DOCSLIB.ORG

Impact of Palifermin on Incidence of Mucositis And

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Impact of Palifermin on Incidence of Mucositis And S174 Abstracts / Biol Blood Marrow Transplant 19 (2013) S167eS177 and nutritional factors. Hypophosphatemia, has been re- 118 ported to precede engraftment (Raanani, et al.). Nurses have Clabsi Reduction: No Longer Just an Inpatient Initiative noted and we therefore hypothesized that phosphorous, Jessica Vega 1, Stacey Knight 1, Kay Sams 2, Amy E. Patterson 3. calcium, and potassium values would drop 2-4 days pre- 1 BMT Treatment Center, Moffitt Cancer Center, Tampa, FL; engraftment, when compared to either admission for 2 Infection Prevention & Control, Moffitt Cancer Center, Tampa, conditioning (time point A) or day of transplant (time point FL; 3 Nursing Professional Development, Moffitt Cancer Center, B). Being able to predict neutrophil recovery helps nurses be Tampa, FL alert for clinical signs and symptoms of complications such as cytokine storm/engraftment syndrome, serious infection, Significance and Background: BMT patients are frequently and hyperacute graft versus host disease. discharged to outpatient care with a central line catheter in Methods: We retrospectively reviewed records of 244 place. These patients are at increased risk for developing patients who underwent hematopoietic SCT from January a central line- associated bloodstream infection (CLABSI). A 2005 through May 2006. Electrolyte values were collected at review of literature and comparison CLABSI rates showed the time of admission for conditioning (time point A); a paucity of studies in the outpatient population. An outpa- transplant day (+/- 1 day; time point B); and 2-4 days prior to tient who develops a CLABSI usually requires admission to engraftment. Two-sided paired t-tests were conducted the hospital, where treatment costs may range from comparing levels for each of the time points A and B $35,000-53,000. CLABSI surveillance began in January 2009 compared to pre-engraftment. For comparison between for our outpatient BMT population utilizing the same NHSN groups, two-sided two-sample t-tests were conducted. No definition used for inpatients. An analysis of data collected adjustment was made for the multiplicity of testing. Patients over 18 months prompted nursing staff to implement a plan were grouped as follows: overall, by stem cell source to target reduction of CLABSIs. (apheresis, bone marrow, or cord), transplant type (alloge- > 6 Interventions: BMT Treatment Center nurses were educated neic or autologous), and CD 34 cell dose ( 5or 5x10 /kg, on CLABSI, current rates, and implications for patients as well for apheresis products only). Patients had their electrolyte as the department. The nurses researched ways to reduce levels measured while in the hospital, and received stan- CLABSIs and developed a post-insertion bundle for central dardized electrolyte replacements. line care utilizing CDC CLABSI prevention strategies and other Results: Overall, the values for all the electrolytes two to four fi evidence-based practices. Patient education materials were days before engraftment were signi cantly lower than at < e developed and a post-line insertion patient education plan time points A or B (P-value range .001 to .01 Table 1). We was initiated. Nursing compliance with the bundle is concluded that drops in electrolyte levels precede neutrophil continually monitored by retrospective reviews of central line engraftment after peripheral blood SCT. Being able to predict charting, monthly central line audits, and review of electronic neutrophil engraftment will help nurses be more aware of patient education tools. CLABSI surveillance is ongoing with possible SCT complications that may occur with an in-depth review of all CLABSIs for defects in nursing care. engraftment, and allow the nurses to work with the Results: The 18 month pre-bundle CLABSI rate was 1.66 per medical team to intervene quickly. 