#237 
Oncology Drugs for Companion Animals
Guidance for Industry 
Submit comments on this guidance at any time.  Submit electronic comments to 
https://www.regulations.gov/.  Submit written comments to the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852.  All comments should be identified with the docket number FDA-2016-D-1248. 
For questions regarding this document, contact AskCVM@fda.hhs.gov. 
Additional copies of this guidance document may be requested from the Policy and Regulations 
Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish 
Place, Rockville, MD 20855, and may be viewed on the Internet at 
https://www.fda.gov/AnimalVeterinary/default.htm or https://www.regulations.gov/. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
August 2017  Contains Nonbinding Recommendations 
Table of Contents 
I.  INTRODUCTION ............................................................................................................ 3 
II. EFFECTIVENESS ............................................................................................................ 3
A.  Dosage Characterization ............................................................................................... 3 
1. Dose escalation studies ........................................................................................... 4
2. Pilot field studies..................................................................................................... 4
3. Foreign field studies ................................................................................................ 4
4. Pharmacokinetic studies .......................................................................................... 4
5. Scientific literature .................................................................................................. 4
B.  Field Effectiveness Study ............................................................................................. 4 
1. Endpoints ................................................................................................................ 5
a. Overall survival (OS) .............................................................................................. 5
b. Time to tumor progression (TTP) and Progression free survival (PFS) ................. 5
c. Progression free survival rate (PFS rate) ................................................................ 6
d. Objective response rate (ORR) ............................................................................... 6
e. Other ....................................................................................................................... 6
2. Treatment groups .................................................................................................... 6
3. Inclusion/Exclusion criteria .................................................................................... 7
4. Patient assessments ................................................................................................. 7
5. Statistical Considerations ........................................................................................ 7
6. Dose reductions, delays, and interruptions ............................................................. 7
7. Adverse Events (AE) .............................................................................................. 8
8. Standard of Care Treatments .................................................................................. 8
9. Informed Consent.................................................................................................... 8
C.  Reasonable Expectation of Effectiveness ..................................................................... 8 
III. TARGET ANIMAL SAFETY .......................................................................................... 9
A.  Multiple Levels of Exposure ......................................................................................... 9 
B.  Duration ........................................................................................................................ 9 
C.  Evaluation of Toxicity .................................................................................................. 9 
IV. HUMAN USER SAFETY .............................................................................................. 10
V.  APPENDIX 1 - Recommendations for Drug Labeling ................................................... 10 
A.  Package Insert ............................................................................................................. 10 
B.  Client Information Sheet ............................................................................................. 11 
2  Contains Nonbinding Recommendations 
Oncology Drugs for Companion Animals
Guidance for Industry 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA 
or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page. 
I.  INTRODUCTION 
This guidance document makes recommendations to sponsors of investigational oncology drugs 
for use in companion animals (e.g., dogs, cats, and horses).  The guidance discusses the contents 
of the target animal safety, effectiveness, and labeling technical sections of a new animal drug 
application (NADA) for oncology drugs administered as single agents.  This guidance also 
includes recommendations on how to address human user safety concerns.  For multi-drug 
regimens, we recommend that you contact the Center for Veterinary Medicine (CVM) to discuss 
your product development plan. 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required. 
You may follow the guidance document or may choose alternate pathways for approval.  We 
recommend that you discuss your proposed study plans with CVM, especially if you choose to 
use an alternative pathway for approval.  We encourage you to schedule a presubmission 
conference with CVM as you begin to make your investigational plans to ensure that you are 
completely informed on the requirements contained in the statute and regulations. 
II. EFFECTIVENESS
A.  Dosage Characterization
Dosage characterization includes information on the dose or dose range, route of 
administration, dosing interval, dosing duration, and evidence that the proposed dosage 
has an effect on the tumor type in the target species.  Dosage characterization is 
submitted in the Effectiveness technical section and is included in the Freedom of 
Information (FOI) Summary. 
For drugs administered based on body surface area (mg/m2), dose exposure may need to 
be considered separately for smaller animals (e.g., 10 kg) based upon the drug product 
and pharmacokinetic profile.  Smaller animals may have higher drug exposure compared 
3  Contains Nonbinding Recommendations 
to larger animals when dosed using body surface area.  It is acceptable to have separate 
dosing tables using mg/m2 dosing for larger animals and mg/kg dosing for smaller 
animals. 
 
