البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
vismodegib
Roche Registration GmbH
L01XX43
vismodegib
Antineoplastic agents
Carcinoma, Basal Cell
Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy
Revision: 15
Authorised
2013-07-12
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ERIVEDGE 150 MG HARD CAPSULES vismodegib Erivedge may cause severe birth defects. It may lead to the death of a _ _ baby before it is born or shortly after being born. You must not become pregnant while taking this medicine. You must follow the contraception advice described in this leaflet. _ _ 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 Erivedge is and what it is used for 2. What you need to know before you take Erivedge 3. How to take Erivedge 4. Possible side effects 5. How to store Erivedge 6. Contents of the pack and other information 1. WHAT ERIVEDGE IS AND WHAT IT IS USED FOR WHAT ERIVEDGE IS Erivedge is an anti-cancer medicine that contains the active substance vismodegib. WHAT ERIVEDGE IS USED FOR Erivedge is used to treat adults with a type of skin cancer called advanced basal cell carcinoma. It is used when the cancer: • has spread to other parts of the body (called “metastatic” basal cell carcinoma) • has spread to areas nearby (called “locally advanced” basal cell carcinoma) and your doctor decides that treatment with surgery or radiation is inappropriate HOW ERIVEDGE WORKS Basal cell carcinoma develops when DNA in normal skin cells becomes damaged and the body cannot repair the damage. This damage can change how certain proteins in these cells work and the damaged cells become cancerous and begin to grow and divide. Erivedge is an anti-cancer medicine that works by controlling one of the key prot اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Erivedge 150 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150 mg of vismodegib. Excipient with known effect Each hard capsule contains 71.5 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Pink coloured opaque body marked “150 mg” and a grey opaque cap marked “VISMO” with black ink. The size of the capsule is ‘Size 1’ (dimensions 19.0 x 6.6 mm). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Erivedge is indicated for the treatment of adult patients with: symptomatic metastatic basal cell carcinoma locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Erivedge should only be prescribed by or under the supervision of a specialist physician experienced in the management of the approved indication. Posology The recommended dose is one 150 mg capsule taken once daily. _Missed doses _ If a dose is missed, patients should be instructed not to take the missed dose but to resume with the next scheduled dose. Duration of treatment In clinical studies, treatment with Erivedge was continued until disease progression or until unacceptable toxicity. Treatment interruptions of up to 4 weeks were allowed based on individual tolerability. Benefit of continued treatment should be regularly assessed, with the optimal duration of therapy varying for each individual patient. _Special populations _ _Elderly _ No dose adjustment is required in patients ≥ 65years of age (see section 5.2). Of a total number of 138 patients in 4 clinical studies of Erivedge in advanced basal cell carcinoma, approximately 40 % of 3 patients were ≥ 65 years old and no overall differences in safety and efficacy were observed between these patients and younger patients. _Renal impairment _ Mild and moderate renal impairment is not expected to impact the eliminati اقرأ الوثيقة كاملة