1000 patient visits. The 18 month post-bundle rate fell to Table 1 0.88 per 1000 patient visits. The actual number of CLABSIs Overall change from admission and transplant to pre-engraftment fell by 30. This resulted in 30 fewer hospital admissions and a minimal savings of over $1,000,000 dollars to the facility. Electrolyte N Timepoint Average change to SD P-value Pre-Engraftment (change) Specifically, the number of coagulase-negative staph infec- < tions, frequently associated with indwelling devices, drop- Phosphorous 244 Admission (A) -0.6836 0.9956 .001 Transplant (B) -0.4012 1.0076 <.001 ped from 32 pre bundle to 7 post bundle implementation. Calcium 242 Admission (A) -0.5851 0.7192 <.001 Nursing compliance with CLABSI prevention strategies Transplant (B) -0.0971 0.6008 .0126 continues to be well over 90%. Potassium 244 Admission (A) -0.2947 0.5642 <.001 Transplant (B) -0.2279 0.5967 <.001 TRANSPLANT NURSING-RESEARCH ORAL 120 119 Impact of Palifermin On Incidence of Mucositis and Predicting Neutrophil Recovery by Changes in Serum Length of Hospitalization in Children Undergoing Electrolyte Levels of Stem Cell Transplantation (SCT) Autologous Hematopoietic Stem-Cell Transplant for Patients Malignant Disorders 1 2 3 4 Zandra Rivera 1, Alison Gulbis 2, Marcos de Lima 1, Leah Violago , Paige Cofnas , Kelly Vitale , Jacquelyn Bishop , 5 5 5 1 Gabriela Rondon 1, Patricia S. Fox 3, Roland Bassett Jr. 4, Yasmin Elsayed , Zhezhen Jin , Prakash Satwani . Children's 2 Mihir Raval 5. 1 Stem Cell Transplantation and Cellular Therapy, Hospital of New York Presbyterian, New York, NY; Master of The University of Texas MD Anderson Cancer Center, Houston, science in nursing, Pediatric Blood and Marrow Transplant, 3 TX; 2 Division of Pharmacy, The University of Texas MD New York Presbyterian Hospital, New York, NY; Morgan Anderson Cancer Center, Houston, TX; 3 Department of Stanley Children`s Hospital, New York Presbyterian-Columbia, 4 Biostatistics, The University of Texas MD Anderson Cancer New York, NY; Pediatrics, New York Presbyterian Hospital, 5 Center, Houston, UT; 4 Department of Biostatistics, The NewYork; Pediatrics, Columbia University, New York, NY University of Texas MD Anderson Cancer Center, Houston, TX; 5 Department of Hospital Internal Medicine, Affiliation - Myeloablative chemotherapy/radiotherapy prior to Essentia Health, Fargo, ND autologous hematopoietic stem cell transplant (AHSCT) is a leading cause of mucositis associated with significant Background: The rapid hematopoietic cell expansion that morbidity. Palifermin has been demonstrated to decrease the leads to engraftment after SCT requires variety of metabolic incidence of severe mucositis in adults following total body Abstracts / Biol Blood Marrow Transplant 19 (2013) S167eS177 S175 irradiation (TBI) conditioning prior to AHSCT. The impact of University of North Carolina Hospitals, Chapel Hill, NC; palifermin on the incidence of mucositis in children 3 Pharmacy, University of North Carolina, Chapel Hill, NC; following AHSCT has never been studied. In this retrospec- 4 UNC Hospitals, Chapel Hill, NC; 5 Department of Medicine, tive study, we compared the incidence of mucositis and UNC Lineberger Comprehensive Cancer Center, University of supportive care required in children who received palifermin North Carolina at Chapel Hill, Chapel Hill, NC; 6 Pharmacy, vs. controls (no palifermin) during non-TBI AHSCT. Mucositis University of North Carolina Hospitals and Clinics, Chapel Hill, was graded as per WHO criteria. The continuous variables NC were summarized by the mean and standard deviation; the categorical variables were summarized by percentage. The Background: The use of filgrastim with or without plerixafor palifermin vs. control group were compared by two-sided t- has been shown to be an effective