There are multiple ways for a sponsor to support dosage characterization including, but 
not limited to: 
 
1.  Dose escalation studies 
 
Dose escalation studies may be performed to determine the maximum tolerated dose 
(MTD).  With chemotherapy, achieving the MTD is often the goal during therapy.  
These studies may be performed in the clinical setting with target species 
experiencing naturally occurring tumors, or in laboratory studies in the target 
species. 
 
2.  Pilot field studies 
 
Pilot field studies in the target species may help determine the appropriate dosage 
and the safety profile.  Pilot field studies may also be conducted to determine which 
tumor types are responsive to the drug. 
 
3.  Foreign field studies 
 
Results from field studies conducted outside the United States (US), i.e., foreign 
field studies, can provide evidence that the proposed dosage has an effect in the 
target population. 
 
4.  Pharmacokinetic studies 
 
Pharmacokinetic studies may be performed to determine the frequency of dosing.  
For oral dosage forms, pharmacokinetic studies may be performed to determine the 
bioavailability under fed and fasted conditions. 
 
5.  Scientific literature 
 
Scientific literature may support dosage characterization. 
 
B.  Field Effectiveness Study 
 
The purpose of a field study is to evaluate the safety and effectiveness of the oncology 
drug in the target animal for the proposed indication(s) under the actual conditions of 
use.  Field studies, whether conducted in the US or in other countries, should use the 
same concomitant medications and standard of veterinary practice as in the US, 
according to an established protocol. 
   
4  Contains Nonbinding Recommendations 
The following are considerations for the design and conduct of the field effectiveness 
study: 
 
1.  Endpoints 
 
For all of the endpoints, a clinically relevant difference between the treated and 
comparator group should be defined prior to study conduct. 
 
Many endpoints evaluate progression of the tumor.  Response Evaluation Criteria in 
Solid Tumors (RECIST)1 and World Health Organization (WHO) criteria2 both 
describe criteria to evaluate disease progression.  The following endpoints are based 
on RECIST and WHO criteria.  Modifications to these criteria may be proposed, or 
an alternative method of assessment may be proposed. 
 
a.  Overall survival (OS) 
 
In field studies, OS is defined as the time from randomization to death.  This 
endpoint is unambiguous and is not subject to investigator interpretation.  When 
using OS as an endpoint, the study design and effectiveness analysis should take 
into account subsequent cancer therapies and euthanasia. 
 
b.  Time to tumor progression (TTP) and Progression free survival (PFS) 
 
In field studies, TTP is defined as the time from randomization to time of 
progressive disease.  PFS is defined as the time from randomization to objective 
tumor progression or death (including euthanasia). 
 
The study protocol should include a detailed definition of disease progression 
because determining progression is a subjective assessment.  The protocol should 
define, prior to study conduct, the specific time points when TTP or PFS are 
evaluated.  Evaluations should assess likely disease sites (i.e., primary tumor, 
secondary tumors, and metastatic sites).  The same assessment technique should 
be used at each follow-up and the same evaluation schedule should be 
consistently used for all enrolled patients.  It is important that the TTP be 
documented close to the actual occurrence of the event.  Therefore, the frequency 
of evaluation of these endpoints should take into consideration the expected 
timing and rate of progression of the tumor.  The sponsor should prospectively 
define when to assign progression and the protocol should clearly state the 
method used to assign the date of progression.  The method used will depend on 
tumor type and the expected rate of tumor progression. 
 
   
                                                 
1 Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours:  Revised RECIST guideline 
(version 1.1). Eur J Cancer, 2009; 45: 228-247. 
2 Park JO, Lee SI, Song SY, et al. Measuring Response in Solid Tumors:  Comparison of RECIST and WHO Response Criteria. 
Jap J Clin Oncol, 2003; 33(10): 533-7. 
5  Contains Nonbinding Recommendations 
An animal may be lost to follow-up before progression or death is observed.  In 
this case, the data point (TTP or PFS) is right- censored3  because it is known to 
be above a certain value but by an unknown amount.  The protocol should 
specify the conditions for right-censoring.  Examples include owner decision to 
withdraw from the study, adverse event that warrants cessation of therapy, and, 
for TTP, death unrelated to disease or treatment.  In most cases, the right-
censored value is the last complete scheduled assessment which documented lack 
of progression. 
 
c.  Progression free survival rate (PFS rate) 
 
PFS rate is defined as the proportion of patients that are alive and progression-
free at a specified time point.  Methods for assessment are similar to TTP and 
PFS.  The expected rate of tumor progression should be considered when 
selecting the time point for evaluating the PFS rate. 
 
d.  Objective response rate (ORR) 
 
Objective response is defined as the sum of partial responses (PRs) and complete 
responses (CRs).  ORR is the proportion of patients with an objective response at 
a specified time point.  The time point when the ORR assessment is performed 
should represent a clinically relevant duration of response.  RECIST is a common 
method used for assessing ORR. 
 
e.  Other 
 
Other endpoints may be considered on a case-by-case basis. 
 
