In pregnant rabbits showing signs of maternal toxicity, reduced embryo-fetal survival (at 20 and 80 mcg/kg/day) and increased abortions (at 80 mcg/kg/day) were observed. Using a warm or cool compress after your injection may also help ease injection site side effects such as swelling or skin irritation. Visit the FDA MedWatch website or call 1-800-FDA-1088. If you have cancer, you may be able to get a Macmillan Grant to help with the extra costs of cancer. Allergic reactions from Neulasta usually happen the first time you take the drug. Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes. properly labeled to warn of hazardous waste inside the container. Throw away (dispose of) any ZARXIO that has been left at room temperature for longer than 4 days. Adverse reactions with 2% higher incidence in filgrastim patients compared to placebo included epistaxis, back pain, pain in extremity, erythema, and rash maculo-papular. Symptoms include left upper quadrant abdominal pain or left shoulder pain. Patients eligible for Study 7 had a history of severe chronic neutropenia documented with an ANC < 500/mm3 on three occasions during a 6-month period, or in patients with cyclic neutropenia 5 consecutive days of ANC < 500/mm3 per cycle. Store in the refrigerator at 2C to 8C (36F to 46F) in the original pack to protect from light. NEUPOGEN should be injected at the same time each day. There were also statistically significant reductions in the incidence and overall duration of infection manifested by febrile neutropenia; the incidence, severity and duration of severe neutropenia (ANC < 500/mm3); the incidence and overall duration of hospital admissions; and the number of reported days of antibiotic use. Do not freeze and do not shake. After your treatment is over, most side effects start to improve. It isnt known if Neulasta is safe to take during pregnancy or while breastfeeding. It is where blood cells are made. If you notice this, do not drive or operate any machinery. Filgrastim is also approved to treat neutropenia that is not caused by cancer treatment. Both mild and serious allergic reactions to the acrylic adhesive in Neulasta Onpro patch have happened. WebHow Long Do Drugs Stay in Your Urine? Pack of 10 (multipack) prefilled syringes (NDC 61314-326-10). Pegfilgrastim is a form of filgrastim that has polyethylene glycol (PEG) attached to it. You can see also see this in-depth article for more information about Neulastas side effects. And it typically affects your back and legs. Serious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products. Contact your health care provider within 24 hours of noticing any of the following: Always inform your health care provider if you experience any unusual symptoms. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. If this happens, talk to your doctor or nurse. Different MDMA drug tests have different detection windows. Step 11. ZARXIO may cause serious side effects, including: The most common side effects experienced in patients receiving ZARXIO include: These are not all the possible side effects of ZARXIO. This form stays in the body longer than does filgrastim, so it doesnt need to be given as Keep in mind that Neulasta is commonly used with chemotherapy. Diluted ZARXIO solution can be stored at room temperature for up to 24 hours. Always tell your doctor, nurse or pharmacist about any side effects you have. With tablets or liquids, the peak effects are seen in two hours. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of filgrastim products. The information may not cover all possible uses, actions, interactions, or side effects of this drug, or precautions to be taken while using it. If the number of platelets is low, you may bruise or bleed easily. Aortitis has been reported in patients receiving filgrastim products. what you should tell your doctor before using this drug. The dosage of filgrastim ranged between 5 to 30 mcg/kg/day and was administered subcutaneously by injection or continuous infusion. To be safe, let your doctor know about all medications you take, including prescription and over-the-counter types. ZARXIO is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies]. Take the injection out of the fridge 30 minutes before you use it. Step 3. (Neutrophils are a type of white blood cell that works to fight off infections.). Advise patients to report pain in these areas to their physician immediately [see WARNINGS AND PRECAUTIONS]. See Table 4 below for product composition of each single-dose prefilled syringe. There are no data on the effects of filgrastim products on milk production. Hold the prefilled syringe by the body (the clear plastic needle guard) with the needle pointing up (see, Step 12. Importance of following the applicable Instructions for Use. