spinosad

To kill fleas and for the prevention and treatment of flea infestations (Ctenocephalides felis) for 1 month on dogs and puppies 14 weeks of age and older and 5.0 pounds or body weight or greater.

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

Comfortis®

Dogs and Puppies (8 Weeks and Older and 5 Lbs or Greater)

Trifexis™ Chewable Tablets kill fleas and are indicated for the prevention and treatment of flea infestations (Ctenocephalides felis), and the treatment and control of adult hookworm (Ancylostoma caninum), adult roundworm (Toxocara canis and Toxascaris leonina) and adult whipworm (Trichuris vulpis) infections in dogs and puppies 8 weeks of age or older and 5 pounds of body weight or greater.

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Treatment with fewer than 3 monthly doses after the last exposure to mosquitos may not provide complete heartworm prevention. Use with caution in breeding females. The safe use of TRIFEXIS in breeding males has not been evaluated. Use with caution in dogs with pre-existing epilepsy.

Trifexis™

Dogs and Puppies (8 Weeks and Older and 5 Lbs or Greater)

Trifexis™Chewable Tablets are indicated for the prevention of heartworm disease (Dirofilaria immitis).

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Treatment with fewer than 3 monthly doses after the last exposure to mosquitos may not provide complete heartworm prevention. Use with caution in breeding females. The safe use of TRIFEXIS in breeding males has not been evaluated. Use with caution in dogs with pre-existing epilepsy.

Trifexis™

To kill fleas and for the prevention and treatment of flea infestations (Ctenocephalides felis) for 1 month on cats and kittens 14 weeks of age and older and 4.1 pounds of body weight or greater.

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

Comfortis®

COMFORTIS kills fleas and is indicated for the prevention and treatment of flea infestations (Ctenocephalides felis), for one month, on cats and kittens 14 weeks of age and older and 4.1 pounds of body weight or greater.

Comfortis™ (spinosad)

There are no known contraindications for the use of COMFORTIS.

Comfortis™ (spinosad)

There are no known contraindications to the use of TRIFEXIS.

TRIFEXIS™

Not for human use. Keep this and all drugs out of the reach of children. Serious adverse reactions have been reported following concomitant extra-label use of ivermectin with COMFORTIS (see Post Approval Experience). Keep COMFORTIS in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Comfortis™ (spinosad)

Not for human use. Keep this and all drugs out of the reach of children. Serious adverse reactions have been reported following concomitant extra-label use of ivermectin with spinosad alone, a component of TRIFEXIS (see ADVERSE REACTIONS ).

TRIFEXIS™

Not for human use. Keep this and all drugs out of the reach of children. Keep COMFORTIS in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Comfortis™ (spinosad)

In a well-controlled US field study, which included a total of 352 dogs (176 treated with TRIFEXIS and 176 treated with an active control), no serious adverse reactions were attributed to administration of TRIFEXIS. All reactions were regarded as mild. Over the 180-day study period, all observations of potential adverse reactions were recorded. Reactions that occurred at an incidence >1% (average monthly rate) within any of the 6 months of observation are presented in the following table. The most frequently reported adverse reaction in dogs in the TRIFEXIS group was vomiting. Average Monthly Rate (%) of Dogs With Adverse Reactions an=176 dogs Adverse Reaction TRIFEXIS Chewable Tabletsa Active Control Tabletsa Vomiting 6.13 3.08 Pruritus 4.00 4.91 Lethargy 2.63 1.54 Diarrhea 2.25 1.54 Dermatitis 1.47 1.45 Skin Reddening 1.37 1.26 Decreased appetite 1.27 1.35 Pinnal Reddening 1.18 0.87 In the US field study, one dog administered TRIFEXIS experienced a single mild seizure 2 ½ hours after receiving the second monthly dose. The dog remained enrolled and received four additional monthly doses after the event and completed the study without further incident. Following concomitant extra-label use of ivermectin with spinosad alone, a component of TRIFEXIS, some dogs have experienced the following clinical signs: trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation. Spinosad alone has been shown to be safe when administered concurrently with heartworm preventatives at label directions. In US and European field studies, no dogs experienced seizures when dosed with spinosad alone at the therapeutic dose range of 13.5-27.3 mg/lb (30-60 mg/kg), including 4 dogs with pre-existing epilepsy. Four epileptic dogs that received higher than the maximum recommended dose of 27.3 mg/lb (60 mg/kg) experienced at least one seizure within the week following the second dose of spinosad, but no seizures following the first and third doses. The cause of the seizures observed in the field studies could not be determined. For technical assistance or to report suspected adverse drug events, contact Elanco US Inc. at 1-888-545-5973. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

