Lojuxta
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
06-11-2023
Fachinformation
(SPC)
06-11-2023
Öffentlichen Beurteilungsberichts
(PAR)
11-03-2016
Wirkstoff:
Lomitapide
Verfügbar ab:
Amryt Pharmaceuticals DAC
ATC-Code:
C10AX12
INN (Internationale Bezeichnung):
lomitapide
Therapiegruppe:
Lipid modifying agents
Therapiebereich:
Hypercholesterolemia
Anwendungsgebiete:
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 hypercholesterolaemia (e.g. nephrotic syndrome, hypothyroidism) must be excluded.,
Produktbesonderheiten:
Revision: 18
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2013-07-31
Gebrauchsinformation
35
B. PACKAGE LEAFLET
36
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 v
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
Lojuxta 30 mg hard capsules
Lojuxta 40 mg hard capsules
Lojuxta 60 mg hard capsules
2.
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.
3
_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.
3.
PHARMACEUTICAL FORM
Hard capsule.
Lojuxta 5 m
g hard capsules
The capsule is an orange cap/orange body hard capsule of
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