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15- 20%, respectively. Your healthcare professional might place the patch on your belly or the back of your arm. The possibility that ZARXIO acts as a growth factor for any tumor type cannot be excluded. Drug class: Colony stimulating factors. With discontinuation of filgrastim therapy neutrophil counts returned to baseline in most cases within 4 days. The cells can then be given back to you after your treatment. Filgrastim may be inadvisable if you have had a hypersensitivity reaction to filgrastim or E. coli-derived proteins. This treatment can cause changes to the lungs. You can visit the electronic Medicines Compendium (eMC) for more detailed information. WebHere are some medications that you should never mix with alcohol, as they can be dangerous, if not life-threatening, depending on the type of drug. It helps the new stem cells in the bone marrow to recover quicker. In patients with cancer receiving ZARXIO as an adjunct to myelosuppressive chemotherapy to avoid the potential risks of excessive leukocytosis it is recommended that ZARXIO therapy be discontinued if the ANC surpasses 10000/mm3 after the chemotherapy-induced ANC nadir has occurred. Clean the injection site using a circular motion with the alcohol wipe. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing. Adverse Reactions in Patients with Cancer Receiving Myelosuppressive Chemotherapy (With 5% Higher Incidence in Filgrastim Compared to Placebo). Heres what you need to know. Rarely, these may be life-threatening. So, its best to have a family member or caregiver nearby for at least 1 day after you receive your first dose. How often youll take Neulasta depends on your condition. And sometimes, biosimilars are less expensive than their parent drugs. Pack of 10 (multipack) prefilled syringes (NDC 61314-318-10). ZARXIO may be allowed to reach room temperature for up to 4 days. Neutrophils are a type of white blood cell that works to fight infections. ZARXIO is a growth factor that primarily stimulates neutrophils. Some G-CSF injections should be stored in the fridge. Step 8. This patient information sheet applies only to approved uses of the drug. Your doctor will recommend the dosage of Neulasta thats right for you. Definition from the NCI Drug Dictionary - Detailed scientific definition and other names for this drug. Do not recycle the syringe, or sharps disposal container or throw them into household trash. It can be used Treatment with filgrastim resulted in a clinically and statistically significant reduction in the incidence of infection as manifested by febrile neutropenia, 40% for filgrastim-treated patients and 76% for placebo-treated patients (p < 0.001). The spleen is an organ that filters blood and helps fight infection. It is not known if ZARXIO will harm your unborn baby. The main efficacy endpoint was duration of severe neutropenia. Effects of filgrastim on prenatal development have been studied in rats and rabbits. Of the 731 patients in the surveillance study, 429 were pediatric patients < 18 years of age (range 0.9 to 17) [see INDICATIONS, DOSAGE AND ADMINISTRATION, and Clinical Studies]. Claritin doesnt usually cause negative side effects. MedlinePlus Information on Pegfilgrastim - A lay language summary of important information about this drug that may include the following: Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. Avoid shaking. Find answers to some commonly asked questions about Neulasta. If you have any questions about possible interactions with Neulasta, talk with your doctor or pharmacist. Filgrastim can cause your spleen to become enlarged and it could rupture (tear). There was a reduction in the median duration of intravenous antibiotic use, filgrastim-treated patients: 15 days versus placebo-treated patients: 18.5 days; a reduction in the median duration of hospitalization, filgrastim-treated patients: 20 days versus placebotreated patients: 25 days. If you have an allergic reaction while youre wearing a Neulasta Onpro patch, immediately grab the edge of the adhesive pad and peel off the patch. But unlike generics, which are made for nonbiologic drugs, biosimilars are made for biologic drugs. These medications are used to help prevent febrile neutropenia. Adverse reactions with 5% higher incidence in filgrastim patients compared to patients receiving no filgrastim included arthralgia, bone pain, back pain, muscle spasms, musculoskeletal pain, pain in extremity, splenomegaly, anemia, upper respiratory tract infection, and urinary tract infection (upper respiratory tract infection and urinary tract infection were higher in the filgrastim arm, total infection related events were lower in filgrastim-treated patients), epistaxis, chest pain, diarrhea, hypoesthesia, and alopecia. If you have headaches, tell your doctor. We also. If youre injecting Neulasta doses yourself at home, take the prefilled syringe of the drug out of the refrigerator at least 30 minutes before your injection. Step 10. But theres conflicting research about this. ZARXIO prefilled syringe parts (see Figure A). All rights reserved. Be careful not to touch the needle guard wings before use. The packaging of some dosage forms may contain latex. