Land: Malta
Språk: engelska
Källa: Medicines Authority
SUNITINIB
Przedsiebiorstwo Farmaceutyczne LEK-AM sp. z o.o 14A Ostrzykowizna Street, 05-170 Zakroczym, , Poland
L01XE01
SUNITINIB 12.5 mg
HARD CAPSULE
SUNITINIB 12.5 mg
POM
ANTINEOPLASTIC AGENTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-08-09
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER SUBINIT 12.5 MG CAPSULES, HARD SUBINIT 25 MG CAPSULES, HARD SUBINIT 50 MG CAPSULES, HARD Sunitinib 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 or pharmacist. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Subinit is and what it is used for 2. What you need to know before you take Subinit 3. How to take Subinit 4. Possible side effects 5. How to store Subinit 6. Contents of the pack and other information 1. WHAT SUBINIT IS AND WHAT IT IS USED FOR Subinit contains the active substance sunitinib, which is a protein kinase inhibitor. It is used to treat cancer by preventing the activity of a special group of proteins which are known to be involved in the growth and spread of cancer cells. Subinit is used to treat adults with the following types of cancer: - Gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel, where imatinib (another anticancer medicine) no longer works or you cannot take imatinib. - Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body. - Pancreatic neuroendocrine tumours (pNET) (tumours of the hormone-producing cells in the pancreas) that have progressed or cannot be removed with surgery. If you have any questions about how Subinit works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUBINIT DO NOT TAKE Subinit Page 2 of 8 - If you are allergic to sunitinib or any of the other ingredients of Subinit (listed in section 6). WARNINGS AND PRECAUTIONS TALK TO YOU Läs hela dokumentet
Page 1 of 32 1. NAME OF THE MEDICINAL PRODUCT Subinit 12.5 mg, capsules, hard Subinit 25 mg, capsules, hard Subinit 50 mg, capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Subinit 12.5 mg, capsules, hard Each capsule contains 16.70 mg of sunitinib malate, equivalent to 12.5 mg of sunitinib. Subinit 25 mg, capsules, hard Each capsule contains 33.40 mg of sunitinib malate, equivalent to 25 mg of sunitinib. Subinit 50 mg, capsules, hard Each capsule contains 66.80 mg of sunitinib malate, equivalent to 50 mg of sunitinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. Subinit 12.5 mg, capsules, hard Hard gelatin capsules, opaque red cap and body, size 4, with yellow to orange granules. Subinit 25 mg, capsules, hard Hard gelatin capsules, opaque yellow cap and opaque red body, size 2, with yellow to orange granules. Subinit 50 mg, capsules, hard Hard gelatin capsules, opaque yellow cap and body, size 1, with yellow to orange granules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gastrointestinal stromal tumour (GIST) Subinit is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) Subinit is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Subinit is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults. Page 2 of 32 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy with sunitinib should be initiated by a physician experienced in the administration of anticancer agents. Posology For GIST and MRCC, the recommended dose of Subinit is 50 mg taken orally once daily, for 4 consecutive weeks, followed by a 2-week rest period (schedule 4/2) to comprise a complete cycle of 6 weeks. For pNET, the recommended dose of S Läs hela dokumentet