Slentrol For Dogs
Obesity Management for Dogs
Management of Obesity in Dogs
SLENTROL (dirlotapide) Oral Solution is indicated for
the management of obesity in dogs. Slentrol is the
first proven and dependable veterinary medication for the management of canine
- Provides a medically appropriate approach to weight management for obese
- Achieves and helps maintain weight loss with 2 phases of medication
- Offers a convenient, once-daily dose that can be used with any
nutritionally complete diet
DOSAGE AND ADMINISTRATION: SLENTROL
should be prescribed as part of an overall weight management program that
incorporates a complete and balanced canine diet and physical activity. The dog
will need to be weighed at the start of treatment and then at monthly intervals
so that the dosing regimen can be adjusted according to the prescribing
Oral solution for use in dogs only.
During the first month of therapy, the dosing regimen
for SLENTROL consists of two fixed dose rates (number of mL administered per
unit of body weight) in all dogs. In subsequent months of therapy, the
recommended dosing regimen prescribed for SLENTROL varies for each individual
dog and the dose volume must be specifically calculated each month, based on the
amount of weight lost (expressed as a percent) during the previous month of
With regard to dosing it is important to note that:
- Initial body weight is used to calculate the dose that
is first administered.
- Subsequent dose adjustments are made by adjusting the
volume of solution administered.
- Dose adjustments are determined at monthly intervals.
The dose should not exceed a maximum
daily dose of 0.2 mL/kg (0.09 mL/lb), based on the dog's current body weight,
during any part of treatment.
Dose Preparation and Administration:
To prepare for oral administration, remove the bottle cap and insert the
supplied oral dosing syringe through the membrane into the bottle. Invert the
bottle and withdraw the appropriate volume required using the graduation marks
on the side of the oral dosing syringe.
SLENTROL can be administered directly into the dog's
mouth or on a small amount of food. It can be given with a meal or at a
different time of day.
Wipe the oral dosing syringe clean after
each use with a clean dry cloth or disposable towel. Do not introduce water into
the oral dosing syringe or the SLENTROL solution.
WEIGHT LOSS PHASE
Initial assessment and dosing in first
Assess the dog prior to initiation of therapy with
SLENTROL to determine the desired weight and to assess the animal's general
health (See Precautions).
The initial dosage of SLENTROL is 0.01 mL/kg (0.0045 mL/lb)
body weight, administered once daily, orally, for the first 14 days. After the
first 14 days of treatment, the dose volume of SLENTROL should be doubled to
0.02 mL/kg (0.009 mL/lb) of body weight, administered once daily for the next 14
days (days 15 to 28 of treatment).
Subsequent Monthly Dose Adjustments for
Dogs should be weighed monthly and the dose volume adjusted
every month, as necessary, to maintain a target percent weight loss of ≥0.7% per
If the dog has gained weight since the last visit, the
dose volume should be increased. Go directly to the First (or Subsequent) Dose
Adjustment Section below.
If the dog has lost weight, determine if an adjustment
in dose is required using the following calculations:
(Number of weeks between visits) X 0.7 % per week =
Target % weight loss
(Weight at last visit - Weight at current visit / Weight
at last visit) X 100 = Actual % loss
Example - in 4 weeks (28 days) the Target weight loss
would be 4 X 0.7% per week, or at least 2.8% of the total body weight
Compare the Target % weight loss (of ≥0.7% per week)
with the Actual % weight loss for that dog.
To determine if a dose adjustment is necessary, compare
the Actual % weight loss to the Target % weight loss and use the following
guidelines. Note: All dose adjustments are based solely on
Monthly weight loss rate achieved
If the Actual % weight loss is the same or greater than
the Target % weight loss, the dose volume (number of mL administered each day)
should remain the same for the next month of dosing until the next scheduled
Monthly weight loss not achieved
If the Actual % weekly weight loss is less than the
Target % weight loss of 0.7% weekly, the following dose adjustment instructions
First dose adjustment
The dose volume (number of mL administered each day)
should be increased by 100%, resulting in an increase of the dose volume to 2.0
times the dose administered during the previous month of dosing. Only perform a
100% dose increase once during treatment after day 14.
