NexGard COMBO: Product Information

NEXGARD COMBO- esafoxolaner, eprinomectin and praziquantel solution
Boehringer Ingelheim Animal Health USA Inc.

For topical use in cats only

Caution:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description:

NexGard® COMBO is a topical solution containing esafoxolaner, eprinomectin and praziquantel available in 0.3 mL and 0.9 mL unit applicators to treat cats from 1.8 lbs to 33 lbs. Each mL of NexGard® COMBO contains 12 mg of esafoxolaner, 4 mg of eprinomectin, and 83 mg of praziquantel. Inactive ingredients: butylated hydroxytoluene, un-stabilized glycerol formal, and dimethyl isosorbide.

Esafoxolaner is a member of the aryl isoxazoline class of compounds. Its chemical name is 4-[(5S)-5-[3-chloro-5-(trifluoromethyl)phenyl]-5-(trifluoromethyl)-4, 5-dihydro-1,2-oxazol-3-yl]-N-{2-oxo-2-[(2,2,2-trifluoroethyl)amino]ethyl}-1-naphthamide.

Eprinomectin belongs to the avermectin class of anthelmintics and is a mixture of homologous components referred to as eprinomectin B1a and B1b. The chemical name for eprinomectin B1a is (4”R)-acetylamino-5-O-demethyl-4”-deoxyavermectin A1a. The chemical name for eprinomectin B1b is (4”R)-acetylamino-5-O-demethyl-25-de(1-methylpropyl)- 4”-deoxy-25-(1-methylethyl)avermectin A1a.

Praziquantel is a pyrazinoisoquinoline anthelmintic. Its chemical name is 2-(Cyclohexylcarbonyl)- 1,2,3,6, 7,11b-hexahydro-4H-pyrazino[2,1-a]-isochinolin-4-one.

Indications:

NexGard® COMBO is indicated for the prevention of heartworm disease caused by Dirofilaria immitis. NexGard® COMBO kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the treatment and control of Ixodes scapularis (black-legged tick) and Amblyomma americanum (lone star tick) infestations, and the treatment and control of roundworms (fourth stage larval and adult Toxocara cati), hookworms (fourth stage larval and adult Ancylostoma tubaeforme ; adult Ancylostoma braziliense), and tapeworms (Dipylidium caninum) in cats and kittens 8 weeks of age and older, and weighing 1.8 lbs or greater.

Dosage and Administration:

NexGard® COMBO is dosed at a minimum of 0.055 mL/lb (0.12 mL/kg), which delivers a minimum dose of 0.66 mg/lb (1.45 mg/kg) esafoxolaner, 0.23 mg/lb (0.51 mg/kg) eprinomectin, and 4.55 mg/lb (10.0 mg/kg) praziquantel.

For heartworm disease prevention, apply once monthly for at least three months after last exposure to mosquitoes ( see Effectiveness).

Administer the entire contents of a NexGard® COMBO unit applicator topically once a month as specified in the following table:

Dosing Schedule

Cat Weight (lb)	Volume (mL)	Esafoxolaner (mg)	Eprinomectin (mg)	Praziquantel (mg)
1.8- 5.5	0.3	3.6	1.2	24.9
5.6-16.5	0.9	10.8	3.6	74.7
16.6-22	0.3 + 0.9	14.4	4.8	99.6
22.1-33	0.9 + 0.9	21.6	7.2	149.4

To apply NexGard® COMBO, pull back the plunger of the unit applicator slightly and remove the cap. Part the hair in one spot on the midline of the neck between the base of the skull and the shoulder blades, place the tip of the unit applicator on the skin and apply the contents directly on the skin. If the weight of the cat requires a second application, apply the contents in the same manner as described above in the same location.

Heartworm Prevention:

For the prevention of heartworm disease, NexGard® COMBO should be administered once a month year-round. At a minimum, administration of NexGard® COMBO should start at least 1 month before the cat’s first expected exposure to mosquitoes and monthly thereafter until at least 3 months after the cat’s last seasonal exposure to mosquitoes (see Effectiveness). If a dose is missed and a 30-day interval between doses is exceeded, administer NexGard® COMBO immediately and resume the monthly dosing schedule. Treatment with fewer than 3 monthly doses may not provide complete heartworm prevention.

When replacing another monthly heartworm preventive product in a heartworm prevention program, the first treatment with NexGard® COMBO should be given within one month of the last dose of the former medication. At the discretion of the veterinarian, cats older than 6 months of age may be tested to determine the presence of existing heartworm infection before treatment with NexGard® COMBO. Cats already infected with adult heartworms can be given NexGard® COMBO monthly to prevent further infections.

Flea Treatment and Prevention:

For the treatment and prevention of flea infestations, the use of NexGard® COMBO may begin at any time of year. NexGard® COMBO should be administered year-round at monthly intervals or begin at least one month before fleas become active. However, an environmental infestation may persist for a short time after beginning treatment with NexGard® COMBO because of the development of adult fleas from eggs that were laid prior to the initiation of treatment.

Tick Treatment and Control:

For the treatment and control of infestations with Ixodes scapularis and Amblyomma americanum , the use of NexGard® COMBO may begin at any time of year. NexGard® COMBO should be administered year-round at monthly intervals or begin at least one month before the ticks become active.

Treatment and Control of Roundworms, Hookworms, and Tapeworms:

NexGard® COMBO provides treatment and control of roundworms (adult and fourth stage larval Toxocara cati), hookworms (adult and fourth stage larval Ancylostoma tubaeforme ; adult Ancylostoma braziliense), and tapeworms (Dipylidium caninum). For the treatment of hookworm, roundworms and tapeworm infections, NexGard® COMBO should be administered once as a single dose. Monthly use of NexGard® COMBO will control any subsequent infections. Cats may be exposed to and can become infected with roundworms, hookworms, and tapeworms throughout the year, regardless of season or climate.

Contraindications:

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

Human Warnings:

Not for human use. Keep this and all drugs out of sight and reach of children.

Avoid direct contact with application site for 4 hours or until visibly dry. This product may act as a mild to moderate eye irritant.

Keep product in the original packaging until use. Wash hands after product administration. If the product accidentally gets into the eyes, rinse thoroughly with water. If wearing contact lenses, flush the eyes first with water and then remove the lenses and continue to flush thoroughly with water. In case of accidental ingestion, or if skin or eye irritation occurs, contact a poison control center or physician for treatment advice.