PRALUENT alirocumab (rch) 300 mg/2 mL solution for injection pre-filled pen

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

alirocumab, Quantity: 300 mg

Tillgänglig från:

Sanofi-Aventis Australia Pty Ltd

Läkemedelsform:

Injection, solution

Sammansättning:

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

Administreringssätt:

Subcutaneous

Enheter i paketet:

1, 3

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: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Bemyndigande status:

Registered

Tillstånd datum:

2022-10-17

Bipacksedel

PRALUENT
®
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING PRALUENT?
Praluent contains the active ingredient alirocumab. Praluent is used
to treat high levels of cholesterol in the blood.
For more information, see Section 1. Why am I using Praluent? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PRALUENT?
Do not use if you have ever had an allergic reaction to Praluent or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Praluent? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Praluent and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE PRALUENT?
•
Follow all directions given to you by your doctor and pharmacist
carefully. They may differ from the information contained in this
leaflet.
More instructions can be found in Section 4. How do I use Praluent? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PRALUENT?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Praluent.
•
Follow your doctor’s instructions carefully.
•
Tell your doctor if you are breastfeeding or become pregnant while you
are using Praluent.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or change the dosage without checking
with your doctor.
•
Do not use Praluent if it is not clear to pale yellow or if it
contains particles.
•
Do not give Praluent to children.
LOOKING AFTER
YOUR MEDICINE
•
Refrigerate do not freeze, do not expose to heat and do not shake
Praluent.
•
Keep in the outer carton in order to protect from light.
For more information, see Section 5. Wh

Produktens egenskaper

praluent-ccdsv12-piv9-17oct22
Page 1 of 34
1
AUSTRALIAN PRODUCT INFORMATION - PRALUENT
® (ALIROCUMAB)
1
NAME OF THE MEDICINE
Praluent 75mg/mL, 150mg/mL and 300mg/2mL solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alirocumab (rch) 75mg/mL,150mg/mL and 300mg/2mL
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
1.1
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.
praluent-ccdsv12-piv9-17oct22
Page 2 of 34
1.2
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).
_ _
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