modality for the mobili- test for continuous measurements and by Chi-square test for zation of peripheral blood stem cells. However, questions categorical measurements. From 2005-2011, 58 patients remain as to the CD34+ count that would best predict for received myeloablative AHSCT, of which n¼25 were in the efficient collection. We developed a filgrastim-based mobi- palifermin group and n¼33 were in the control group. lization algorithm with a predetermined decision point for Demographic characteristics are presented in Table. the inclusion of plerixafor and a CD34+ count of 20 cells/uL as Comparing palifermin vs. the control group: the average time the trigger for collection. The purpose of our evaluation was for neutrophil engraftment was 12.16Æ3.21 days vs. 11.5 to determine the efficacy of this algorithm, as well as the Æ1.68 (P¼.127), the incidence of grade I and III-IV mucositis impact on plerixafor use, in patients undergoing mobiliza- was 80% vs. 90.9%, and 20% (P¼ .02) vs. 42.4% (P¼.07), the tion with filgrastim prior to autologous hematopoietic stem number of days with fever were 4.92Æ3.49 vs. 7.09Æ4.86 cell transplant (HSCT). (P¼.063), the number of days patients received PCA were Methods: Patients received filgrastim 10 mcg/kg SC once 8.80Æ8.39 vs. 8.30Æ8.54 (P¼.826), and the number of days daily for 4 days. If the day 5 CD34+ count was > 20/ul, patients were on TPN were 13.52Æ11.32 vs. 11.55Æ9.63 apheresis was started and filgrastim was continued until the (P¼.484), respectively. The incidence of blood stream and collection goal was met. If the day 5 CD34+ count was <10, Clostridium difficile infection was 36% vs. 27.3% (P¼.4) and plerixafor was started, and if the day 5 CD34+ count was 10- 24% vs. 18.2% (P¼.5), respectively. The average length of 20, filgrastim was continued for 1 day with plerixafor added hospital stay 31.44Æ7.42 vs. 28.61Æ10.38 (P¼.252) was not if the day 6 CD34+ count remained <20/uL. Mobilization statistically different between the palifermin and control efforts were stopped if the blood CD34+ count remained < groups. In summary, we were unable to demonstrate that 10. The CD34+ cell collection goal was 4 x 106 cells/kg, with there was a statistical difference with incidence of mucositis a minimum requirement of 2 x 106 to proceed to HSCT. and other supportive care needs or a decrease in hospital Results: To date, 21 patients (18 multiple myeloma and 3 stay in the palifermin group.
Load more

Recommended publications
  • Assessment of Overall Survival, Quality of Life, And
    Supplementary Online Content Salas-Vega S, Iliopoulos O, Mossialos E. Assesment of overall survival, quality of life, and safety benefits associated with new cancer medicines [published online December 29, 2016]. JAMA Oncol. doi:10.1001/jamaoncol.2016.4166 eTable 1. Therapeutic profile of all cancer medicines approved by the FDA between 2003- 2013 eTable 2. Regulatory evidence in support of classification of drug clinical benefits eFigure 1. Number of cancer drugs that were evaluated by all three HTA agencies, sorted by magnitude of clinical benefits eTable 3. Interagency agreement–Krippendorff’s alpha coefficients eMethods This supplementary material has been provided by the authors to give readers additional information about their work. Online-Only Supplement © 2016 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/25/2021 Clinical value of cancer medicines Contents eExhibits ......................................................................................................................................................... 3 eTable 1. Therapeutic profile of all cancer medicines approved by the FDA between 2003- 2013 (Summary of eTable 2) ................................................................................................................... 3 eTable 2. Regulatory evidence in support of classification of drug clinical benefits ....................... 6 eFigure 1. Number of cancer drugs that were evaluated by all three HTA agencies, sorted by magnitude of clinical benefits
