Χώρα: Ευρωπαϊκή Ένωση
Γλώσσα: Αγγλικά
Πηγή: EMA (European Medicines Agency)
Thalidomide
Bristol-Myers Squibb Pharma EEIG
L04AX02
thalidomide
Immunosuppressants
Multiple Myeloma
Thalidomide BMS in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy.Thalidomide BMS is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).
Revision: 31
Authorised
2008-04-16
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT THALIDOMIDE BMS 50 MG HARD CAPSULES thalidomide WARNING THALIDOMIDE CAUSES BIRTH DEFECTS AND FOETAL DEATH. DO NOT TAKE THALIDOMIDE IF YOU ARE PREGNANT OR COULD BECOME PREGNANT. YOU MUST FOLLOW THE CONTRACEPTION ADVICE GIVEN TO YOU BY YOUR DOCTOR. 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 Thalidomide BMS is and what it is used for 2. What you need to know before you take Thalidomide BMS 3. How to take Thalidomide BMS 4. Possible side effects 5. How to store Thalidomide BMS 6. Contents of the pack and other information 1. WHAT THALIDOMIDE BMS IS AND WHAT IT IS USED FOR WHAT THALIDOMIDE BMS IS Thalidomide BMS contains an active substance called thalidomide. This belongs to a group of medicines which affect how your immune system works. WHAT THALIDOMIDE BMS IS USED FOR Thalidomide BMS is used with two other medicines called ‘melphalan’ and ‘prednisone’ to treat adults with a type of cancer called multiple myeloma. It is used in people who have recently been diagnosed and who have not been prescribed another medicine for their multiple myeloma before who are aged 65 years and over, or aged less than 65 years who cannot be treated with high dose chemotherapy, which can be very difficult for the body to handle. WHAT IS MULTIPLE MYELOMA Multiple myeloma is a type of cancer which affects a certain type of white blood cell, called the plasma cell. These cells collect in the bone marrow and divide out of contro Διαβάστε το πλήρες έγγραφο
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Thalidomide BMS 50 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50 mg of thalidomide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. White opaque capsules marked “Thalidomide BMS 50 mg”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Thalidomide BMS in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy. Thalidomide BMS is prescribed and dispensed according to the Thalidomide BMS Pregnancy Prevention Programme (see section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment must be initiated and monitored under the supervision of physicians with expertise in managing immunomodulatory or chemotherapeutic agents and a full understanding of the risks of thalidomide therapy and monitoring requirements (see section 4.4). Posology The recommended dose of thalidomide is 200 mg orally per day. A maximum number of 12 cycles of 6 weeks (42 days) should be used. TABLE 1: STARTING DOSES FOR THALIDOMIDE IN COMBINATION WITH MELPHALAN AND PREDNISONE AGE (YEARS) ANC * (/ΜL) PLATELET COUNT (/ΜL) THALIDOMIDE A,B MELPHALAN C,D,E PREDNISONE F ≤ 75 ≥ 1,500 AND ≥ 100,000 200 mg daily 0.25 mg/kg daily 2 mg/kg daily ≤ 75 < 1,500 but ≥ 1,000 OR < 100,000 but ≥ 50,000 200 mg daily 0.125 mg/kg daily 2 mg/kg daily > 75 ≥ 1,500 AND ≥ 100,000 100 mg daily 0.20 mg/kg daily 2 mg/kg daily > 75 < 1,500 but ≥ 1,000 OR < 100,000 but ≥ 50,000 100 mg daily 0.10 mg/kg daily 2 mg/kg daily * ANC: Absolute Neutrophil Count a Thalidomide dosed once daily at bedtime on Days 1 to 42 of each 42-day cycle. b Due to the sedative effect associated with thalidomide, administration at bedtime is known to generally improve tolerability. c Melphalan dosed once daily on Days 1 to 4 of each 42-day cycle. d Melphalan dosing: reduce by 50 % for mode Διαβάστε το πλήρες έγγραφο