Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Thalidomide
Lipomed GmbH
L04AX02
thalidomide
Immunosuppressants
Multiple Myeloma
Thalidomide Lipomed 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 Lipomed is prescribed and dispensed in accordance with the Thalidomide Lipomed Pregnancy Prevention Programme (see section 4.4).
Authorised
2022-09-19
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT THALIDOMIDE LIPOMED 100 MG COATED TABLETS 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 Lipomed is and what it is used for 2. What you need to know before you take Thalidomide Lipomed 3. How to take Thalidomide Lipomed 4. Possible side effects 5. How to store Thalidomide Lipomed 6. Contents of the pack and other information 1. WHAT THALIDOMIDE LIPOMED IS AND WHAT IT IS USED FOR WHAT THALIDOMIDE LIPOMED IS Thalidomide Lipomed contains an active substance called thalidomide. This belongs to a group of medicines which affect how your immune system works. WHAT THALIDOMIDE LIPOMED IS USED FOR Thalidomide Lipomed 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 Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Thalidomide Lipomed 100 mg coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 100 mg of thalidomide. Excipients with known effect Lactose monohydrate (100 mg per coated tablet), sucrose (81 mg per coated tablet) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet White, round, domed sugar-coated tablets with diameter of approximately 10.2 mm and thickness of approximately 5.5 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Thalidomide Lipomed 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 Lipomed is prescribed and dispensed in accordance with the Thalidomide Lipomed 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. Each coated tablet of Thalidomide Lipomed contains 100 mg of thalidomide, whereas other available thalidomide-containing medicinal products usually contain 50 mg of thalidomide. This must be taken into account, and the patient must be instructed accordingly. A maximum number of 12 cycles of 6 weeks (42 days) should be used. 3 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 d Read the complete document