Slentrol for Dogs, 150 mL (dirlotapide)

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 obesity.

• Provides a medically appropriate approach to weight management for obese dogs
• 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 instructions below.

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 therapy.

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 month

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 Weight Loss

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 week.

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 volume (mL).

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 assessment.

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 apply:

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 the same.

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 discontinued.

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 veterinarian.

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 liver disease.

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.

ADVERSE REACTIONS:

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 corn oil.

Adverse Reactions During Weight Loss:

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.