PRALUENT Solution for injection

Active ingredients: Alirocumab

Product name and form

Praluent 75 mg solution for injection in pre-filled pen.
Praluent 150 mg solution for injection in pre-filled pen.
Praluent 75 mg solution for injection in pre-filled syringe.
Praluent 150 mg solution for injection in pre-filled syringe.
Praluent 300 mg solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection (injection).

Clear, colourless to pale yellow solution.

pH: 5.7-6.3

Osmolality:

Praluent 75 mg solution for injection: 293-439 mOsm/kg
Praluent 150 mg solution for injection: 383-434 mOsm/kg
Praluent 300 mg solution for injection: 383-434 mOsm/kg

Qualitative and quantitative composition

Praluent 75 mg solution for injection in pre-filled pen: Each single-use pre-filled pen contains 75 mg alirocumab in 1 ml solution.

Praluent 75 mg solution for injection in pre-filled syringe: Each single-use pre-filled syringe contains 75 mg alirocumab in 1 ml solution.

Praluent 150 mg solution for injection in pre-filled pen: Each single-use pre-filled pen contains 150 mg alirocumab in 1 ml solution.

Praluent 150 mg solution for injection in pre-filled syringe: Each single-use pre-filled syringe contains 150 mg alirocumab in 1 ml solution.

Praluent 300 mg solution for injection in pre-filled pen: Each single-use pre-filled pen contains 300 mg alirocumab in 2 ml solution.

Alirocumab is a human IgG1 monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Alirocumab is a fully human IgG1 monoclonal antibody that binds with high affinity and specificity to proprotein convertase subtilisin kexin type 9 (PCSK9). PCSK9 binds to the low-density lipoprotein receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. LDLR is the primary receptor that clears circulating LDL, therefore the decrease in LDLR levels by PCSK9 results in higher blood levels of LDL-C. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels.

List of Excipients

Histidine
Sucrose
Polysorbate 20
Water for injections

Pack sizes and marketing

1 ml solution in a siliconised Type 1 clear glass syringe, equipped with a stainless steel staked needle, a styrene-butadiene rubber soft needle shield, and an ethylene tetrafluoroethylene-coated bromobutyl rubber plunger stopper.

Pre-filled pen 75 mg: The syringe components are assembled into a single-use pre-filled pen with activation button.

Pack size:

1, 2 or 6 pre-filled pens.

Or

The syringe components are assembled into a single-use pre-filled pen with a blue cap and without activation button.

Pack size: 1, 2 or 6 pre-filled pens without activation button.

Pre-filled pen 150 mg: The syringe components are assembled into a single-use pre-filled pen with activation button.

Pack size:

1, 2 or 6 pre-filled pens.

Or

The syringe components are assembled into a single-use pre-filled pen with a blue cap and without activation button.

Pack size: 1, 2 or 6 pre-filled pens without activation button.

300 mg solution for injection in pre-filled pen: The syringe components are assembled into a single-use pre-filled pen with a blue cap and without activation button.

Pack size: 1 or 3 pre-filled pens without activation button.

75 mg solution for injection in pre-filled syringe: The syringe is equipped with a light green polypropylene plunger rod.

Pack size: 1, 2 or 6 pre-filled syringes.

150 mg solution for injection in pre-filled syringe: The syringe is equipped with a dark grey polypropylene plunger rod.

Pack size: 1, 2 or 6 pre-filled syringes.

Not all presentations and pack sizes may be marketed.

Marketing authorization holder

Marketing Authorisation Holder: sanofi-aventis groupe, 54, rue La Bo├ętie, F – 75008 Paris, France

Marketing authorization dates and numbers

EU/1/15/1031/001
EU/1/15/1031/002
EU/1/15/1031/003
EU/1/15/1031/004
EU/1/15/1031/005
EU/1/15/1031/006
EU/1/15/1031/007
EU/1/15/1031/008
EU/1/15/1031/009
EU/1/15/1031/010
EU/1/15/1031/011
EU/1/15/1031/012
EU/1/15/1031/013
EU/1/15/1031/014
EU/1/15/1031/015
EU/1/15/1031/016
EU/1/15/1031/017
EU/1/15/1031/018
EU/1/15/1031/019
EU/1/15/1031/020

Date of first authorisation: 23 September 2015
Date of latest renewal: 2 June 2020

Drugs

Drug
Countries
Austria, Brazil, Canada, Cyprus, Spain, France, Hong Kong, Ireland, Lithuania, Netherlands, Singapore, United Kingdom, United States