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for ZARXIO and any potential adverse effects on the breastfed child from ZARXIO or from the underlying maternal condition. are allergic to latex. Patients were randomized to receive filgrastim (n=99) at a dose of 230 mcg/m2 (4 to 8 mcg/kg/day) or placebo (n=111). Neulastas effects last longer than either Granixs or Neupogens do. Find Clinical Trials for Filgrastim - Check for trials from NCI's list of cancer clinical trials now accepting patients. The following adverse reaction data were identified in a randomized, controlled study in patients with SCN receiving filgrastim (Study 7). Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. If you have radiation sickness or take chemotherapy drugs that increase your risk for serious infection, your doctor may recommend Neulasta. Call your doctor right away if you have an allergic reaction to Neulasta. A total of 100 patients received either 30 mcg/kg/day as a 4-hour infusion (Study 5) or 10 mcg/kg/day or 30 mcg/kg/day as a 24-hour infusion (Study 6) filgrastim (n=72), no treatment control or placebo (n=28). Neulasta begins working shortly after its given. We make every effort to ensure that the information we provide is accurate and up-to-date but it should not be relied upon as a substitute for specialist professional advice tailored to your situation. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard ZARXIO if frozen more than once. Do not administer ZARXIO within the 24-hour period prior to chemotherapy [see WARNINGS AND PRECAUTIONS]. Its important to discuss all your concerns with your doctor. However, if your urine is less acidic than average, it can take longer for Molly to leave your body. Do not shake the medication. (zar-zee-oh) Do not leave the medicine at room temperature for longer than 24 hours. Recommended Dosage Adjustments During Neutrophil Recovery in Patients with Cancer Following BMT. Opioids. Do not administer ZARXIO if particulates or discoloration are observed. And keep reading to learn more about the conditions themselves. small cell lung cancer receiving ifosfamide, doxorubicin and etoposide (Study 2), and non-Hodgkins lymphoma (NHL) receiving doxorubicin, cyclophosphamide, vindesine, bleomycin, methylprednisolone, and methotrexate (ACVBP) or mitoxantrone, ifosfamide, mitoguazone, teniposide, methotrexate, folinic acid, methylprednisolone, and methotrexate (VIM3) (Study 3). Here's what the research, Can apple cider vinegar really treat or prevent cancer? Mollys half-life is about eight to nine hours. WebOxycodone is a potent prescription medication that alters how your brain responds to pain, says WebMD. The relationship of these events to filgrastim administration is unknown [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS]. In clinical trials of filgrastim for the mobilization of hematopoietic progenitor cells filgrastim was administered to patients at doses between 5 to 24 mcg/kg/day after reinfusion of the collected cells until a sustainable ANC ( 500/mm3) was reached. ZARXIO prefilled syringes come in two strengths. This treatment can reduce the number of platelets in your blood. Cutaneous vasculitis may occur, which may be signaled by purpura or erythema. Common side effects of filgrastim may include: This is not a complete list of side effects and others may occur. Doing so may help to lessen stinging when you inject your dose. Therefore, to ensure a sustained therapeutic response administer ZARXIO daily for up to 2 weeks or until the ANC has reached 10000/mm3 following the expected chemotherapy-induced neutrophil nadir. Cocaine typically stays in your system for 1 to 4 days, but it can be detected for up to a couple of weeks in some people. Cancer treatments such as chemotherapy and radiation therapy can effect these cells which put a person at risk for developing infections, anemia, and bleeding problems. But if white blood cell levels are too low, chemotherapy may have to be delayed or given in a lower dose. See How should I dispose of used ZARXIO