2.  Treatment groups 
 
Studies supporting substantial evidence of effectiveness should be well-controlled, 
utilizing an active control, placebo control, untreated control, or historical control.  
Refer to 21 CFR 514.117(b)(4) for more information. 
 
The ratio of patients receiving the investigational drug versus the control should be 
considered when designing the study.  For example, cancers with low incidences of 
spontaneous partial responses may allow for fewer patients in a placebo control 
group compared to the group treated with the investigational drug. 
 
The study should be masked appropriately to control potential bias, taking into 
consideration different observable drug effects and routes of administration of the 
investigational drug and the control group. 
 
                                                 
3 Right censored - A data point is right censored if it is known that it is above a certain value but by an unknown amount.  For 
example, the overall survival for a subject that is known to be alive up to a certain time point but lost to follow-up after that has 
an observation that is right censored at the time point. 
6  Contains Nonbinding Recommendations 
3.  Inclusion/Exclusion criteria 
 
The patient population enrolled in the study affects the indication and labeling 
language.  Therefore, you should consider the following when choosing the patient 
population for enrollment: 
 
  Previous and concurrent treatments (e.g., use of corticosteroids, other 
chemotherapy, surgery, radiation) 
  Metastases 
  Tumor stages or grades 
  Tumor locations 
 
4.  Patient assessments 
 
The study protocol should define intervals for assessment of patients.  All anatomical 
sites of possible disease occurrence should be assessed to determine if progression 
has occurred.  For PFS and TTP, it is essential to accurately capture progression, 
therefore monitoring may need to occur more frequently than traditionally conducted 
in clinical practice. 
 
Additional safety assessments may be necessary for particular drug classes to 
monitor for specific target organ effects.  For example, a dog treated with an 
anthracycline drug may need echocardiograms to monitor for cardiotoxicity. 
 
5.  Statistical Considerations 
 
The study should enroll a sufficient number of subjects to adequately power the 
primary statistical test, taking into account subject attrition, censoring, and other 
factors that can affect the efficiency of the tests.  The study should be powered to 
detect a clinically relevant effect size. 
 
Appropriate stratification factors should be considered; for example, tumor grade, 
tumor location, or mutation type.  Agreement with CVM is recommended prior to 
study conduct regarding the difference in treatment groups that would be considered 
clinically relevant. 
 
6.  Dose reductions, delays, and interruptions 
 
Dose reductions, delays, and interruptions may be used to manage adverse reactions.  
If dose reductions, delays, and interruptions are part of the dosing schedule, they 
should be pre-defined in the protocol so that all investigators use them consistently.  
Effectiveness and safety of the reduced dose should be demonstrated in the field 
study. 
 
7  Contains Nonbinding Recommendations 
For products that are eligible for conditional approval4, the dose reductions, delays, 
or interruptions should be justified in the reasonable expectation of effectiveness 
technical section. 
 
7.  Adverse Events (AE) 
 
The most current Veterinary Co-operative Oncology Group-Common Terminology 
Criteria for Adverse Events (VCOG-CTCAE)5 for grading AEs should be used in the 
clinical field study.  This system supplies descriptive terminology and a severity 
scale for each AE term.  Grading AEs in this manner will allow for uniform 
description of AEs across oncology drugs.  Adverse events not covered under 
VCOG-CTCAE should be captured utilizing other appropriate methods. 
 
8.  Standard of Care Treatments 
 
The effectiveness of an investigational new animal drug may be evaluated in 
conjunction with standard of care.  Standard of care can include, but is not limited to, 
surgery, radiation, or other chemotherapeutics.  Standard of care should be justified 
through use of literature or other means.  We recommend you contact CVM prior to 
conduct of the study to discuss study design options that include standard of care 
interventions. 
 
