title: Frequency and Severity of Neutropenia Associated with Food and Drug Administration Approved and Compounded Formulations of Lomustine in Dogs with Cancer.
abstract: BACKGROUND
  Compounded lomustine is used commonly in veterinary patients. However, the potential variability in these formulations is unknown and concern exists that compounded formulations of drugs may differ in potency from Food and Drug Administration (FDA)-approved products.
  
  
  OBJECTIVE
  The initial objective of this study was to evaluate the frequency and severity of neutropenia in dogs treated with compounded or FDA-approved formulations of lomustine. Subsequent analyses aimed to determine the potency of lomustine obtained from several compounding pharmacies.
  
  
  METHODS
  Thirty-seven dogs treated with FDA-approved or compounded lomustine.
  
  
  METHODS
  Dogs that received compounded or FDA-approved lomustine and had pretreatment and nadir CBCs performed were eligible for inclusion. Variables assessed included lomustine dose, neutrophil counts, and severity of neutropenia. Lomustine 5 mg capsules from 5 compounding sources were tested for potency using high-pressure liquid chromatography (HPLC) with ultraviolet (UV) detection.
  
  
  RESULTS
  Twenty-one dogs received FDA-approved lomustine and 16 dogs were treated with lomustine prescribed from a single compounding pharmacy. All dogs treated with FDA-approved lomustine were neutropenic after treatment; 15 dogs (71%) developed grade 3 or higher neutropenia. Four dogs (25%) given compounded lomustine became neutropenic, with 2 dogs (12.5%) developing grade 3 neutropenia. The potency of lomustine from 5 compounding pharmacies ranged from 50 to 115% of the labeled concentration, with 1 sample within ±10% of the labeled concentration.
  
  
  CONCLUSIONS
  These data support broader investigation into the potency and consistency of compounded chemotherapy drugs and highlight the potential need for greater oversight of these products.
authors.affiliation: Department of Surgical and Radiological Sciences, University of California, Davis, CA.
authors.forename: J H
authors.initials: JH
authors.lastname: Burton
authors.affiliation: Department of Molecular Biosciences, University of California, Davis, CA.
authors.forename: S D
authors.initials: SD
authors.lastname: Stanley
authors.affiliation: Department of Molecular Biosciences, University of California, Davis, CA.
authors.forename: H K
authors.initials: HK
authors.lastname: Knych
authors.affiliation: Department of Surgical and Radiological Sciences, University of California, Davis, CA.
authors.forename: C O
authors.initials: CO
authors.lastname: Rodriguez
authors.affiliation: Department of Surgical and Radiological Sciences, University of California, Davis, CA.
authors.forename: K A
authors.initials: KA
authors.lastname: Skorupski
authors.affiliation: Department of Surgical and Radiological Sciences, University of California, Davis, CA.
authors.forename: R B
authors.initials: RB
authors.lastname: Rebhun
mesh_terms: D000818:Animals; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects*; D004283:Dog Diseases / Q000139:chemically induced* / Q000188:drug therapy; D004285:Dogs; D004339:Drug Compounding; D005260:Female; D008130:Lomustine / Q000009:adverse effects* / Q000737:chemistry / Q000627:therapeutic use; D008297:Male; D009369:Neoplasms / Q000188:drug therapy / Q000662:veterinary*; D009503:Neutropenia / Q000139:chemically induced / Q000662:veterinary*; D010604:Pharmacy / Q000592:standards
chemical_list: D018906:Antineoplastic Agents, Alkylating; D008130:Lomustine
keywords: CCNU; Canine; Chemotherapy