prefilled syringes? at the end of this Instructions for Use. zarxio (filgrastim-sndz injection) drug. G-CSF (granulocyte-colony stimulating factor) is a type of protein called a growth factor. Do not use a ZARXIO prefilled syringe that has been activated. Side effects while treatment is being given. Put your used prefilled syringes in a FDA-cleared sharps disposal container right away after use (see Figure N). What is the mechanism of action? Table 3. With this serious type of infection, you have a low level of neutrophils and a fever. If you have pain that becomes severe or doesnt go away, tell your doctor. After you inject your dose, throw away (dispose of) any unused ZARXIO left in the prefilled syringe. But unlike generics, which are made for nonbiologic drugs, biosimilars are made for biologic drugs such as Neulasta. The safety and efficacy of filgrastim to reduce the duration of neutropenia in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by autologous bone marrow transplantation was evaluated in 2 randomized controlled trials of patients with lymphoma (Study 6 and Study 9). The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. The product is available in single-dose prefilled syringes. Some G-CSF injections contain a sugar called sorbitol. The manufacturer recommends that the first dose of filgrastim be given no sooner than 24 hours after chemotherapy. This is called a platelet transfusion. Neutropenia means having a lower-than-normal level of neutrophils. Neutrophils are white blood cells that work to protect your body from infection. Importance of informing the healthcare provider if difficulty occurs when measuring or administering partial contents of the ZARXIO prefilled syringe. If you have questions about Neulasta, talk with your doctor or pharmacist. You may be wondering how long this bone pain lasts. The effect of filgrastim products on the development of abnormal cytogenetics and the effect of continued filgrastim products administration in patients with abnormal cytogenetics or MDS are unknown. The number of days you receive filgrastim will be prescribed by your doctor. Do not save unused drug for later administration. These side effects occur around the site where the drug was injected. You may get some of the side effects we mention, but you are unlikely to get all of them. Gently tap the syringe with your fingers until the air bubble rises to the top of the syringe (see. A statistically significant reduction in the median number of days of severe neutropenia (ANC < 500/mm3) occurred in the filgrastimtreated groups versus the control group (23 days in the control group 11 days in the 10 mcg/kg/day group and 14 days in the 30 mcg/kg/day group [11 days in the combined treatment groups p=0.004]). In general, after one injection, Neulasta is completely eliminated from your system within 14 days. Some people have G-CSF as a drip into a vein, which takes about 30 minutes. Single-dose preservative-free, prefilled syringes with an UltraSafe Passive Needle Guard, containing 300 mcg/0.5 mL of a clear, colorless to slightly yellowish filgrastim-sndz solution. Generic name: filgrastim [ fil-GRAS-tim ] Brand names: Neupogen, Neupogen SingleJect Drug class: Colony stimulating factors Medically reviewed by In rare instances, patients with congenital neutropenia have required doses of filgrastim greater than or equal to 100 mcg/kg/day. Call your healthcare provider if you develop any of these symptoms during treatment with ZARXIO. ZARXIO (filgrastim-sndz) is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. This means you can have it at home. Discard unused portion of ZARXIO in prefilled syringes. The OBI device will begin to administer Neulasta to you about 27 hours after your doctor applies the patch to your skin. A transient increase in neutrophil count is typically seen 1 to 2 days after initiation of ZARXIO therapy. Filgrastim is a medication used to manage and treat neutropenia in patients with myelosuppression from chemotherapy or radiation, which increases the risk of Slowly release the plunger and allow the needle guard to automatically cover the exposed needle (see. Follow. It has been reviewed by expert health professionals and people living with cancer. Congenital neutropenia: 6 mcg/kg/day divided 2 times per day. Here are some common questions related to Neulastas dosage. Patients receiving autologous bone marrow transplantation only were included in the analysis. An analysis of variance showed no significant interaction between treatment and diagnosis suggesting that efficacy did not differ substantially in the different diseases. Also, you can learn about chemotherapys side effects to help you