Frequency and Severity of Neutropenia Associated with Food and Drug Administration Approved and Compounded Formulations of Lomustine in Dogs with Cancer

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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. Hypothesis/Objectives: 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. Animals: 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 and Clinical Importance: 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.

Original languageEnglish (US)
Pages (from-to)242-246
Number of pages5
JournalJournal of Veterinary Internal Medicine
Volume30
Issue number1
DOIs
StatePublished - Jan 1 2016

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Lomustine
neutropenia
United States Food and Drug Administration
Neutropenia
Dogs
neoplasms
dogs
Neoplasms
Pharmacies
drug formulations
pet foods
drug therapy
neutrophils
Drug Compounding
pretreatment
high performance liquid chromatography
drugs
Capsules

Keywords

  • CCNU
  • Canine
  • Chemotherapy

ASJC Scopus subject areas

  • veterinary(all)

Cite this

@article{e9957fe5f7d04bc69ee814acb049f78e,
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. Hypothesis/Objectives: 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. Animals: 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 and Clinical Importance: 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.",
keywords = "CCNU, Canine, Chemotherapy",
author = "Burton, {Jenna H} and Stanley, {Scott D} and Knych, {Heather K} and Rodriguez, {C. O.} and Skorupski, {Katherine A} and Rebhun, {Robert B}",
year = "2016",
month = "1",
day = "1",
doi = "10.1111/jvim.13805",
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volume = "30",
pages = "242--246",
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TY - JOUR

T1 - Frequency and Severity of Neutropenia Associated with Food and Drug Administration Approved and Compounded Formulations of Lomustine in Dogs with Cancer

AU - Burton, Jenna H

AU - Stanley, Scott D

AU - Knych, Heather K

AU - Rodriguez, C. O.

AU - Skorupski, Katherine A

AU - Rebhun, Robert B

PY - 2016/1/1

Y1 - 2016/1/1

N2 - 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. Hypothesis/Objectives: 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. Animals: 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 and Clinical Importance: 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.

AB - 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. Hypothesis/Objectives: 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. Animals: 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 and Clinical Importance: 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.

KW - CCNU

KW - Canine

KW - Chemotherapy

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U2 - 10.1111/jvim.13805

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