Leading the way to safer medication
 Crosscheck  Recommender

PRALUENT Solution for injection (2018)

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.

Pharmaceutical form

Solution for injection (injection).

Clear, colourless to pale yellow solution.

Qualitative and Quantitative Composition

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

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

Chemical substance
Description
Alirocumab

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.

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

Pre-filled syringe 75 mg: The syringe is equipped with a light green polypropylene plunger rod.

Pre-filled syringe 150 mg: The syringe is equipped with a dark grey polypropylene plunger rod.

Pack size:

1, 2, or 6 pre-filled pens.
1, 2, or 6 pre-filled syringes.

Not all presentations and pack sizes may be marketed.

Marketing authorization holder
Authorization dates

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

Date of first authorisation: 23 September 2015

Marketing authorization number:

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