Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Entrectinib
ROCHE (MALAYSIA) SDN. BHD.
Entrectinib
90 Capsules
Mayne Pharma Inc.
_ _ _Consumer Medication Information Leaflet (RiMUP) _ ROZLYTREK ® HARD CAPSULES Entrectinib (100mg, 200mg) _ _ 1 WHAT IS IN THIS LEAFLET 1. What Rozlytrek is used for 2. How Rozlytrek works 3. Before you use Rozlytrek 4. How to use Rozlytrek 5. While you are using Rozlytrek 6. Side effects 7. Storage and disposal of Rozlytrek 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision 12. Serial Number WHAT ROZLYTREK IS USED FOR Rozlytrek is used to treat adults with a type of lung cancer called non- small cell lung cancer. It is used if your cancer: is 'ROS1-positive' – this means your cancer cells have an alteration in a gene called ROS1 and is advanced or has spread to another part of your body (metastatic) Rozlytrek is also used to treat children (12 years and older), adolescents and adults with cancer that is ‘NTRK fusion-positive’. This means that your cancer cells have an alteration in one of the NTRK genes. Rozlytrek is used when the cancer is advanced or has spread to another part of your body (metastatic) and other treatments have not worked or are not suitable for you. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. HOW ROZLYTREK WORKS Rozlytrek contains the active ingredient entrectinib. Rozlytrek belongs to a group of medicines called anti-neoplastic (or anti-cancer) agents which are used to treat cancer. Rozlytrek works by blocking the action of enzymes which have an alteration in them. This is due to the alteration in the NTRK or ROS1 genes that make them. The altered enzymes encourage the cancer cells to grow. Rozlytrek may slow down or stop the cancer growing. It may also help to shrink your cancer. BEFORE YOU USE ROZLYTREK - _WHEN YOU MUST NOT USE IT _ Do not take Rozlytrek if you have an allergy to: any medicine containing entrectinib any of the ingredients listed at the end of Lesen Sie das vollständige Dokument
PACK INSERT FOR MALAYSIA ROZLYTREK ® 100mg and 200mg Hard Capsules Entrectinib 1. NAME OF THE MEDICINE entrectinib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient_: entrectinib Each 100 mg hard capsule contains 100 mg entrectinib. Each 200 mg hard capsule contains 200 mg entrectinib. _Excipients_: _Capsule fill mass_: Lactose anhydrous, Microcrystalline cellulose, Tartaric acid, Hypromellose, Crospovidone, Magnesium stearate, Colloidal silicon dioxide _Capsule shell 100 mg_: Hypromellose, Titanium dioxide (E171, CI77891), Yellow iron oxide (E172, CI77492), Printing Ink (shellac, propylene glycol, strong ammonia solution, and FD & C Blue #2 Aluminum Lake) _Capsule shell_ 200 mg: Hypromellose, Titanium dioxide (E171, CI77891), FD&C Yellow #6 (E110, CI15985), Printing Ink (shellac, propylene glycol, strong ammonia solution, and FD & C Blue #2 Aluminum Lake) 3. PHARMACEUTICAL FORM Hard capsule. Rozlytrek 100 mg are size 2 hard capsules with yellow body and cap with “ENT 100” imprinted in blue on the body. Rozlytrek 200 mg are size 0 hard capsules with orange body and cap with “ENT 200” imprinted in blue on the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION(S) NON-SMALL CELL LUNG CANCER (NSCLC) Rozlytrek is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours are ROS1-positive. SOLID TUMOURS Rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have either progressed following treatment or have no satisfactory alternative therapy. This indication is approved under conditional registration which is based on overall response rate and duration of response (see section 5.1 _ Pharmacodynamic properties; Clinical trials_). Continued approval for this indicatio Lesen Sie das vollständige Dokument