Subsequent dose adjustments
If additional dose increases are necessary in the
following months, the dose volume (number of mL administered each day) should be
increased by 50%, resulting in an increase of the dose volume to 1.5 times the
dose administered the previous month of dosing. Based on the dog's current body
weight a daily dose of 0.2 mL/kg (0.09 mL/lb) should not be exceeded.
If a dog's food consumption is greatly reduced for
several consecutive days, the dose may be withdrawn until the appetite returns
(usually 1-2 days) and then resume dosing at the same volume.
The monthly adjustments should continue in this way
until the desired weight determined at the start of therapy is reached. When the
desired weight is reached, begin the weight management phase.
WEIGHT MANAGEMENT PHASE
A 3-month weight management phase is recommended to
successfully maintain the weight loss achieved with treatment. During the weight
management phase, the veterinarian and the pet owner should establish the
optimal level of food intake and physical activity needed. SLENTROL
administration should be continued during the weight management phase until the
dog owner can establish the food intake and physical activity needed to
stabilize body weight at the dog's desired weight.
To dose for weight management, body weight should
continue to be assessed at monthly intervals.
First dose adjustment
If the dog lost ≥1% body weight per week in the last
month of the weight loss phase, the dose volume (number of mL administered each
day) should be decreased by 50% resulting in a decrease of the dose volume to
0.5 times the dose administered the previous month.
If the dog lost between 0 and 1% the dose should remain
If the dog gained weight, the dose should be increased
by 50% resulting in an increase of the dose volume to 1.5 times the dose
administered the previous month.
Subsequent dose adjustments
In subsequent months the dose volume should be increased
or decreased by 25% to maintain a constant weight.
If the dog is within -5% to +5% of the body weight at
the end of the weight loss phase, the dose volume (number of mL administered
each day) should remain unchanged.
If the dog lost >5% body weight, then the dose should be
decreased by 25%.
If the dog gained > 5% body weight, then the dose should
be increased by 25%. Based on the dog's current body weight a daily dose of 0.2
mL/kg (0.09 mL/lb) should not be exceeded.
When SLENTROL is discontinued, the daily amount of food
offered and physical activity should be continued as established during the
weight management phase. Reverting to previous food intake or physical activity
levels at this point can contribute to a re-gain of some or all of the weight
loss that has been achieved.
The safety of SLENTROL use in dogs has
not been evaluated beyond 1 year.
INFORMATION FOR OWNER OR PERSON TREATING
ANIMAL: Successful implementation of any weight loss program for dogs
requires active, on-going communication between the dog owner/caretaker and the
veterinary professional treating the pet. It is important that the prescribing
veterinarian maintains an active veterinarian-client-patient relationship with
the dog and the dog owner/caretaker during all phases of therapy and proactively
communicates about their role in making the program successful in the short as
well as the long-term. When drug therapy such as SLENTROL is included in the
program, this discussion may include, but may not be limited to:
SLENTROL is not a cure for obesity. The decreased
appetite experienced when dogs are treated with dirlotapide is only temporary
and lasts no longer than 1-2 days beyond the cessation of therapy. Weight gain
will occur if the amount of food offered is not limited at the time SLENTROL is
Successful, long-term weight management requires changes
that extend beyond the period of drug therapy. To maintain the weight lost when
treated with SLENTROL, the adjustments in dietary management as well as physical
activity that were begun as part of the overall weight loss program must be
continued by the owner after drug therapy is discontinued.
SLENTROL decreases the food intake of the dog. A
decrease in appetite and associated begging behavior can be expected with
SLENTROL treatment. However, if total inappetence or anorexia is observed for
more than one day, these signs should be reported to the prescribing
Almost 1 in 4 of dogs placed on SLENTROL therapy
experienced occasional episodes of vomiting and diarrhea. In most cases these
episodes lasted for one or two days. The vomiting occurred most often during the
first month of treatment or within a week of a dose increase. If vomiting does
occur it is recommended to continue dosing at the same dose volume, however, the
time of day or method of administration (with or without food) may be changed.
If vomiting is severe or lasts longer than 2 days, consult your veterinarian and
have your dog evaluated.
CONTRAINDICATIONS: SLENTROL should not
be used in cats. SLENTROL increases the risk of producing hepatic lipidosis
during weight loss in obese cats. SLENTROL is not recommended for use in dogs
currently receiving long-term corticosteroid therapy. Do not use in dogs with
WARNINGS: Not for use in humans. Keep
this and all drugs out of reach of children.
