País: União Europeia
Língua: inglês
Origem: EMA (European Medicines Agency)
Maralixibat chloride
Mirum Pharmaceuticals International B.V.
A05AX04
Maralixibat chloride
Other drugs for bile therapy
Alagille Syndrome
Livmarli is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.
Revision: 3
Authorised
2022-12-09
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 Leia o documento completo
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 Leia o documento completo