CHENODEOXYCHOLIC ACID LEADIANT

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CHENODEOXYCHOLIC ACID

Available from:

MBI PHARMA LTD., ISRAEL

ATC code:

A05AA01

Pharmaceutical form:

HARD CAPSULE

Composition:

CHENODEOXYCHOLIC ACID 250 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

PHARMALOOP S.L, SPAIN

Therapeutic area:

CHENODEOXYCHOLIC ACID

Therapeutic indications:

The treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, children and adolescents aged 1 month to 18 years and adults.

Authorization date:

2022-09-30

Patient Information leaflet

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
Dispensing this medicine requires a doctor’s prescription
Chenodeoxycholic acid Leadiant
Hard capsules
ACTIVE INGREDIENT: Each capsule contains 250 mg chenodeoxycholic acid.
For a list of inactive ingredients and allergens see section 6:
'Additional information'.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise information about
this medicine. If you have further questions, ask 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?
This medicine is intended for treating inborn problems producing
primary bile acids because the enzyme sterol 27
hydroxylase is missing (an illness called cerebrotendinous
xanthomatosis [CTX]. This medicine is intended for
treating infants from one month old, children and adolescents up to 18
years old, and adults.
THERAPEUTIC GROUP: digestive tract and metabolism - bile treatments -
bile acid medication.
ABOUT CHENODEOXYCHOLIC ACID
Chenodeoxycholic acid Leadiant capsules contain a substance called
chenodeoxycholic acid. Normally, this
substance is made from cholesterol in the liver. It is a component of
bile, a fluid which helps in the digestion of fat
and vitamins from food. People with a rare condition known as
cerebrotendinous xanthomatosis (CTX) cannot
produce chenodeoxycholic acid and this causes a buildup of fatty
deposits in various areas of the body. These
deposits can cause damage to the affected areas.
Chenodeoxycholic acid Leadiant capsules can be used from the age of
one month and patients with CTX will
require treatment for the rest of their lives.
2. BEFORE USING THIS MEDICINE
DO NOT TAKE THIS MEDICINE IF:
−
you are sensitive (allergic) to chenodeoxycholic acid or to any of the
other ingredients that this
medicine contains (listed in Section 6).
SPECIAL WARNINGS

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Chenodeoxycholic acid Leadiant
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 250 mg of chenodeoxycholic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Size 0 capsule, 21.7 mm in length with a yellow body and orange cap,
containing a white, compressed
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chenodeoxycholic acid Leadiant is indicated for the treatment of
inborn errors of primary bile acid
synthesis due to sterol 27 hydroxylase deficiency (presenting as
cerebrotendinous xanthomatosis
(CTX)) in infants, children and adolescents aged 1 month to 18 years
and adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated and monitored by physicians experienced in
the management of CTX or
inborn errors of primary bile acid synthesis.
During the initiation of therapy and dose adjustment, serum
cholestanol levels and/or urine bile
alcohols should be monitored every 3 months till metabolic control and
then annually. The lowest dose
of chenodeoxycholic acid that effectively reduces the serum
cholestanol and/or urine bile alcohols
levels to within the normal range should be chosen. Liver function
should also be monitored.
Concurrent elevation of liver enzymes above normal levels may indicate
overdose. After the initiation
period, cholestanol, urine bile alcohols and liver function should be
determined annually, at a
minimum, and the dose adjusted accordingly (see section 4.4).
Additional or more frequent
investigations may need to be undertaken to monitor therapy during
periods of fast growth,
concomitant disease and pregnancy (see section 4.6).
In case of persistent lack of therapeutic response to chenodeoxycholic
acid monotherapy, other
treatment options should be considered.
Posology
_Adults _
The starting dose in adults is 750 mg/day, in three divided doses
provided that it is sufficient to
normalise serum cholestanol and/or urine bile alcohols. The daily dose
can be subsequently inc