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Neulasta (Pegfilgrastim) - Summary

 
 



NEULASTA SUMMARY

Neulasta®
(pegfilgrastim)

Neulasta™ (pegfilgrastim) is a covalent conjugate of recombinant methionyl human G-CSF (Filgrastim) and monomethoxypolyethylene glycol.

Neulasta™ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.


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NEWS HIGHLIGHTS

Published Studies Related to Neulasta (Pegfilgrastim)

Pegfilgrastim vs. filgrastim for supportive care after autologous stem cell transplantation: can we decide? [2011.10.31]
Ziakas PD, Kourbeti IS.Both drugs are at least equally effective, though methodology and disease stratification in published trials warrant further improvement.

Pegfilgrastim versus filgrastim after high-dose chemotherapy and autologous peripheral blood stem cell support. [2010.07]
BACKGROUND: American Society of Clinical Oncology guidelines recommend the use of growth factor after high-dose chemotherapy (HDC) and peripheral blood stem cell (PBSC) support. This randomized trial aims to demonstrate the noninferiority of pegfilgrastim (PEG) compared with filgrastim (FIL) after HDC... CONCLUSION: PEG is not inferior to FIL in hematological reconstitution and represents an effective alternative after HDC and PBSC.

Pegfilgrastim appears equivalent to daily dosing of filgrastim to treat neutropenia after autologous peripheral blood stem cell transplantation in patients with non-Hodgkin lymphoma. [2010.06]
BACKGROUND: Filgrastim decreases the time to neutrophil recovery after autologous peripheral blood stem cell transplantation (PBSCT). We hypothesized that single-dose pegfilgrastim would mimic multiple daily doses of filgrastim, resulting in an equivalent shortening of post-PBSCT neutropenia... CONCLUSION: Pegfilgrastim after PBSCT appears equivalent to multiple daily doses of filgrastim. This approach might be considered in lieu of filgrastim, thus obviating the need for multiple daily injections.

Randomized phase III trial of pegfilgrastim versus filgrastim after autologus peripheral blood stem cell transplantation. [2010.05]
Nonrandomized trials suggest that pegfilgrastim, a pegylated granulocyte colony-stimulating factor, could be used in lieu of filgrastim after autologus peripheral blood stem cell transplantation...

A randomized, placebo-controlled phase ii study evaluating the reduction of neutropenia and febrile neutropenia in patients with colorectal cancer receiving pegfilgrastim with every-2-week chemotherapy. [2010.04]
BACKGROUND: Adding irinotecan and/or oxaliplatin to every-2-week 5-fluorouracil (5-FU)/leucovorin (LV) prolongs survival in patients with colorectal cancer (CRC) but increases neutropenia frequency. Pegfilgrastim is indicated to decrease infection as manifested by febrile neutropenia (FN) in patients receiving chemotherapy at > 14-day intervals. This randomized, placebo-controlled phase II study examined pegfilgrastim efficacy and safety in patients with CRC receiving every-2-week chemotherapy... CONCLUSION: Pegfilgrastim was well tolerated in patients with CRC receiving every-2-week chemotherapy and significantly reduced neutropenia and FN compared with placebo, though FN was uncommon in both treatment groups. Results suggest that pegfilgrastim administration is feasible in CRC patients receiving every-2-week chemotherapy.

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Clinical Trials Related to Neulasta (Pegfilgrastim)

Pegfilgrastim (Neulasta) for Stem Cell Mobilization in Patients With Multiple Myeloma [Completed]
In recent years PBPC have replaced bone marrow as the source of hematopoietic stem cells for autologous transplantation. One of the cited advantages of this procedure is the avoidance of bone marrow harvest, which frequently requires general anesthesia. Other advantages include faster neutrophil and platelet engraftment times, faster immune recovery, decrease in the amount of tumor contamination and technical ability to obtain stem cells from patients previously considered unharvestable because of marrow fibrosis or because of prior radiotherapy to the pelvis. Filgrastim has emerged as the preferred cytokine for stem cell mobilization based on its safety profile and the positive experience in granulocyte donors however, the number of circulating CD34+ cells does not occur until the third day after starting filgrastim injections. Pegfilgrastim stimulates the production and maturation of neutrophil precursors and enhances the functions of mature neutrophils in the same manner as filgrastim. Data form normal volunteers and in studies of patients with cancer have shown prolonged serum levels of the cytokine, with "self-regulation" of pegfilgrastim levels as a function of the neutrophil count. This confers a therapeutic advantage in clinical settings by allowing a less frequent dosing.

Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer [Active, not recruiting]
The main purpose of this study is to see if pegfilgrastim (Neulasta) is safe and useful in supporting people through dose-dense chemotherapy, and to see if a long-acting red blood cell growth factor, darbepoetin alfa(Aranesp) can reduce the need for blood transfusion in chemotherapy recipients.

NeulastaŽ in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) During Chemotherapy [Completed]
The purpose of this study is to estimate the relationship between patient reported outcomes (PROs) and neutropenia (or its complications) in NSCLC subjects receiving chemotherapy with or without NeulastaŽ (pegfilgrastim).

Neulasta in Type 1 Diabetes [Recruiting]
This study seeks to determine if giving a a 12 week course of Neulasta to people with recent onset type 1 diabetes is (1) safe and (2) can preserve insulin production.

Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating Pegfilgrastim Hospira Compared to Neulasta (Amgen) in Healthy Volunteers [Recruiting]
Compare pegylated granulocyte colony-stimulating factor (PEG-GCSF) pharmacokinetics (PK) and pharmacodynamics (PD) from Pegfilgrastim Hospira and Neulasta (R) following a single dose of 6 mg delivered by subcutaneous (SC) injection in healthy volunteers.

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Reports of Suspected Neulasta (Pegfilgrastim) Side Effects

Febrile Neutropenia (100)Neutropenia (83)Drug Ineffective (68)Dyspnoea (65)Pyrexia (63)Bone Pain (56)Fatigue (56)Anaemia (44)Chest Pain (39)Nausea (39)more >>


Page last updated: 2011-12-09

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