Kerendia Abbreviated Prescribing Information - Kuwait, Oman and Bahrain
Kerendia ® film-coated tablet:
contains 10 mg or 20 mg of Finerenone -
Indications:
Kerendia ® is used for the treatment of adults with chronic
kidney disease (CKD) (stage 3 and 4 with abnormal presence of
the protein albumin in the urine) associated with type 2
diabetes (T2D).
- Posology & method of administration:
Posology
:
The starting dose is 10 mg finerenone once daily. The
recommended & maximum dose is 20 mg finerenone once daily -
Initiation of treatment:
Measure serum potassium & estimated glomerular filtration
rate (eGFR)
to determine if finerenone treatment can be initiated:
If serum potassium ≤ 4.8 mmol/L, finerenone treatment can be
started at 10 mg once daily - If serum potassium > 4.8 to 5.0
mmol/L, initiation of finerenone treatment may be considered
with additional serum potassium monitoring within the first 4
weeks based on pt. characteristics & serum potassium levels
-
If serum potassium > 5.0 mmol/L, initiation of finerenone
treatment is not recommended - If eGFR ≥ 25 mL/min/1.73 m
2
, finerenone treatment can be started at 10 mg once daily - If
eGFR < 25 mL/min/1.73 m
2
initiation of finerenone treatment is not recommended -
Remeasure serum potassium & eGFR 4 weeks after initiation or
re-start of finerenone treatment or increase in dose –
Thereafter: remeasure serum potassium periodically & as
needed based on pt. characteristics & serum potassium
levels.
- Missed dose:
A missed dose should be taken as soon as the patient notices,
but only on the same day. The patient should not take 2 doses to
make up for a missed dose.
- Method of administration: Oral use & Food:
Tablets may be taken with a glass of water & with or without
food - Tablets should not be taken with grapefruit or grapefruit
juice
- Crushing of tablets:
For pts who are unable to swallow whole tablets, Kerendia ®
tablets may be crushed & mixed with water or soft foods,
such as apple sauce, directly before oral use.
- Overdose:
No cases of adverse reactions associated with Kerendia ®
overdose have been reported. -
Contraindications:
Hypersensitivity to the active substance or to any of the
excipients, Concomitant treatment with strong inhibitors of
CYP3A4 -
Concomitant use contraindicated: Strong & moderate CYP3A4
inhibitors:
Concomitant use not recommended
- Certain medicinal products that increase serum potassium:
Concomitant use of Kerendia ® with potassium-sparing
diuretics & other MRAs is not recommended. It is anticipated
that these medicinal products increase the risk for
hyper-kalaemia
- Grapefruit:
Concomitant intake of grapefruit or grapefruit juice is not
recommended; as it is expected to increase the plasma
concentrations of Finerenone
- Concomitant use with precautions: Moderate CYP3A4
inhibitors:
Serum potassium may increase, & therefore, monitoring of
serum potassium is recommended
- Special warnings & precautions for use: Hyperkalaemia:
Hyperkalaemia has been observed in patients treated with
Kerendia ®. Some patients are at a higher risk to develop
hyperkalaemia - Risk factors include low eGFR, higher serum
potassium & previous episodes of hyperkalaemia. Consider
more frequent monitoring in these patients.-
Concomitant medications:
The risk of hyperkalaemia also may increase with the intake of
concomitant medications that may increase serum potassium
, Concomitant use of Kerendia ® is
not recommended
with
potassium-sparing diuretics
&
other mineralocorticoid receptor antagonists
-
Use Kerendia ®
with caution
& monitor serum potassium when taken concomitantly with
moderate or weak CYP3A4 inhibitors, potassium supplements.
trimethoprim, or trimethoprim / sulfamethoxazole. Temporary
discontinuation of Kerendia ® may be necessary and consider
additional serum potassium monitoring & adapt monitoring
according to patient characteristics -
Special populations: Elderly:
No dose adjustment is necessary in elderly patients,
Renal impairment:
Initiation of treatment: In patients with eGFR < 25
mL/min/1.73 m
2
, initiation of finerenone treatment is
not recommended
due to limited clinical data -
Continuation of treatment
: In patients with mild, moderate or severe renal impairment,
continue finerenone treatment & adjust dose based on serum
potassium. Measure eGFR 4 weeks after initiation to determine
whether the starting dose can be increased to the recommended
daily dose - In patients who have progressed to end-stage renal
disease (eGFR < 15 mL/min/1.73 m
2
), continue finerenone treatment with caution regarding serum
potassium levels due to limited clinical data -
Hepatic impairment:
Patients with severe hepatic impairment (Child Pugh C):
Finerenone is not recommended - No data are available.
