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Neupogen dosing in obese patients in hospitals – Effect of Body Mass on Filgrastim Pharmacokinetics

Neupogen Dosage Medically reviewed by Drugs. These patients will be in the hospital already and will not need to make additional trips back to have blood drawn.

Lucas Cox
Saturday, August 17, 2019
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  • Primary Outcome Measures : Systemic clearance of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ].

  • A total of about tablespoons of blood will be drawn for this study. These patients will be in the hospital already and will not need to make additional trips back to have blood drawn.

  • These data suggest that higher BMI ovese a better HSC mobilization response to G-CSF and identify a dose threshold above which there is no appreciable increase in progenitor cell yield in obese and severely obese healthy unrelated donors. However, differences were noted in the severity of pain and toxicities at both the pericollection and early postdonation recovery periods.

  • The other 61 patients studied had weights greater than 60 kg and received less than the recommended dose, with 53 patients weighing between 60 and 85 kg medium weight group and eight patients with weights greater than 85 kg high weight group. Information regarding the type of cell separator used to perform the apheresis procedure and details of procedural factors that may have affected the collection were not available.

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Drug Information available for: Filgrastim. Last Update Posted : December 17, FDA Resources. Study Description. Shaw, John R.

Persons with latex allergies should not administer the NEUPOGEN prefilled syringe, because the needle cap contains dry natural rubber derived from latex. Federal Government. Hematologic Neoplasms Neutropenia Neoplasms Agranulocytosis. This study will use blood samples taken at different time points for patients taking Neupogen to determine if higher body weights affect drug exposure.

  • View large Download PPT. The severity of skeletal pain was defined as the maximum grade of pain among these sites.

  • Effect of Body Mass on Filgrastim Pharmacokinetics.

  • Whether this dosing strategy would also reduce pain and acute toxicities should be further studied. Article history Submitted:.

  • Study record managers: refer to the Data Element Definitions if submitting registration or results information. Persons with latex allergies should not administer the NEUPOGEN prefilled syringe, because the needle cap contains dry natural rubber derived from latex.

Hematological Malignancy Neutropenia. Neupogen Dosage Medically reviewed by Drugs. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Actual Enrollment :. Search for terms. Talk with your doctor and family members or friends about deciding to join a study.

Chronic daily administration is required to maintain clinical benefit. Study Description. Actual Primary Completion Date :. Actual Enrollment :.

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Drug Information available for: Filgrastim. Neupogen Dosage Medically reviewed by Drugs. Studies have shown that different percentages of body fat can alter un way drugs are distributed in the body. If patients or caregivers are to administer NEUPOGEN, instruct them in appropriate injection technique and ask them to follow the subcutaneous injection procedures in the Instructions for Use for the vial or prefilled syringe [see Patient Counseling Information 17 ].

Subscribe to our newsletters. Study Nuepogen :. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The information gathered from this study will help understand if patients with higher body weights need a different dosing plan. Actual Primary Completion Date :. Medically reviewed by Drugs. Save this study.

Chronic daily administration is required to maintain clinical benefit. Persons with latex allergies should not administer hospitls NEUPOGEN prefilled syringe, because the needle cap contains dry natural rubber derived from latex. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. More Information. Please refer to this study by its ClinicalTrials.

More about Neupogen (filgrastim)

Select one or more newsletters to continue. Read our disclaimer for details. Persons with latex allergies should not administer the NEUPOGEN prefilled syringe, because the needle cap contains dry natural rubber derived from latex.

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 NEUPOGEN or whether the patient would benefit from a different NEUPOGEN presentation. Filgrastim Obese Non-obese Pharmacokinetics. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Subscribe to our newsletters. Study Type :. Patient or their legally authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. Hematologic Neoplasms Neutropenia Neoplasms Agranulocytosis.

  • Edwards School of Medicine. A randomized multicenter comparison of bone marrow and peripheral blood in recipients of matched sibling allogeneic transplants for myeloid malignancies.

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  • Do not save unused drug for later administration.

  • Hockings, J. Cost-effectiveness analysis of granulocyte colony-stimulating factors for the prophylaxis of chemotherapy-induced febrile neutropenia in patients with non-Hodgkin lymphoma in Greece.

