Jan 01, 2020 neulasta is provided in a dispensing pack containing one sterile 6 mg0. Pegfilgrastim clinical trials safety data are based upon 932 patients receiving pegfilgrastim in seven randomized clinical trials. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for neulasta pegfilgrastim. Pegfilgrastim information for patients and caregivers. Review important safety information regarding neupogen filgrastim. Neulasta is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a. Severe mucocutaneous reactions, some with fatal outcomes 5. Highlights of prescribing information posterior reversible. Highlights of prescribing information these highlights do. The member will not receive chemotherapy and radiotherapy concurrently. The first fdaapproved biosimilar for neulasta pegfilgrastim. The indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the. Pegfilgrastim biosimilarity udenyca pegfilgrastimcbqv.
N, nbis 2chloroethylphosphoric acid diamide ifosphoramide and acrolein are also found. Make sure the medication name on the package or syringe label matches what your doctor prescribed for you. Amgen is committed to keeping our patients, customers, staff and their families safe. Neulasta between 14 days before and 24 hours after administration of cytotoxic chemotherapy. Highlights of prescribing information these highlights do not include all the information needed to use neupogen safely and effectively. Fulphila is first fda approved biosimilar for neulasta indicated to decrease the incidence of infection,as manifested by febrile neutropenia,in patients with nonmyeloid malignancies. Neulasta singledose prefilled syringe for manual use. Neulasta is dosed no more frequently that every 14 days do not administer within 14 days before or 24 hours after administration of a cytotoxic chemotherapy onbody injector may be administered on the same day as chemotherapy as long as the neulasta is administered no less than 24 hours after administration of chemotherapy vi. Neulasta pegfilgrastim and neulasta onpro onbody injector. A short needle will insert the cannula, which is designed to allow neulasta to be delivered under. If the prefilled syringe copackaged in neulasta onpro kit is used for manual. For patients who have had severe skin reactions to acrylic adhesives, consider the benefit. See full prescribing information for complete boxed warning.
Udenyca is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. For more about febrile neutropenia risk after chemo administration, see patient risk factors. Prevnar is to be administered as a fourdose series at 2, 4, 6, and 1215 months of age. Decitabine dacogen mds myelodysplasia chemoexperts. Chronic immunosuppression in the posttransplant setting including organ transplant note. Neulasta pegfilgrastim onpro kit healthcare provider. Singulair is indicated for prevention of exerciseinduced bronchoconstriction eib in patients 6years of age and older. The recommended dosage of neulasta is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. Neulasta is a leukocyte growth factor indicated to. The neulasta onpro is a kit that includes a single dose of neulasta.
Download leaflet view the patient leaflet in pdf format. Plan to be in a place where you or your caregiver can appropriately monitor the onbody injector for neulasta during the approximately 45 minute neulasta delivery and for an hour after the delivery. Pba occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by. Holding the syringe like a pencil, insert the needle either straight up and down 90. You should discuss any questions you have about treatment with neulasta with your doctor. Neulasta injection is a clear, colorless solution supplied in a prefilled singledose syringe for manual use containing 6 mg pegfilgrastim, supplied with a 27gauge, 12inch needle with an ultrasafe needle guard. The plunger must be pushed fully in order to inject the full dose. Neulasta 6 mg solution injectable en seringue preremplie. Information for the user neulasta 6 mg solution for injection with onbody injector pegfilgrastim read all of this leaflet carefully before you start using this medicine because it contains important information for you. Patients currently receiving sandostatin injection patients currently receiving sandostatin injection can be switched to sandostatin lar depot in a dosage of 20 mg given im intragluteally at 4week intervals for 2 months.
Neulasta, the patient may receive less than the recommended dose. Your spleen may become enlarged and can rupture while taking neupogen. Nov 29, 2019 serious allergic reactions can happen with neulasta. Do not remove the onbody injector during cannula insertion to avoid needle stick injury to you. Read all of this leaflet carefully before you start using this medicine because it contains important information for you. See important safety including boxed warnings for more information. Fulphila is an effective treatment option for patients with febrile neutropenia. Neulasta, innpegfilgrastim european medicines agency. The clinical trials performed in support of efficacy were up to 6 months in duration.
Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe. The patient should also be given the patient alert card. Neulasta 6 mg solution for injection with onbody injector pegfilgrastim. This leaflet is part iii of a threepart product monograph. Privigen is contraindicated in patients with history of anaphylactic or severe systemic reaction to human immune globulin, in patients with hyperprolinemia, and in igadeficient patients with antibodies to iga and a history of hypersensitivity. Akynzeo netupitant and palonosetron capsulesfosnetupitant and palonosetron for injection is a prescription medicine called an antiemetic.
