Country: Եվրոպական Միություն
language: անգլերեն
source: EMA (European Medicines Agency)
Lusutrombopag
Shionogi B.V.
B02BX
lusutrombopag
Antihemorrhagics
Thrombocytopenia
Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures
Revision: 8
Authorised
2019-02-18
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MULPLEO 3 MG FILM-COATED TABLETS lusutrombopag READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 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 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 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 Mulpleo is and what it is used for 2. What you need to know before you take Mulpleo 3. How to take Mulpleo 4. Possible side effects 5. How to store Mulpleo 6. Contents of the pack and other information 1. WHAT MULPLEO IS AND WHAT IT IS USED FOR Mulpleo contains the active substance lusutrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists. The medicine helps to increase the number of _platelets_ in your blood. Platelets are blood components that help the blood to clot and so prevent bleeding. Mulpleo is used to REDUCE THE RISK OF BLEEDING DURING SURGERY AND OTHER PROCEDURES (including tooth extractions and endoscopy). It is given to adults who have low numbers of platelets because of chronic liver disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MULPLEO DO NOT TAKE MULPLEO: - IF YOU ARE ALLERGIC to lusutrombopag or any of the other ingredients of this medicine (listed in section 6 under ‘_What Mulpleo contains_’). ➤ CHECK WITH YOUR DOCTOR if this applies to you before you take Mulpleo WARNINGS AND PRECAUTIONS Talk to your doctor: - IF YOU ARE AT RISK OF BLOOD CLOTS in your veins or arteries, or if you previously have had blood clots - IF YOU HAVE SEVERE LIVER DISEASE - IF YOUR SPLEEN HAS BEEN REMOVED - IF YOU ARE HAVING INTERFERON TREATMENT. ➤ TALK TO YOUR DOCTOR before taki read_full_document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Mulpleo 3 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 3 mg of lusutrombopag. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Light red, 7.0 mm round film-coated tablets debossed with the Shionogi trademark above the identifier code “551” on one side and debossed on the other side with the strength “3”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures (see section 5.1)._ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 3 mg lusutrombopag once daily for 7 days. The procedure should be performed from day 9 after the start of lusutrombopag treatment. Platelet count should be measured prior to the procedure. _Missed dose _ If a dose is missed it should be taken as soon as possible. A double dose should not be taken to make up for a missed dose. _Duration of treatment _ Mulpleo should not be taken for more than 7 days. Special populations _Elderly _ No dose adjustment is necessary in patients 65 years of age or older (see section 5.2). _Renal impairment _ No dose adjustment is necessary in patients with renal impairment (see section 5.2). _Hepatic impairment _ Due to limited information available, the safety and efficacy of Mulpleo in patients with severe hepatic impairment (Child-Pugh class C) have not been established (see sections 4.4 and 5.1). No dose adjustment is expected for these patients. Lusutrombopag therapy should only be initiated in patients 3 with severe hepatic impairment if the expected benefit outweighs the expected risks (see sections 4.4 and 5.2). No dose adjustment is necessary for patients with mild (Child-Pugh class A) to moderate (Child-Pugh class B) hepatic impairment. _Paediatric population _ The safety and efficacy of lusutrombopag in ch read_full_document