    [Show full text]
  • Palifermin (Kepivance™) in the Treatment of Mucositis
    Session V • From cell biology to cell therapy Palifermin (Kepivance™) in the treatment of mucositis [haematologica reports] 2005;1(8):41-45 EMMANOUILIDES C n patients undergoing high dose chemo- factor (KGF) is a 28 kD member of the therapy and hematopoietic stem cell fibroblast growth factor family with epithe- Associate Profesor transplant, oral mucositis (OM) is one of lial cell proliferative properties.26 Palifermin of Medicine, UCLA, I Division Haematology-Oncology, the most debilitating and annoying side (Kepivance™) is a truncated, recombinant Thessaloniki, Greece effects. This complication results from form of human keratinocyte growth factor cytotoxic injury to the epithelial lining of (rHuKGF) that has been approved in the the oropharyngeal mucosa, although USA in 2004 to decrease the incidence and lesions of the whole gastrointestinal tract duration of severe OM in patients with also occur.1 The severity of OM varies from hematologic malignancies receiving myelo- erythema and edema accompanied by mild toxic therapy requiring HSCT support. Pal- soreness to full mucosal thickness ulcera- ifermin (recombinant human keratinocyte tions penetrating into the submucosa, growth factor) is an N-terminal, truncated often resulting in severe pain requiring version of endogenous keratinocyte growth narcotic analgesia and impaired swallow- factor with biologic activity similar to that ing, prolonged hospitalization, and of the native protein, but with increased increased risks for infections and poten- stability 26 In animal models of chemother- tially life-threatening sequelae.2,3 Between apy, radiotherapy, and hematopoietic stem- 40% to 80% of cancer patients undergo- cell transplantation27,28 palifermin protected ing intensive treatment regimens requiring several types of epithelial tissues.
    [Show full text]
  • September 2017 ~ Resource #330909
    −This Clinical Resource gives subscribers additional insight related to the Recommendations published in− September 2017 ~ Resource #330909 Medications Stored in the Refrigerator (Information below comes from current U.S. and Canadian product labeling and is current as of date of publication) Proper medication storage is important to ensure medication shelf life until the manufacturer expiration date and to reduce waste. Many meds are recommended to be stored at controlled-room temperature. However, several meds require storage in the refrigerator or freezer to ensure stability. See our toolbox, Medication Storage: Maintaining the Cold Chain, for helpful storage tips and other resources. Though most meds requiring storage at temperatures colder than room temperature should be stored in the refrigerator, expect to see a few meds require storage in the freezer. Some examples of medications requiring frozen storage conditions include: anthrax immune globulin (Anthrasil [U.S. only]), carmustine wafer (Gliadel [U.S. only]), cholera (live) vaccine (Vaxchora), dinoprostone vaginal insert (Cervidil), dinoprostone vaginal suppository (Prostin E2 [U.S.]), varicella vaccine (Varivax [U.S.]; Varivax III [Canada] can be stored in the refrigerator or freezer), zoster vaccine (Zostavax [U.S.]; Zostavax II [Canada] can be stored in the refrigerator or freezer). Use the list below to help identify medications requiring refrigerator storage and become familiar with acceptable temperature excursions from recommended storage conditions. Abbreviations: RT = room temperature Abaloparatide (Tymlos [U.S.]) Aflibercept (Eylea) Amphotericin B (Abelcet, Fungizone) • Once open, may store at RT (68°F to 77°F • May store at RT (77°F [25°C]) for up to Anakinra (Kineret) [20°C to 25°C]) for up to 30 days.