know what to expect during treatment. Your skin may become red and itchy around the area where you had the G-CSF injection. For example, if you have breast cancer and receive the chemotherapy drug carboplatin, your doctor may prescribe Neulasta. In some people, almost all of the drug is eliminated from the body within two days. Such changes were transient and were not associated with clinical sequelae, nor were they necessarily associated with infection. Usually, stem cells stay in the bone marrow while they develop into blood cells. Available data from published studies, including several observational studies of pregnancy outcomes in women exposed to filgrastim products and those who were unexposed, have not established an association with filgrastim products use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Read and carefully follow any Instructions for Use provided with your medicine. Blood cells are made in the body's bone marrow (the soft, sponge-like material found inside bones). Do not dilute with saline at any time, because the product may precipitate. Medical Conditions. If you need medical treatment for any reason other than cancer, always tell the doctors and nurses you are having cancer treatment. Biosimilars are like generic drugs. Can alcohol be consumed while Im taking Neulasta? Thrombocytopenia has been reported in patients receiving filgrastim products. This should be considered when interpreting bone-imaging results. For more information, see this side-by-side comparison of Neulasta and Fulphila. This helps to reduce the risk of infection. Patients received daily filgrastim 24 hours after stem cell infusion at a dose of 5 mcg/kg/day. The underlying disease was: 67% hematologic malignancy, 24% aplastic anemia, 9% other. No malformations were observed in either species. Heroin stays in the body for different amounts of time, depending on how it is ingested: Saliva injected: 6 hours. Is there anything I should do to prepare for my first Neulasta dose? Review the steps for direct patient administration with patients and caregivers. Copyright 2023 by RxList Inc. An Internet Brands company. Neulasta comes as a liquid solution thats injected under your skin. The safety and efficacy of filgrastim to reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) was established in a randomized, double-blind placebo-controlled multi-center trial in patients with newly diagnosed, de novo AML (Study 4). You will have regular blood tests to check the number of white blood cells in your body during your treatment. Pregnancy category C (use the pregnancy only when benefit to the mother outweighs risk to the fetus). Dyspnea, with or without fever, progressing to Acute Respiratory Distress Syndrome, may occur. In Study 10, 70 patients scheduled to undergo bone marrow transplantation for multiple underlying conditions using multiple preparative regimens were randomized to receive filgrastim 300 mcg/m2/day (n=33) or placebo (n=37) days 5 through 28 after marrow infusion. Urine: 60 hours. Neulasta is a biologic medication, which means its made from living organisms. IT STIMULATES THE GROWTH OF NEUTROPHILS, A TYPE OF WHITE BLOOD CELL IMPORTANT IN THE BODYS FIGHT AGAINST INFECTION. (For more detail, see "How this drug works" section below). If you miss a dose of ZARXIO, talk to your healthcare provider about when you should give your next dose. All G-CSF agents (including Neulasta, Neupogen, and Udenyca) mimic the effects of G-CSF. Limited data from patients who were followed in the phase 3 study for 1.5 years did not suggest alterations in sexual maturation or endocrine function. Below are commonly used dosages, but always take the dosage your doctor prescribes. Look through the viewing window on the ZARXIO prefilled syringe. The recommended dosage of ZARXIO following bone marrow transplantation (BMT) is 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours. These cells then move (mobilise) from the bone marrow into the bloodstream. However, do not use it within 24 hours before you at the National Institutes of Health, An official website of the United States government, Drugs Approved for Different Types of Cancer, Drugs Approved for Conditions Related to Cancer, Complementary & Alternative Medicine (CAM), U.S. Department of Health and Human Services. You may get fever and chills as a side effect of G-CSF. See additional information. Inactive ingredients: glutamic acid, polysorbate 80, sorbitol, sodium hydroxide, water for injection, ZARXIO Your nurse will give you telephone numbers for the hospital. You can also call 800-222-1222 to reach the American Association of Poison Control Centers, or use its online resource. Neutrophils