LIVMARLI

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MARALIXIBAT CHLORIDE

Available from:

NEOPHARM (ISRAEL) 1996 LTD

ATC code:

A05AX04

Pharmaceutical form:

SOLUTION (ORAL)

Composition:

MARALIXIBAT CHLORIDE 10 MG/ML

Administration route:

ORAL

Prescription type:

Required

Manufactured by:

MIRUM PHARMACEUTICALS INC., USA

Therapeutic area:

MARALIXIBAT CHLORIDE

Therapeutic indications:

Livamrli ® is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older.

Authorization date:

2022-10-06

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
LIVMARLI
ORAL SOLUTION
ACTIVE INGREDIENT:
Each 1 ml contains 10 mg maralixibat chloride (equivalent to 9.5 mg of
maralixibat).
For the list of inactive ingredients, see section 6: ‘Additional
information’.
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 medical condition is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Livmarli is indicated for the treatment of cholestatic pruritus in
patients with Alagille syndrome (ALGS) 1 year of
age and older.
THERAPEUTIC GROUP: medicines for treatment of bile duct
diseases.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients in this
medicine (see section 6 ‘Additional information’).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
BEFORE TREATMENT WITH LIVMARLI, TELL YOUR DOCTOR OR PHARMACIST IF:
- You have liver problems.
- You are pregnant, think you are pregnant or plan to become pregnant.
It is not known whether Livmarli
may harm the fetus.
- You are breastfeeding or plan to breastfeed. It is not known whether
Livmarli passes into breast milk.
CHILDREN AND ADOLESCENTS:
Livmarli is intended for treating children one year of age and older.
There is no information regarding the safety
and efficacy of using Livmarli in children under 1 year of age.
TESTS AND FOLLOW-UP:
•
Your doctor may refer you for liver function tests before and during
the treatment with Livmarli.
•
Your doctor may refer you for a blood test for levels of fat soluble
vitamins (vitamins A, D, E, and K)
before and during the treatment with Livmarl

Summary of Product characteristics

FULL PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
LIVMARLI
®
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Maralixibat chloride 10 mg/ml (equivalent to 9.5 mg/ml maralixibat).
For the full list of excipients, see section 12.
3
PHARMACEUTICAL FORM
Oral solution.
A clear, colorless to yellow solution.
4
INDICATIONS AND USAGE
LIVMARLI is indicated for the treatment of cholestatic pruritus in
patients with Alagille syndrome
(ALGS) 1 year of age and older.
5
DOSAGE AND ADMINISTRATION
5.1
DOSING
The recommended dosage is 380 mcg/kg once daily, taken 30 minutes
before the first meal of the
day. Start dosing at 190 mcg/kg administered orally once daily; after
one week, increase to 380
mcg/kg once daily, as tolerated. The maximum daily dose volume for
patients above 70kg is 3 mL or
28.5 mg per day. Refer to the dosing by weight guidelines presented in
Table 1.
TABLE 1: INDIVIDUAL DOSE VOLUME BY PATIENT WEIGHT
PATIENT WEIGHT
(KG)
DAYS 1-7
(190 MCG/KG ONCE DAILY)
BEGINNING DAY 8
(380 MCG/KG ONCE DAILY)
Volume QD
(mL)
Dosing dispenser
size (mL)
Volume QD
(mL)
Dosing dispenser
size (mL)
5 TO 6
0.1
0.5
0.2
0.5
7 TO 9
0.15
0.3
10 TO 12
0.2
0.45
13 TO 15
0.3
0.6
1
16 TO 19
0.35
0.7
20 TO 24
0.45
0.9
25 TO 29
0.5
1
30 TO 34
0.6
1
1.25
3
35 TO 39
0.7
1.5
40 TO 49
0.9
1.75
50 TO 59
1
2.25
60 TO 69
1.25
3
2.5
70 OR HIGHER
1.5
3
5.2
MISSED DOSE
If a dose is missed, it should be taken as soon as possible within 12
hours of the time it is usually
taken, and the original dosing schedule should be resumed. If a dose
is missed by more than 12
hours, the dose can be omitted and the original dosing schedule
resumed.
5.3
ADMINISTRATION
For patients taking bile acid binding resins, take LIVMARLI at least 4
hours before or 4 hours after
taking a bile acid binding resin _[see Drug interactions (9.1)]_.
A calibrated measuring device (0.5 mL, 1 mL or 3 mL oral dosing
dispenser) shell be used by the
patient to measure and deliver the prescribed dose accurately.
5.4
DOSE MODIFICATION FOR MANAGEMENT OF ADVERSE EVENTS
Establish the baseline