National Library of Medicine U. Effect of Body Mass on Filgrastim Pharmacokinetics The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Study Description. This 24 hour time period includes the time during room temperature storage of the infusion solution and the duration of the infusion. Filgrastim Obese Non-obese Pharmacokinetics.

Multiple doing regression was used to model log collection yield as a function of the primary variables of interest BMI group and G-CSF dosage as well as donor characteristics. Try out Obese patients Labs and tell us what you think. Cost-effectiveness analysis of granulocyte colony-stimulating factors for the prophylaxis of chemotherapy-induced febrile neutropenia in patients with non-Hodgkin lymphoma in Greece. This information was provided to ClinicalTrials. In addition, older donors were at a higher risk for grade 2 to 4 toxicities at 1 week after collection. J Clin Oncol 7 10 — Methods A retrospective chart review of patients with acute leukemia or stem cell transplant recipients who received G-CSF from May to September was conducted.

Key Points

Previous Article Next Article. The largest cohort of donors was the overweight group Real-world impact of granulocyte-colony stimulating factor on febrile neutropenia. Hemant S.

Shaw, John R. A retrospective chart review of patients with acute leukemia or stem hospitaals transplant recipients who received G-CSF from May to September was conducted. Grade 3 to 4 pain and toxicities were infrequently experienced in all BMI groups, but obese and severely obese donors had a slightly higher percentage of reported grade 3 to 4 skeletal pain and toxicities on days 1 to 5 of G-CSF administration. Solh, Thomas Spitzer, Jean A. The primary outcomes of our analysis were examining complications relating to neutropenia, including FN, infections, hospitalizations, dose reductions, or missed subsequent chemotherapy cycles during the two weeks following treatment with filgrastim. Another study examining the possible benefit of filgrastim among breast cancer patients reported that The scientists looked at complications that result from chemotherapy-induced neutropenia to determine how effective the dose was.

Do not dilute with saline at any time because the product may precipitate. Chronic daily administration is required to maintain clinical benefit. Actual Enrollment :. These patients will be in the hospital already and will not need to make additional trips back to have blood drawn.

Introduction

Patients in this study will have blood draws once before they take Neupogen and 6 times after they obese patients the Neuopen for a total of 24 hours. Eligibility Criteria. Secondary Neupohen Measures : Alpha and beta half-life of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ] Maximum concentration Cmax of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ] Time to maximum concentration Tmax of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ] Volume of distribution Vds and Vdss of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ].

Effect of Body Mass on Filgrastim Pharmacokinetics The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Actual Study Start Date :. Effect of Body Mass on Filgrastim Pharmacokinetics. Neupogen Dosage Medically reviewed by Drugs. Study Description.

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  • Administration Instructions for Dilution Vial Only.

  • ShahNirali N. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

  • The authors have declared that no competing interests exist. Other factors considered in this analysis were donor race, donor sex, volume of blood processed, baseline neutrophils, and preapheresis WBC, platelet, and neutrophil counts.

  • Kimberly A.

  • Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

Monitor CBCs and platelet counts frequently following marrow transplantation. If patients or caregivers are to administer NEUPOGEN, instruct hospitxls in appropriate injection technique and ask them to follow the subcutaneous injection procedures in the Instructions for Use for the vial or prefilled syringe [see Patient Counseling Information 17 ]. Hematological Malignancy Neutropenia. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

Results Ninety-four admissions were included. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Conflict-of-interest disclosure: The authors declare no competing financial interests. Ahmed G. The authors have declared that no competing interests exist.

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Search for terms. Thereafter, if the patient is clinically stable, less hospita,s routine monitoring is recommended. Persons with latex allergies should not administer the NEUPOGEN prefilled syringe, because the needle cap contains dry natural rubber derived from latex. Drug Information available for: Filgrastim. A copy of the signed informed consent form will be retained by the treating institution.

Reproduction in dosinf or in part without permission is prohibited. However, differences were hospitals in the severity of pain and toxicities at both the pericollection and early postdonation recovery periods. Previous studies in unrelated donors have identified higher BMI as a risk factor in developing toxicities with apheresis. Multivariate analysis of grade 2 to 4 skeletal pain between days 1 and day 5 of G-CSF administration. In the prior study, hypercholesterolemia was also associated with higher hematopoietic progenitor cell yields in patients receiving cyclophosphamide and G-CSF for mobilization before autologous transplantation. However, patients can receive only mcg or mcg due to vial-size availability. Whether this dosing strategy would also reduce pain and acute toxicities should be further studied.

