Lojuxta 10mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lomitapide

Available from:

Amryt Pharma

ATC code:

C10AX12

INN (International Name):

Lomitapide

Dosage:

10mg

Pharmaceutical form:

Capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 5060345160017

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER_ _
LOJUXTA 5 MG HARD CAPSULES
LOJUXTA 10 MG HARD CAPSULES
LOJUXTA 20 MG HARD CAPSULES
lomitapide
▼This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
_ _
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET
1.
What Lojuxta is and what it is used for
2.
What you need to know before you take Lojuxta
3.
How to take Lojuxta
4.
Possible side effects
5.
How to store Lojuxta
6.
Contents of the pack and other information
1.
WHAT LOJUXTA IS AND WHAT IT IS USED FOR
Lojuxta contains the active substance called lomitapide. Lomitapide is
a “lipid-modifying agent” which
works by blocking the action of “microsomal triglyceride transfer
protein.” This protein is located within
the liver and the gut cells, where it is involved in assembling fatty
substances into larger particles that are
then released into the blood stream. By blocking this protein, the
medicine decreases the level of fats and
cholesterol (lipids) in the blood.
Lojuxta is used to treat adult patients with very high cholesterol
because of a condition that runs in their
families (homozygous familial hypercholesterolaemia or HoFH). It is
typically passed down by both
father and mother, who also have high cholesterol passed down from
their parents. The patient’s “bad”
cholesterol level is very high from a very early age. The “

Summary of Product characteristics

LOJUXTA HARD CAPSULES
Summary of Product Characteristics Updated 12-Dec-2016 | Aegerion
Pharmaceuticals Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Lojuxta 5 mg hard capsules
Lojuxta 10 mg hard capsules
Lojuxta 20 mg hard capsules
2. Qualitative and quantitative composition
Each 5 mg hard capsule contains lomitapide mesylate equivalent to 5 mg
lomitapide.
Each 10 mg hard capsule contains lomitapide mesylate equivalent to 10
mg lomitapide.
Each 20 mg hard capsule contains lomitapide mesylate equivalent to 20
mg lomitapide.
Excipient with known effect
Each 5 mg hard capsule contains 70.12 mg of lactose (as monohydrate)
(see section 4.4).
Each 10 mg hard capsule contains 140.23 mg of lactose (as monohydrate)
(see section 4.4).
Each 20 mg hard capsule contains 129.89 mg of lactose (as monohydrate)
(see section 4.4).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard.
The 5 mg 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.
The 10 mg 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.
The 20 mg 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.
4. Clinical particulars
4.1 Therapeutic indications
Lojuxta is indicated as an adjunct to a low-fat diet and other
lipid-lowering medicinal products with or
without low density lipoprotein (LDL) apheresis in adult patients with
homozygous familial
hypercholesterolaemia (HoFH).
Genetic confirmation of HoFH should be obtained whenever possible.
Other forms of primary
hyperlipoproteinaemia and secondary causes of hypercholesterola