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Topic: Neulasta

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	i-Newswire.com - Press Release And News Distribution - Neulasta Significantly Lowers Incidence of Neutropenia with ...
		Neulasta was also associated with a significantly lower incidence of hospitalizations with one percent of patients (6/463) requiring hospitalization versus 14 percent of patients receiving placebo (64/465).
		In addition, first-cycle administration of Neulasta resulted in a 91 percent reduction in the incidence of febrile neutropenia occurring in the first cycle of chemotherapy, an 89 percent reduction in the incidence of hospitalization and an 83 percent reduction in the incidence of intravenous anti-infective use.
		Neulasta was approved by the U.S. Food and Drug Administration (FDA) in 2002 for decreasing the incidence of infection, as manifested by neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
	i-newswire.com /pr8411.html (1457 words)

	Amgen
		Neulasta, administered as a single fixed dose per chemotherapy cycle, is indicated for decreasing the incidence of infection, as manifested by febrile neutropenia (fever associated with a severe drop in infection-fighting white blood cells) in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
		Self-regulation (neutrophil-mediated clearance) of Neulasta allows the drug to remain in the blood throughout the time during which a patient is neutropenic -- when it is needed -- and then be cleared rapidly when it is no longer needed (as neutrophils recover toward normal levels).
		Neulasta was comparable to NEUPOGEN with respect to rates of febrile neutropenia across all chemotherapy cycles in both studies.
	www.amgen.com /media/media_pr_detail.jsp?year=2002&releaseID=254317 (1141 words)

	LMRP for Neupogen (Filgrastim) and Neulasta (Pegfilgrastim) (L13239) (Site not responding. Last check: 2007-11-06)
		Therapy with Neupogen and Neulasta is recommended in conditions in which worsening of the course is predicted, there is an expected long delay in recovery of the marrow, patients remain severely neutropenic and have documented infections that do not respond to appropriate antimicrobial therapy.
		Neulasta is indicated to decrease the incidence of febrile neutropenia and the duration of neutropenia in patients treated with cytotoxic chemotherapy for malignancy, with the exception of chronic myeloid leukemia and myelodysplastic syndromes.
		Neulasta should not be administered in the period between 14 days before and 24 hours after administration of cytotoxic chemotherapy because of the potential for an increase in sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy.
	www.riverbendgba.com /vlmrp/095-03.html (2610 words)

	Product Label (Site not responding. Last check: 2007-11-06)
		Neulasta ?(pegfilgrastim) is a covalent conjugate of recombinant methionyl human G-CSF (Filgrastim) and monomethoxypolyethylene glycol.
		Neulasta ?was evaluated in two randomized, double-blind, active control studies, employing doxorubicin 60 mg/m2 and docetaxel 75 mg/m2 administered every 21 days for up to 4 cycles for the treatment of metastatic breast cancer.
		Neulasta is indicated to decrease the incidence of infection, as manifested by febrileneutropenia, in patients with non-myeloid malignancies receiving myelosuppressiveanti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
	www.accessdata.fda.gov /scripts/cder/onctools/labels.cfm?GN=Pegfilgrastim (2620 words)

	neulasta drug information, neulasta side effects
		Neulasta® (pegfilgrastim) is prescribed to reduce the risk of infection (initially marked by fever) in patients with...
		Neulasta is approved as a treatment for patients undergoing chemotherapy, to decrease the...
		Neulasta ?(pegfilgrastim) is a covalent conjugate of recombinant methionyl human...
	www.drugs.com /ns/neulasta (481 words)

	Amgen Receives European Commission Approval For Both Aranesp And Neulasta (Darbepoetin Alfa) In Oncology
		With Neulasta, a polyethylene glycol molecule or "PEG" unit is covalently bound to the Filgrastim molecule, extending its half-life and causing it to be cleared more slowly from the body mainly through neutrophil and neutrophil precursor-mediated clearance mechanisms.
		Data from a pivotal phase 3 study in breast cancer patients demonstrated that a single once-per-cycle dose of Neulasta provided patients, irrespective of their weight, with protection from infection comparable to a median of 11 daily injections of Filgrastim, by reducing the duration of severe neutropenia.
		In the U.S., Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeoid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
	www.docguide.com /dg.nsf/PrintPrint/1D92DD21F3DDBB0485256C23004D57CE (1233 words)

	Oncology Nursing Society.
		Neulasta, or pegfilgrastim, is formulated by adding a polyethylene glycol molecule, or "peg" unit, to enlarge the parent filgrastim molecule, causing it to be removed more slowly from the body.
		The less frequent dosing of Neulasta means that patients will require fewer painful injections, fewer office visits for those injections, and fewer disruptions to their lives at a time when they are overwhelmed with a serious disease.
		Neulasta should be given about 24 hours after the completion of chemotherapy but no later than 14 days prior to the next cycle.
	www.ons.org /Publications/journals/ONF/Volume29/Issue4/2904733.asp (1993 words)