are a type of white blood cell that work to fight off infections. For example, if a person uses weed once a week, traces of weed remain in urine for up to 10 days. There was statistically significant reduction in the median number of days of severe neutropenia (ANC < 500/mm3) in the filgrastim-treated groups versus the control group (21.5 days in the control group versus 10 days in the filgrastim-treated groups, p < 0.001). Other side effects experienced were attributed to the chemotherapy and/or the disease. Do not use ZARXIO for a condition for which it was not prescribed. Certain factors can change the detection window. For instance, inactivated vaccines contain a form of a germ thats no longer alive. If causality is likely, consider dose-reduction or interruption of ZARXIO. Oxycodone is a potent prescription medication that alters how your brain responds to pain, says WebMD. After you eat, it takes about six to eight hours for food to pass through your stomach and small intestine. The median age was 12 years (range 7 months to 76 years) and 46% were male. Thereafter, if the patient is clinically stable, less frequent routine monitoring is recommended. And to learn more about Neulastas uses, see the What is Neulasta used for? section below. expiration date on the prefilled syringe label has not passed. There arent any known interactions between Neulasta and alcohol. Our website services, content, and products are for informational purposes only. The dose of filgrastim was determined by the category of neutropenia. Study 11 was a randomized, unblinded study of patients with Hodgkins disease or non-Hodgkins lymphoma undergoing myeloablative chemotherapy 27 patients received filgrastim-mobilized autologous hematopoietic progenitor cells and 31 patients received autologous bone marrow. Neulasta contains the active drug pegfilgrastim. White blood cells help your body fight against infection. Stop using filgrastim and call your doctor at once if you have: easy bruising, unusual bleeding, purple or red spots under your skin; fever, tiredness, stomach pain, back pain; rapid breathing, feeling short of breath, pain while breathing; capillary leak syndrome--sudden dizziness or light-headed feeling, tiredness, trouble breathing, swelling or puffiness and feeling full; kidney problems--little or no urinating, blood in your urine, swelling in your face or ankles; low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or. Zarxio is a man-made form of a substance produced by the body known as granulocyte colony-stimulating factor (G-CSF). Tell your doctor all medications and supplements you use. This content is currently being reviewed. Throw away (dispose of) the used ZARXIO prefilled syringe right away after use. Your nurse will give you advice about managing your side effects. The visibility of these markings is necessary to accurately measure doses of ZARXIO less than 0.3 mL (180 mcg) for direct administration to patients. Call your pharmacist for new medicine. There are a few case reports describing the use of filgrastim in breastfeeding mothers with no adverse effects noted in the infants. In a study with healthy volunteers, subjects with moderate renal impairment, and subjects with end stage renal disease (n=4 per group), higher serum concentrations were observed in subjects with end-stage renal disease. If frozen, thaw in the refrigerator before use. What's going on near you? Heres a summary of the active drugs in these medications and how theyre taken: Neulasta begins working shortly after its given. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers. Its made naturally by your body, and it works by signaling your bone marrow to make neutrophils. Meth Urine Test: Meth can be detected in the urine approximately 2 to 5 hours post-ingestion and anywhere from 3 to 7 days following the last dose. Neulasta may also be used off-label for other conditions. An interaction occurs when medications, vaccines, foods, and other substances affect how a certain drug works. We explain what you need to know about coverage requirements, costs, and finding doctors who accept Medicare. Thrombocytopenia [see WARNINGS AND PRECAUTIONS] Neulasta is given as an injection under your skin. General information about the safe and effective use of ZARXIO: Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. The main white blood cells that fight infection are called neutrophils. You usually have G-CSF as an injection under the skin (subcutaneously). When diluted in 5% Dextrose Injection, USP, or 5% Dextrose plus Albumin (Human) ZARXIO is compatible with glass, polyvinylchloride, polyolefin, and polypropylene. WebPegfilgrastim is a form of filgrastim