Livmarli

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Maralixibat chloride

Saatavilla:

Mirum Pharmaceuticals International B.V.

ATC-koodi:

A05AX04

INN (Kansainvälinen yleisnimi):

Maralixibat chloride

Terapeuttinen ryhmä:

Other drugs for bile therapy

Terapeuttinen alue:

Alagille Syndrome

Käyttöaiheet:

Livmarli is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.

Tuoteyhteenveto:

Revision: 3

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2022-12-09

Pakkausseloste

B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
LIVMARLI 9.5 MG/ML ORAL SOLUTION
maralixibat
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 OR YOUR CHILD 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, pharmacist or
nurse.
-
This medicine has been prescribed for you or your child 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 or your child get any side effects, talk to your doctor,
pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Livmarli is and what it is used for
2.
What you need to know before you or your child take Livmarli
3.
How to take Livmarli
4.
Possible side effects
5.
How to store Livmarli
6.
Contents of the pack and other information
1.
WHAT LIVMARLI
IS AND WHAT IT IS USED FOR
WHAT IS LIVMARLI
Livmarli contains the active substance maralixibat. It helps to remove
substances called bile acids
from the body.
Bile acids are found in digestive fluid called bile which is produced
by the liver. Bile acids move from
the liver into the gut, where they help with digesting food. After
helping with digestion, they move
back into the liver.
WHAT IS LIVMARLI
USED FOR
Livmarli is used to treat cholestatic pruritus in patients aged 2
months and older who have Alagille
syndrome (ALGS).
ALGS is a rare genetic disease that can lead to a build-up of bile
acids in the liver. This is called
cholestasis. Cholestasis may get worse over time and often causes
severe itching, fatty deposits under
the skin (xanthomas), poor growth and feeling tired.
HOW DOES LIVMARLI (MARALIXIBAT) WORK
Maralixibat works

Valmisteyhteenveto

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
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
Livmarli 9.5 mg/mL oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains maralixibat chloride equivalent to 9.5 mg
maralixibat.
Excipient with known effect
Each mL of oral solution contains 364.5 mg propylene glycol (E1520)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear, colourless to light-yellow liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Livmarli is indicated for the treatment of
cholestatic pruritus in patients with Alagille syndrome
(ALGS) 2 months of age and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Livmarli should be initiated under the supervision of a
physician experienced in the
management of patients with cholestatic liver diseases.
Posology
The recommended target dose is 380 mcg/kg once daily. The starting
dose is 190 mcg/kg once daily
and should be increased to 380 mcg/kg once daily after one week. Table
1 provides the dose in mL of
solution to be given for each weight range. In case of poor
tolerability, dose reduction from
380 mcg/kg/day to 190 mcg/kg/day, or treatment interruption can be
considered. Renewed dose-
escalation can be attempted as tolerated. The maximum recommended
daily dose for patients above
70 kg is 3 mL (28.5 mg).
2
TABLE 1: INDIVIDUAL DOSE VOLUME BY PATIENT WEIGHT
PATIENT WEIGHT
(KG)
DAYS 1 TO 7
(190 MCG/KG ONCE DAILY)
FROM DAY 8 AND AFTER
(380 MCG/KG ONCE DAILY)
Volume once
daily
(mL)
Oral syringe size
(mL)
Volume once
daily
(mL)
Oral syringe size
(mL)
5-6
0.1
0.5
0.2
0.5
7-9
0.15
0.3
10-12
0.2
0.45
13-15
0.3
0.6
1
16-19
0.35
0.7
20-24
0.45
0.9
25-29
0.5
1
30-34
0.6
1
1.25
3
35-39
0.7
1.5
40-49
0.9
1.75
50-59
1
2.25
60-69
1.25
3
2.5
70