Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
sonidegib diphosphate
Sun Pharmaceutical Industries Europe B.V.
L01XJ02
sonidegib
Antineoplastic agents
Carcinoma, Basal Cell
Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.
Revision: 10
Authorised
2015-08-14
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ODOMZO 200 MG HARD CAPSULES sonidegib Odomzo 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 instructions contained 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 Odomzo is and what it is used for 2. What you need to know before you take Odomzo 3. How to take Odomzo 4. Possible side effects 5. How to store Odomzo 6. Contents of the pack and other information 1. WHAT ODOMZO IS AND WHAT IT IS USED FOR WHAT ODOMZO IS Odomzo contains the active substance sonidegib. It is an anti-cancer medicine. WHAT ODOMZO IS USED FOR Odomzo is used to treat adults with a type of skin cancer called basal cell carcinoma. It is used when the cancer has spread locally and cannot be treated with surgery or radiation. HOW ODOMZO WORKS The normal growth of cells is controlled by various chemical signals. In patients with basal cell carcinoma, changes occur to genes controlling a part of this process known as the “hedgehog pathway”. This switches on signals that make the cancer cells grow out of control. Odomzo works by blocking this process, stopping cancer cells from growing and making new cells. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ODOMZO Read the specific instructions given to you by your doctor, particularly on the effects of Odomzo on unborn babies. Read caref Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Odomzo 200 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg sonidegib (as phosphate). Excipient with known effect Each hard capsule contains 38.6 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Opaque pink hard capsule containing white to almost white powder with granules, with “NVR” imprinted in black ink on the cap and “SONIDEGIB 200MG” imprinted in black ink on the body. The size of the capsule is “Size #00” (dimensions 23.3 x 8.53 mm). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Odomzo 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 200 mg sonidegib taken orally. Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity develops. _Dose modifications for creatine phosphokinase (CK) elevations and muscle-related adverse reactions _ Temporary dose interruption and/or dose reduction of Odomzo therapy may be required for CK elevations and muscle-related adverse reactions. 3 Table 1 summarises recommendations for dose interruption and/or dose reduction of Odomzo therapy in the management of symptomatic CK elevations and muscle-related adverse reactions (such as myalgia, myopathy, and/or spasm). TABLE 1 RECOMMENDED DOSE MODIFICATIONS AND MANAGEMENT FOR SYMPTOMATIC CK ELEVATIONS AND MUSCLE-RELATED ADVERSE REACTIONS SEVERITY OF CK ELEVATION DOSE MODIFICATIONS* AND MANAGEMENT RECOMMENDATIONS Grade 1 [CK elevation >ULN - 2.5 x ULN] • Continue treatment at the same dose and monitor CK levels weekly until resolution to baseline level an Lestu allt skjalið