9.  Informed Consent 
 
The informed consent should include language that conveys the safety risks to the 
patient, to other animals in the household, and conveys human user safety risks to the 
owner.  The information should include instructions for safe handling of the drug, if 
applicable, and instructions for safe disposal of urine, feces, and vomit from the 
animal to minimize potential drug or active metabolite exposure to the owner. 
 
C.  Reasonable Expectation of Effectiveness 
 
The Reasonable Expectation of Effectiveness technical section replaces the 
Effectiveness technical section when a sponsor is pursuing conditional approval.  The 
drug must be determined by CVM to be a minor use in a major species (e.g., cat, dog, or 
horse) or be intended for use in a minor species. 
 
We recommend you contact CVM early in your development plan regarding the 
approach to demonstrate reasonable expectation of effectiveness.  Demonstration of 
reasonable expectation of effectiveness may include pilot studies, literature, and other 
                                                 
4 Applications for conditional approval allow a drug sponsor to legally market a new animal drug intended for a minor use or a 
minor species after proving it is safe under 21 U.S.C.  360b(d), but before collecting all the necessary effectiveness data.  The 
drug sponsor can keep the product on the market for up to five years, while collecting effectiveness data required by 21 U.S.C.  
360b(d), if FDA approves the sponsor's annual renewal requests. 
5 Veterinary Co-operative Oncology Group.  Veterinary Co-operative Oncology Group - Common Terminology Criteria for 
Adverse Events (VCOG-CTCAE) following chemotherapy or biological antineoplastic therapy in dogs and cats v1.0. Vet Comp 
Oncol, 2004 Dec; 2(4): 195-213. 
8  Contains Nonbinding Recommendations 
sources.  The information to support reasonable expectation of effectiveness may also 
include safety information in the target population. 
III. TARGET ANIMAL SAFETY
The purpose of the target animal safety (TAS) study is to identify the margin of safety and
provide veterinarians with information regarding the safe use of the drug.6  Safety studies
conducted in the laboratory should be carried out in compliance with FDA's good laboratory
practices (GLP) regulations (21 CFR Part 58).
A.  Multiple Levels of Exposure
For oncology drugs with a low margin of safety, modifications of the dose levels 
administered to the animals in the TAS study may be necessary to avoid unnecessary 
toxicity or death.  The highest recommended (1X) dose should be evaluated in addition 
to two other dose levels above 1X, if possible.  For drugs administered at the MTD, it 
may not be possible to evaluate doses above 1X. 
If dose reductions will be used to manage toxicity, the reduced dose should be included 
in the TAS study as a multiple of the 1X dose (e.g., 0.8X dose).  The reduced dose 
should demonstrate lower toxicity than the 1X dose to justify its use in managing 
toxicity. 
B.  Duration 
Refer to Guidance for Industry #185/VICH GL43, Target Animal Safety for Veterinary 
Pharmaceutical Products, Section 2.4, entitled Dose, Frequency, and Duration of 
Administration.  If a drug has a low margin of safety, a modification of the dosing 
interval and/or duration may be necessary, including temporary drug interruptions.  A 
cumulative toxicity, such as cardiac toxicity with anthracyclines, is also an example of 
when the duration of the target animal safety study may be modified.  We recommend 
that you contact CVM prior to study conduct to discuss your specific drug and dosing 
schedule. 
C.  Evaluation of Toxicity 
The study should be designed to capture the drug effects at the time points of maximum 
exposure and/or maximum toxicity.  For example, drugs that cause hematopoietic 
toxicity should have a complete blood count at the time of the white blood cell nadir. 
Toxicity should be graded using an appropriate system such as the VCOG- CTCAE.  
Collection of pharmacokinetic data during the study may be valuable in helping identify 
potential associations between drug blood levels and toxicity. 
6 See Guidance for Industry #185/VICH GL43, Target Animal Safety for Veterinary Pharmaceutical Products, for more details. 
9  Contains Nonbinding Recommendations 
IV. HUMAN USER SAFETY
Human user safety covers human exposures resulting from actual conditions of use, and it is
part of the Target Animal Safety technical section.  Human user safety concerns should be
addressed, including potential exposure to the drug and the active metabolites by: veterinary
personnel, people handling the drug, and people in contact with the animal (including
exposure to the patients urine, feces, vomit, and saliva).  Informed consent for the field
studies is important to ensure that owners understand the risks of potential exposure to the
