PRALUENT alirocumab 75mg/mL, solution for injection, pre-filled syringe

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

alirocumab, Quantity: 75 mg

Tillgänglig från:

Sanofi-Aventis Australia Pty Ltd

INN (International namn):

alirocumab

Läkemedelsform:

Injection, solution

Sammansättning:

Excipient Ingredients: histidine; sucrose; polysorbate 20; water for injections

Administreringssätt:

Subcutaneous

Enheter i paketet:

1 (starter pack), 1, 2, 6

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

Primary hypercholesterolaemia Praluent is indicated as an adjunct to diet and exercise to reduce LDL-C in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to very high cardiovascular risk: - In combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with maximum tolerated dose of a statin, - alone or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach LDL-C goals.,Prevention of cardiovascular events Praluent is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies (see section 5.1 Pharmacodynamic Properties, Clinical Trials).

Produktsammanfattning:

Visual Identification: Clear, colourless to pale yellow; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Bemyndigande status:

Licence status A

Tillstånd datum:

2016-05-17

Bipacksedel

PRALUENT
®
_Alirocumab (rch)_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Praluent.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Praluent
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
YOU MAY NEED TO READ IT AGAIN.
WHAT PRALUENT IS USED
FOR
Praluent contains the active
substance alirocumab, a protein
produced in Chinese hamster ovary
cells.
Praluent is used with other
cholesterol lowering medicines to
treat high levels of cholesterol in the
blood.
Cholesterol is one of several fatty
substances found in the bloodstream.
Your total cholesterol is made up of
mainly of Low Density Lipoprotein
(LDL) and High Density Lipoprotein
(HDL) cholesterol. Praluent reduces
LDL cholesterol.
LDL cholesterol can build up in the
walls of your arteries forming plaque.
Eventually this plaque build-up can
lead to a narrowing of the arteries.
This narrowing can slow or block
blood flow to vital organs such as the
heart and brain. This blocking of
blood flow can result in a heart attack
or stroke and can cause other health
problems.
Praluent reduces the risk of heart
attack, stroke, and chest pain that
may be caused by too little blood and
oxygen getting to the heart (angina),
in adults with cardiovascular disease
and high cholesterol levels in their
blood.
Praluent is used in adults who cannot
reduce their cholesterol levels by
cholesterol lowering diet and
exercise.
Praluent should be used with other
lipid lowering medicines such as
statins to treat high cholesterol and
lipid disorders. When a statin cannot
be used or does not work well,
Praluent can be used alone or
together with other cholesterol
lowering medicines.
Praluent should be used along with
cholesterol lowering diet

Produktens egenskaper

praluent-ccdsv7-piv7-10jan20
Page 1 of 34
AUSTRALIAN PRODUCT INFORMATION - PRALUENT
®
(ALIROCUMAB)
1
NAME OF THE MEDICINE
Praluent 75mg/mL and 150mg/mL solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alirocumab (rch) 75mg/mL and 150mg/mL
Alirocumab is a fully human monoclonal antibody (IgG1 isotype) that
targets PCSK9.
Alirocumab is produced by recombinant DNA technology in Chinese
Hamster Ovary cell
suspension culture.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection
Praluent is a sterile, clear, colourless to pale yellow solution for
subcutaneous injection with pH of
about 6.0, containing no antimicrobial preservatives.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PRIMARY HYPERCHOLESTEROLAEMIA
Praluent is indicated as an adjunct to diet and exercise to reduce
LDL-C in adults with primary
(heterozygous familial or non-familial) hypercholesterolaemia in
patients with moderate to very
high cardiovascular risk:
- In combination with a statin, or statin with other lipid-lowering
therapies in patients unable to
reach LDL-C goals with maximum tolerated dose of a statin,
- alone or in combination with other lipid lowering therapies in
patients who are statin intolerant
or for whom a statin is contraindicated who are unable to reach LDL-C
goals.
PREVENTION OF CARDIOVASCULAR EVENTS
praluent-ccdsv7-piv7-10jan20
Page 2 of 34
Praluent is indicated to reduce the risk of cardiovascular events
(myocardial infarction, stroke,
unstable angina requiring hospitalisation) in adults with established
cardiovascular disease, in
combination with optimally dosed statins and/or other lipid-lowering
therapies (see section 5.1
Pharmacodynamic properties, CLINICAL TRIALS).
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended starting dose of Praluent is 75 mg once every 2 weeks
or 300 mg once every 4
weeks (monthly), administered subcutaneously.
The dose of Praluent can be individualised based on patient
characteristics such as baseline LDL-
C level, goal of therapy and res