that has polyethylene glycol (PEG) attached to it. There are three ways to know when Neulasta Onpro is done administering the drug to you: For more details on using Neulasta Onpro, you can view instructions for use on the manufacturers website. It comes as a liquid solution thats given as an injection in one of two ways: Neulasta is used to help prevent infections in adults and some children. G-CSF (granulocyte-colony stimulating factor) is a type of protein called a growth factor. Talk to your doctor or nurse if you notice this. Store filgrastim in the original container in a refrigerator. It gives the dose to you over a 45-minute period. This is quite rare. and a collection of links to more information about the use of Symptoms of a mild allergic reaction can include: A more severe allergic reaction is rare but possible. Patients were randomized to receive subcutaneous filgrastim (n=259) at a dose of 5 mcg/kg/day or placebo (n=262) from 24 hours after the last dose of chemotherapy until neutrophil recovery (ANC 1,000/mm3 for 3 consecutive days or 10,000/mm3 for 1 day) or for a maximum of 35 days. Having neutropenia can make it harder for your body to fight infections. If the patient or caregiver misses a dose of ZARXIO, instruct them to contact their healthcare provider. In patients receiving chemotherapy, filgrastim can accelerate the recovery of neutrophils, reducing the neutropenic phase (the time in which people are susceptible to infections). Its a place where people with certain conditions can find support and connect with others. I also had headache after exercise and activities, when hungry, etc. Throw it away after one use, even if there is still medicine left inside. If you are performing your own subcutaneous self-injections, remove the syringe from the refrigerator 30 minutes prior to injection. Side Effects of Neulasta: What You Need to Know, Cancer, Depression, and Anxiety: Caring for Your Physical and Mental Health. No malformations were observed in either species. The main efficacy endpoint was number of days of platelet transfusions. If glomerulonephritis is suspected, evaluate for cause. The main efficacy endpoint was duration of severe neutropenia ANC < 500/mm3. Symptoms of a severe allergic reaction can include swelling under your skin, typically in your eyelids, lips, hands, or feet. 2003. Injecting into a different place on your body each time helps to reduce the risk of irritation. It is used to help your body make more white blood cells. A fever is often a sign of infection. Confirm the diagnosis of SCN before initiating ZARXIO therapy. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastimsndz. Neulasta is given as part of a cancer treatment plan that includes other drugs. Health. Seek medical care or call 911 at once if you have the following serious side effects: This document does not contain all possible side effects and others may occur. Saliva smoked: 24 hours. Your healthcare provider will tell you how much ZARXIO to inject and when to inject it. For example, if a person uses weed once a week, traces of weed remain in urine for up to 10 days. During the period of neutrophil recovery titrate the daily dosage of ZARXIO against the neutrophil response (see Table 1). White blood cell counts of 100000/mm3 or greater were observed in approximately 2% of patients receiving filgrastim at dosages above 5 mcg/kg/day. Manufactured by: Sandoz Inc., Princeton, NJ 08540, US License No. You may have some discomfort or a dull ache in some of your bones. MDS and AML have been reported to occur in the natural history of congenital neutropenia without cytokine therapy. These injections encourage your bone marrow to make stem cells and increase the number of stem cells in the blood. G-CSF encourages the bone marrow to make white blood cells. The pharmacokinetics of filgrastim in pediatric patients after chemotherapy are similar to those in adult patients receiving the same weight-normalized doses, suggesting no age-related differences in the pharmacokinetics of filgrastim products [see Use In Specific Populations]. Neulasta is available in biosimilar forms. If you have serious side effects from Neulasta, call your doctor right away. If youre using Neulasta to increase your level of neutrophils, you shouldnt get any live vaccines. The lists below describe some of the more common side effects that Neulasta may cause. Monitor patients for signs and symptoms of MDS/AML in these settings. It isnt known how often allergic reactions occur with Neulasta. Neulasta and Granix belong to the same group of drugs called G-CSF agents. It can be used withchemotherapy. Cancer isnt a fungus. ZARXIO may be allowed to reach room