	Pharmacy Update, Nov-Dec 2002 (Site not responding. Last check: 2007-11-06)
		Neulasta is contraindicated in patients with known hypersensitivity to E. coli-derived proteins, pegfilgrastim, filgrastim, or any other component of the product.
		Neulasta 6 mg subcutaneously is given once per chemotherapy cycle.
		Neulasta has not been studied in patients receiving chemotherapy associated with delayed myelosuppression (e.g., nitrosoureas, mitomycin) or in patients receiving radiation therapy.
	www.cc.nih.gov /phar/updates/novdec02/page4.html (537 words)

	Neulasta® During First and Subsequent Chemotherapy Cycles Drastically Reduces Infection in Breast Cancer Patients
		Neulasta® has been designed so that only one injection is given per chemotherapy cycle.
		This trial, the largest randomized placebo-controlled study to date evaluating Neulasta®, demonstrated that administration of Neulasta® during the initial chemotherapy cycle significantly reduced the risk of patients developing fever and neutropenia, the need for intravenous antibiotics for treatment of infection and the need for hospitalization.
		The researchers concluded that the one-time administration of Neulasta® during the first and each subsequent cycle of chemotherapy reduces the risk of infection, hospitalization and intravenous anti-infective use in all cycles of chemotherapy.
	patient.cancerconsultants.com /news.aspx?id=33343 (722 words)

	Neulasta - Talk Medical
		· Neulasta is used to increase white blood cells and therefore decrease the risk of infection in patients with non-myeloid (not bone marrow) cancers while receiving cancer chemotherapy (drugs).
		Neulasta left at room temperature for more than 48 hours should be thrown away.
		Continue to use Neulasta and talk to your doctor if you experience: ·muscle, joint, or bone pain; ·fatigue; ·headache; ·weakness; ·dizziness; ·sores in the mouth or throat; or ·nausea, vomiting, diarrhea, or constipation.
	www.talkmd.com /medications/print-4248 (854 words)

	PTCommunity.com - Daily News Briefing
		Specifically, one percent of patients in the Neulasta arm (6/463) developed febrile neutropenia compared with 17 percent of patients in the placebo arm (78/465).
		A lower percentage of serious adverse events were reported for Neulasta patients compared with placebo patients (12 percent versus 24 percent); this difference was attributable to the lower percentage of febrile neutropenia events reported in Neulasta patients compared with placebo patients.
		Neulasta was approved by the U.S. Food and Drug Administration in 2002 for decreasing the incidence of infection, as manifested by chemotherapy-induced neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs with a clinically significant incidence of febrile neutropenia.
	www.formkit.com /Daily/DailyDetail.cfm?chosen=48248 (578 words)

	University of Florida Shands Cancer Center - Drug Dictionary (Site not responding. Last check: 2007-11-06)
		Specifically, Neulasta® is approved for patients being treated for non-hematologic cancers with agents that are associated with causing low white blood cell levels often accompanied by a fever, a condition that leaves patients susceptible to potential life-threatening infections.
		Neulasta® stimulates the growth of neutrophils, a type of white blood cell, which are important immune cells that fight infection caused by bacteria, viruses or fungus.
		Neulasta® is given as a subcutaneous (under the skin) injection and comes in prefilled syringes.
	www.ufscc.ufl.edu /drug_dictionary.aspx?id=797 (1125 words)

	GCIG
		Neulasta, the only once-per-chemotherapy cycle stimulator of white blood cells, represents a major advance over current therapies in managing chemotherapy-induced infections.
		The approval of Neulasta by the EC will permit prescription of a longer- acting form of Filgrastim that allows for once-per-chemotherapy cycle dosing.
		Neulasta is a pegylated recombinant protein that stimulates the production of neutrophils that are depleted by cytotoxic chemotherapy.
	ctep.info.nih.gov /resources/gcig/news1.html (1109 words)

	Neulasta® Allows for More Effective Chemotherapy in Non-Hodgkin’s Lymphoma
		Neulasta® requires administration only once during a chemotherapy cycle, whereas the use of Neupogen® requires daily injections.
		Clinical trials have indicated that Neulasta® is as effective as Neupogen® in reducing the incidence and/or severity of neutropenia in patients undergoing treatment for non-myeloid (blood) cancer and further trials are being conducted to determine the true clinical efficacy of treatment with Neulasta®.
		The researchers concluded that the use of Neulasta® once per chemotherapy cycle of CHOP-R 14 is comparable to daily injections with Neupogen® in patients with aggressive B-cell NHL.
	patient.cancerconsultants.com /news.aspx?id=32977 (689 words)

	Neulasta Information from Drugs.com
		Neulasta is used to increase white blood cells and therefore decrease the risk of infection in patients with non-myeloid (not bone marrow) cancers while receiving cancer chemotherapy (drugs).
		Neulasta is in the FDA pregnancy category C. This means that it is not known whether Neulasta will be harmful to an unborn baby.
		Neulasta is supplied in prefilled syringes, each intended to administer a single dose.
	www.drugs.com /neulasta.html (1192 words)