drug and metabolites to people and animals that may come in contact with the patient.
Veterinarians and technicians handling oncology drugs should refer to Occupational Safety
and Health Administration (OSHA)7 for appropriate guidelines, recommendations, and
regulations for handling antineoplastic agents.
Investigational and approved drug labeling and the client information sheet should address
human user safety concerns.  A client information sheet should be part of labeling for all
oncology drugs.  The client information sheet should be provided to the owner when the
approved product is prescribed and also during the conduct of the field studies.  See
Appendix 1 for recommendations for drug labeling specific to oncology drugs including the
client information sheet.
V.  APPENDIX 1 - Recommendations for Drug Labeling 
A.  Package Insert 
The package insert may include certain labeling information unique to oncology drugs, if 
applicable. 
The Dosage and Administration section should include information on dosage 
reductions, delays, or interruptions used to manage adverse reactions. 
The Warnings section should contain additional information on human user safety when 
there is evidence of an association of a serious hazard with the drug.  Warning 
statements should also refer to accidental exposure.  Examples of statements could 
include: 
 Recommendations for seeking professional medical help, and general treatment
procedures
 Information for physicians on specific treatment procedures for potential exposure
 Specific first aid measures that can be undertaken to reduce potential harm (e.g.,
washing hands or eyes, inducing vomiting, wearing gloves, etc.)
7 https://www.osha.gov/SLTC/hazardousdrugs/index.html 
10  Contains Nonbinding Recommendations 
B.  Client Information Sheet 
The following are examples of formats that may be used and they may be modified 
based on the characteristics of each drug.  The client information sheet should use lay-
terms or provide definitions for medical or scientific terms. 
11  Contains Nonbinding Recommendations 
For Oral Dosage Forms 
Client Information Sheet 
PROPRIETARY NAME (established name) 
The Client Information Sheet contains important information about PROPRIETARY NAME.  
You should read this information before you start giving PROPRIETARY NAME to your pet 
and review it each time the prescription is refilled as there may be new information.  This 
sheet is provided only as a summary and does not take the place of instructions from your 
veterinarian.  Talk with your veterinarian if you do not understand any of this information or 
if you want to know more about PROPRIETARY NAME. 
For conditional approvals only: 
PROPRIETARY NAME is conditionally approved by the FDA, and full demonstration of 
effectiveness (how well the drug works) is dependent on completion of a clinical trial.  The 
use of conditionally approved new animal drugs is limited to a specific use, which can be 
found on the package insert.  Additional information on drugs conditionally approved under 
section 571 can be found by searching https://www.fda.gov for conditional approval. 
What is PROPRIETARY NAME? 
 PROPRIETARY NAME is a <drug class or mechanism of action> used to treat
<indication>, a form of cancer that affects <dogs/cats>.
What should I tell my veterinarian about my pet before he/she receives 
PROPRIETARY NAME? 
 Tell your veterinarian about other medications your pet is taking, including prescription
drugs, over the counter medications, heartworm preventatives, flea and tick medications,
and vitamins and supplements, including herbal medications.
 Tell your veterinarian about your pets previous or current medical conditions.
 Tell your veterinarian if your pet is pregnant, nursing, or you intend to breed him/her.
How do I give PROPRIETARY NAME to my pet? 
 PROPRIETARY NAME should be given to your pet by mouth (orally).
 PROPRIETARY NAME <may/may not> be hidden inside a treat; be certain that your pet
swallows the entire <tablet/capsule>.
 Follow your veterinarians instructions for how much and how often to give
PROPRIETARY NAME.
12  Contains Nonbinding Recommendations 
Client Information Sheet 
PROPRIETARY NAME (established name) 
*Comment on missed doses if appropriate, e.g., If a dose is missed, the next scheduled dose
should be given as prescribed.  Do not increase or double the dose. 
See the Handling Instructions section below for directions on how to administer 
PROPRIETARY NAME safely to your pet. 
How will PROPRIETARY NAME affect my pet? 
 PROPRIETARY NAME is intended to treat your pets cancer.  As with other cancer
treatments, your veterinarian cannot predict whether your pets cancer will respond to
PROPRIETARY NAME.
 Regular check-ups by your veterinarian are necessary to determine whether your pet is
responding as expected, and to decide whether your pet should continue to receive
PROPRIETARY NAME.
