Program Cat Injectable (40 mg) (Canada)

Treatment with PROGRAM should continue year round in areas where fleas are present throughout the year. All cats inhabiting the same household must receive PROGRAM. Failure to treat all pets (including dogs) in the household with an appropriate flea control product may result in suboptimal flea control, caused by re-infestation from untreated animals. Discontinuation of the PROGRAM regimen may result in flea re-infestation from sources outside the pet’s immediate environment.

Program Cat Injectable (40 mg) Cautions

For use in cats only. Do NOT use in dogs. Anaphylaxis has been reported with the use of this product. If an allergic reaction or anaphylaxis occurs, appropriate therapy should be instituted.

Warnings

Keep this and all drugs out of the reach of children. If accidentally self injected, call a physician.

Adverse Reactions

Although all adverse reactions are not reported, the following information is based on voluntary post-approval drug experience reporting. It is generally recognized that this results in significant under-reporting. The adverse events listed here reflect reporting and not necessarily causality. The clinical signs reported were rare¹ or very rare². The following adverse events are listed by body system, in decreasing order of frequency.

Systemic disorders: lack of efficacy¹*, lethargy², anorexia²

Application site disorders: injection site lump², injection site edema², injection site pain²

Digestive tract disorders: vomiting²

*Lack of efficacy, real or perceived, may occur if product directions are not followed and all animals in a household are not treated with an appropriate flea control product (see DOSAGE AND ADMINISTRATION section).

In very rare cases, death has also been reported.

¹Reported in at least 1 but not more than 10 animals in 10,000 animals.

²Reported in less than 1 in 10,000 animals.

To report suspected adverse drug events or for technical assistance, contact Elanco Canada Limited at 1-800-265-5475.

Pharmacology

Lufenuron, the active ingredient of PROGRAM, belongs to the chemical group of benzoylphenylurea compounds. These compounds are classified as insect development inhibitors, which interfere with the transport process involved in polymerization of chitin or in the deposition of chitin chains. Chitin is the principle component of the flea egg case and cuticle that forms the exoskeleton of larval stages and adult fleas. Most affected flea eggs fail to hatch and, of those that do hatch, surviving larval stages fail to develop.

PROGRAM acts by interrupting the early stages of the flea life cycle, thereby preventing the build-up of flea infestations on cats and their surroundings. The development-inhibiting effect of this drug occurs when the adult flea is exposed through the blood meal to lufenuron present in the animal’s blood. Eggs and larvae from adult fleas exposed to lufenuron in this manner fail to develop properly and die. Because female fleas must feed on blood before they can lay eggs, entire populations of immature life stages are eliminated, resulting in flea control.

Lufenuron has no direct effect on mature fleas since they have fully developed exoskeletons.

Pharmacokinetics

Following administration, lufenuron is distributed from the vascular compartment to adipose tissue. It is released steadily back into the blood, thus maintaining levels above the minimum effective concentration between treatments.

Safety

PROGRAM has a wide margin of safety in cats.

PROGRAM has been tested safely in over 10 breeds of cats, including pregnant females, breeding males and females, and kittens. In well controlled clinical studies, PROGRAM was safely used in cats, many of which received other commonly used veterinary products such as vaccines, anthelmintics, antibiotics, steroids, flea collars, insecticide shampoos and dips. Breeding studies in purpose-bred cats demonstrated no adverse responses in either the parental generation or in the birth and survival rate of their progeny following exposure to high doses of lufenuron (in excess of 3 times the blood level achieved by a single dose). Males and females were given multiple doses 60 days prior to mating through pairing, and females were continually dosed throughout gestation and weaning.

Lufenuron was evaluated in young adult cats approximately 9 months of age for 3 months at rates up to 17 times the monthly use rate, administered on 3 consecutive days each month, without observable adverse effects. In the same study, the drug was administered at exaggerated levels (17x) concomitantly with commonly used carbamate and pyrethroid insecticide products for fleas. No toxicity enhancing effects were observed when lufenuron was administered simultaneously with the topically applied commercial insecticides. Tolerability studies in juvenile cats (11 weeks of age) and young adult cats (7 months of age) at 10 times the monthly use rate indicated a high degree of tolerance to lufenuron.

Storage Conditions

PROGRAM should be stored at room temperature, between 15 - 30 °C. Keep from freezing.

Presentation

PROGRAM is available in unit dose packaging (see DOSAGE AND ADMINISTRATION section) designed to deliver 40 mg or 80 mg lufenuron per unit.

MANUFACTURED FOR

Elanco Canada Limited, 1919 Minnesota Court, Suite 401, Mississauga, Ontario L5N 0C9

DATE: May 2022

Program, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

© 2022 Elanco or its affiliates.

18May2022

CPN: 1231023.5