-
moderate hepatic impairment (Child Pugh B): Consider additional
serum potassium monitoring & adapt monitoring according to
pt. characteristics -
Body weight:
No dose adjustment is necessary based on body weight,
Pediatric population:
The safety & efficacy of Kerendia ® in children &
adolescents aged under 18 years have not yet been established.
No clinical data are available -
Breast-feeding:
It is unknown whether finerenone or its metabolites are excreted
in human breast milk - Breast-feeding should be discontinued
during treatment with Kerendia ® -
Embryo-fetal
toxicity:
Animal data have shown reproductive toxicity. - In the
embryo-foetal toxicity in rats: finerenone resulted in reduced
placental weights & signs of foetal toxicity, including
reduced foetal weights & retarded ossification at the
maternal toxic dose of 10 mg/kg/day corresponding to an
AUCunbound of 19 times that in humans The relevance for humans
is unknown as risk for the nursing newborn/infant cannot be
excluded
Pregnancy:
Kerendia ® should not be used during pregnancy unless there
has been careful consideration of the benefit for the mother
& the risk to the foetus. If a woman becomes pregnant while
taking Kerendia ®, she should be informed of potential risks
to the foetus - Advise women of childbearing potential to use
effective contraception & not to breast-feed during
treatment with Kerendia ®
- Fertility:
There are no data on the effect of finerenone on human fertility
- No effect on male fertility has been observed -
Female fertility:
Finerenone caused reduced female fertility as well as signs of
early embryonic toxicity at about 21 times the human AUCunbound.
In addition, reduced ovarian weights were found at about 17
times the human AUCunbound. No effects on female fertility &
early embryonic development were found at 10 times the human
AUCunbound -
Ability to drive & use machines:
No influence on the ability to drive & use machines -
Cardiac electrophysiology:
A dedicated QT study in 57 healthy participants showed that
finerenone has no effect on cardiac repolarisation. There was no
indication of a QT/QTc prolonging effect of finerenone after
single doses of 20 mg (therapeutic) or 80 mg (supratherapeutic)
-
Repeated dose toxicity:
Effects observed in repeat-dose toxicity studies were mainly due
to exaggerated pharmacodynamic activities of finerenone &
secondary adaptive responses -
Carcinogenic potential:
In 2-year carcinogenicity studies, finerenone did not show
carcinogenic potential in male & female rats or female mice
-
Preclinical safety data:
Non-clinical data reveal no special hazard for humans based on
conventional studies of safety pharmacology, single dose
toxicity, genotoxicity, phototoxicity, carcinogenic potential
& male & female fertility
Adverse reactions:
Reporting suspected adverse reactions is important. It allows
continued monitoring of the benefit/risk balance of the
medicinal product -
Very common:
Hyper-kalaemia (≥ 10%)
- Common:
Hypo-natraemia, Hypotension & Glomerular filtration rate
decreased.
