KERENDIA 10 MG

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

FINERENON

Fáanlegur frá:

BAYER ISRAEL LTD

ATC númer:

C03DA05

Lyfjaform:

FILM COATED TABLETS

Samsetning:

FINERENON 10 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

BAYER AG, GERMANY

Lækningarsvæði:

FINERENON

Ábendingar:

Kerendia is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

Leyfisdagur:

2023-01-04

Upplýsingar fylgiseðill

1 FULL PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Kerendia 10 mg
Kerendia 20 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kerendia 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of finerenone.
Kerendia 20 mg film-coated tablets
Each film-coated tablet contains 20 mg of finerenone.
For the full list of excipients, see section 12.
3.
PHARMACEUTICAL FORM
Kerendia 10 mg film-coated tablets
Pink Film-coated tablet, oval oblong, diameter of 10 mm and radius of
curvature of 3.4 mm, Marked with “10” on Top
side, and “FI” on the Bottom side
Kerendia 20 mg film-coated tablets
Pale Yellow Film-coated tablet, oval oblong, diameter of 10 mm and
radius of curvature of 3.4 mm, Marked with “20” on
Top side, and “FI” on the Bottom side.
4.
THERAPEUTIC INDICATIONS
Kerendia is indicated to reduce the risk of sustained eGFR decline,
end-stage kidney disease, cardiovascular death, non-
fatal myocardial infarction, and hospitalization for heart failure in
adult patients with chronic kidney disease (CKD)
associated with type 2 diabetes (T2D).
5. DOSAGE AND ADMINISTRATION
5.1 PRIOR TO INITIATION OF KERENDIA
Measure serum potassium levels and estimated glomerular filtration
rate (eGFR) before initiation. Do not initiate
treatment if serum potassium is > 5.0 mEq/L
_ [see Warnings and Precautions (7.1_
_)]. _
5.2 RECOMMENDED STARTING DOSAGE
The recommended starting dose of Kerendia is based on eGFR and is
presented in Table 1.
2
TABLE 1: RECOMMENDED STARTING DOSAGE
EGFR (ML/MIN/1.73M
2
)
STARTING DOSE
≥ 60
20 mg once daily
≥ 25 to < 60
10 mg once daily
< 25
Not Recommended
For patients who are unable to swallow whole tablets, Kerendia may be
crushed and mixed with water or soft foods such
as applesauce immediately prior to use and administered orally
_[see Clinical Pharmacology (13.3_
_)]_
.
5.3 MONITORING AND DOSE ADJUSTMENT
The target daily dose of Kerendia is 20 mg.
Measure serum potassium 4 weeks after initiating treatment and adjust
dose (see Table 2); if serum potassium levels are

Vara einkenni

1
FULL PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Kerendia 10 mg
Kerendia 20 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kerendia 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of finerenone.
Kerendia 20 mg film-coated tablets
Each film-coated tablet contains 20 mg of finerenone.
For the full list of excipients, see section 12.
3.
PHARMACEUTICAL FORM
Kerendia 10 mg film-coated tablets
Pink Film-coated tablet, oval oblong, diameter of 10 mm and radius of
curvature of 3.4 mm, Marked with “10” on Top
side, and “FI” on the Bottom side
Kerendia 20 mg film-coated tablets
Pale Yellow Film-coated tablet, oval oblong, diameter of 10 mm and
radius of curvature of 3.4 mm, Marked with “20” on
Top side, and “FI” on the Bottom side.
4.
THERAPEUTIC INDICATIONS
Kerendia is indicated to reduce the risk of sustained eGFR decline,
end-stage kidney disease, cardiovascular death, non-
fatal myocardial infarction, and hospitalization for heart failure in
adult patients with chronic kidney disease (CKD)
associated with type 2 diabetes (T2D).
5. DOSAGE AND ADMINISTRATION
5.1 Prior to Initiation of Kerendia
Measure serum potassium levels and estimated glomerular filtration
rate (eGFR) before initiation. Do not initiate
treatment if serum potassium is > 5.0 mEq/L
_ [see Warnings and Precautions (7.1_
_)]. _
5.2 Recommended Starting Dosage
The recommended starting dose of Kerendia is based on eGFR and is
presented in Table 1.
2
Table 1: Recommended Starting Dosage
eGFR (mL/min/1.73m
2
)
Starting Dose
≥ 60
20 mg once daily
≥ 25 to < 60
10 mg once daily
< 25
Not Recommended
For patients who are unable to swallow whole tablets, Kerendia may be
crushed and mixed with water or soft foods such
as applesauce immediately prior to use and administered orally
_[see Clinical Pharmacology (13.3_
_)]_
.
5.3 Monitoring and Dose Adjustment
The target daily dose of Kerendia is 20 mg.
Measure serum potassium 4 weeks after initiating treatment and adjust
dose (see Table 2); if serum potassium levels are