TRIFEXIS™

In a well-controlled US field study, which included a total of 470 dogs (330 dogs treated with COMFORTIS and 140 dogs treated with an active control), no serious adverse reactions were observed with COMFORTIS. All reactions were regarded as mild and did not result in any dog being removed from the study. Over the 90-day study period, all observations of potential adverse reactions were recorded. Reactions that occurred at an incidence > 1% within any of the 3 months of observation are presented in the following table. The most frequently reported adverse reaction in dogs in the COMFORTIS and active control groups was vomiting. The occurrence of vomiting, most commonly within 48 hours after treatment, decreased with repeated doses of COMFORTIS. Percentage of Dogs (%) with Adverse Reactions a This number (n=139) is less than the total number of dogs in the safety population for the active control group (n=140) because one dog joined the study late and was only dosed at Month 3. Month 1 Month 2 Month 3 COMFORTIS Chewable Tablets (N=330) Active Topical Control (N=139a) COMFORTIS Chewable Tablets (N=282) Active Topical Control (N=124) COMFORTIS Chewable Tablets (N=260) Active Topical Control (N=125) Vomiting 12.7 12.2 7.8 3.2 5.8 4.8 Decreased Appetite 9.1 5.0 2.8 1.6 1.9 0.8 Lethargy 7.6 5.0 3.5 4.0 1.2 0.8 Diarrhea 6.7 5.0 4.3 0.8 1.2 0.0 Cough 3.9 5.0 0.4 2.4 0.0 0.0 Polydipsia 2.4 1.4 0.7 0.0 0.4 0.0 Vocalization 1.8 0.0 0.4 0.0 0.4 0.0 Increased Appetite 1.5 0.0 0.4 0.8 0.4 0.0 Erythema 1.5 0.0 0.4 0.0 0.4 0.0 Hyperactivity 1.2 1.4 0.0 0.0 0.4 0.0 Excessive Salivation 1.2 0.0 0.4 0.0 0.0 0.0 In US and European field studies, no dogs experienced seizures when dosed with COMFORTIS at the therapeutic dose range of 13.5-27.3 mg/lb (30-60 mg/kg), including 4 dogs with pre-existing epilepsy. Four epileptic dogs that received higher than the maximum recommended dose of 27.3 mg/lb (60 mg/kg) experienced at least one seizure within the week following the second dose of COMFORTIS, but no seizures following the first and third doses. The cause of the seizures observed in the field studies could not be determined.

Comfortis™ (spinosad)

In a well-controlled US field study, which included a total of 211 cats (139 treated with COMFORTIS and 72 treated with an active topical control once a month for 3 treatments), no serious adverse reactions were attributed to the administration of COMFORTIS. Over the 90-day study period, all observations of potential adverse reactions were recorded. Reactions that occurred at an incidence > 1% within any of the 3 months of observations are presented in the following table. The most frequently reported adverse reaction in cats was vomiting. Percentage of Cats (%) with Adverse Reactions Month 1 Month 2 Month 3 COMFORTIS (n=139) Active Topical Control (n=72) COMFORTIS (n=135) Active Topical Control (n=69) COMFORTIS (n=132) Active Topical Control (n=67) Vomiting 14.4 1.4 14.8 1.4 13.6 4.5 Lethargy 3.6 0.0 0.7 0.0 1.5 1.5 Anorexia 2.2 0.0 0.7 0.0 2.3 1.5 Weight Loss 1.4 0.0 0.0 0.0 3.0 0.0 Diarrhea 1.4 1.4 0.7 2.9 2.3 1.5 Over the 3-month (3-dose) study, vomiting occurred on the day of or the day after at least one dose in 28.1% (39/139) of the cats treated with COMFORTIS and in 2.8% (2/72) of the cats treated with the active topical control. Three of the 139 cats treated with COMFORTIS vomited on the day of or the day after all three doses. Two cats that received extra-label topical otic ivermectin on Day -1 of the field study developed lethargy on Day 1 after COMFORTIS administration on Day 0.

Comfortis™ (spinosad)

Administer tablets once a month at a recommended minimum dosage of 13.5 mg per pound (30 mg per kilogram) of body weight.