temperature for up to 4 days. Do not change your dose or stop ZARXIO unless your healthcare provider tells you to. When ZARXIO is used to mobilize PBPC tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. Prepare your injection only when you are ready to give it. Filgrastim exhibits nonlinear pharmacokinetics with a short half-life of 3.5 hours, with filgrastim concentration and neutrophil count being the determinants of clearance. In patients with cancer receiving myelosuppressive chemotherapy discontinuation of filgrastim therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days with a return to pretreatment levels in 1 to 7 days. And these side effects may include altering your bodys natural production of neutrophils. The duration of ZARXIO therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed. Your doctor will explain how Neulasta will be given to you. Bring someone with you to your appointment if doing so will help you feel more comfortable. The median age was 12 years (range 7 months to 76 years); 46% males; 34% idiopathic, 17% cyclic and 49% congenital neutropenia. The patients in these studies were median age 61 (range 29 to 78) years and 64% were male. To learn more about Neulastas uses, see the What is Neulasta used for? section below. Because of the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy do not use ZARXIO in the period 24 hours before through 24 hours after the administration of cytotoxic chemotherapy [see DOSAGE AND ADMINISTRATION]. This page contains brief information about pegfilgrastim Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. Single parenteral doses or daily intravenous doses over a 14-day period resulted in comparable half-lives. A dose less than 0.3 mL cannot be accurately measured using the ZARXIO prefilled syringe. Colony-stimulating factors are substances that stimulate the production of blood cells and promote their ability to function. Its common to get pain in your arms or legs from Neulasta injections. Recommend stopping ZARXIO if the ANC increases beyond 10000/mm3 [see WARNINGS AND PRECAUTIONS]. Is Difficulty Swallowing a Symptom of Cancer? Your doctor may prescribe Neulasta for you if you have an increased risk for serious infections. If a patient with SCN develops abnormal cytogenetics or myelodysplasia the risks and benefits of continuing ZARXIO should be carefully considered. Apply a warm compress if you have any pain, redness or swelling at the injection site, and notify your doctor. You may also want to check out the online communities at Bezzy. Adverse reaction data below are from a randomized, double-blind, placebo-controlled study in patients with AML (Study 4) who received an induction chemotherapy regimen of intravenous daunorubicin days 1, 2, and 3; cytosine arabinoside days 1 to 7; and etoposide days 1 to 5 and up to 3 additional courses of therapy (induction 2, and consolidation 1, 2) of intravenous daunorubicin, cytosine arabinoside, and etoposide. It signals your bone marrow to make more neutrophils. Our cancer information has been awarded the PIF TICK. The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established. Talk to your doctor before breast feeding while taking this medication. The amount of filgrastim that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition being treated. You should not inject a dose of ZARXIO less than 0.3 mL (180 mcg) from a ZARXIO prefilled syringe. Other drugs may affect filgrastim, including prescription and over-the-counter medicines, vitamins, and herbal products. If youre unsure about which OTC medications are best for you, talk with your doctor or pharmacist. Patient self-administration and administration by a caregiver may benefit from training by a healthcare professional. Chemotherapy can lower the number of white blood cells in the blood. ZARXIO injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection). Its made naturally by your body. Some cancer treatments can cause severe side effects. Hemoptysis resolved with discontinuation of filgrastim products. Always tell your cancer doctor about any drugs you are taking or planning to take, such as: Tell other doctors, pharmacists or dentists who prescribe or give you medicines that you are having this cancer treatment. If a patient or caregiver is not able to demonstrate that they can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration of ZARXIO. Over-the-counter (OTC) medications are usually effective in preventing or relieving bone pain from Neulasta. Increases in lymphocyte counts following filgrastim administration have been reported in some normal subjects and patients with cancer. 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