Credelio: Product Information (Page 2 of 2)

Animal Safety:

In a margin of safety study, CREDELIO CAT was administered orally to 24 (8 cats/group) 8-week-old cats at 1, 3 and 5X the maximum labeled dose of 26 mg/kg every 28 days for eight consecutive doses. The 8 cats in the control group (0X) were untreated.

There were no clinically-relevant, treatment-related effects on physical and neurologic examinations or gross pathology. Dry food consumption was reduced in male cats in all treated groups compared to control cats. Body weights of male cats in the 3X group were less than the control male cats. Vomiting occurred post-dosing in cats in all groups, including the control group, but was increased in the 5X group. At multiple time points, neutrophil counts were decreased (750-2710/μL; low end of normal: approximately 2800/μL) in cats in all treated groups compared to control cats, including in a cat in the 3X group that died during anesthesia to obtain the electrocardiogram (ECG). From Days 28 to 92, two and three female cats in the 3X and 5X group, respectively, had elevations in blood urea nitrogen (BUN) at least at one time point (37-43 mg/dL; high end of normal: 36 mg/dL). Three cats each in the control, 1X and 5X groups and six cats in the 3X group had minimal, usually unilateral, tubular regeneration of the kidneys. One cat each in the control, 1X and 5X groups and four cats in the 3X group had minimal generalized lymphoid depletion of the thymus. Four of the five cats in the two high-dose groups (3X and 5X) with the thymus changes also had neutropenia at 25% or more of the time points.

Blood concentrations of lotilaner confirmed systemic exposure in all cats administered lotilaner, although the exposure was less than dose proportional.

Storage Information:

Store at 15-25°C (59 -77°F), excursions permitted between 5 to 40°C (41 to 104°F).

How Supplied:

CREDELIO CAT is available in two chewable tablet sizes for use in cats: 12 and 48 mg lotilaner. Each chewable tablet size is available in color-coded packages containing 1 chewable tablet. The 48 mg chewable tablet size is also available in color-coded packages containing 3 or 6 chewable tablets.

Approved by FDA under NADA # 141-528

Manufactured for:
Elanco US Inc
Greenfield, IN 46140 USA

CredelioCAT.com

Credelio, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2021 Elanco or its affiliates

Rev. date 05/2021

PA103327X

Elanco TM

Principal Display Panel — 1 Tablet 12 mg Box Label

1 TABLET

Cats &
Kittens

2.0-4.0 lbs

Credelio™
CAT (lotilaner)

Treats and prevents flea infestations in
cats and kittens 8 weeks of age and older.
Treats and controls Ixodes scapularis
tick infestations in cats and kittens
6 months of age and older.

12 mg chewable tablet

Kills fleas

Kills I. scapularis
ticks

Monthly dose

Give with
food

CAUTION: Federal (USA) law restricts this drug touse by or on the order of a licensed veterinarian.

Approved by FDA under NADA # 141-528

ElancoTM

Principal Display Panel -- 1 Tablet 12 mg Box Label
(click image for full-size original)

Principal Display Panel — 1 Tablet 48 mg Box Label

1 TABLETS

Cats &
Kittens

4.1-17.0 lbs

Credelio™
CAT (lotilaner)

Treats and prevents flea infestations in
cats and kittens 8 weeks of age and older.
Treats and controls Ixodes scapularis
tick infestations in cats and kittens
6 months of age and older.

48 mg chewable tablet

Kills fleas

Kills I. scapularis
ticks

Monthly dose

Give with
food

CAUTION: Federal (USA) law restricts this drug touse by or on the order of a licensed veterinarian.

Approved by FDA under NADA # 141-528

ElancoTM

Principal Display Panel -- 1 Tablet 48 mg Box Label
(click image for full-size original)

Principal Display Panel — 3 Tablet 48 mg Box Label

3 TABLETS

Cats &
Kittens

4.1-17.0 lbs

Credelio™
CAT (lotilaner)

Treats and prevents flea infestations in
cats and kittens 8 weeks of age and older.
Treats and controls Ixodes scapularis
tick infestations in cats and kittens
6 months of age and older.

48 mg chewable tablet

Kills fleas

Kills I. scapularis
ticks

Monthly dose

Give with
food

CAUTION: Federal (USA) law restricts this drug touse by or on the order of a licensed veterinarian.

Approved by FDA under NADA # 141-528

ElancoTM

Principal Display Panel -- 3 Tablet 48 mg Box Label
(click image for full-size original)

Principal Display Panel — 6 Tablet 48 mg Box Label

6 TABLETS

Cats &
Kittens

4.1-17.0 lbs

Credelio™
CAT (lotilaner)

Treats and prevents flea infestations in
cats and kittens 8 weeks of age and older.
Treats and controls Ixodes scapularis
tick infestations in cats and kittens
6 months of age and older.

48 mg chewable tablet

Kills fleas

Kills I. scapularis
ticks

Monthly dose

Give with
food

CAUTION: Federal (USA) law restricts this drug touse by or on the order of a licensed veterinarian.

Approved by FDA under NADA # 141-528

ElancoTM

Principal Display Panel -- 6 Tablet 48 mg Box Label
(click image for full-size original)
CREDELIO lotilaner tablet, chewable
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-5487
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lotilaner (Lotilaner) Lotilaner 12 mg
Product Characteristics
Color White (white to brownish with brownish spots) Score no score
Shape ROUND (biconvex beveled edges) Size 5mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-5487-2 16 CARTON in 1 BOX contains a CARTON (58198-5487-1)
1 NDC:58198-5487-1 1 BLISTER PACK in 1 CARTON This package is contained within the BOX (58198-5487-2) and contains a BLISTER PACK
1 1 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within a CARTON (58198-5487-1) and a BOX (58198-5487-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141528 04/12/2021
CREDELIO lotilaner tablet, chewable
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-5488
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lotilaner (Lotilaner) Lotilaner 48 mg
Product Characteristics
Color White (white to brownish with brownish spots) Score no score
Shape ROUND (biconvex beveled edges) Size 8mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-5488-4 16 CARTON in 1 BOX contains a CARTON (58198-5488-1)
1 NDC:58198-5488-1 1 BLISTER PACK in 1 CARTON This package is contained within the BOX (58198-5488-4) and contains a BLISTER PACK
1 1 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within a CARTON (58198-5488-1) and a BOX (58198-5488-4)
2 NDC:58198-5488-5 16 CARTON in 1 BOX contains a CARTON (58198-5488-2)
2 NDC:58198-5488-2 1 BLISTER PACK in 1 CARTON This package is contained within the BOX (58198-5488-5) and contains a BLISTER PACK
2 3 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within a CARTON (58198-5488-2) and a BOX (58198-5488-5)
3 NDC:58198-5488-6 10 CARTON in 1 BOX contains a CARTON (58198-5488-3)
3 NDC:58198-5488-3 1 BLISTER PACK in 1 CARTON This package is contained within the BOX (58198-5488-6) and contains a BLISTER PACK
3 6 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within a CARTON (58198-5488-3) and a BOX (58198-5488-6)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141528 04/12/2021
Labeler — Elanco US Inc. (966985624)
Establishment
Name Address ID/FEI Operations
Siegfried Ltd 482824026 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Siegfried (Nantong) Pharmaceuticals Co., Ltd. 421329766 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Elanco France S.A.S. 736833104 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Allpack Group AG 484572565 LABEL, PACK
Establishment
Name Address ID/FEI Operations
Elanco Clinton Laboratories 039138631 LABEL, PACK

Revised: 11/2021 Elanco US Inc.

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