Full prescribing information 1 indications and usage nuedexta is indicated for the treatment of pseudobulbar affect pba. Jan 06, 2020 neulasta is a leukocyte growth factor indicated to. Patients with a history of serious allergic reactions to human granulocyte. Neulasta pegfilgrastim information for patients and caregivers. Neulasta fda prescribing information, side effects and uses. Highlights of prescribing information these highlights do not include all the information needed to use neulasta safely and effectively. Sandostatin lar depot in the dosage regimen as described below patients currently receiving sandostatin injection. This patient package insert does not tell you everything about neulasta. Patients must have failed, or have a contraindication, or intolerance to neulasta and udenyca prior to consideration of any other longacting gcsf product. In controlled outpatient and sleep laboratory studies, lunesta administered at bedtime decreased sleep latency and improved sleep maintenance. Neulasta therapy should be initiated and supervised by physicians experienced in oncology andor haematology. The ethnicity was 75% caucasian, 18% hispanic, 5% black, and 1% asian. The obi for neulasta should be applied to intact, nonirritated skin on the arm or abdomen. L using slow and constant pressure, push the plunger rod until it reaches the bottom.
You should discuss any questions you have about treatment with neulasta with your. Xtandi enzalutamide capsules, for oral use initial u. Mobilization of peripheral blood progenitor cells pbpcs a. Neulasta pegfilgrastim healthcare professional website. If you have any questions, you should talk to your doctor.
Learn about gazyva obinutuzumab in firstline fl, relapsedrefractory follicular lymphoma, and previously untreated cll treatment. Highlights of prescribing information these highlights do not include all the information needed to use xtandi safely and effectively. Eligard leuprolide acetate for injectable suspension is a medicine for the treatment of advanced prostate cancer. Neulasta is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile. Neulasta 6 mg solution for injection in prefilled syringe with onbody injector. Highlights of prescribing information neulasta safely and. Neulasta pegfilgrastim injection, for subcutaneous use. What are possible serious side effects of neupogen.
Page 1 of 36 highlights of prescribing information these highlights do not include all the information needed to use perjeta safely and effectively. Insert the needle into the skin between 45 to 90 degrees. Gleevec imatinib mesylate tablets, for oral use initial u. Neulasta will be administered at least 24 hours after chemotherapy or radiotherapy v. Information for the user neulasta 6 mg solution for. Neulasta pegfilgrastim information for patients and. Designed to deliver neulasta, which helps you fight the risk of infection at home or other appropriate setting. Neulasta is provided in a dispensing pack containing one sterile 6 mg0. Neulasta 6 mg prefilled syringe 555190xx amgen neulasta 6 mg prefilled syringe with onbody injector 555192xx amgen vii.
Neulasta will not be administered with chemotherapy regimens of less than 14 days iv. The onbody injector for neulasta should be applied to intact, nonirritated skin on the arm or abdomen. The first fdaapproved biosimilar for neulasta pegfilgrastim fulphila is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive. This patient package insert provides information and instructions for people who will be receiving neulasta or their caregivers. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Leukine sargramostim is a recombinant human granulocytemacrophage colony. Neulasta pegfilgrastim injection,for subcutaneous use initial u. Posology one 6 mg dose a single prefilled syringe of neulasta is recommended for each chemotherapy cycle. Enzymatic oxidation of the chloroethyl side chains and subsequent dealkylation produces the major urinary.
January 1, 2020 page 4 of 5 revision history na references 1. Neupogen is contraindicated in patients with a history of serious allergic reactions to human granulocyte colonystimulating factors gcsfs, such as filgrastim or pegfilgrastim. Do not use the onbody injector for neulasta to deliver any other drug product except the neulasta prefilled syringe copackaged with the onbody injector for neulasta. Read all of this leaflet carefully before you start.
It works by reducing the amount of testosterone in the blood. Click on the decitabine dacogen package insert below for reported side effects and possible drug interactions. Lunesta eszopiclone is indicated for the treatment of insomnia. Neulasta prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe 6 mg0. Akynzeo is used in combination with the medicine dexamethasone in adults to help prevent the nausea and vomiting that happens right away or later with certain anti. Monitor patients and discontinue rituxan infusion for severe reactions 5. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer. Fatal infusionrelated reactions within 24 hours of rituxan infusion.
The spleen is located in the upper left section of your stomach area. Neulasta 6 mg solution for injection with onbody injector. Neulasta pegfilgrastim fulphila pegfilgrastimjmdp udenyca pegfilgrastimcbqv policy. Neupogen filgrastim injection, for subcutaneous or intravenous use initial u. Leukine sargramostim a recombinant gmcsfyeastexpressed. Keep the prefilled syringe in neulasta onpro kit carton until use toprotect from light. Patients with cancer receiving myelosuppressive chemotherapy. In controlled outpatient and sleep laboratory studies, lunesta administered at bedtime decreased sleep latency and improved.
Neulasta on body injector patient information leaflet pil. Side effect videos nausea and vomiting diarrhea fatigue constipation pain anemia see dailymed package insert. M once the entire dose has been injected, the needle safety guard will be. Highlights of prescribing information acute respiratory. Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. The printed package leaflet of the medicinal product must state the name and.
Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively. Do not use the obi for neulasta to deliver any other drug product except the neulasta prefilled syringe copackaged with the obi for neulasta. Neulasta and udenyca are the preferred longacting granulocyte colonystimulating factor products. Neulasta on body injector patient information leaflet. Neulasta prescribing information amgen slidelegend. The population was 21 to 88 years of age and 92% female. Find information about neulasta pegfilgrastim and neulasta onpro, including efficacy data, patient resources, and important safety information. Find information about neulasta pegfilgrastim and neulasta onpro, the onbody injector designed to administer neulasta. Sections or subsections omitted from the full prescribing information are not.