Afoxolaner, moxidectin and pyrantel

Indications

NexGard® PLUS is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm ( Ancylostoma caninum , Ancylostoma braziliense , and Uncinaria stenocephala ) and roundworm ( Toxocara canis and Toxascaris leonina ) infections. NexGard® PLUS kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick) and Haemaphysalis longicornis (longhorned tick) infestations for one month in dogs and puppies eight weeks of age and older, weighing four pounds of body weight or greater. NexGard® PLUS is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

Dosage and Administration

NexGard® PLUS is given orally once a month at the minimum dosage of 1.14 mg/lb (2.5 mg/kg) afoxolaner, 5.45 mcg/lb (12 mcg/kg) moxidectin, and 2.27 mg/lb (5.0 mg/kg) pyrantel (as pamoate salt). For heartworm disease prevention, give once monthly for at least six months after last exposure to mosquitoes (see Effectiveness ). Dosing Schedule: Body Weight (lbs.) Afoxolaner Per Chewable (mg) Moxidectin Per Chewable (mcg) Pyrantel* Per Chewable (mg) Chewables Administered 4 - 8 9.375 45 18.75 One 8.1 - 17 18.75 90 37.5 One 17.1 - 33 37.5 180 75 One 33.1 - 66 75 360 150 One 66.1 - 132 150 720 300 One Over 132 Administer the appropriate combination of chewables *As pamoate salt. NexGard® PLUS can be administered with or without food. Care should be taken to ensure that the dog consumes the complete dose and that part of the dose is not lost or refused. If a dose is missed, administer NexGard® PLUS and resume a monthly dosing schedule. Heartworm Prevention: NexGard® PLUS should be administered at monthly intervals year-round or, at a minimum, administration should start within one month of the dog’s first seasonal exposure to mosquitoes and should continue at monthly intervals until at least six months after the dog’s last exposure (see Effectiveness ). When replacing another monthly heartworm preventive product, the first dose of NexGard® PLUS should be given within a month of the last dose of the former medication. Flea Treatment and Prevention: NexGard® PLUS should be administered year-round at monthly intervals or started at least one month before fleas become active. To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea control product. Tick Treatment and Control: NexGard® PLUS should be administered year-round at monthly intervals or started at least one month before ticks become active. Intestinal Nematode Treatment and Control: NexGard® PLUS treats and controls adult hookworms ( Ancylostoma caninum , Ancylostoma braziliense , and Uncinaria stenocephala ) and roundworms ( Toxocara canis and Toxascaris leonina ). For the treatment of adult hookworm and roundworm infections, NexGard® PLUS should be administered as a single dose. Monthly use of NexGard® PLUS will control any subsequent infections. Dogs may be exposed to and can become infected with hookworms and roundworms throughout the year, regardless of season or climate.

Contraindications

There are no known contraindications for the use of NexGard® PLUS.

Warnings

Not for use in humans. Keep this and all drugs out of the reach of children. In case of accidental ingestion, contact a physician for treatment advice. Keep NexGard® PLUS in a secure location out of the reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Precautions

Afoxolaner, one of the ingredients in NexGard® PLUS, is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. Treatment with fewer than six monthly doses after the last exposure to mosquitoes has not been evaluated and may not provide complete heartworm prevention. Prior to administration of NexGard® PLUS, dogs should be tested for existing heartworm infection. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. NexGard® PLUS is not effective against adult D. immitis . The safe use of NexGard® PLUS in breeding, pregnant, or lactating dogs has not been evaluated.

Adverse Reactions

In a field safety and effectiveness study, NexGard® PLUS was administered to dogs for the prevention of heartworm disease. The study included a total of 272 dogs (134 administered NexGard® PLUS and 138 administered active control) treated once monthly for 11 treatments. Over the 330-day study period, all observations of potential adverse reactions were recorded. The most frequent reactions reported in the NexGard® PLUS group are presented in the following table. Table 1. Dogs With Adverse Reactions Clinical Sign NexGard® PLUS n = 134 Number (Percentage) Active Control n = 138 Number (Percentage) Diarrhea 9 (6.7%) 7 (5.1%) Vomiting 6 (4.5%) 7 (5.1%) Lethargy 3 (2.2%) 5 (3.6%) Itching 3 (2.2%) 3 (2.2%) Dermatitis 2 (1.5%) 1 (0.7%) Anorexia 1 (0.7%) 4 (2.9%) Muscle tremor 1 (0.7%) 1 (0.7%) One dog in the NexGard® PLUS group was reported to exhibit muscle tremors along with nausea and depression for one day after the Day 0 treatment. The dog remained in the study and muscle tremors were not reported after any subsequent treatments.

Description

NexGard® PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets) is available in five sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. Each chewable is formulated to provide minimum doses of 1.14 mg/lb (2.5 mg/kg) afoxolaner, 5.45 mcg/lb (12 mcg/kg) moxidectin, and 2.27 mg/lb (5.0 mg/kg) pyrantel (as pamoate salt). Afoxolaner is a member of the isoxazoline family of compounds. Its chemical name is 1-Naphthalenecarboxamide,4-[5-[3-chloro-5-(trifluoromethyl)-phenyl]-4,5-dihydro-5-(trifluoromethyl)-3-isoxazolyl]-N-[2-oxo-2-[(2,2,2-trifluoroethyl)amino]ethyl. Moxidectin is a semisynthetic macrocyclic lactone derived from the actinomycete Streptomycetes cyaneogriseus noncyanogenus . The chemical name for moxidectin is [6R,23E,25S(E)]-5-O-Demethyl-28-deoxy-25-(1,3-dimethyl-1-butenyl)-6,28-epoxy-23-(methoxyimino) milbemycin B. Pyrantel is a member of the tetrahydropyrimidine family of compounds. Its chemical name is (E)-1,4,5,6-Tetrahydro-1-methyl-2-[2-(2-thienyl) vinyl] pyrimidine 4,4’methylenebis [3-hydroxy-2-naphthoate](1:1).

Storage

Store in original package at or below 25°C (77°F) with excursions permitted up to 40°C (104°F). Approved by FDA under NADA # 141-554 Marketed by: Boehringer Ingelheim Animal Health USA Inc., Duluth, GA 30096 NEXGARD ® is a registered trademark of Boehringer Ingelheim Animal Health France, used under license. ©2025 Boehringer Ingelheim Animal Health USA Inc. All rights reserved. 181531-006 Rev. 07/2025 Principal Display Panel – Display Carton – For Dogs 4 – 8 lbs – 3 chewables Picture of display carton containing 3 chewables for dogs 4 - 8 lbs Principal Display Panel - Display Carton – For Dogs 8.1 - 17 lbs - 3 chewables Picture of display carton containing 3 chewables for dogs 8.1 - 17 lbs Principal Display Panel - Display Carton – For Dogs 17.1 - 33 lbs - 3 chewables Picture of display carton containing 3 chewables for dogs 17.1 - 33 lbs Principal Display Panel - Display Carton – For Dogs 33.1 – 66 lbs - 3 chewables Picture of display carton containing 3 chewables for dogs 33.1 - 66 lbs Principal Display Panel – Display Carton – For Dogs 66.1 – 132 lbs – 3 chewables Picture of display carton containing 3 chewables for dogs 66.1 - 132 lbs

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 afoxolaner and moxidectin and pyrantel 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.