Email alerts Article Activity Alert. Support Care Cancer. Reprints and Permissions. PBSCs were collected by apheresis over 1 or 2 days. Published : 25 January Please review our privacy policy. Table 3 Multivariate logistic regressions examining impact of potential prognostic factors on neutropenia-related complications following filgrastim administration.

This study will use blood samples taken at different time points for patients taking Neupogen to determine if higher body weights affect drug exposure. The duration of NEUPOGEN therapy needed to attenuate chemotherapy-induced hospitals may be dependent on the myelosuppressive potential of the chemotherapy regimen employed. Email address. Actual Enrollment :. Listing a study does not mean it has been evaluated by the U. Training by the healthcare provider should aim to demonstrate to those patients and caregivers how to measure the dose of NEUPOGEN, and the focus should be on ensuring that a patient or caregiver can successfully perform all of the steps in the Instructions for Use for the vial or prefilled syringe.

Effect of Body Mass on Filgrastim Pharmacokinetics

If patients or caregivers are to administer NEUPOGEN, instruct them in appropriate injection technique and ask them to follow the subcutaneous injection procedures in the Instructions for Use for the vial or prefilled syringe [see Patient Counseling Information 17 ]. Dos ag e Adjustments in Patients with Severe Chronic Neutropenia Chronic daily administration is required to maintain clinical benefit. Chronic daily administration is required to maintain clinical benefit. A copy of the signed informed consent form will be retained by the treating institution.

Read our disclaimer for details. Effect of Body Mass on Filgrastim Pharmacokinetics. These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. WVU

Thereafter, if the patient is clinically stable, less frequent routine monitoring is recommended. Study Type :. Federal Government. Listing a study does not mean it has been evaluated by the U. Email address. A total of about tablespoons of blood will be drawn for this study. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Frequently asked questions

This 24 hour time period includes lbese time during room temperature storage of the infusion solution and the duration of the infusion. A total of about tablespoons of blood will be drawn for this study. Monitor CBCs and platelet counts frequently following marrow transplantation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Peripheral blood stem cell yield in normal donors mobilised with granulocyte colony-stimulating factor G-CSF : impact of age, sex, donor weight and type of G-CSF used. As another area of interest, we analyzed neupogen dosing in obese patients in hospitals cost-savings of administering the two-day course of low dose of filgrastim as compared to a two-day course at the recommended dose that would necessitate the purchase of a ug dose. All content published within Cureus is intended only for educational, research and reference purposes. Other factors considered in this analysis were donor race, donor sex, volume of blood processed, baseline neutrophils, and preapheresis WBC, platelet, and neutrophil counts. Actual Study Completion Date :. Current use and trends in hematopoietic cell transplantation in the united states.

Read our disclaimer for details. Please refer to this study by its ClinicalTrials. Last updated on June 21, More Information. Actual Enrollment :.

Received Aug 28; Accepted Dec Highest toxicity level of key symptoms fever in the absence of signs of infection, fatigue, skin rash, local reactions, nausea, vomiting, anorexia, insomnia, dizziness, and syncope A and hospital skeletal pain level B experienced by PBSC adult donors at baseline, 24 hours after first dose of G-CSF, between days 1 to 5 of G-CSF administration, and after donation. Do not disregard or avoid professional medical advice due to content published within Cureus. In conclusion, we have demonstrated that in unrelated donors, there is a correlation between higher BMI and apheresis yields, consistent with previously published findings.

Neupogen Dosage Medically reviewed by Drugs. Monthly Newsletter. Dos im e Adjustments in Patients with Severe Chronic Neutropenia Chronic daily administration is required to maintain clinical benefit. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Methods A retrospective chart review of patients with acute leukemia or stem cell transplant recipients who received G-CSF from May to September was conducted. Support Care Cancer 18 5 — A high-fat diet increases interleukin-3 and granulocyte colony-stimulating factor production by bone marrow cells and triggers bone marrow hyperplasia and neutrophilia in Wistar rats. Myeloid growth factors. Data analysis was performed using Stata A double-blind, placebo-controlled trial.

