VARENZIN-CA1- molidustat oral suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MOLIDUSTAT SODIUM (UNII: CI0NE7C96T) (MOLIDUSTAT - UNII:9JH486CZ13)

Available from:

Elanco US Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Varenzin-CA1 should not be administered to cats with known hypersensitivity to molidustat or to any of the inactive ingredients. Varenzin-CA1 should not be administered to cats that are pregnant, lactating, or intended for breeding. In an embryo-fetal-developmental toxicity study in rats, an increase incidence of ocular malformations such as flat eye rudiments and microphthalmia were observed at doses of 30 mg/kg bw per day. These effects may be due to an increase in oxygen availability, caused by molidustat-induced polycythemia. Localized hypoxia is an important factor in normal eye development. Developmental toxicity studies have not been conducted in cats. Available animal data have shown excretion of other HIF-PH inhibitors into milk. It is unknown whether molidustat is excreted into the milk of lactating cats.

Product summary:

27 mL of a 25 mg/mL oral suspension in a bottle with an oral dosing syringe. Manufactured for: Elanco US Inc. Greenfield, IN 46140 USA Product of Germany Varenzin-CA1, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. ©2023 Elanco or its affiliates. Revision date - 05/2023 90203666 Elanco™

Authorization status:

Conditional New Animal Drug Application

Summary of Product characteristics

VARENZIN-CA1- MOLIDUSTAT ORAL SUSPENSION
ELANCO US INC.
----------
ELANCO
VARENZIN™-CA1
(MOLIDUSTAT ORAL SUSPENSION)
Hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor
25 mg/mL
For oral use in cats only
CONDITIONALLY APPROVED BY FDA PENDING A FULL DEMONSTRATION OF
EFFECTIVENESS
UNDER APPLICATION NUMBER 141-571. IT IS A VIOLATION OF FEDERAL LAW TO
USE THIS
PRODUCT OTHER THAN AS DIRECTED IN THE LABELING.
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
Varenzin-CA1 (molidustat oral suspension) is a white to yellow-white
oily suspension.
Each mL of Varenzin-CA1 contains 25 mg of molidustat sodium. The
inactive ingredients
are glycerol dibehenate, fish oil, sunflower oil, butylhydroxytoluene,
and sorbic acid. The
empirical formula is C
H
N O Na and the molecular weight is 336.28. The chemical
name is Sodium
1-[6-(morpholin-4-yl)pyrimidin-4-yl]-4-(1H-1,2,3-triazol-1-yl)-1H-pyrazol-
5-olate. The chemical structure of molidustat sodium is:
INDICATION
Varenzin-CA1 is indicated for the control of nonregenerative anemia
associated with
chronic kidney disease (CKD) in cats.
13
13
8
2
DOSAGE AND ADMINISTRATION
Shake well before use.
The dosage of Varenzin-CA1 is 2.3 mg/lb (5 mg/kg) body weight (bw)
administered orally
once daily for up to 28 consecutive days. Treatment may be repeated
after a minimum
7-day pause (see MONITORING AND REPEATING TREATMENT). Varenzin-CA1
should be
administered using the dosing syringe provided in the package. The
dosing syringe is
marked in increments of 0.1 mL. The dose should be rounded up to the
nearest 0.1 mL.
DOSING INFORMATION
To ensure the correct dose is administered, body weight should be
determined prior to
starting treatment.
Table 1. Dosing Chart
WEIGHT RANGE IN
POUNDS (LB)
VOLUME OF
VARENZIN-CA1 (ML)
3.4 to 4.4
0.4
4.5 to 5.5
0.5
5.6 to 6.6
0.6
6.7 to 7.7
0.7
7.8 to 8.8
0.8
8.9 to 9.9
0.9
10 to 11
1
11.1 to 12.1
1.1
12.2 to 13.2
1.2
Note: The syringe included with the Varenzin-CA1 product cannot be
used to accura