ADVANTAGE MULTI FOR DOGS: Product Information (Page 3 of 5)

Heartworm-Positive Dogs

Field Study: A 56-day field safety study was conducted in 214 D. immitis heartworm and microfilaria positive dogs with Class 1, 2 or 3 heartworm disease. All dogs received Advantage Multi for Dogs on Study Days 0 and 28; 108 dogs also received melarsomine dihydrochloride on Study Days – 14, 14, and 15. All dogs were hospitalized for a minimum of 12 hours following each treatment. Effectiveness against circulating D. immitis microfilariae was > 90 % at five of six sites; however, one site had an effectiveness of 73.3 %. The microfilaria count in some heartworm-positive dogs increased or remained unchanged following treatment with Advantage Multi for Dogs alone or in a dosing regimen with melarsomine dihydrochloride.

Following treatment with Advantage Multi for Dogs alone or in a dosing regimen with melarsomine dihydrochloride, the following adverse reactions were observed:

Adverse Reaction

Dogs Treated with Advantage Multi for Dogs Only n = 106

Dogs Treated with Advantage Multi for Dogs + Melarsomine n = 108

Cough

24 (22.6 %)

25 (23.1 %)

Lethargy

14 (13.2 %)

42 (38.9 %)

Vomiting

11 (10.4 %)

18 (16.7 %)

Diarrhea, including hemorrhagic

10 (9.4 %)

22 (20.4 %)

Inappetence

7 (6.6 %)

19 (17.6 %)

Dyspnea

6 (5.7 %)

10 (9.3 %)

Tachypnea

1 (< 1 %)

7 (6.5 %)

Pulmonary Hemorrhage

0

1 (< 1 %)

Death

0

3 (2.8 %)

Three dogs treated with Advantage Multi for Dogs in a dosing regimen with melarsomine dihydrochloride died of pulmonary embolism from dead and dying heartworms. One dog, treated with Advantage Multi for Dogs and melarsomine dihydrochloride, experienced pulmonary hemorrhage and responded to supportive medical treatment. Following the first treatment with Advantage Multi for Dogs alone, two dogs experienced adverse reactions (coughing, vomiting, and dyspnea) that required hospitalization. In both groups, there were more adverse reactions to Advantage Multi for Dogs following the first treatment than the second treatment.

To report a suspected adverse reaction, call 888-545-5973.

Post-Approval Experience (2022)

The following adverse events are based on post-approval adverse drug experience reporting for Advantage Multi for Dogs. Not all adverse events are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data.

The following adverse events reported in dogs are listed in decreasing order of reporting frequency:
depression/lethargy, pruritus, vomiting, diarrhea, anorexia, application site reactions (alopecia, pruritus, erythema, and lesions, including blisters), hyperactivity, ataxia, trembling, seizures, panting, hypersalivation, anaphylaxis/anaphylactic reactions (hives, facial swelling, edema of the head), and corneal ulceration.

Serious reactions, including neurologic signs and death have been reported when cats have been exposed (orally and topically) to this product.

In humans, nausea, numbness or tingling of the mouth/lips and throat, ocular and dermal irritation, pruritus, headache, vomiting, diarrhea, depression and dyspnea have been reported following exposure to this product.

Contact Information:

For product questions, to report adverse drug experiences, or for a copy of the Safety Data Sheet (SDS), call Elanco Product & Veterinary Support at 888-545-5973.

For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

ANIMAL SAFETY:

Heartworm-Negative Dogs

Field Study: In a controlled, double-masked, field safety study, Advantage Multi for Dogs was administered to 128 dogs of various breeds, 3 months to 15 years of age, weighing 4 to 157 pounds. Advantage Multi for Dogs was used safely in dogs concomitantly receiving ACE inhibitors, anticonvulsants, antihistamines, antimicrobials, chondroprotectants, corticosteroids, immunotherapeutics, MAO inhibitors, NSAIDs, ophthalmic medications, sympathomimetics, synthetic estrogens, thyroid hormones, and urinary acidifiers. Owners reported the following signs in their dogs after application of Advantage Multi for Dogs: pruritus, flaky/ greasy residue at the treatment site, medicinal odor, lethargy, inappetence, and hyperactivity.

(See ADVERSE REACTIONS.)

Safety Study in Puppies: Advantage Multi for Dogs was applied topically at 1, 3 and 5X the recommended dose to 7-week-old Beagle puppies once every 2 weeks for 6 treatments on days 0, 14, 28, 42, 56, and 70. Loose stools and diarrhea were observed in all groups, including the controls, throughout the study. Vomiting was seen in one puppy from the 1X treatment group (day 57), in two puppies from the 3X treatment group (days 1 and 79), and in one puppy from the 5X treatment group (day 1). Two puppies each in the 1X, 3X, and 5X groups had decreased appetites within 24 hours post-dosing. One puppy in the 1X treatment group had pruritus for one hour following the fifth treatment. A puppy from the 5X treatment group displayed rapid, difficult breathing from 4 to 8 hours following the second treatment.

Dermal Dose Tolerance Study: Advantage Multi for Dogs was administered topically to 8-month-old Beagle dogs at 10X the recommended dose once. One dog showed signs of treatment site irritation after application. Two dogs vomited, one at 6 hours and one at 6 days post-treatment. Increased RBC, hemoglobin, activated partial thromboplastin, and direct bilirubin were observed in the treated group. Dogs in the treated group did not gain as much weight as the control group.

Oral Safety Study in Beagles: Advantage Multi for Dogs was administered once orally at the recommended topical dose to 12 dogs. Six dogs vomited within 1 hour of receiving the test article, 2 of these dogs vomited again at 2 hours, and 1 dog vomited again up to 18 hours post-dosing. One dog exhibited shaking (nervousness) 1 hour post-dosing. Another dog exhibited abnormal neurological signs (circling, ataxia, generalized muscle tremors, and dilated pupils with a slow pupillary light response) starting at 4 hours post-dosing through 18 hours post-dosing. Without treatment, this dog was neurologically normal at 24 hours and had a normal appetite by 48 hours post-dosing.

(See CONTRAINDICATIONS.)

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2024. All Rights Reserved.