Information regarding the type of cell separator used to perform the apheresis howpitals and details of procedural factors that may have affected the collection were not available. Marshall University IRB issued approval Bronwen E. Upper CL. Second, there is the possibility of under-reporting, particularly with regards to incidences of FN and subsequent hospitalizations. Kuderer NM, Dale DC, Crawford J, Lyman GH Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: a systematic review.

Peiman Dowing neupogen dosing in obese patients in hospitals, Peiman Hematti. Observational study of the prevalence of febrile neutropenia in patients who received filgrastim or pegfilgrastim associated with week chemotherapy regimens in community oncology practices. We identified 91 patients from our facility with chemotherapy-induced neutropenia treated with ug of filgrastim daily for two consecutive days, and we separated them into low, medium, and high weight groups. Thousand Oaks, CA Length of stay was similar for patients regardless of initial G-CSF dose

Overweight Filgrastim, a inn analog of granulocyte colony-stimulating factor G-CSFis commonly used to prevent infection in immunocompromised cancer patients by stimulating production of neutrophils by the bone marrow [ 3 ]. Am J Health Syst Pharm 65 16 — The primary outcomes of our analysis were examining complications relating to neutropenia, including FN, infections, hospitalizations, dose reductions, or missed subsequent chemotherapy cycles during the two weeks following treatment with filgrastim.

In multivariate analysis, in addition to BMI, other donor characteristics, including age and sex, neuopgen also associated with different risks of toxicities and pain supplemental Tables All content published within Cureus is intended hospitals for educational, research and reference purposes. In addition, capping G-CSF doses in obese and severely obese donors may achieve adequate collection yields at a lower cost. National Center for Biotechnology InformationU. This study will use blood samples taken at different time points for patients taking Neupogen to determine if higher body weights affect drug exposure. Wheelis Authors Jennifer K. For general information, Learn About Clinical Studies.

Thousand Oaks, CA Hematologic Neoplasms Neutropenia Neoplasms Agranulocytosis. Version 1. Primary outcomes were obtained from laboratory findings dated from 1 to 22 days following treatment mean 6.

November 1, Key Record Dates. Primary Outcome Measures : Systemic clearance of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ]. Discard any vial or prefilled syringe left at room temperature for greater than 24 hours. Medically reviewed by Drugs. Last updated on June 21,

Support Care Cancer 25, — Values are median range unless otherwise indicated. Featured Issue Featured Supplements. National Center for Biotechnology InformationU.

Multivariate logistic regressions were run to determine the effect that potential prognostic factors included in our study had on the probability of relevant outcomes previously discussed. Upper CL. ConferDennis L. Previous studies evaluating the impact of BMI on PBSC yield in related and unrelated donors were mostly single-center studies limited by small numbers of donors. WVU

Peiman HemattiPeiman Hematti. The severity of skeletal pain was defined as the maximum grade of pain among these sites. View large Download slide. Continuous Publishing Alert.

Search ADS. KasowKimberly A. Secondary outcomes included donor symptoms associated with PBSC mobilization and collection. Table 3. Sign In. PBSC collection yield relies on effective mobilization of hematopoietic precursors from the bone marrow.

Received : 02 September The average weight of the cohort was SeesJennifer A. Donors in the obese and morbidly obese groups were older median age, 35 years compared with donors with normal BMI median age, 28 years. Patient admissions were reviewed in regards to neutropenia length, incidence of FN, length of stay, and final disposition alive or deceased.

  • One other factor that was independently associated with an increase in toxicities and pain in the pericollection period was a higher baseline MNC count. Table 2.

  • Study Description.

  • Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. Donor skeletal pain and toxicities.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Eligibility Criteria. Talk with your doctor and family members or friends about deciding to join a study. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Email address. Search for terms.

Monitor CBCs and platelet counts frequently following marrow transplantation. Email address. FDA Resources. The duration of NEUPOGEN therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed. Medically reviewed by Drugs.

Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. Daily MedNews. Actual Study Completion Date :. FDA Resources.

