Repatha

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Evolocumab

Available from:

Amgen Europe B.V.

ATC code:

C10AX13

INN (International Name):

evolocumab

Therapeutic group:

Lipid modifying agents

Therapeutic area:

Dyslipidemias; Hypercholesterolemia

Therapeutic indications:

Hypercholesterolaemia and mixed dyslipidaemiaRepatha 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 or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.Homozygous familial hypercholesterolaemiaRepatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.Established atherosclerotic cardiovascular diseaseRepatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.

Product summary:

Revision: 24

Authorization status:

Authorised

Authorization date:

2015-07-17

Patient Information leaflet

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE USER
REPATHA 140 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
evolocumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
-
The warnings and instructions in this document are intended for the
person taking the medicine.
If you are a parent or carer responsible for giving the medicine to
someone else, such as a child,
you will need to apply the information accordingly
WHAT IS IN THIS LEAFLET
1.
What Repatha is and what it is used for
2.
What you need to know before you use Repatha
3.
How to use Repatha
4.
Possible side effects
5.
How to store Repatha
6.
Contents of the pack and other information
1.
WHAT REPATHA IS AND WHAT IT IS USED FOR
WHAT REPATHA IS AND HOW IT WORKS
Repatha is a medicine that lowers levels of ‘bad’ cholesterol, a
type of fat, in the blood.
Repatha contains the active substance evolocumab, a monoclonal
antibody (a type of specialised
protein designed to attach to a target substance in the body).
Evolocumab is designed to attach to a
substance called PCSK9 that affects the liver’s ability to take in
cholesterol. By attaching to, and
mopping up PCSK9, the medicine increases the amount of cholesterol
entering the liver and so lowers
the level of cholesterol in the blood.
WHAT REPATHA IS USED FOR
_ _
Repatha is used in addition to your cholesterol lowering diet if you
are:
•
an adult with a high cholesterol level in your blood (primary
hypercholesterolaemia
[heterozygous familial and non-familial] or mixed dyslipidaemia). It
is

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Repatha 140 mg solution for injection in pre-filled syringe
Repatha 140 mg solution for injection in pre-filled pen
Repatha 420 mg solution for injection in cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Repatha 140 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 140 mg of evolocumab in 1 mL of
solution.
Repatha 140 mg solution for injection in pre-filled pen
Each pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.
Repatha 420 mg solution for injection in cartridge
Each cartridge contains 420 mg of evolocumab in 3.5 mL of solution
(120 mg/mL).
Repatha is a human IgG2 monoclonal antibody produced in Chinese
hamster ovary (CHO) cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Solution for injection (injection) in pre-filled pen (SureClick).
Solution for injection (injection) (automated mini-doser).
The solution is clear to opalescent, colourless to yellowish, and
practically free from particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypercholesterolaemia and mixed dyslipidaemia
Repatha is indicated in adults with primary hypercholesterolaemia
(heterozygous familial and
non-familial) or mixed dyslipidaemia, and in paediatric patients aged
10 years and over with
heterozygous familial hypercholesterolaemia, as an adjunct to diet:
•
in combination with a statin or statin with other lipid-lowering
therapies in patients unable to
reach LDL-C goals with the maximum tolerated dose of a statin or,
•
alone or in combination with other lipid-lowering therapies in
patients who are statin-intolerant,
or for whom a statin is contraindicated.
Homozygous familial hypercholesterolaemia
Repatha is indicated in adults and paediatric patients aged 10 years
and over with homozygous
familial hypercholesterolaemia in combination with other
lipid-lowering therapies.
3
Established atheroscleroti