LOJUXTA 20 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LOMITAPIDE AS MESYLATE

Available from:

MEDISON PHARMA LTD

ATC code:

C10AX12

Pharmaceutical form:

CAPSULES

Composition:

LOMITAPIDE AS MESYLATE 20 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

CATALENT CTS, USA

Therapeutic area:

LOMITAPIDE

Therapeutic indications:

An adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).

Authorization date:

2019-10-31

Patient Information leaflet

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)
– 1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR'S PRESCRIPTION ONLY
LOJUXTA 5 MG
LOJUXTA 10 MG
LOJUXTA 20 MG
CAPSULES
ACTIVE INGREDIENT:
Each capsule of Lojuxta 5 mg contains lomitapide (as mesilate) 5 mg
Each capsule of Lojuxta 10 mg contains lomitapide (as mesilate) 10 mg
Each capsule of Lojuxta 20 mg contains lomitapide (as mesilate) 20 mg
Inactive ingredients and allergens in this medicine: See section 6
‘Additional information’ and
section 2: ‘Important information about some of this medicine’s
ingredients’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have any further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Lojuxta is used with a low-fat diet and other lipid lowering
treatments, including LDL apheresis in
patients with homozygous familial hypercholesterolaemia (HoFH) to
lower:
LDL cholesterol (“bad
" cholesterol)
total cholesterol (TC)
apolipoprotein-B
non-HDL cholesterol
THERAPEUTIC GROUP:
Lipid-modifying agents.
Lojuxta contains the active ingredient called lomitapide 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
in the blood.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient (lomitapide) or
to any of the other
ingredients this medicine contains (see section 6 -
‘Additional information’)
•
You have liver problems or unexplained abnormal l

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lojuxta 5 mg
Lojuxta 10 mg
Lojuxta 20 mg
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).
For the full list of excipients, see section 6.1.
3.
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lojuxta is indicated as an adjunct to a low-fat diet and other
lipid-lowering treatments, including LDL
apheresis where available, to reduce low-density lipoprotein
cholesterol (LDL-C), total cholesterol (TC),
2
apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol
(non-HDL-C) in patients with
homozygous familial hypercholesterolaemia (HoFH).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Lojuxta should be initiated and monitored by a
physician experienced in the treatment
of lipid disorders.
Posology
The recommended starting dos