Colony-stimulating neupogen dosing in obese patients in hospitals like filgrastim have decreased the amount of time patients spend hospitalized, improved their ability to recover from neutropenia, and decreased the duration of antibiotic use, but research has not yet demonstrated a mortality benefit [ 10 ]. In addition, our results suggest that the higher PBSC collection yield observed in obese donors is not solely due to a relatively higher average daily G-CSF dose but also may be influenced by some intrinsic factor associated with obesity. Ann Intern Med 7 — Open in a separate window. Jack W. Correspondence: Bronwen E. The severity of skeletal pain was defined as the maximum grade of pain among these sites.

ALSO READ: 20 Obesity Facts In America

Study Type :. Received : 02 September A similar trend was found with regards to incidences of FN-related hospitalizations, which were highest among the higher weight group 8. These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. Solh, Thomas Spitzer, Jean A.

Training by the healthcare provider should aim to obese patients to those patients and caregivers how to measure the dose of NEUPOGEN, and the focus should be on ensuring that a patient or caregiver can successfully perform all of the steps in the Instructions for Use for the vial or prefilled syringe. Secondary Outcome Measures : Alpha and beta half-life of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ] Maximum concentration Cmax of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ] Time to maximum concentration Tmax of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ] Volume of distribution Vds and Vdss of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ]. FDA Resources. Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. Actual Enrollment :. Primary Outcome Measures : Systemic clearance of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ]. This 24 hour time period includes the time during room temperature storage of the infusion solution and the duration of the infusion.

The authors have declared that no competing interests exist. SwitzerGalen E. Febrile neutropenia FN is a major risk factor for infection-related morbidity and mortality.

This 24 hour time period includes the time during room im storage of the infusion solution and the duration of the hospitals. Study Description. This study will use blood samples taken at different time points for patients taking Neupogen to determine if higher body weights affect drug exposure. If patients or caregivers are to administer NEUPOGEN, instruct them in appropriate injection technique and ask them to follow the subcutaneous injection procedures in the Instructions for Use for the vial or prefilled syringe [see Patient Counseling Information 17 ]. Email address.

View large Download PPT. About this article. Learn More. More Information. Studies on a larger scale with a greater subject population would be required to validate these results. Please review our privacy policy.

These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. In one of the largest multicenter studies representing a variety of cancer sites conducted to date, patients receiving a mean of 5. Siddhartha GangulySiddhartha Ganguly. J Natl Cancer Inst 12 — There are limitations to our study that merit attention. Thousand Oaks, CA Previous Article Next Article.

In addition, older donors were at a higher risk for grade 2 to 4 toxicities at 1 week after collection. Raquel SchearsRaquel Schears. Ann Intern Med 7 — Filgrastim is approved to help prevent chemotherapy-induced neutropenia in patients who have received certain chemotherapy agents.

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 NEUPOGEN or whether the patient would benefit from a different NEUPOGEN presentation. Daily MedNews. Administration Instructions for Dilution Vial Only. Chronic daily administration is required to maintain clinical benefit.

The other 61 patients studied had weights greater than 60 kg and received hospiyals than the recommended dose, with 53 patients weighing between 60 and 85 kg medium weight group and eight patients with weights greater than 85 kg high weight group. Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. G-CSF agent used for stem cell collection was filgrastim. Cancer 10 — View author publications. Budget impact analysis of treating chemotherapy patients with health care provider-administered Tbo-Filgrastim, Filgrastim-Sndz, and Filgrastim in the United States.

Do not save unused drug for later administration. Drug Information available for: Filgrastim. These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. Patient or their legally authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures.

Toxicity was defined as fever in the absence of signs of infection, fatigue, skin rash, local reactions, nausea, hospita,s, anorexia, dizziness, syncope, and insomnia. Table 3. Increased volume of blood processed on day 5 was associated with lower stem cell collection yield. Outcome Measures. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Older donors were neupoegn less risk of grade 2 to 4 pain and toxicities in the pericollection period, but they were more likely to have persistent pain and toxicities at state 2011 days after collection. Patients were excluded if they did not have a recorded WBC and ANC within two days of the first dose of filgrastim administration. PBSCs were collected by apheresis over 1 or 2 days. Wingard; Weighty choices: selecting optimal G-CSF doses for stem cell mobilization to optimize yield. Issue Date : June Support Care Cancer 25, —

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