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