LOJUXTA Hard, capsule Ref.[27700] Active ingredients: Lomitapide

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Amryt Pharmaceuticals DAC, 45 Mespil Road, Dublin 4, Ireland

Product name and form

Lojuxta 5 mg hard capsules.
Lojuxta 10 mg hard capsules.
Lojuxta 20 mg hard capsules.
Lojuxta 30 mg hard capsules.
Lojuxta 40 mg hard capsules.
Lojuxta 60 mg hard capsules.

Pharmaceutical Form

Hard, capsule.

Lojuxta 5 mg hard capsules: The capsule is an orange cap/orange body hard capsule of 19.4 mm, printed with black ink imprinted with “5 mg” on body and “A733” on cap.

Lojuxta 10 mg hard capsules: The capsule is an orange cap/white body hard capsule of 19.4 mm, printed with black ink imprinted with “10 mg” on body and “A733” on cap.

Lojuxta 20 mg hard capsules: The capsule is a white cap/white body hard capsule of 19.4 mm, printed with black ink imprinted with “20 mg” on body and “A733” on cap.

Lojuxta 30 mg hard capsules: The capsule is an orange cap/yellow body hard capsule of 21.6 mm, printed with black ink imprinted with “30 mg” on body and “A733” on cap.

Lojuxta 40 mg hard capsules: The capsule is a yellow cap/white body hard capsule of 23.4 mm, printed with black ink imprinted with “40 mg” on body and “A733” on cap.

Lojuxta 60 mg hard capsules: The capsule is a yellow cap/yellow body hard capsule of 23.4 mm, printed with black ink imprinted with “60 mg” on body and “A733” on cap.

Qualitative and quantitative composition

Lojuxta 5 mg hard capsules

Each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide.

Excipient with known effect:

Each hard capsule contains 70.12 mg of lactose (as monohydrate) (see section 4.4).

Lojuxta 10 mg hard capsules

Each hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide.

Excipient with known effect:

Each hard capsule contains 140.23 mg of lactose (as monohydrate) (see section 4.4).

Lojuxta 20 mg hard capsules

Each hard capsule contains lomitapide mesylate equivalent to 20 mg lomitapide.

Excipient with known effect:

Each hard capsule contains 129.89 mg of lactose (as monohydrate) (see section 4.4).

Lojuxta 30 mg hard capsules

Each hard capsule contains lomitapide mesylate equivalent to 30 mg lomitapide.

Excipient with known effect:

Each hard capsule contains 194.84 mg of lactose (as monohydrate) (see section 4.4).

Lojuxta 40 mg hard capsules

Each hard capsule contains lomitapide mesylate equivalent to 40 mg lomitapide.

Excipient with known effect:

Each hard capsule contains 259.79 mg of lactose (as monohydrate) (see section 4.4).

Lojuxta 60 mg hard capsules

Each hard capsule contains lomitapide mesylate equivalent to 60 mg lomitapide.

Excipient with known effect:

Each hard capsule contains 389.68 mg of lactose (as monohydrate) (see section 4.4).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lomitapide

Lomitapide directly binds and inhibits microsomal triglyceride transfer protein (MTP), which resides in the lumen of the endoplasmic reticulum, thereby preventing the assembly of apo B-containing lipoproteins in enterocytes and hepatocytes. This inhibits the synthesis of chylomicrons and VLDL. The inhibition of the synthesis of VLDL leads to reduced levels of plasma LDL-C.

List of Excipients

Capsule content:

Pregelatinised starch (maize)
Sodium starch glycolate (Type A)
Microcrystalline cellulose
Lactose monohydrate
Silica, colloidal anhydrous
Magnesium stearate

Capsule shell:

Lojuxta 5 mg, 10 mg hard capsules:

Gelatin
Titanium dioxide (E171)
Red iron oxide (E172)

Lojuxta 20 mg hard capsules:

Gelatin
Titanium dioxide (E171)

Lojuxta 30 mg hard capsules:

Gelatin
Titanium dioxide (E171)
Red iron oxide (E172)
Yellow iron oxide (E172)

Lojuxta 40 mg, 60 mg hard capsules:

Gelatin
Titanium dioxide (E171)
Yellow iron oxide (E172)

Printing ink:

Shellac
Black iron oxide (E172)
Propylene glycol

Pack sizes and marketing

High density polyethylene (HDPE) bottle fitted with a polyester/aluminium foil/cardboard induction seal and polypropylene screw cap.

Package sizes are: 28 capsules.

Marketing authorization holder

Amryt Pharmaceuticals DAC, 45 Mespil Road, Dublin 4, Ireland

Marketing authorization dates and numbers

EU/1/13/851/001 – Lojuxta 5 mg hard capsules
EU/1/13/851/002 – Lojuxta 10 mg hard capsules
EU/1/13/851/003 – Lojuxta 20 mg hard capsules
EU/1/13/851/004 – Lojuxta 30 mg hard capsules
EU/1/13/851/005 – Lojuxta 40 mg hard capsules
EU/1/13/851/006 – Lojuxta 60 mg hard capsules

Date of first authorisation: 31 July 2013
Date of latest renewal: 23 April 2018

Drugs

Drug Countries
LOJUXTA Austria, Brazil, Estonia, France, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, United Kingdom

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