The safety profile of Mirataz®

230 cats were enrolled in a field study to assess the clinical safety and effectiveness of Mirataz. Cats enrolled in the study with underlying disease may have received concurrent medications.1

PRE-EXISTING CONDITIONS AND RELEVANT MEDICAL HISTORY OF CATS ENROLLED IN THE STUDY (SAFETY POPULATION)2
Description of ConditionMirataz [n=115 (%)]Placebo [n=115 (%)]
Any condition109 (94.8%)107 (93.0%)
Renal insufficiency49 (42.6%)35 (30.4%)
Vomiting32 (27.8%)28 (24.3%)
Hyperthyroidism21 (18.3%)15 (13.0%)
Dental disease15 (13.0%)15 (13.0%)
Heart murmur15 (13.0%)13 (11.3%)
Arthritis15 (13.0%)11 (9.6%)
Periodontal disorder12 (10.4%)15 (13.0%)
Elevated BUN13 (11.3%)12 (10.4%)

Mirataz was safely used with a number of concomitant medications in a clinical study. For more information, please call 1-888-608-2542 to speak with a Professional Services Veterinarian.

Mirataz adverse events

The most common adverse reactions observed in the clinical field study included application-site reactions, behavioral abnormalities (vocalization and hyperactivity), and vomiting.2

  • Application-site reactions improved, but did not resolve upon discontinuation of dosing2

  • Of the Mirataz-treated cats that experienced vomiting, 26% had pre-existing vomiting due to underlying conditions1

ADVERSE REACTIONS REPORTED DURING THE CLINICAL FIELD STUDY
(OCCURRING IN >3% OF CATS IN THE MIRATAZ GROUP [SAFETY POPULATION])2
Adverse ReactionMirataz [n=115 (%)] Placebo [n=115 (%)]
Application Site (Ear pinna)
Erythema12 (10.4%)20 (17.4%)
Behavioral
Vocalization (including crying, mewing)13 (11.3%)2 (1.7%)
Hyperactivity (including pacing, restlessness, sleeplessness)8 (7.0%)1 (0.9%)
Disoriented state or ataxia 4 (3.5%)2 (1.7%)
Lethargy and/or weakness (including depressed, sedation, or weakness)4 (3.5%)9 (7.8%)
Physical Examination or Observational
Vomiting13 (11.3%)15 (13.0%)
Dehydration6 (5.2%)5 (4.3%)
Diarrhea or soft stool6 (5.2%)7 (6.1%)
Heart murmur5 (4.3%)7 (6.1%)
Inappetence5 (4.3%)5 (4.3%)
Renal insufficiency*4 (3.5%)0
Clinical Pathology
Hematuria7 (6.1%)1 (0.9%)
Elevated BUN
(without creatinine)**
6 (5.2%)0
Elevated creatinine and BUN5 (4.3%)1 (0.9%)
Hyperphosphatemia5 (4.3%)0
Hypokalemia5 (4.3%)2 (1.7%)
Pyuria5 (4.3%)0

*One cat with renal insufficiency was reported with a serious adverse reaction of acute renal failure, hematuria, and pyuria at the Week 2 visit. The cat was enrolled with a history of chronic kidney disease. Euthanasia was elected and necropsy revealed hypertrophic cardiomyopathy, bilateral parathyroid hyperplasia, and mild to moderate renal disease.

**At Week 2, blood urea nitrogen (BUN) values were significantly higher in the Mirataz group compared to the vehicle control group (p<0.10). The BUN in the Mirataz group was 43.60 mg/dL (reference range 16-37 mg/dL) compared to 36.05 mg/dL in the vehicle control group.

Mirataz is indicated for the management of weight loss in cats.

Important Safety Information

Mirataz® (mirtazapine transdermal ointment) is for topical use in cats only under veterinary supervision. Do not use in cats with a known hypersensitivity to mirtazapine or any of the excipients. Do not use in cats treated with monoamine oxidase inhibitors (MAOIs). Not for human use. Keep out of reach of children. Wear gloves when handling/applying, wash hands after and avoid contact between the treated cat and people or other animals for 2 hours following application. Use with caution in cats with hepatic and kidney disease. Cat’s food intake should be monitored upon discontinuation. Safety has not been evaluated in cats less than 2 kg, less than six months of age or in breeding, pregnant or lactating cats. The most common adverse reactions observed during clinical trials were application site reactions, behavioral abnormalities (vocalization and hyperactivity) and vomiting. For product label, including complete safety information, click here.

References

1. Data on file. Kindred Biosciences, Inc.

2. Mirataz® (mirtazapine transdermal ointment) [package insert], Kindred Biosciences, Inc. (Burlingame, CA). Rev. 5/2018.