Country: Իսրայել
language: անգլերեն
source: Ministry of Health
MARALIXIBAT CHLORIDE
NEOPHARM (ISRAEL) 1996 LTD
A05AX04
SOLUTION (ORAL)
MARALIXIBAT CHLORIDE 10 MG/ML
ORAL
Required
MIRUM PHARMACEUTICALS INC., USA
MARALIXIBAT CHLORIDE
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.
2022-10-06
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 read_full_document
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 read_full_document