Aservo EquiHaler: Product Information (Page 3 of 3)

Animal Safety:

In a 1-month target animal safety study, 32 healthy adult horses (16 mares and 16 geldings) were assigned to 1 of 4 treatment groups, with 8 horses per group. Each treatment group contained 6 average weight horses (371.9 to 539.8 kg; mean 477.0 kg) and 2 light weight horses (121.5 to 260.5 kg; mean 179.5 kg). Light weight horses were specifically included to assess the safety of the highest mg ciclesonide/kg body weight dose.

Horses were randomized into four treatment groups, each receiving a different multiple of the therapeutic dose for 30 days (three times the treatment duration) administered with the nasal inhaler device. The treatment groups received 0X (vehicle control), 1X, 2X, and 3X the therapeutic dose of ciclesonide, respectively. Each treatment group included a total of 8 horses, six average weight horses (3 males and 3 females) and two light weight horses (1 male and 1 female). Horses in the control group received the same number of actuations as the highest dose group (3X) from the nasal inhaler device with vehicle only.

Mild mucoid to seromucoid nasal discharge was observed in all treatment groups, including controls, and did not appear to increase after treatment. In general, for the 0X, 2X, and 3X groups, the number of different fungal species isolated from the nares increased by Day 30; however, the result may have been an effect of extended time in the barn with direct contact with other horses and the environment rather than related to treatment with the inhaler. One horse cultured Candida species post-treatment, and that horse had no abnormal clinical signs. The dosing was intended to mimic twice daily dosing for the first 15 days, and then the once daily dosing for the second half of the study.

Facial asymmetry or deviation of the muzzle was observed in two horses during the study in the ciclesonide-treated groups. The signs resolved in one horse prior to the study conclusion.

No other related abnormal signs were observed, and no pathologic findings were correlated with this abnormality.

Cortisol levels were measured as a marker for suppression of the hypothalamic-pituitary-adrenal axis by systemic action of corticosteroids. Two light weight horses in the 3X ciclesonide-treatment group had values (16.3 and 14.1 ng/mL) that were lower than any other values recorded in the study (including baseline values and values from control horses), and lower than the normal reference range (27.6-73.2 ng/mL) on Day 14 (the end of the twice daily treatment period). At Day 29, one horse’s cortisol value returned to within the reference range (55.9 ng/mL) and the other remained low (15.9 ng/mL). These reductions in cortisol values in the smallest horses in the highest dose group may represent cortisol suppression from corticosteroid administration; however, neither of these horses had adverse events attributable to administration of ciclesonide.

Sorbitol dehydrogenase (SDH) levels were not statistically significantly different between ciclesonide treatment groups and the control group. However, one control horse (Day 14, SDH 13.6 U/L), one light weight horse in the 2X treatment group (Day 29, SDH 9.3 U/L), and two light weight horses in the 3X treatment group (Day 29, SDH values of 10.4 and 8.8 U/L) had SDH values that were above the reference range (reference range 1-8 U/L). These values did not correspond with increases in other liver enzymes and the horses remained clinically normal.

Storage Information:

Store at 15-30°C (59°-86°F), with excursions permitted up to 40°C (104°F). Protect from freezing.

Use within 12 days of activation.

How Supplied:

ASERVO EQUIHALER is supplied as one inhaler with a pre-inserted cartridge consisting of a plastic container crimped in an aluminum cylinder which contains inhalation solution for 140 treatment actuations (puffs).

Approved by FDA under NADA # 141-533

Marketed by:

Boehringer Ingelheim Animal Health USA Inc.

Duluth, GA 30096

Made in France

ASERVO® and EQUIHALER® are registered trademarks of Boehringer Ingelheim Vetmedica GmbH, used under license.

The Horse Head Logo is a trademark of Boehringer Ingelheim Animal Health USA Inc.

© 2020 Boehringer Ingelheim Animal Health USA Inc. All rights reserved.

449301-00

Revised 02/2020

Principal Display Panel – Label, 140 actuations (puffs)

NDC 0010-4493-01

Aservo® Equihaler®

(ciclesonide inhalation spray)

343 mcg/actuation

Glucocorticoid

For intranasal inhalation in horses only

140 actuations (puffs)

A picture of the device label.
(click image for full-size original)

Principal Display Panel – Display Carton, 140 actuations (puffs)

NDC 0010-4493-01

Aservo® Equihaler

(ciclesonide inhalation spray)

343 mcg/actuation

Glucocorticoid

For intranasal inhalation in horses only

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

Net Contents: 140 actuations (puffs)

Approved by FDA under NADA # 141-533

A picture of the carton Top
(click image for full-size original)
A picture of the carton side (1 of 2)
(click image for full-size original)
A picture of the carton side (2 of 2)
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ASERVO EQUIHALER
ciclesonide spray, metered
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0010-4493
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CICLESONIDE (CICLESONIDE) CICLESONIDE 343 ug
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0010-4493-01 1 INHALER in 1 CARTON contains a INHALER
1 140 SPRAY, METERED in 1 INHALER This package is contained within the CARTON (0010-4493-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141533 07/01/2020
Labeler — Boehringer Ingelheim Animal Health USA Inc. (007134091)

Revised: 06/2020 Boehringer Ingelheim Animal Health USA Inc.

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