    [Show full text]
  • WA Essential Drug List Updated: January 1, 2021
    Washington Essential Rx Drug List The Essential Rx Drug List includes a list of drugs covered by Health Net. This drug list is for Washington. The drug list is updated often and may change. To get the most up-to-date information, you may view the latest drug list on our website at www.healthnet.com/wadruglistpdf or call us at the toll-free telephone number on your Health Net ID card. WA Essential Drug List Updated: January 1, 2021 Welcome to Health Net What is the Essential Rx Drug List? The Essential Rx Drug List or formulary is a list of covered drugs used to treat common diseases or health problems. The drug list is selected by a committee of doctors and pharmacists who meet regularly to decide which drugs should be included. The committee reviews new drugs and new information about existing drugs and chooses drugs based on: • Safety; • Effectiveness; • Side effects; and • Value (If two drugs are equally effective, the less costly drug will be preferred) How much will I pay for my drugs? To figure out how much you will pay for a drug, the abbreviations in the table below appear in the Drug Tier column on the formulary. The copayment or coinsurance levels are defined in the table below. If you do not know your copayment or coinsurance for each tier, please refer to your Summary of Benefits or other plan documents. Abbreviation Copayment/Coinsurance Description 1 Tier 1 copayment or Generic drugs coinsurance 2 Tier 2 copayment or Preferred brand drugs coinsurance 3 Tier 3 copayment or Non-preferred brand drugs coinsurance SP Specialty copayment or Specialty drugs.
    [Show full text]
  • Anthem Blue Cross Prescription Formulary List
    National Drug List Drug list — Three Tier Drug Plan Your prescription benefit comes with a drug list, which is also called a formulary. This list is made up of brand-name and generic prescription drugs approved by the U.S. Food & Drug Administration (FDA). We’re here to help. If you are a current Anthem member with questions about your pharmacy benefits, we're here to help. Just call us at the Member Services number on your ID card. The plan names to which this formulary applies are shown below. Solution PPO 1500/15/20 $5/$15/$50/$65/30% to $250 after deductible Solution PPO 2000/20/20 $5/$20/$30/$50/30% to $250 Solution PPO 2500/25/20 $5/$20/$40/$60/30% to $250 Solution PPO 3500/30/30 $5/$20/$40/$60/30% to $250 Rx ded $150 Solution PPO 4500/30/30 $5/$20/$40/$75/30% to $250 Solution PPO 5500/30/30 $5/$20/$40/$75/30% to $250 Rx ded $250 $5/$15/$25/$45/30% to $250 $5/$20/$50/$65/30% to $250 Rx ded $500 $5/$15/$30/$50/30% to $250 $5/$20/$50/$70/30% to $250 $5/$15/$40/$60/30% to $250 $5/$20/$50/$70/30% to $250 after deductible Here are a few things to remember: o You can view and search our current drug lists when you visit anthem.com/ca/pharmacyinformation. Please note: The formulary is subject to change and all previous versions of the formulary are no longer in effect.
    [Show full text]
  • Palifermin USPI V
    Kepivance™ (palifermin) DESCRIPTION Kepivance™ (palifermin) is a human keratinocyte growth factor (KGF) produced by recombinant DNA technology in Escherichia coli (E coli). Kepivance™ is a water-soluble, 140 amino acid protein with a molecular weight of 16.3 kilodaltons. It differs from endogenous human KGF in that the first 23 N-terminal amino acids have been deleted to improve protein stability. Kepivance™ is supplied as a sterile, white, preservative-free, lyophilized powder for IV injection after reconstitution with 1.2 mL of Sterile Water for Injection, USP. Reconstitution yields a clear, colorless solution of Kepivance™ (5 mg/mL) with a pH of 6.5. Each single-use vial of Kepivance™ contains 6.25 mg palifermin, 50 mg mannitol, 25 mg sucrose, 1.94 mg L-histidine, and 0.13 mg polysorbate 20 (0.01% w/v). CLINICAL PHARMACOLOGY Mechanism of Action Keratinocyte growth factor (KGF) is an endogenous protein in the fibroblast growth factor (FGF) family that binds to the KGF receptor. Binding of KGF to its receptor has been reported to result in proliferation, differentiation, and migration of epithelial cells. The KGF receptor, one of four receptors in the FGF family, has been reported to be present on epithelial cells in many tissues examined including the tongue, buccal mucosa, esophagus, stomach, intestine, salivary gland, lung, liver, pancreas, kidney, bladder, mammary gland, skin (hair follicles and sebaceous gland), and the lens of the eye. The KGF receptor has been reported to not be present on cells of the hematopoietic lineage. Endogenous KGF is produced by mesenchymal cells and is upregulated in response to epithelial tissue injury.