- Please refer to local product package insert leaflet (PIL) for full prescribing details
MARKETING AUTHORISATION HOLDER : Bayer AG - 51368 Leverkusen – Germany ME PIL Version: Feb., 2022
Kerendia Abbreviated Prescribing Information - KSA
Kerendia ® film-coated tablet: contains 10 mg or 20 mg of Finerenone - Indications: 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).- Posology & method of administration: Posology: The starting dose is 10 mg finerenone once daily. The recommended & maximum dose is 20 mg finerenone once daily - Initiation of treatment: Measure serum potassium & estimated glomerular filtration rate (eGFR) to determine if finerenone treatment can be initiated: If serum potassium ≤ 4.8 mmol/L, finerenone treatment can be started at 10 mg once daily - If serum potassium > 4.8 to 5.0 mmol/L, initiation of finerenone treatment may be considered with additional serum potassium monitoring within the first 4 weeks based on pt. characteristics & serum potassium levels - If serum potassium > 5.0 mmol/L, initiation of finerenone treatment is not recommended - If eGFR ≥ 25 mL/min/1.73 m2, finerenone treatment can be started at 10 mg once daily - If eGFR < 25 mL/min/1.73 m2 initiation of finerenone treatment is not recommended - Remeasure serum potassium & eGFR 4 weeks after initiation or re-start of finerenone treatment or increase in dose – Thereafter: remeasure serum potassium periodically & as needed based on pt. characteristics & serum potassium levels.( Please refer to Table 1 below for the recommended dosing per eGFR:
-
Missed
dose:
A
missed
dose
should
be
taken
as
soon
as
the
patient notices,
but only
on
the
same
day. The patient should not take 2 doses to make up for a
missed dose. - Method
of
administration: Oral
use & Food: Tablets
may
be
taken
with
a
glass
of water
&
with
or
without
food -
Tablets should not be taken with grapefruit or grapefruit
juice
- Crushing
of
tablets:
For pts
who
are
unable
to
swallow
whole
tablets,
Kerendia ®
tablets
may
be
crushed
&
mixed with water or soft foods, such as apple sauce,
directly before oral use. - Overdose: No
cases
of
adverse
reactions
associated
with
Kerendia ®
overdose
have
been
reported. - Contraindications:
Hypersensitivity
to
the
active
substance
or
to
any
of
the
excipients, Concomitant
treatment
with
strong
inhibitors
of
CYP3A4 - Concomitant
use
contraindicated: Strong & moderate CYP3A4
inhibitors: Concomitant
use
not
recommended - Certain
medicinal
products
that
increase
serum
potassium: Concomitant
use
of
Kerendia ®
with
potassium-sparing
diuretics
&
other MRAs is not recommended. It is anticipated that these
medicinal products increase the risk for hyper-kalaemia - Grapefruit: Concomitant
intake
of grapefruit
or grapefruit juice
is
not recommended;
as
it
is
expected
to
increase the plasma concentrations of Finerenone - Concomitant
use
with
precautions: Moderate
CYP3A4
inhibitors:
Serum
potassium
may
increase,
&
therefore,
monitoring
of
serum
potassium
is
recommended - Special
warnings
&
precautions
for
use: Hyperkaliemia: Hyperkaliemia
has
been
observed
in
patients
treated
with
Kerendia ®. Some patients are at a higher risk to
develop hyperkalemia - Risk
factors
include
low
eGFR,
higher
serum
potassium
&
previous
episodes
of
hyperkalemia. Consider more frequent monitoring in these
patients.-
Concomitant
medications: The
risk
of hyperkalemia
also
may
increase
with
the
intake
of
concomitant
medications
that may increase serum potassium, Concomitant
use
of
Kerendia ®
is
not
recommended
with
potassium-sparing
diuretics
&
other
mineralocorticoid
receptor
antagonists - Use
Kerendia ®
with
caution
&
monitor
serum
potassium
when
taken
concomitantly
with moderate or weak CYP3A4 inhibitors, potassium
supplements. trimethoprim,
or
trimethoprim
/ sulfamethoxazole.