Oral

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

Comfortis®

Dogs and Puppies (8 Weeks and Older and 5 Lbs or Greater)

Given orally, once a month at a minimum dosage of 13.5 mg/lb (30 mg/kg) spinosad and 0.2 mg/lb (0.5 mg/kg) milbemycin oxime body weight.

Oral

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Treatment with fewer than 3 monthly doses after the last exposure to mosquitos may not provide complete heartworm prevention. Use with caution in breeding females. The safe use of TRIFEXIS in breeding males has not been evaluated. Use with caution in dogs with pre-existing epilepsy.

Trifexis™

Administer tablets once a month at the minimum dosage of 22.5 mg per pound (50 mg per kilogram) of body weight.

Oral

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

Comfortis®

COMFORTIS is given orally once a month, at the recommended minimum dosage of 13.5 mg/lb (30 mg/kg). Do not use the dosing schedule below when administering COMFORTIS to cats, as it can result in an underdosage. Dosage Schedule for Dogs: * Dogs over 120 lbs should be administered the appropriate combination of tablets. Body Weight of Dog Spinosad Per Tablet (mg) Tablets Administered 5 to 10 lbs 140 One 10.1 to 20 lbs 270 One 20.1 to 40 lbs 560 One 40.1 to 60 lbs 810 One 60.1 to 120* lbs 1620 One Administer COMFORTIS with food for maximum effectiveness. COMFORTIS is a chewable tablet and is readily consumed by dogs when offered by the owner just prior to feeding. Alternatively, COMFORTIS may be offered in food or administered like other tablet medications. COMFORTIS should be administered at monthly intervals. If vomiting occurs within an hour of administration, redose with another full dose. If a dose is missed, administer COMFORTIS with food and resume a monthly dosing schedule. Treatment with COMFORTIS may begin at any time of the year, preferably starting one month before fleas become active and continuing monthly through the end of flea season. In areas where fleas are common year-round, monthly treatment with COMFORTIS should continue the entire year without interruption. To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea protection product.

ORAL

Comfortis™ (spinosad)

COMFORTIS is given orally once a month, at the minimum dosage of 22.5 mg/lb (50 mg/kg). Do not use the dosing schedule below when administering COMFORTIS to dogs, as it can result in an overdosage. Dosage Schedule for Cats: *Cats over 24 lbs should be administered the appropriate combination of tablets. Body Weight of Cat Spinosad Per Tablet (mg) Tablets Administered 4.1 to 6 lbs 140 One 6.1 to 12 lbs 270 One 12.1 to 24* lbs 560 One Administer COMFORTIS with food for maximum effectiveness. COMFORTIS is a chewable tablet that can be consumed by cats when offered by the owner just prior to or after feeding. Alternatively, COMFORTIS may be offered in food or administered like other tablet medications. COMFORTIS should be administered at monthly intervals. If vomiting occurs within an hour of administration, redose with another full dose. If a dose is missed, administer COMFORTIS with food and resume a monthly dosing schedule. Treatment with COMFORTIS may begin at any time of the year, preferably starting one month before fleas become active and continuing monthly through the end of flea season. In areas where fleas are common year-round, monthly treatment with COMFORTIS should continue the entire year without interruption. To minimize the likelihood of flea reinfestations, it is important to treat all animals within a household with an approved flea protection product.

ORAL

Comfortis™ (spinosad)

TRIFEXIS is given orally, once a month at the minimum dosage of 13.5 mg/lb (30 mg/kg) spinosad and 0.2 mg/lb (0.5 mg/kg) milbemycin oxime body weight. For heartworm prevention, give once monthly for at least 3 months after exposure to mosquitoes (see EFFECTIVENESS ). Dosage Schedule: Body Weight Spinosad Per Tablet (mg) Milbemycin oxime Per Tablet (mg) Tablets Administered 5 to 10 lbs 140 2.3 One 10.1 to 20 lbs 270 4.5 One 20.1 to 40 lbs 560 9.3 One 40.1 to 60 lbs 810 13.5 One 60.1 to 120 lbs 1620 27 One Over 120 lbs Administer the appropriate combination of tablets Administer TRIFEXIS with food for maximum effectiveness. To ensure heartworm prevention, owners should observe the dog for one hour after dosing. If vomiting occurs within an hour of administration, redose with another full dose. If a dose is missed and a monthly interval between doses is exceeded, then immediate administration of TRIFEXIS with food and resumption of monthly dosing will minimize the opportunity for the development of adult heartworm infections and flea reinfestations.

ORAL

TRIFEXIS™