Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Alectinib Hydrochloride
ROCHE (MALAYSIA) SDN. BHD.
Alectinib Hydrochloride
224 Capsules
Excella GmbH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ ALECENSA ® HARD CAPSULES _ _ Alectinib (150 mg) _ _ 1 WHAT IS IN THIS LEAFLET 1. What Alecensa is used for 2. How Alecensa works 3. Before you use Alecensa 4. How to use Alecensa 5. While you are using it 6. Side effects 7. Storage and disposal of Alecensa 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT ALECENSA IS USED FOR Alecensa is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer’ (‘NSCLC’). It is used if your lung cancer: is ‘ALK-positive’ - this means your cancer cells have a fault in a gene that makes an enzyme called ALK (‘anaplastic lymphoma kinase’), see ‘How Alecensa works’, below and is advanced. Alecensa can be prescribed to you as first treatment of your lung cancer, or if you have been previously treated with a medicine containing ‘crizotinib’. HOW ALECENSA WORKS Alecensa blocks the action of an enzyme called ‘ALK tyrosine kinase’. Abnormal forms of this enzyme (due to fault in the gene that makes it) help encourage cancer cell growth. Alecensa may slow down or stop the growth of your cancer. It may also help to shrink your cancer. If you have any questions about how Alecensa works or why this medicine has been prescribed for you, ask your doctor, pharmacist or nurse. BEFORE YOU USE ALECENSA - _When you must not use it _ If you are allergic to alectinib or any of the other ingredients of this medicine (listed in Product Description). If you are not sure, talk to your doctor, pharmacist or nurse before taking Alecensa. - _Before you start to use it _ Talk to your doctor, pharmacist or nurse before taking Alecensa: if you have an inherited problem called ‘galactose intolerance’, ‘congenital lactase deficiency’ or ‘glucose-galactose malabsorption’. Alecensa contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor befor Leggi il documento completo
PACK INSERT FOR MALAYSIA ALECENSA ® 150MG Hard Capsules Alectinib 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Antineoplastic agent, Protein Kinase inhibitor ATC code: L01ED03 1.2 TYPE OF DOSAGE FORM White to yellowish white hard capsule of 19.2 mm, with “ALE” printed in black ink on the cap and “150 mg” printed in black ink on the body. 1.3 ROUTE OF ADMINISTRATION Oral 1.4 STERILE / RADIOACTIVE STATEMENT Not applicable 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: Alectinib Each hard capsule contains: Alectinib 150 mg (equivalent to 161.3 mg alectinib hydrochloride). _Capsule fill mass_ : lactose monohydrate, hydroxypropylcellulose, sodium lauryl sulfate, carboxymethylcellulose calcium, magnesium stearate, purified water. _Capsule shell_ : carrageenan, potassium chloride, titanium dioxide (E171), carnauba wax, corn starch, hypromellose, printing ink (red iron oxide E172, yellow iron oxide E172, FD&C blue No. 2 aluminum lake E132, carnauba wax, white shellac, glyceryl monooleate, 1-butanol, dehydrated ethyl alcohol). 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATIONS Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC). Alecensa as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib. 2.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Alecensa should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. A validated ALK assay is necessary for the selection of ALK-positive NSCLC patients. ALK-positive NSCLC status should be established prior to initiation of Alecensa therapy. Posology The recommended dose of Alecensa is 600 mg (four 150 mg capsules) taken twice daily with food (total daily dose of 1200 mg). Patients with underlying severe hepatic impairment (Child-Pugh C) should receive a starting dose of 450 mg taken twi Leggi il documento completo