Temporary
discontinuation
of
Kerendia ®
may be necessary and consider
additional
serum
potassium monitoring & adapt monitoring according to
patient characteristics -
Special
populations: Elderly: No
dose
adjustment
is
necessary
in
elderly
patients, Renal
impairment: Initiation
of
treatment: In
patients
with
eGFR
<
25
mL/min/1.73
m2,
initiation
of
finerenone
treatment
is
not
recommended due
to
limited
clinical
data
- Continuation
of
treatment: In
patients
with
mild,
moderate
or
severe
renal
impairment,
continue
finerenone
treatment
&
adjust dose based on serum potassium. Measure eGFR 4 weeks
after initiation to determine whether the starting dose can
be increased to the recommended daily dose - In
patients
who
have
progressed
to
end-stage
renal
disease
(eGFR
<
15
mL/min/1.73
m2),
continue finerenone treatment with caution regarding serum
potassium levels due to limited clinical data -
Hepatic
impairment:
Patients
with severe
hepatic
impairment
(Child
Pugh
C): Finerenone
is
not
recommended
- No
data
are
available.- moderate
hepatic
impairment
(Child
Pugh
B): Consider
additional
serum
potassium
monitoring
&
adapt
monitoring
according
to
pt. characteristics
- Body
weight:
No
dose
adjustment
is
necessary
based
on
body
weight, Pediatric
population:
The
safety
&
efficacy
of
Kerendia ®
in
children
&
adolescents
aged
under
18
years
have
not yet been established. No clinical data are available -
Breast-feeding: It
is
unknown
whether
finerenone
or
its
metabolites
are
excreted
in
human
breast
milk - Breast-feeding
should
be
discontinued
during
treatment
with
Kerendia ® - Embryo-fetal
toxicity: Animal
data
have
shown
reproductive
toxicity. - In the embryo-foetal toxicity in rats: finerenone resulted
in reduced placental weights & signs of foetal toxicity,
including reduced foetal weights & retarded ossification
at the maternal toxic dose of
10 mg/kg/day corresponding to an AUC unbound
of 19 times that in humans The
relevance
for
humans
is
unknown as risk
for
the nursing newborn/infant cannot be excluded Pregnancy:
Kerendia ® should not be used during pregnancy unless
there has been careful consideration of the benefit
for the
mother
&
the
risk
to
the
foetus.
If a
woman
becomes
pregnant while
taking
Kerendia ®, she should be informed of potential risks
to the foetus - Advise
women
of
childbearing
potential
to
use
effective
contraception &
not
to
breast-feed
during
treatment
with
Kerendia ® - Fertility:
There
are
no
data
on
the
effect
of
finerenone
on
human
fertility - No effect on male fertility has been observed -
Female
fertility:
Finerenone
caused
reduced
female
fertility
as well as signs of early embryonic toxicity at about
21 times the human
AUC unbound. In addition, reduced ovarian weights were found at
about 17 times the human AUC
unbound. No effects on female fertility & early embryonic
development were found at 10 times the human AUC
unbound
- Ability
to
drive
&
use
machines: No
influence
on
the
ability
to
drive
&
use
machines - Cardiac
electrophysiology: A dedicated QT study in 57 healthy participants showed that
finerenone has no effect on cardiac repolarization. There
was no indication of a QT/QTc prolonging effect of
finerenone after single doses of 20 mg (therapeutic) or 80
mg (supratherapeutic) -
Repeated
dose
toxicity: Effects
observed
in
repeat-dose
toxicity
studies
were
mainly
due
to
exaggerated
pharmacodynamic activities of finerenone & secondary
adaptive responses -
Carcinogenic
potential: In 2-year carcinogenicity studies, finerenone did not show
carcinogenic potential in male & female rats or female
mice
- Preclinical
safety
data: Non-clinical data reveal no special hazard for humans based
on conventional studies of safety pharmacology,
single
dose
toxicity,
genotoxicity,
phototoxicity,
carcinogenic
potential
&
male
& female fertility Adverse
reactions: Reporting
suspected adverse reactions is important. It allows
continued monitoring of the benefit/risk balance of the
medicinal product -
Very
common: Hyper-kalaemia
(≥
10%) - Common: Low sodium level (hypo-natraemia), Possible signs of low
sodium level in the blood may include feeling sick (nausea),
tiredness, headache, confusion; muscle weakness, spasms or
cramps, decrease in how well the kidneys filter blood
(glomerular filtration rate decreased), high uric acid level
(hyperuricemia), low blood pressure (hypotension), Possible
signs of low blood pressure may include dizziness,
lightheadedness, fainting & itching (pruritus)
Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist, send it to your local health authority or local Bayer PV, This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
The National Pharmacovigilance Centre (NPC): SFDA Call Center: 19999, E-mail: npc.drug@sfda.gov.sa - Website: https://ade.sfda.gov.sa
- Please refer to the product package insert leaflet (PIL) for full product information & usage data
MARKETING AUTHORISATION HOLDER: Bayer AG - 51368 Leverkusen – Germany KSA PIL Version: Feb., 2023