Bravecto Plus Topical Solution for Cats 2.6-6.2 lbs (1.2-2.8 kg)

Description

Bravecto Plus Topical Solution for Cats 2.6-6.2 lbs (1.2-2.8 kg) is a bi-monthly spot-on formulation combining fluralaner (isoxazoline class) and moxidectin (milbemycin class) to address both ectoparasite infestations and endoparasite infections in a single dose. Each tube contains 112.5 mg fluralaner and 5.6 mg moxidectin.

Recommended for

Cats and kittens weighing 2.6–6.2 lbs (1.2–2.8 kg) from 6 months of age and older.

Indication/Coverage

For cats suffering from, or at risk from, mixed parasitic infections, the labeled indications for Bravecto Plus Topical Solution (2.6–6.2 lbs) are as follows:

• Heartworm prevention: Prevention of heartworm disease caused by Dirofilaria immitis larvae through systemic moxidectin activity.
• Flea treatment and prevention: Treatment and prevention of flea infestations (Ctenocephalides felis); kills adult fleas within 12 hours of treatment.
• Black-legged tick control: Treatment and control of Ixodes scapularis infestations for up to 2 months; laboratory data show 98.1% or greater effectiveness at 48 hours post-treatment.
• American dog tick control: Treatment and control of Dermacentor variabilis infestations for up to 2 months; effectiveness exceeds 90% at 48 hours.
• Asian longhorned tick control: Treatment and control of Haemaphysalis longicornis infestations for up to 2 months; laboratory studies confirm 98.1% or greater effectiveness at 48 hours.
• Gulf Coast tick control: Treatment and control of Amblyomma maculatum infestations for up to 2 months; 100% effectiveness demonstrated at 72 hours post-treatment.
• Intestinal roundworm treatment: Treatment of Toxocara cati infections, targeting 4th-stage larvae, immature adults, and adults.
• Intestinal hookworm treatment: Treatment of Ancylostoma tubaeforme infections, targeting 4th-stage larvae, immature adults, and adults.

Key Benefits

The following characteristics are drawn from Merck Animal Health’s prescribing information and controlled laboratory studies for this formulation.

• Minimum age 6 months: Bravecto Plus is labeled for cats and kittens from 6 months of age; kittens below this age threshold have not been evaluated for efficacy and the product should not be administered.
• Dual active ingredient coverage: One topical application delivers both fluralaner (ectoparasites) and moxidectin (endoparasites), removing the need to administer a separate oral heartworm preventative each month.
• Systemic absorption mechanism: Both fluralaner and moxidectin are absorbed transdermally and act systemically; fluralaner reaches peak plasma concentration between 3 and 21 days, while moxidectin peaks between 1 and 5 days post-application.
• Flea kill speed: Laboratory studies confirm that Bravecto Plus killed 100% of fleas within 12 hours of treatment and reduced live flea counts by more than 99% within 12 hours after treatment or infestation throughout the 2-month period.
• Extended 2-month dosing interval: A single application provides heartworm prevention and flea and tick control for 2 months; this is distinct from monthly oral products and reduces the frequency of handling required.
• Multi-stage worm efficacy: Moxidectin addresses Toxocara cati and Ancylostoma tubaeforme across larval and adult stages, not adults alone, which narrows the window for re-establishment of intestinal burdens.
• Topical format for cats that resist oral dosing: Spot-on administration eliminates the compliance problems associated with oral chewables in cats that actively refuse tablet administration.
• No neurologic history contraindication for most cats: The FDA-approved label states there are no known absolute contraindications; however, cats with a history of neurologic disorders should be assessed by a veterinarian before use, given the isoxazoline class association with tremors, ataxia, and seizures.

Caution

Hazards to Humans

This product is not for human use. Keep out of reach of children and do not permit children to contact the application site for at least 2 hours following administration. Avoid skin and eye contact during application; if eye contact occurs, flush slowly with water and seek medical attention if contact lenses are worn. Wash hands and any exposed skin with soap and water immediately after handling. The formulation is highly flammable; keep away from heat sources and open flame.

Hazards to Domestic Animals

Bravecto Plus is for topical use in cats only and must not be ingested. This variant is labeled for cats weighing 2.6 – 6.2 lbs (1.2 – 2.8 kg) that are at least 6 months of age; cats below this age or weight threshold should not receive this product. Safety has not been established in breeding, pregnant, or lactating cats, and use in these animals should be evaluated by a veterinarian. Fluralaner, an isoxazoline-class compound, has been associated with neurologic adverse reactions including tremors, ataxia, and seizures; cats with a history of neurologic disorders warrant veterinary assessment before administration. Use with caution in cats confirmed or suspected to be heartworm-positive; consult a veterinarian prior to initiating treatment in these animals.

Possible Side Effects

Monitor your cat following each application, particularly within the first 48 hours when post-approval adverse event reports indicate the highest incidence of reactions.

The following adverse reactions were identified across clinical field studies and post-approval experience reporting to FDA/CVM, listed in decreasing frequency of occurrence:

• Application site alopecia: Hair loss localized to the application site; generally self-limiting and resolving without intervention.
• Hypersalivation: Observed in cats that lick the application site; a consequence of the bitter taste of the formulation’s inactive ingredients, most notably diethyltoluamide, rather than a systemic toxic reaction.
• Vomiting: Reported in 5.9% of cats in the controlled U.S. field study; rate was lower than the active control group (12.2%) during the 120-day observation period.
• Lethargy: Identified in 3.7% of treated cats in the field study; transient in most cases.
• Diarrhea: Reported at 3.7% incidence in the Bravecto Plus group versus 7.3% in the active control group.
• Elevated ALT: Alanine aminotransferase elevations greater than twice the upper reference range (100 IU/L) were observed in 3.0% of treated cats, accompanied by mild AST elevations; no clinical signs of liver disease were recorded in these animals.
• Neurologic signs (rare): Tremors, ataxia, and seizures have been reported in cats receiving isoxazoline-class medications, including cats with no prior neurologic history. Discontinue use and contact a veterinarian immediately if any of these signs appear.
• Post-approval reports (48 hours post-dose): Behavioral changes including aggression and hyperactivity, periorbital swelling, erythema, excessive grooming, mydriasis, and pyrexia have been reported voluntarily in foreign markets.