Fluralaner and moxidectin

Indications

Bravecto Plus is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm ( Toxocara cati ; 4 th stage larvae, immature adults and adults) and hookworm ( Ancylostoma tubaeforme ; 4 th stage larvae, immature adults and adults). Bravecto Plus kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of tick infestations [ Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Haemaphysalis longicornis (Asian longhorned tick), and Amblyomma maculatum (Gulf Coast tick)] for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.

Dosage and Administration

Bravecto Plus should be administered topically as a single dose every 2 months according to the Dosage Schedule below to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin. For prevention of heartworm disease, Bravecto Plus should be administered at 2-month intervals. Bravecto Plus may be administered year-round without interruption or at a minimum should be administered at 2-month intervals beginning at the cat's first seasonal exposure to mosquitoes and continuing until the cat's last seasonal exposure to mosquitoes. If a dose is missed and a 2-month interval between doses is exceeded, administer Bravecto Plus immediately and resume the dosing every 2 months. When replacing a monthly heartworm preventative product, the first dose of Bravecto Plus should be given within one month of the last dose of the former medication. Dosing Schedule: Body Weight Ranges (lb) Fluralaner content (mg/tube) Moxidectin content (mg/tube) Tubes Administered 2.6 – 6.2 112.5 5.6 One >6.2 – 13.8 250 12.5 One >13.8 – 27.5 Cats over 27.5 lb should be administered the appropriate combination of tubes. 500 25 One A veterinarian or veterinary technician should demonstrate or instruct the pet owner regarding the appropriate technique for applying Bravecto Plus topically to cats prior to first use. Step 1: Immediately before use, open the pouch and remove the tube. Put on gloves. Hold the tube at the crimped end with the cap in an upright position (tip up). The cap should be rotated clockwise or counter clockwise one full turn. The cap is designed to stay on the tube for dosing and should not be removed . The tube is open and ready for application when a breaking of the seal is felt. Step 2: The cat should be standing or lying with its back horizontal during application. Part the fur at the administration site. Place the tube tip vertically against the skin at the base of the skull of the cat. Step 3: Squeeze the tube and gently apply the entire contents of Bravecto Plus directly to the skin at the base of the skull of the cat. Avoid applying an excessive amount of solution that could cause some of the solution to run and drip off of the cat. If a second spot is needed to avoid run off, then apply the second spot slightly behind the first spot. Greasy, oily, or wet appearance may occur at the application site in some cats. Image Image

Contraindications

There are no known contraindications for the use of the product.

Warnings

Human Warnings: Not for human use. Keep this and all drugs out of the reach of children. Do not contact or allow children to contact the application site until 2 hours post application. Keep the product in the original packaging until use in order to prevent children from getting direct access to the product. Do not eat, drink or smoke while handling the product. Avoid contact with skin and eyes. If contact with eyes occurs, then flush eyes slowly and gently with water. If wearing contact lenses, eyes should be rinsed first, then remove contact lenses and continue rinsing, then seek medical advice immediately. Wash hands and contacted skin thoroughly with soap and water immediately after use of the product. If the product accidentally contacts skin and a sticky residue persists after washing, rubbing alcohol (70% isopropyl alcohol) can be applied to the area to remove the residue. The product is highly flammable. Keep away from heat, sparks, open flame or other sources of ignition.

Precautions

For topical use only. Avoid oral ingestion (see

Adverse Reactions

In a well-controlled U.S. field study, which included a total of 176 treated cats (135 with Bravecto Plus and 41 with a monthly topical active control), there were no serious adverse reactions. Percentage of Cats with Adverse Reactions (AR) in the Field Study Adverse Reaction Bravecto Plus Group: Percent of Cats with the AR During the 120-Day Study (n=135 cats) Active Control Group: Percent of Cats with the AR During the 120-Day Study (n=41 cats) Vomiting 5.9% 12.2% Alopecia (not at application site) 5.2% 2.4% Pruritus 4.4% 12.2% Application site pruritus 4.4% 4.9% Diarrhea 3.7% 7.3% Lethargy 3.7% 9.8% Dry Skin 3.0% 0.0% Elevated alanine aminotransferase (ALT) ALT was greater than twice the upper reference range of 100 IU/L. These cats also had mild elevations of aspartate aminotransferase (AST) (less than twice the upper reference range of 100 IU/L). No clinical signs associated with liver disease were noted in these cats. 3.0% 0.0% Hypersalivation 1.5% 1.5% Application site alopecia 0.7% 0.0% In well-controlled laboratory effectiveness studies, the following adverse reactions were seen after application of Bravecto Plus: pyrexia, tachypnea, mydriasis, pruritus, scabbing, and bloody stool. Foreign Market Experience: The following adverse events were reported voluntarily during post-approval use of the product in cats in foreign markets: polydipsia, swelling of chin and lips, periorbital swelling, blepharospasm, pruritus, erythema, aggression, agitation, pyrexia, mydriasis, hypersalivation, hyperactivity, alopecia, and excessive grooming. These adverse events occurred within 48 hours of administration. In a European field study for fluralaner topical solution for cats, there were three reports of facial dermatitis in humans after close contact with the application site which occurred within 4 days of application. In foreign market experience reports for Bravecto Plus, one veterinarian experienced tingling and numbness of the fingers, hand, and arm, and swelling of the hand and arm after getting Bravecto Plus on her fingers. Additional signs, including blurred vision and disorientation, occurred after taking an antihistamine. Post-Approval Experience (2022): The following adverse events are based on post-approval adverse drug experience reporting for Bravecto Plus. 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 these data. The following adverse events reported in cats are listed in decreasing order of reporting frequency: Application site alopecia, lethargy, hypersalivation, vomiting, anorexia, application site disorders (including pruritus, erythema, and lesions), behavioral disorders (including hiding and hyperactivity), ataxia, generalized pruritus, muscle tremor, alopecia, weight loss, and diarrhea.

Description

Each tube is formulated to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin. Each milliliter contains 280 mg of fluralaner and 14 mg of moxidectin. The chemical name of fluralaner is (±)-4-[5-(3,5-dichlorophenyl)-5-(trifluoromethyl)- 4,5-dihydroisoxazol-3-yl]-2-methyl- N -[2-oxo-2-(2,2,2- trifluoroethylamino)ethyl]benzamide. The chemical name of moxidection is (2aE,4E,5'R,6R,6'S,8E,11R,13S,15S,17aR,20R,20aR,20bS)-6'-[(E)-1,3-Dimethyl-1-butenyl]-5',6,6',7,10,11,14,15,17a,20,20a,20b-dodecahydro-20,20b-dihydroxy-5',6,8,19-tetramethylspiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6] benzodioxacyclooctadecin-13,2'-[2H]pyran]-4',17(3'H)-dione 4'-(E)-(O-methyloxime). Inactive ingredients: dimethylacetamide, glycofurol, diethyltoluamide, acetone, butylhydroxytoluene

Storage

Do not store above 77°F (25°C). Store in the original package in order to protect from moisture. The pouch should only be opened immediately prior to use.

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 fluralaner and moxidectin 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.