Praziquantel and emodepside

Indications

PROFENDER Topical Solution is indicated for the treatment and control of hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults, and fourth stage larvae), roundworm infections caused by Toxocara cati (adults and fourth stage larvae), and tapeworm infections caused by Dipylidium caninum (adults) and Taenia taeniaeformis (adults) in cats.

Dosage and Administration

The recommended minimum dose is 1.36 mg/lb (3 mg/kg) emodepside + 5.45 mg/lb (12 mg/kg) praziquantel as a single topical dose. A single treatment is effective and a second treatment should not be necessary. If re-infection occurs, the product can be re-applied after 30 days. 1. Select the package that correctly corresponds with the body weight of the cat. (See Table below.) * Cats over 17.6 lbs should be treated with the appropriate combination of tubes. Cat Weight* Profender Topical Solution Volume (mL) Emodepside (mg) Praziquantel (mg) 2.2-5.5 lbs. Small 0.35 7.5 30.0 >5.5-11 lbs. Medium 0.70 15.0 60.1 >11-17.6 lbs. Large 1.12 24.0 96.1 2. Remove one unit dose tube from the package. 3. While holding the tube in an upright position, remove the cap from the tube. 4. Turn the cap over and place the other end of cap onto the tip of the tube. 5. Twist the cap to break the seal and then remove cap from the tube. 6. Part the hair on the back of the cat’s neck at the base of the head, until the skin is visible. 7. The ensure the entire contents of the tube are administered, place the tip of the tube on the skin and squeeze the entire contents directly onto the skin. Lift tube away from the skin before releasing pressure on the tube. Do not apply to broken skin or if hair coat is wet. Do not get this product in the cat’s mouth or eyes or allow the cat to lick the application site for one hour. Oral exposure can cause salivation and vomiting. Treatment at the base of the head will minimize the opportunity for ingestion while grooming. In households with multiple pets, keep animals separated to prevent licking of the application site. Stiff hair, a damp appearance of the hair, or a slight powdery residue may be observed at the treatment site. These effects are temporary and do not affect the safety or effectiveness of the product. Figure 1 Figure 2 HUMAN WARNINGS: Not for human use. Keep out of reach of children. To prevent accidental ingestion of the product, children should not come in contact with the application site for twenty-four (24) hours while the product is being absorbed. Pregnant women, or women who may become pregnant, should avoid direct contact with, or wear disposable gloves when applying, this product. Studies performed in rats and rabbits suggest that emodepside may interfere with fetal development in those species. PROFENDER Topical Solution may be irritating to skin and eyes. Reactions such as facial, tongue and hand swelling have been reported in humans in rare instances. Avoid contact with the application area while it is wet and wash hands thoroughly with soap and warm water after handling. People with known hypersensitivity to butylhydroxyanisole, emodepside or praziquantel should administer the product with caution. If the product accidentally gets into eyes, flush thoroughly with water. May be harmful if swallowed. In case of accidental ingestion or if skin or eye irritation occurs, call a poison control center or physician for treatment advice. The Safety Data Sheet (SDS) provides additional occupational safety information. For product questions, to report adverse reactions, or for a copy of the Safety Data Sheet (SDS), call Elanco Product & Veterinary Support at 888-545-5973.

Precautions

Safe use of this product has not been evaluated in cats less than 8 weeks of age or weighing less than 2.2 lbs (1 kg), in cats used for breeding, during pregnancy or in lactating queens. The effectiveness of this product when used before bathing has not been evaluated. Use with caution in sick or debilitated cats. Oral ingestion or exposure should be avoided. Use with caution in heartworm positive cats. The cats enrolled in the field study were heartworm antigen and antibody negative prior to entering the study. In a laboratory study, cats artificially infected with adult heartworms and treated with PROFENDER Topical Solution had fewer worms recovered than the placebo control group. ( See ANIMAL SAFETY. )

Adverse Reactions

Field study: In a controlled, double-masked field safety study, owners administered PROFENDER Topical Solution to 606 cats. Adverse reactions reported by the cat owners included licking/excessive grooming in 18 cats (3.0%), scratching treatment site in 15 cats (2.5%), salivation in 10 cats (1.7%), lethargy in 10 cats (1.7%), alopecia in 8 cats (1.3%), agitation/nervousness in 7 cats (1.2%), vomiting in 6 cats (1.0%), diarrhea in 3 cats (0.5%), eye irritation in 3 cats (0.5%), respiratory irritation in 1 cat (0.2%) and shaking/tremors in 1 cat (0.2%). All adverse reactions were self-limiting. Laboratory effectiveness studies: One cat died 10 days after receiving PROFENDER Topical Solution. The necropsy showed chronic active cholangiohepatitis. While the use of the drug did not appear to be the direct cause of death, treatment with the drug cannot be ruled out as a contributing factor ( See PRECAUTIONS ). One cat treated with a vehicle placebo (formulation minus the active ingredients) showed salivation, gagging, lethargy and a swollen tongue. Foreign Market Experience: The following adverse events were reported voluntarily during post-approval use of the product in foreign markets: application site reaction (hair loss, dermatitis, pyoderma, edema, and erythema), salivation, pruritus, lethargy, vomiting, diarrhea, dehydration, ataxia, loss of appetite, facial swelling, rear leg paresis, seizures, hyperesthesia, twitching, and death. Post-Approval Experience: The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse events are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data. The following adverse events are listed in decreasing order of reporting frequency in cats: Application site reaction (hair loss, dermatitis, pyoderma, edema, and erythema), hypersalivation, lethargy/depression, vomiting, ataxia, anorexia, trembling/twitching, diarrhea, mydriasis, fever, hyper-activity/nervousness. In some cases, death has been reported as an outcome of the adverse events listed. For a complete listing of the adverse reactions for Profender Topical Solution reported to the CVM see: http://www.fda.gov/ADEreports . This listing includes Adverse Events reported to CVM for products, such as Profender, that contain the combined active ingredients emodepside and praziquantel. Listings by active ingredient may represent more than one brand name.

Description

PROFENDER [1.98% emodepside/7.94% praziquantel] Topical Solution is a clear yellow ready-to-use solution packaged in single unit dosing applicator tubes for topical (dermal) treatment of cats 8 weeks of age and older and weighing at least 2.2 lbs (1 kg). The formulation and dosage schedule is designed to provide a minimum of 1.36 mg/lb (3 mg/kg) emodepside and 5.45 mg/lb (12 mg/kg) praziquantel based on body weight. Emodepside, a semi-synthetic molecule, is a cyclic depsipeptide. The chemical name is Cyclo [D-2-hydroxypropanoyl-N-methyl-L-leucyl-3-[4-(4-morpholinyl)phenyl]-D-2-hydroxypropanoyl-N-methyl-L-leucyl-D-2-hydroxypropanoyl-N-methyl-L-leucyl-3-[4-(4-morpholinyl)phenyl]-D-2-hydroxypropanoyl-N-methyl-L-leucyl]. Praziquantel is an isoquinoline cestocide. The chemical name is 2-Cyclohexylcarbonyl-1,2,3,6,7,11b-hexahydro-4H-pyrazine-2,1-a-iso-quinoline-4-one.

Storage

Store at or below 77º F (25º C). Protect from freezing.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming praziquantel and emodepside as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.