Nustendi

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Bempedoic acid, Ezetimibe

Available from:

Daiichi Sankyo Europe GmbH

ATC code:

C10B

INN (International Name):

bempedoic acid, ezetimibe

Therapeutic group:

Lipid modifying agents

Therapeutic area:

Hypercholesterolemia; Dyslipidemias

Therapeutic indications:

Nustendi is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibealone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin

Product summary:

Revision: 5

Authorization status:

Authorised

Authorization date:

2020-03-27

Patient Information leaflet

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NUSTENDI 180 MG/10 MG FILM-COATED TABLETS
bempedoic acid / ezetimibe
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nustendi is and what it is used for
2.
What you need to know before you take Nustendi
3.
How to take Nustendi
4.
Possible side effects
5.
How to store Nustendi
6.
Contents of the pack and other information
1.
WHAT NUSTENDI IS AND WHAT IT IS USED FOR
WHAT NUSTENDI IS AND HOW IT WORKS
Nustendi is a medicine that lowers levels of ‘bad’ cholesterol
(also called “LDL-cholesterol”), a type
of fat, in the blood.
Nustendi contains two active substances, which reduce your cholesterol
in two ways:
•
bempedoic acid decreases the production of cholesterol in the liver
and increases the removal of
LDL-cholesterol from the blood;
•
ezetimibe works in your bowel by reducing the amount of cholesterol
absorbed from food.
WHAT NUSTENDI IS USED FOR
Nustendi is given to adults with primary hypercholesterolaemia or
mixed dyslipidaemia, which are
conditions that cause a high cholesterol level in the blood. It is
given in addition to a cholesterol-
lowering diet.
Nustendi is given:
•
if you have been using a statin (such as simvastatin, a commonly used
medicine that treats high
cholesterol) together with ezetimibe and this does not lower your
LDL-cholesterol sufficiently;
•
if you have been using ezetimibe and this does not lower your
LDL-cholesterol sufficiently;
•
to replace bempedoic acid and ezetimibe if

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nustendi 180 mg/10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 180 mg of bempedoic acid and 10 mg of
ezetimibe.
Excipient(s) with known effect
Each 180 mg/10 mg film-coated tablet contains 71.6 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Blue, oval, film-coated tablet of approximately 15.00 mm × 7.00 mm ×
5.00 mm debossed with “818”
on one side and “ESP” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nustendi is indicated in adults with primary hypercholesterolaemia
(heterozygous familial and non-
familial) or mixed dyslipidaemia, as an adjunct to diet:
•
in combination with a statin in patients unable to reach LDL-C goals
with the maximum
tolerated dose of a statin in addition to ezetimibe (see sections 4.2,
4.3, and 4.4),
•
alone in patients who are either statin-intolerant or for whom a
statin is contraindicated, and are
unable to reach LDL-C goals with ezetimibe alone,
•
in patients already being treated with the combination of bempedoic
acid and ezetimibe as
separate tablets with or without statin.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Nustendi is one film-coated tablet of 180
mg/10 mg taken once daily.
_Coadministration with bile acid sequestrants _
Dosing of Nustendi should occur either at least 2 hours before or at
least 4 hours after administration
of a bile acid sequestrant.
_Concomitant simvastatin therapy _
When Nustendi is coadministered with simvastatin, simvastatin dose
should be limited to 20 mg daily
(or 40 mg daily for patients with severe hypercholesterolaemia and
high risk for cardiovascular
complications, who have not achieved their treatment goals on lower
doses and when the benefits are
expected to outweigh the potential risks) (see sections 4.4 and 4.5).
3
_Special populations _
_ _
_Elderly patients _
No dose adjustm