    [Show full text]
  • Kepivance, INN-Palifermin
    SCIENTIFIC DISCUSSION 1. Introduction Oral mucositis Oral mucositis is a significant problem in patients receiving chemotherapy or radiotherapy. Estimates of oral mucositis incidence among cancer therapy patients range from 40% of those receiving standard chemotherapy to 76% of bone marrow transplant patients [1]. Virtually, all patients who receive radiotherapy to the head and neck area develop oral complications. Cancer therapy-induced mucositis occurs when radiation or chemotherapy destroys rapidly proliferating cells such as those lining the mouth, throat, and gastrointestinal tract. In the setting of high-dose myelotoxic therapy, mucositis is a frequent, extremely painful and debilitating complication [2]. Mucositis can arise along the entire gastrointestinal tract and can be associated with significant morbidity, including: pain, specifically in the oral cavity, pharynx, and esophagus (esophagitis), requiring opioid analgesia; difficulty or inability to swallow, because of ulcerations in the oral cavity, pharynx, and esophagus, leading to a compromised nutritional status necessitating parenteral feeding and hydration; infection due to the breakdown of the epithelial barrier and exacerbated by accompanying neutropenia (when present); difficulty or inability to speak; nausea, vomiting, and diarrhoea, which may require intravenous (i.v.) rehydration and may predispose the patient to severe electrolyte and acid-base disorders; gastrointestinal bleeding due to ulceration at any site of the gastrointestinal tract, authorisedbut typically in the esophagus or stomach. These manifestations diminish the quality of life of patients with cancer and can interfere with management of the primary disease, e.g., requiring dose reductions or treatment delays [3]. The effect of mucositis on length of hospital stay, admissions for fluid support or treatment of infection, and alteration of optimum anticancer treatment have significant clinical and economic consequences [4].
    [Show full text]
  • CDER List of Licensed Biological Products With
    Center for Drug Evaluation and Research List of Licensed Biological Products with (1) Reference Product Exclusivity and (2) Biosimilarity or Interchangeability Evaluations to Date DATE OF FIRST REFERENCE PRODUCT DATE OF LICENSURE LICENSURE EXCLUSIVITY EXPIRY DATE INTERCHANGEABLE (I)/ BLA STN PRODUCT (PROPER) NAME PROPRIETARY NAME (mo/day/yr) (mo/day/yr) (mo/day/yr) BIOSIMILAR (B) WITHDRAWN 125118 abatacept Orencia 12/23/05 NA NA 103575 abciximab ReoPro 12/22/94 NA NA Yes 125274 abobotulinumtoxinA Dysport 04/29/09 125057 adalimumab Humira 12/31/02 NA NA 761071 adalimumab-adaz Hyrimoz 10/30/18 B 761058 adalimumab-adbm Cyltezo 08/25/17 B 761118 adalimumab-afzb Abrilada 11/15/19 B 761024 adalimumab-atto Amjevita 09/23/16 B 761059 adalimumab-bwwd Hadlima 07/23/19 B 125427 ado-trastuzumab emtansine Kadcyla 02/22/13 125387 aflibercept Eylea 11/18/11 103979 agalsidase beta Fabrazyme 04/24/03 NA NA 125431 albiglutide Tanzeum 04/15/14 017835 albumin chromated CR-51 serum Chromalbin 02/23/76 103293 aldesleukin Proleukin 05/05/92 NA NA 103948 alemtuzumab Campath, Lemtrada 05/07/01 NA NA 125141 alglucosidase alfa Myozyme 04/28/06 NA NA 125291 alglucosidase alfa Lumizyme 05/24/10 125559 alirocumab Praluent 07/24/15 103172 alteplase, cathflo activase Activase 11/13/87 NA NA 103950 anakinra Kineret 11/14/01 NA NA 020304 aprotinin Trasylol 12/29/93 125513 asfotase alfa Strensiq 10/23/15 101063 asparaginase Elspar 01/10/78 NA NA 125359 asparaginase erwinia chrysanthemi Erwinaze 11/18/11 761034 atezolizumab Tecentriq 05/18/16 761049 avelumab Bavencio 03/23/17