What are some of the possible side effects of PROPRIETARY NAME? 
 Like all drugs, PROPRIETARY NAME may cause side effects, even at the prescribed
dose.  Serious side effects can occur, with or without warning, and may in some
situations result in death.
 The most common side effects which may occur with PROPRIETARY NAME include:
<list adverse reactions here>.
 Other side effects may occur.  For more information about side effects ask your
veterinarian.
Stop PROPRIETARY NAME immediately and contact your veterinarian if you notice 
any of the following changes in your pet: 
 < List items here>
Handling Instructions: 
Because PROPRIETARY NAME is an anti-cancer (chemotherapy) drug, extra care must be 
taken when handling the <tablets/capsules>, giving the drug to your pet, and cleaning up 
after your pet. 
 PROPRIETARY NAME is not for use in humans.
 You should keep PROPRIETARY NAME in a secure storage area out of the reach of
children and pets.  Do not store near food or with your medications.
 Do not come in direct contact with PROPRIETARY NAME.
13  Contains Nonbinding Recommendations 
Client Information Sheet 
PROPRIETARY NAME (established name) 
 If you are pregnant, a nursing mother, or may become pregnant and you choose to
administer PROPRIETARY NAME to your pet, you should be particularly careful and
follow the handling procedures described below.
*Provide a cautionary comment for men if this product or products in its class can affect
male fertility. 
 PROPRIETARY NAME may harm an unborn baby (cause birth defects).  For pregnant
and nursing women, accidental ingestion of PROPRIETARY NAME may have adverse
effects on pregnancy or the nursing baby.
 If PROPRIETARY NAME is accidentally ingested, seek medical advice
immediately.  It is important to show the treating physician a copy of the package
insert, label, or client information sheet.
The following handling procedures will help to minimize exposure to the active 
ingredient in PROPRIETARY NAME for you and other members of your household: 
 Anyone in your household who gives PROPRIETARY NAME to your pet should wear
disposable chemotherapy resistant gloves and wash their hands thoroughly after handling
<tablets/capsules>.  Check with your veterinarian to ensure you have the appropriate
gloves.
 Minimize the number of people handling PROPRIETARY NAME.
 When handling the tablets:
 Do not split or break the <tablets/capsules> to avoid disrupting the protective film
coating.
 PROPRIETARY NAME should be administered to your pet immediately after
removal from the bottle.
 Protective disposable chemotherapy resistant gloves should be worn if handling
broken or moistened tablets.  If your pet spits out the PROPRIETARY
NAME<tablets/capsules>, the <tablets/capsules> will be moistened and should be
handled with protective gloves.
 If the PROPRIETARY NAME <tablets/capsules> is hidden in food make sure that
your pet eats the entire dose to minimize the potential for exposure to other household
members.
 Return any unused PROPRIETARY NAME to your veterinarian.
14  Contains Nonbinding Recommendations 
Client Information Sheet 
PROPRIETARY NAME (established name) 
Because PROPRIETARY NAME is an anti-cancer drug, extra care must be taken 
when handling and cleaning up after your pet during treatment and for X days after 
the last treatment. 
The following handling procedures will help minimize exposure to the active ingredient in 
PROPRIETARY NAME for you and members of your household. 
 Cleaning up after your pet:
 Avoid direct contact with urine, stool, vomit, and saliva during treatment and for X
days after the last treatment with PROPRIETARY NAME.
 When cleaning up urine, stool, vomit or saliva, you should wear disposable
chemotherapy resistant gloves and collect the contaminated material with disposable
absorptive material (such as paper towels) and place them into a plastic bag.
Carefully remove the gloves and place them in the bag and tie or fasten it securely for
general household disposal.  Wash your hands thoroughly afterwards.
 You should not wash any items soiled with urine, stool, vomit, or saliva from your pet
with other laundry.
 Do not let your pet urinate or defecate in areas where people may come in direct
contact with the urine or stool.
 Because PRORIETARY NAME may be present in the pets saliva during treatment and
for X days after the last treatment, take precautions in handling the dogs toys, food
bowl, and water bowl.  Wash food and water bowls separately from other items.
This client information sheet contains a summary of important information about 
PROPRIETARY NAME.  For more detailed information about PROPRIETARY NAME, 
talk with your veterinarian. 
To report a suspected adverse reaction (side effect) call xxx-xxx-xxxx.  For additional 
information about adverse drug experience reporting for animal drugs, contact the FDA at 1- 
888-FDA-VETS or online at https://www.fda.gov/AnimalVeterinary/SafetyHealth/. 
