Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Brigatinib
Takeda Malaysia Sdn Bhd
Brigatinib
7 Tablets; 30 Tablets; 1 x 7 Tablets; 4 x 7 Tablets; 7Tx1 90mg 21T (3x7T) 180mg Tablets
PENN PHARMACEUTICAL SERVICES LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ALUNBRIG _® _ Brigatinib (30mg, 90mg and 180mg) WHAT IS IN THIS LEAFLET 1. What Alunbrig ® is used for 2. How Alunbrig ® works 3. Before you use Alunbrig ® 4. How to use Alunbrig ® 5. While you are using it 6. Side Effects 7. Storage and Disposal of Alunbrig ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ALUNBRIG ® IS USED FOR Alunbrig ® contains the active substance brigatinib, a type of cancer medicine called a kinase inhibitor. Alunbrig ® is used to treat adults with advanced stages of a lung cancer called non-small cell lung cancer. It is given to patients whose lung cancer is related to an abnormal form of a gene called anaplastic lymphoma kinase (ALK). HOW ALUNBRIG ® WORKS The abnormal gene produces a protein known as a kinase that stimulates the growth of the cancer cells. Alunbrig ® blocks the action of this protein and thus slows down the growth and spread of the cancer. BEFORE YOU USE ALUNBRIG® - _When you must not use it _ • You are allergic to brigatinib or any other ingredients in Alunbrig® - _Before you start to use it _ Before you take Alunbrig ® , tell your doctor if you have: • lung or breathing problems. Lung problems, some severe, are more frequent within the first 7 days of treatment. Symptoms may be similar to symptoms from lung cancer. Tell your doctor of any new or worsening symptoms including breathing discomfort, shortness of breath, chest pain, cough and fever. • High blood pressure • A slow heartbeat (bradycardia) • Vision disturbance. Inform your doctor of any visual disturbance that occurs during treatment, such as seeing flashes of light, blurry vision or light hurting your eyes. • Muscle problems. Report any unexplained muscle pain, tenderness or weakness to your doctor. • Pancreas problems • Liver problems • High blood sugar • Sensitivity to sunlight Avoid spending extended time in the sunlight during treatment and for at least 5 days after your l Izlasiet visu dokumentu
1 NAME OF THE MEDICINAL PRODUCT Alunbrig 30mg Film-Coated Tablet Alunbrig 90mg Film-Coated Tablet Alunbrig 180mg Film-Coated Tablet NAME AND STRENGTH OF ACTIVE SUBSTANCES Each tablet contains 30mg, 90mg or 180mg of Brigatinib. Excipients: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), silica colloidal hydrophobic, magnesium stearate, talc, macrogol, polyvinyl alcohol, titanium dioxide. PRODUCT DESCRIPTION Alunbrig is supplied as a film-coated tablet containing Brigatinib. • 30mg tablet are round, white to off-white in color and are debossed “U3” on one side and plain on the other side • 90mg tablet are oval, white to off-white in color and are debossed “U7” on one side and plain on the other side • 180mg tablet are oval, white to off-white in color and are debossed “U13” on one side and plain on the other side INDICATION Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. Alunbrig is indicated as monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib. POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Alunbrig should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. ALK-positive NSCLC status should be known prior to initiation of Alunbrig therapy. A validated ALK assay is necessary for the selection of ALK-positive NSCLC patients (see Pharmacodynamics Section). Assessment for ALK-positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilised. Posology The recommended starting dose of Alunbrig is 90 mg once daily for the first 7 days, then 180 mg once daily. If Alunbrig is interrupted for 14 days or longer for reasons other than adverse reactions, treatment should be resumed at 90 mg once daily for 7 days before increasing to the previo Izlasiet visu dokumentu