国: 欧州連合
言語: 英語
ソース: EMA (European Medicines Agency)
cabozantinib
Ipsen Pharma
L01XE
cabozantinib
Antineoplastic agents
Thyroid Neoplasms
Treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.
Revision: 28
Authorised
2014-03-21
47 B. PACKAGE LEAFLET 48 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COMETRIQ 20 MG HARD CAPSULES COMETRIQ 80 MG HARD CAPSULES cabozantinib 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 COMETRIQ is and what it is used for 2. What you need to know before you take COMETRIQ 3. How to take COMETRIQ 4. Possible side effects 5. How to store COMETRIQ 6. Contents of the pack and other information 1. WHAT COMETRIQ IS AND WHAT IT IS USED FOR WHAT COMETRIQ IS COMETRIQ is a cancer medicine that contains the active substance cabozantinib ( _S_ )-malate. It is a medicine used to treat medullary thyroid cancer, a rare type of thyroid cancer, that cannot be removed by surgery or that has spread to other parts of the body. HOW COMETRIQ WORKS COMETRIQ blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them. These proteins can be present in high amounts in cancer cells, and by blocking their action COMETRIQ can slow down the rate at which the tumour grows and help to cut off the blood supply that the cancer needs. COMETRIQ may slow or stop the growth of medullary thyroid cancer. It may help shrink tumours associated with this type of cancer. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COMETRIQ DO NOT TAKE COMETRIQ - if you are allergic to cabozantinib or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking COMETRIQ if you: - ha 完全なドキュメントを読む
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT COMETRIQ 20 mg hard capsules COMETRIQ 80 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One hard capsule contains cabozantinib ( _S_ )-malate equivalent to 20 mg or 80 mg cabozantinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. The hard capsules are grey with “XL184 20mg” printed in black on the body of the capsule. The capsule contains an off-white to white powder. The hard capsules are orange with “XL184 80mg” printed in black on the body of the capsule. The capsule contains an off-white to white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS COMETRIQ is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma. For patients in whom rearranged during transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision (see important information in section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy with COMETRIQ should be initiated by a physician experienced in the administration of anticancer medicinal products. Posology COMETRIQ (cabozantinib) capsules and CABOMETYX (cabozantinib) tablets are not bioequivalent and should not be used interchangeably (see section 5.2). The recommended dose of COMETRIQ is 140 mg once daily, taken as one 80 mg orange capsule and three 20 mg grey capsules. Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs. It should be expected that a majority of patients treated with COMETRIQ will require one or more dose adjustments (reduction and/or interruption) due to toxicity. Patients should therefore be closely monitored during the first eight weeks of therapy (see section 4.4). Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction o 完全なドキュメントを読む