    [Show full text]
  • Standard Oncology Criteria C16154-A
    Prior Authorization Criteria Standard Oncology Criteria Policy Number: C16154-A CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DATE DUE BEFORE 03/2016 12/2/2020 1/26/2022 HCPCS CODING TYPE OF CRITERIA LAST P&T APPROVAL/VERSION N/A RxPA Q1 2021 20210127C16154-A PRODUCTS AFFECTED: See dosage forms DRUG CLASS: Antineoplastic ROUTE OF ADMINISTRATION: Variable per drug PLACE OF SERVICE: Retail Pharmacy, Specialty Pharmacy, Buy and Bill- please refer to specialty pharmacy list by drug AVAILABLE DOSAGE FORMS: Abraxane (paclitaxel protein-bound) Cabometyx (cabozantinib) Erwinaze (asparaginase) Actimmune (interferon gamma-1b) Calquence (acalbrutinib) Erwinia (chrysantemi) Adriamycin (doxorubicin) Campath (alemtuzumab) Ethyol (amifostine) Adrucil (fluorouracil) Camptosar (irinotecan) Etopophos (etoposide phosphate) Afinitor (everolimus) Caprelsa (vandetanib) Evomela (melphalan) Alecensa (alectinib) Casodex (bicalutamide) Fareston (toremifene) Alimta (pemetrexed disodium) Cerubidine (danorubicin) Farydak (panbinostat) Aliqopa (copanlisib) Clolar (clofarabine) Faslodex (fulvestrant) Alkeran (melphalan) Cometriq (cabozantinib) Femara (letrozole) Alunbrig (brigatinib) Copiktra (duvelisib) Firmagon (degarelix) Arimidex (anastrozole) Cosmegen (dactinomycin) Floxuridine Aromasin (exemestane) Cotellic (cobimetinib) Fludara (fludarbine) Arranon (nelarabine) Cyramza (ramucirumab) Folotyn (pralatrexate) Arzerra (ofatumumab) Cytosar-U (cytarabine) Fusilev (levoleucovorin) Asparlas (calaspargase pegol-mknl Cytoxan (cyclophosphamide)
    [Show full text]
  • Palifermin-Associated Papular Eruption
    OBSERVATION Palifermin-Associated Papular Eruption Brett King, MD, PhD; Eleanor Knopp, MD; Anjela Galan, MD; Gerard Nuovo, MD; Robert Tigelaar, MD; Jennifer McNiff, MD Background: Palifermin is a recombinant human ke- mavirus. Immunohistochemical staining with antibod- ratinocyte growth factor that is used to reduce the du- ies to Ki-67 and cytokeratin 5/6 showed increased ke- ration and severity of oral mucositis in patients under- ratinocyte proliferation in lesional skin. going hematopoietic stem cell transplantation after myelotoxic therapy. Cutaneous adverse reactions asso- Conclusions: After treatment with palifermin, a papu- ciated with keratinocyte growth factor are reported to be lar eruption clinically resembling lichen planus or plane rash, pruritus, and erythema. warts, with histologic features of verruca plana, and in- tertriginous erythema may occur. In this case, neither Observations: After receiving palifermin following au- eruption required treatment, and spontaneous resolu- tologous hematopoietic stem cell transplantation and treat- tion was observed over days to weeks. Histopathologic ment with melphalan, a patient developed erythema and staining patterns of Ki-67 and cytokeratin 5/6 may be use- lichenoid papules that were distributed primarily in in- ful in identifying adverse reactions to palifermin therapy. tertriginous areas. A biopsy specimen of the papules showed a striking resemblance to verrucae, but in situ hybridization studies were negative for human papillo- Arch Dermatol. 2009;145(2):179-182 ERATINOCYTE GROWTH FAC- be “rash, pruritus, erythema, and paresthe- tor (KGF) is a member of sia.” The rash is not described further. the family of fibroblast A review of the literature since 2004 re- growth factors. While many vealed 3 case reports of cutaneous erup- fibroblast growth factors tions in the setting of palifermin treat- Kaffect the proliferation, migration, and/or dif- ment.
