Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
bexarotene
Eisai GmbH
L01XF03
bexarotene
Antineoplastic agents
Lymphoma, T-Cell, Cutaneous
Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment.
Revision: 23
Authorised
2001-03-29
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: INFORMATION FOR THE USER TARGRETIN 75 MG SOFT CAPSULES BEXAROTENE 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Targretin is and what it is used for 2. What you need to know before you take Targretin 3. How to take Targretin 4. Possible side effects 5. How to store Targretin 6. Contents of the pack and other information 1. WHAT TARGRETIN IS AND WHAT IT IS USED FOR The active substance in Targretin, bexarotene, belongs to a group of medicines known as retinoids, which are related to vitamin A. Targretin capsules are used by patients with advanced stage cutaneous T-cell lymphoma (CTCL) whose disease has not responded to other therapies. CTCL is a condition in which certain cells of the body’s lymph system called T-lymphocytes become cancerous and affect the skin. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TARGRETIN DO NOT TAKE TARGRETIN: - if you are allergic to bexarotene or any of the other ingredients of this medicine (listed in section 6). - if you are pregnant or breast feeding or if you can become pregnant and are not using effective birth control measures. - if you have a history of pancreatitis, have uncontrolled lipid (blood fats) elevations (high blood cholesterol or high blood triglycerides), have a condition known as hypervitaminosis A, have uncontrolled thyroid disease, have insufficient liver function or have an ongoing systemic infection. WARNINGS AND PRECAUTIONS Talk to your doctor before taking Targretin - if you have a known hypersensiti Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Targretin 75 mg soft capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 75 mg of bexarotene. Excipient(s) with known effect: sorbitol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule. Off-white capsule, containing a liquid suspension and imprinted with “Targretin”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Targretin is indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) in adult patients refractory to at least one systemic treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Bexarotene therapy should only be initiated and maintained by physicians experienced in the treatment of patients with CTCL. Posology The recommended initial dose is 300 mg/m 2 /day. Initial dose calculations according to body surface area are as follows: TABLE 1 RECOMMENDED INITIAL DOSE Initial dose level (300 mg/m 2 /day) Number of 75 mg Targretin capsules Body Surface Area (m 2 ) Total daily dose (mg/day) 0.88 – 1.12 300 4 1.13 - 1.37 375 5 1.38 - 1.62 450 6 1.63 - 1.87 525 7 1.88 - 2.12 600 8 2.13 - 2.37 675 9 2.38 - 2.62 750 10 _Dose modification guidelines_ The 300 mg/m 2 /day dose level may be adjusted to 200 mg/m 2 /day then to 100 mg/m 2 /day, or temporarily suspended, if necessitated by toxicity. When toxicity is controlled, doses may be carefully readjusted upward. With appropriate clinical monitoring, individual patients may benefit from doses above 300 mg/m 2 /day. Doses greater than 650 mg/m 2 /day have not been evaluated in patients with CTCL. In clinical trials, bexarotene was administered for up to 118 weeks to patients with CTCL. Treatment should be continued as long as the patient is deriving benefit. 3 _Paediatric population_ The safety and efficacy of bexarotene in children (aged below 18 years) have not been established. No data are available. _Elderly patients_ Of the total number of patients with CTCL in clinical st Przeczytaj cały dokument