-sndz to treat severe chronic neutropenia, you should know that filgrastim will control your condition but will not cure it. Continue to use filgrastim or filgrastim-sndz even if you feel well. Do not stop using filgrastim or filgrastim-sndz without talking to your doctor. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before using filgrastim, filgrastim-sndz, or tbo-filgrastim, tell your doctor and pharmacist if you are allergic to filgrastim, pegfilgrastim (Neulasta), medications made from E. coli bacteria, or any other medications. Ask your pharmacist if you do not know if a medication you are allergic to is made from E. coli bacteria. Also tell your doctor if you or the person who will be injecting filgrastim or filgrastim-sndz for you is allergic to latex. 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 (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 and if you have or have ever had chronic myeloid leukemia (a slowly progressing disease in which too many white blood cells are made in the bone marrow), myelodysplasia (problems with bone marrow cells that may develop into leukemia), or an enlarged spleen (an organ located under the ribs that is needed to clean the blood and fight infection). 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 filgrastim, filgrastim-sndz, or tbo-filgrastim. Drink plenty of fluids during your treatment with filgrastim, filgrastim-sndz, or tbo-filgrastim and 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 filgrastim, filgrastim-sndz, or tbo-filgrastim, call your doctor. if you are having surgery, including dental surgery, tell the doctor or dentist that you are using filgrastim, filgrastim-sndz, or tbo-filgrastim. you should know that filgrastim, filgrastim-sndz, and tbo-filgrastim decrease 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 filgrastim, filgrastim-sndz, or tbo-filgrastim at home, talk to your doctor about what you should do if you forget to inject the medication on schedule.

Filgrastim, filgrastim-sndz, and tbo-filgrastim 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 place where the medication was injected bone, joint, or muscle pain headache 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 the left shoulder fever shortness of breath trouble breathing fast breathing wheezing dizziness sweating hives rash itching swelling around the mouth, face, eyes, stomach, feet, ankles, or lower legs unusual bruising or purple markings under the skin unusual bleeding or bruising nosebleeds decreased urination tiredness Some people who used filgrastim or filgrastim-sndz to treat severe chronic neutropenia developed leukemia (cancer that starts in the bone marrow) or changes in the bone marrow cells that show that leukemia may develop in the future. People who have severe chronic neutropenia may develop leukemia even if they do not use filgrastim. There is not enough information to tell if filgrastim or filgrastim-sndz increases the chance that people with severe chronic neutropenia will develop leukemia. Talk to your doctor about the risks of using this medication. Filgrastim, filgrastim-sndz, and tbo-filgrastim may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store filgrastim, filgrastim-sndz, and tbo-filgrastim in the refrigerator. If you accidentally freeze filgrastim or filgrastim-sndz, you may allow it to thaw in the refrigerator. However, if you freeze the same syringe or vial of filgrastim or filgrastim-sndz a second time, you should dispose of that syringe or vial. Filgrastim and filgrastim-sndz may be kept at room temperature for up to 24 hours but should be kept away from direct sunlight. Tbo-filgrastim may be kept at room temperature for up to 5 days but should be protected from light. 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 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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to filgrastim, filgrastim-sndz, or tbo-filgrastim. Before having a bone imaging study, tell your doctor and the technician that you are using filgrastim, filgrastim-sndz, or tbo-filgrastim. Filgrastim, filgrastim-sndz, and tbo-filgrastim 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. 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.