    [Show full text]
  • WO 2018/218208 Al 29 November 2018 (29.11.2018) W !P O PCT
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2018/218208 Al 29 November 2018 (29.11.2018) W !P O PCT (51) International Patent Classification: Fabio; c/o Bruin Biosciences, Inc., 10225 Barnes Canyon A61K 31/00 (2006.01) A61K 47/00 (2006.01) Road, Suite A104, San Diego, California 92121-2734 (US). BEATON, Graham; c/o Bruin Biosciences, Inc., 10225 (21) International Application Number: Barnes Canyon Road, Suite A104, San Diego, California PCT/US20 18/034744 92121-2734 (US). RAVULA, Satheesh; c/o Bruin Bio (22) International Filing Date: sciences, Inc., 10225 Barnes Canyon Road, Suite A l 04, San 25 May 2018 (25.05.2018) Diego, Kansas 92121-2734 (US). (25) Filing Language: English (74) Agent: MALLON, Joseph J.; 2040 Main Street, Four teenth Floor, Irvine, California 92614 (US). (26) Publication Langi English (81) Designated States (unless otherwise indicated, for every (30) Priority Data: kind of national protection available): AE, AG, AL, AM, 62/5 11,895 26 May 2017 (26.05.2017) US AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, 62/5 11,898 26 May 2017 (26.05.2017) US CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, (71) Applicants: BRUIN BIOSCIENCES, INC. [US/US]; DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, 10225 Barnes Canyon Road, Suite A104, San Diego, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, California 92121-2734 (US).
    [Show full text]
  • Kepivance, INN-Palifermin
    authorised ANNEX I SUMMARY OF PRODUCT CHARACTERISTICSlonger no product Medicinal 1 1. NAME OF THE MEDICINAL PRODUCT Kepivance 6.25 mg powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 6.25 mg of palifermin. Palifermin is a human keratinocyte growth factor (KGF), produced by recombinant DNA technology in Escherichia coli. Once reconstituted, Kepivance contains 5 mg/ml of palifermin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection (powder for injection). authorised White lyophilised powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications longer Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiringno autologous haematopoietic stem cell support. 4.2 Posology and method of administration Kepivance treatment should be supervised by a physician experienced in the use of anti-cancer therapy. Posology product Adults The recommended dosage of Kepivance is 60 micrograms/kg/day, administered as an intravenous bolus injection for three consecutive days before and three consecutive days after myeloablative radiochemotherapy for a total of six doses. The duration between last dose of Kepivance before myeloablative radiochemotherapy and the first dose of Kepivance after myeloablative radiochemotherapy should be at least seven days. Pre- myeloablative radiochemotherapy: The first three doses should be administered prior to myeloablative therapy, with the third dose 24 to 48 hours before myeloablative radiochemotherapy. Medicinal Post- myeloablative radiochemotherapy: The last three doses should be administered post myeloablative radiochemotherapy; the first of these doses should be administered after, but on the same day of haematopoietic stem cell infusion and at least seven days after the most recent Kepivance administration (see section 4.4).
    [Show full text]