Trifexis: Product Information

TRIFEXIS- spinosad and milbemycin oxime tablet
Elanco US Inc,

Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Description:

TRIFEXIS (spinosad and milbemycin oxime) is available in five sizes for oral administration to dogs and puppies according to their weight. Each chewable flavored tablet is formulated to provide a minimum spinosad dose of 13.5 mg/lb (30 mg/kg) and a minimum milbemycin oxime dose of 0.2 mg/lb (0.5 mg/kg). Spinosad is a member of the spinosyns class of insecticides, which are non-antibacterial tetracyclic macrolides. Spinosad contains two major factors, spinosyn A and spinosyn D, derived from the naturally occurring bacterium, Saccharopolyspora spinosa. Spinosyn A and spinosyn D have the chemical compositions C41 H65 NO10 and C42 H67 NO10 , respectively. Milbemycin oxime is a macrocyclic lactone anthelmintic, containing two major factors, A3 and A4 of milbemycin oxime. The approximate ratio of A3 :A4 is 20:80. Milbemycin A4 5-oxime has the chemical composition of C32 H45 NO7 and milbemycin A3 5-oxime has the chemical composition of C31 H43 NO7 .

Indications:

TRIFEXIS is indicated for the prevention of heartworm disease (Dirofilaria immitis). TRIFEXIS kills fleas and is 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.

Dosage and Administration:

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 Milbemycin oxime Tablets
Per Tablet (mg) Per Tablet (mg) 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.

Heartworm Prevention:

TRIFEXIS should be administered at monthly intervals beginning within 1 month of the dog’s first seasonal exposure and continuing until at least 3 months after the dog’s last seasonal exposure to mosquitoes (see EFFECTIVENESS). TRIFEXIS may be administered year round without interruption. When replacing another heartworm preventative product, the first dose of TRIFEXIS should be given within a month of the last dose of the former medication.

Flea Treatment and Prevention:

Treatment with TRIFEXIS 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 TRIFEXIS 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.

Intestinal Nematode Treatment and Control:

TRIFEXIS also provides treatment and control of roundworms

(T. canis, T. leonina), hookworms (A. caninum) and whipworms (T. vulpis). Dogs may be exposed to and can become infected with roundworms, whipworms and hookworms throughout the year, regardless of season or climate. Clients should be advised of measures to be taken to prevent reinfection with intestinal parasites.

Contraindications:

There are no known contraindications to the use of TRIFEXIS.

Warnings:

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).

Precautions:

Treatment with fewer than 3 monthly doses after the last exposure to mosquitoes may not provide complete heartworm prevention (see EFFECTIVENESS).

Prior to administration of TRIFEXIS, 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. TRIFEXIS is not effective against adult D. immitis. While the number of circulating microfilariae may decrease following treatment, TRIFEXIS is not indicated for microfilariae clearance (see ANIMAL SAFETY). Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some dogs treated with milbemycin oxime carrying a high number of circulating microfilariae. These reactions are presumably caused by release of protein from dead or dying microfilariae.

Use with caution in breeding females (see ANIMAL SAFETY). The safe use of TRIFEXIS in breeding males has not been evaluated.

Use with caution in dogs with pre-existing epilepsy (see ADVERSE REACTIONS).

Puppies less than 14 weeks of age may experience a higher rate of vomiting (see ANIMAL SAFETY).

Adverse Reactions:

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

a n=176 dogs

Adverse Reaction TRIFEXIS Chewable Active Control
Tablets a Tablets a
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/AnimalVeterinary/SafetyHealth

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