15  Contains Nonbinding Recommendations 
For Injectable Dosage Forms 
Client Information Sheet 
PROPRIETARY NAME (established name) 
The Client Information Sheet contains important information about PROPRIETARY NAME.  
You should read this information when your pet begins treatment with PROPRIETARY 
NAME and review it each time your pet receives treatment as there may be new information.  
This sheet is provided only as a summary and does not take the place of instructions from 
your veterinarian.  Talk with your veterinarian if you do not understand any of this 
information or if you want to know more about PROPRIETARY NAME. 
For conditional approvals only: 
PROPRIETARY NAME is conditionally approved by the FDA, and full demonstration of 
effectiveness (how well the drug works) is dependent on completion of a clinical trial.  The 
use of conditionally approved new animal drugs is limited to a specific use, which can be 
found on the package insert.  Additional information on drugs conditionally approved under 
section 571 can be found by searching https://www.fda.gov/ for conditional approval. 
What is PROPRIETARY NAME? 
 PROPRIETARY NAME is a <drug class or mechanism of action> used to treat
<indication>, a form of cancer that affects <dogs/cats>.
What should I tell my veterinarian about my pet before he/she receives 
PROPRIETARY NAME? 
 Tell your veterinarian about other medications your pet is taking, including prescription
drugs, over the counter medications, heartworm preventatives, flea and tick medications,
and vitamins and supplements, including herbal medications.
 Tell your veterinarian about your pets previous or current medical conditions.
 Tell your veterinarian if your pet is pregnant, nursing, or you intend to breed him/her.
How is my pet given PROPRIETARY NAME? 
 Your veterinarian will give PROPRIETARY NAME <route of administration> during an
office visit.
How will PROPRIETARY NAME affect my pet? 
 PROPRIETARY NAME is intended to treat your pets cancer.  As with other cancer
treatments, your veterinarian cannot predict whether your pets cancer will respond to
PROPRIETARY NAME.
16  Contains Nonbinding Recommendations 
Client Information Sheet 
PROPRIETARY NAME (established name) 
 Regular check-ups by your veterinarian are necessary to determine whether your pet is
responding as expected, and to decide whether your pet should continue to receive
PROPRIETARY NAME.
What are some of the possible side effects of PROPRIETARY NAME 
 Like all drugs, PROPRIETARY NAME may cause side effects, even at the prescribed
dose.  Serious side effects can occur, with or without warning, and may in some
situations result in death.
 The most common side effects which may occur with PROPRIETARY NAME include:
<list adverse reactions here>.
 Other side effects may occur. For more information about side effects ask your
veterinarian.
Contact your veterinarian immediately if you notice any of the following changes in 
your dog: 
 <List items here>
Because PROPRIETARY NAME is an anti-cancer (chemotherapy) drug, extra care 
must be taken when handling and cleaning up after your pet for X days after treatment. 
The following handling procedures will help minimize exposure to the active ingredient in 
PROPRIETARY NAME for you and members of your household. 
 Cleaning up after your pet:
 Avoid direct contact with urine, stool, vomit, and saliva for X days after your pet is
treated with PROPRIETARY NAME.
 When cleaning up urine, stool, vomit or saliva you should wear disposable
chemotherapy resistant gloves and collect the contaminated material with disposable
absorptive material (such as paper towels) and place them into a plastic bag.
Carefully remove the gloves and place them in the bag and tie or fasten it securely for
general household disposal.  Wash your hands thoroughly afterwards.  Check with
your veterinarian to ensure you have the appropriate gloves.
 You should not wash any items soiled with urine, stool, vomit, or saliva from your pet
with other laundry.
 Do not let your pet urinate or defecate in areas where people may come in direct
contact with the urine or stool.
17  Contains Nonbinding Recommendations 
Client Information Sheet 
PROPRIETARY NAME (established name) 
 Because PRORIETARY NAME may be present in the pets saliva for X days after
treatment, take precautions in handling the dogs toys, food bowl, and water bowl.  Wash
food and water bowls separately from other items.
This client information sheet contains a summary of important information about 
PROPRIETARY NAME.  For more detailed information about PROPRIETARY NAME, 
talk with your veterinarian. 
To report a suspected adverse reaction (side effect) call xxx-xxx-xxxx.  For additional 
information about adverse drug experience reporting for animal drugs, contact the FDA at 1- 
888-FDA-VETS or online at https://www.fda.gov/AnimalVeterinary/SafetyHealth/
default.htm. 
18