Safety

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

PREEXISTING CONDITIONS AND RELEVANT MEDICAL HISTORY OF CATS ENROLLED IN THE STUDY (SAFETY POPULATION)2
Preexisting ConditionMirataz [N=115, n(%)]Placebo [N=115, n(%)]
Renal64 (55.7%)48 (41.7%)
Multisystemic56 (48.7%)48 (41.7%)
Dental35 (30.4%)39 (33.9%)
Gastrointestinal31 (27.0%)35 (30.4%)
Cardiovascular25 (21.7%)25 (21.7%)
Endocrine24 (20.9%)19 (16.5%)
Urinary23 (20.0%)32 (27.8%)
Musculoskeletal22 (19.1%)14 (12.2%)
Skin and aural20 (17.4%)15 (13.0%)
Behavioral11 (9.6%)16 (13.9%)
Respiratory8 (7.0%)17 (14.8%)
Hepatobiliary8 (7.0%)4 (3.5%)

Mirataz was safely used with a number of concomitant medications in a clinical study. For more information, please contact Veterinary Technical Support at (866) 933-2472 or support@dechra.com

Mirataz adverse events

The most common adverse events observed in the clinical field study included application-site reactions, vocalization, hyperactivity, and vomiting.3

  • Of the cats in the clinical field study, 27.8% had preexisiting vomiting at the time of enrollment due to underlying conditions.1

ADVERSE EVENTS REPORTED DURING THE CLINICAL FIELD STUDY
(OCCURRING IN >3% OF CATS IN THE MIRATAZ GROUP [SAFETY POPULATION])3,4
Description of Adverse EventMirataz [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 (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.

  • Elevated BUN levels were not considered clinically relevant and were likely due to the increased incidence of renal disease (based on clinical pathology and urinalysis) at the time of enrollment in the Mirataz group1

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. Poole M, Quimby JM, Hu T, et al. A double-blind, placebo-controlled, randomized study to evaluate the weight gain drug, mirtazapine transdermal ointment, in cats with unintended weight loss. J Vet Pharmacol Ther. 2019;42(2):179-188.

2. Data on file. REF-0194. Dechra, Ltd.

3. Mirataz® (mirtazapine transdermal ointment) [package insert], Rev. 05/2020.

4. Freedom of Information Summary, Original New Animal Drug Application, NADA 141-481, for Mirataz® (mirtazapine transdermal ointment). May 2018.

US Patent 10,603,272
Mirataz® is a registered trademark of Dechra Ltd.