	Neulasta® Prevents Febrile Neutropenia in Breast Cancer Patients
		Neulasta® was safe, with slightly more bone and musculoskeletal pain observed compared to placebo.
		Serious adverse event rate were 24% in the control group and 2% in the Neulasta® group, with fatal adverse events occurring in 3% of the placebo arm, compared to 1% in the Neulasta® arm.
		Comments: The authors concluded that Neulasta® is extremely effective when used with first and subsequent cycles of moderate myelosuppressive chemotherapy that has an expected febrile neutropenia rate of 15-20% in the absence of growth factor use.
	professional.cancerconsultants.com /oncology_main_news.aspx?id=33337 (762 words)

	Newly Approved Drug Therapies (757): Neulasta, Amgen
		Neulasta is approved as a treatment for patients undergoing chemotherapy, to decrease the incidence of infection by febrile neutropenia.
		Approval of Neulasta was supported by two phase III clinical trials involving subjects with breast cancer, who were undergoing up to four cycles of chemotherapy.
		Neulasta (pegfilgrastim) is a protein that stimulates the production of neutrophils, a type of white blood cell that is depleted during cytotoxic chemotherapy.
	www.centerwatch.com /patient/drugs/dru757.html (433 words)

	UNM Cancer Research and Treatment Center
		Administration of NeulastaÂ® prior to the first cycle of chemotherapy reduced the incidence of febrile neutropenia by 90%, reduced the hospitalization rate by 89%, and reduced the incidence of intravenous (in a vein) anti-infective use by 83% compared to placebo during the first cycle of treatment.
		Patients who received NeulastaÂ® in chemotherapy cycles 2-4 also fared better than those treated with placebo, with a reduced incidence of febrile neutropenia (less than 1% vs. 6%, respectively), a reduced incidence of hospitalization (less than 1% vs. 5%, respectively), and a reduced incidence of intravenous anti-infective use (less than 1% vs. 4%, respectively).
		The researchers concluded that the one-time administration of NeulastaÂ® during the first and subsequent cycles of chemotherapy drastically reduces the risk of infection, hospitalization and intravenous anti-infectives in all cycles of chemotherapy in patients with breast cancer undergoing treatment with TaxotereÂ®-based regimens.
	cancer.unm.edu /cancernews.aspx?section=cancernews&id=32898 (813 words)

	News - Health Canada Approves Neulasta (Pegfilgrastim), Treatment for Chemotherapy-Related Neutropenia (Site not responding. Last check: 2007-11-06)
		Neulasta™ (pegfilgrastim) is a unique and innovative treatment that requires only one subcutaneous injection per chemotherapy cycle, reducing the number of injections from 40-50 to only 4 or 5.
		Two phase III studies in breast cancer patients showed that a single injection of Neulasta™ is as effective as a mean of 11 daily injections of filgrastim.
		Neulasta™ was proven to reduce the duration of severe neutropenia and the frequency of neutropenia with fever.
	www.docguide.com /news/content.nsf/news/8525697700573E1885256E9F0062BF16 (825 words)

	Neulasta
		Neulasta is used to boost the white blood cells after chemotherapy
		Neulasta is the new drug which has replaced Neupogen, and it means that instead of having to give yourself an injection every day, you now only need to get the one injection, that will work over a period of time.
		Neulasta is used to stimulate the growth of white blood cells after you have received your chemotherapy.
	homepage.ntlworld.com /lawrence.wray1/neulasta (294 words)

	Neulasta Pharmacology, Pharmacokinetics, Studies, Metabolism - Pegfilgrastim - RxList Monographs
		Neutrophil receptor binding is an important component of the clearance of Neulasta
		Based on the correlation between the duration of severe neutropenia and the incidence of febrile neutropenia found in studies with Filgrastim, duration of severe neutropenia was chosen as the primary endpoint in both studies, and the efficacy of Neulasta
		In study 1, 157 subjects were randomized to receive a single SC dose of 6 mg of Neulasta
	www.rxlist.com /cgi/generic3/neulasta_cp.htm (615 words)

	Amgen Earnings Get a Blast From Neulasta
		Neupogen sales growth has fallen into the single digits, but that was expected because doctors are moving patients over to the company's longer-acting version of the drug, Neulasta, which was launched in April.
		Neulasta sales are very strong out of the gate, totaling $110 million in the second quarter, well above the most bullish Wall Street estimates, which had sales coming in around $92 million.
		Amgen said it believed Neulasta sales were primarily demand driven, although inventory stocking also pushed the number higher.
	www.thestreet.com /pf/tech/adamfeuerstein/10033939.html (1058 words)

	Fever and Low White Blood Cell Count Reduced With Neulasta (Site not responding. Last check: 2007-11-06)
		Neulasta is given once with every chemotherapy cycle by injection under the skin.
		Those in the Neulasta group were also hospitalized less frequently due to febrile neutropenia than those in the placebo group (1% compared to 14%).
		In this study, Neulasta reduced the incidence of febrile neutropenia by 94% for women in a lower-risk category.
	www.breastcancer.org /research_recurrence_033005_pf.html (1089 words)

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