Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
mifamurtide
Takeda France SAS
L03AX15
mifamurtide
Immunostimulants,
Osteosarcoma
Mepact is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with postoperative multi-agent chemotherapy. Safety and efficacy have been assessed in studies of patients two to 30 years of age at initial diagnosis.
Revision: 18
Authorised
2009-03-06
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE USER MEPACT 4 MG POWDER FOR CONCENTRATE FOR DISPERSION FOR INFUSION mifamurtide _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What MEPACT is and what it is used for 2. What you need to know before you use MEPACT 3. How to use MEPACT 4. Possible side effects 5. How to store MEPACT 6. Contents of the pack and other information 1. WHAT MEPACT IS AND WHAT IT IS USED FOR MEPACT contains the active substance mifamurtide, similar to a component of the cell wall of certain bacteria. It stimulates your immune system to help your body kill tumour cells. MEPACT is used to treat osteosarcoma (bone cancer) in children, adolescents and young adults (between 2 and 30 years). It is used after you have had surgery to remove the tumour and together with chemotherapy to kill remaining cancer cells to reduce the risk of cancer coming back. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MEPACT DO NOT USE MEPACT: - if you are allergic to mifamurtide or any of the other ingredients of this medicine (listed in section 6). - if you are taking medicines containing ciclosporin or other calcineurin inhibitors or high doses of non-steroidal-anti-inflammatory drugs (NSAIDs) (see “Using other medicines” below). WARNINGS AND PRECAUTIONS Talk to your doctor before using MEPACT: - if you have or have had problems with your heart or blood vessels, like blood clots (thrombosis), bleeding (haemorrhage) or inflammation of the veins (vasculitis). You should be more closely monitored while receiving MEPACT treatment. If you have long-lasting or worsening symptoms, you should contact your doctor, as MEPACT treatment may need to be delayed or discontinue Leggi il documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT MEPACT 4 mg powder for concentrate for dispersion for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 4 mg mifamurtide*. After reconstitution, each mL of suspension in the vial contains 0.08 mg mifamurtide. *fully synthetic analogue of a component of _Mycobacterium sp._ cell wall. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for dispersion for infusion White to off-white homogeneous cake or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MEPACT is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with post-operative multi-agent chemotherapy. Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Mifamurtide treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of osteosarcoma. _ _ Posology The recommended dose of mifamurtide for all patients is 2 mg/m 2 body surface area. It should be administered as adjuvant therapy following resection: twice weekly at least 3 days apart for 12 weeks, followed by once-weekly treatments for an additional 24 weeks for a total of 48 infusions in 36 weeks _. _ Special populations _ _ _Adults > 30 years _ None of the patients treated in the osteosarcoma studies were 65 years or older and in the phase III randomised study, only patients up to the age of 30 years were included. Therefore, there are not sufficient data to recommend the use of MEPACT in patients > 30 years of age. _Renal or hepatic impairment_ There are no clinically meaningful effects of mild to moderate renal (creatinine clearance (CrCL) ≥ 30 mL/min) or hepatic impairment (Child-Pugh class A or B) on the pharmacokinetics of mifamurtide; the Leggi il documento completo