Adverse reactions associated with humans
ingesting dirlotapide include: abdominal distention, abdominal pain, diarrhea,
flatulence, headache, increased serum transaminases, nausea, and vomiting.
SLENTROL may cause eye-irritation. If accidental eye
exposure occurs, flush the eyes immediately with clean water.
PRECAUTIONS: Safety in breeding,
pregnant, or lactating dogs has not been established. Caution should be taken
when considering any weight loss program in growing dogs, including treatment
with SLENTROL. SLENTROL has not been evaluated in dogs less than 1 year of age.
All dogs should undergo a thorough history and physical
examination that includes laboratory tests to screen for underlying conditions.
Pre-existing endocrine disease, including hyperadrenalcorticalism (Cushing's
disease), should be managed prior to use of SLENTROL.
SLENTROL may produce a mild to moderate elevation in
serum hepatic transaminase activity. If the elevation in alanine
aminotransferase (ALT) activity is mild, continue SLENTROL and monitor as
needed. If there is a marked elevation in ALT activity above the normal
reference range or there is a simultaneous increase in aspartate
aminotransferase (AST), alkaline phosphatase (ALP), γ-glutamyl transferase
(GGT), or total bilirubin, discontinue treatment with SLENTROL. Elevations in
hepatic transaminase activity usually decrease when SLENTROL is discontinued.
The safety of SLENTROL use in dogs has
not been evaluated beyond 1 year.
The adverse reactions associated with treatment with
SLENTROL include vomiting, loose stools/diarrhea, lethargy, and anorexia. These
adverse reactions were mainly observed during the first month of treatment or
during the week after a dose increase. Vomiting was usually mild in severity, of
short duration, and resolved with continued SLENTROL treatment. The
SLENTROL-treated dogs generally had an increased frequency and duration of
vomiting and diarrhea compared to the control dogs. The control dogs received
Adverse Reactions During Weight Loss:
Percentage of Patients with Reported Signs
n = 88
n = 170
In addition to the adverse reactions listed above, there
were other abnormal findings. Many control and SLENTROL-treated dogs had dental
disease, abnormal skin and ear findings, and lameness/arthritis. The incidence
of these findings were similar in both control and SLENTROL treated groups and
most dogs had similar lesions noted pre-treatment. Two dogs in the SLENTROL
treatment group developed corneal ulcers. One SLENTROL-treated and one control
dog developed signs consistent with pancreatitis. One treated dog developed
inappropriate urination and defecation and another treated dog developed
polyuria and polydipsia.
A 5 year old Beagle with no medical history of seizures
in the SLENTROL treatment group had a seizure on Day 52 of the study. The dog
continued to receive SLENTROL until additional seizures occurred 11 and 12 days
later. The investigator referred the case to a neurologist and the seizures
continued approximately twice weekly. The neurologist found no lesions that
support the causality of the seizures.
A 5 year old Dachshund developed a hepatopathy after 82
days of treatment and was withdrawn from the study for vomiting, increased
hepatic enzymes, and anorexia. Vomiting continued for a few days after stopping
treatment and the dog was hospitalized due to the anorexia. ALT activity levels
continued to rise after all clinical observations resolved.
During weight stabilization, vomiting (16.1%) and
lethargy (4.8%) were the most frequent adverse reactions associated with
treatment with SLENTROL. Other adverse reactions included diarrhea (1.6%),
anorexia (1.6%), and ataxia (1.6%).
In the post-treatment period, a 6 year old spayed female
Chihuahua, was found dead by the owner 7 days after stopping dirlotapide
therapy. The cause of death was not conclusive but did not appear to be related
to the dirlotapide therapy.
Some dogs treated with SLENTROL displayed a mild to
moderate elevation in serum hepatic transaminase activity early in treatment
that decreased over time while treatment continued. Hepatic transaminases
generally returned to normal when treatment was discontinued.
Store in original container at room temperature 15°
to 30° C (59° to 86° F).
SLENTROL is available in 20, 50 and 150 mL bottles
containing 5 mg/mL of dirlotapide in solution. Easy
to use calibrated oral dosing syringes are included.
CAUTION: Federal (USA) law
restricts this drug to use by or on the order of a licensed veterinarian.