KERENDIA 20 MG

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

FINERENON

Disponible des:

BAYER ISRAEL LTD

Codi ATC:

C03DA05

formulario farmacéutico:

FILM COATED TABLETS

Composición:

FINERENON 20 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricat per:

BAYER AG, GERMANY

Área terapéutica:

FINERENON

indicaciones terapéuticas:

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).

Data d'autorització:

2023-01-04

Informació per a l'usuari

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
KERENDIA 10 MG
KERENDIA 20 MG
film-coated tablets
ACTIVE INGREDIENT
KERENDIA 10 MG: Each tablet contains 10 mg finerenone.
KERENDIA 20 MG: Each tablet contains 20 mg finerenone.
Inactive ingredients and allergens: see section 2 under ”Important
information about some of this medicine’s ingredients”
and section 6 ”Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise information about
this medicine. If you have any further questions, consult your doctor
or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it seems to you that
their medical condition is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
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 associated
with type 2 diabetes.
THERAPEUTIC GROUP: diuretics, aldosterone antagonists.
Kerendia contains the active substance finerenone. Finerenone works by
blocking the action of certain hormones
)mineralocorticoids( that can damage the kidneys, heart and blood
vessels.
Chronic kidney disease is a long-term condition. The kidneys keep
getting worse at removing waste and fluids from the
blood.
Type 2 diabetes develops when the body cannot maintain normal blood
sugar levels. The body does not produce enough
of the hormone insulin or cannot use the insulin properly. This leads
to a high level of sugar in the blood.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
You are sensitive )allergic( to the active ingredient or to any of the
other ingredients in this medicine )see section 6(.
You are taking medicines that belong to the group of strong CYP3A4
inhibitors, for example
ITRACONAZOL

Fitxa tècnica

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