Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
trametinib dimethyl sulfoxide, Quantity: 2.254 mg (Equivalent: trametinib, Qty 2 mg)
Novartis Pharmaceuticals Australia Pty Ltd
Trametinib dimethyl sulfoxide
Tablet, film coated
Excipient Ingredients: mannitol; colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; sodium lauryl sulfate; hypromellose; titanium dioxide; polysorbate 80; iron oxide red; macrogol 400
Oral
7, 30
(S4) Prescription Only Medicine
Unresectable or metastatic melanoma,MEKINIST in combination with dabrafenib is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma.,MEKINIST as a monotherapy is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma and in whom either there is intolerance to BRAF inhibitors or BRAF inhibitors cannot be used.,MEKINIST as monotherapy has not demonstrated clinical activity in patients who have progressed on BRAF inhibitor therapy (see section 5.1 Clinical Trials).,Adjuvant treatment of melanoma,MEKINIST in combination with dabrafenib is indicated for the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of the lymph node(s), following complete resection.,Anaplastic thyroid cancer (ATC),MEKINIST in combination with dabrafenib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with a BRAF V600 mutation and with no satisfactory locoregional treatment options.,Non-small cell lung cancer (NSCLC),MEKINIST in combination with dabrafenib is indicated for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.,Low-grade glioma,Mekinist in combination with dabrafenib is indicated for the treatment of paediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy (see section 5.1 Clinical studies).,High-grade glioma,Mekinist in combination with dabrafenib is indicated for the treatment of paediatric patients 1 year of age and older with high-grade glioma (HGG) with a BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 5.1 Clinical studies). .
Visual Identification: MEKINIST 2 mg tablets are pink, round, biconvex, film-coated tablets with GS debossed on one face and HMJ on the opposing face.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-02-14
MEKINIST ® _trametinib (as dimethyl sulfoxide) tablets_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START USING MEKINIST. This leaflet answers some common questions about MEKINIST (trametinib). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. You can also download the most up to date Consumer Medicine Information from www.novartis.com.au. The updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking MEKINIST against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT MEKINIST IS USED FOR MEKINIST tablets contain the active ingredient trametinib. MEKINIST belongs to a group of medicines called "selective MEK-inhibitors". MEKINIST can be used by itself or in combination with another medicine called TAFINLAR IF YOU ARE TAKING THESE TWO MEDICINES TOGETHER, READ THE FULL TAFINLAR CONSUMER MEDICINE INFORMATION AS WELL AS THIS ONE CAREFULLY. MEKINIST is used to: • treat types of: - thyroid cancers called anaplastic thyroid cancer (ATC) - lung cancers called non-small cell lung cancer (NSCLC) - skin cancers called melanoma that have spread to other parts of the body. • prevent melanoma from coming back after the melanoma has been removed by surgery. All of these cancers have a change (mutation) in a gene called "BRAF" that may have caused the cancer to develop. MEKINIST targets proteins made from this changed gene and slows down or stops the development Læs hele dokumentet
Page 1 of 44 AUSTRALIAN PRODUCT INFORMATION - MEKINIST (TRAMETINIB) TABLETS 1 NAME OF THE MEDICINE Trametinib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE MEKINIST 0.5 mg film coated tablet Each film coated tablet contains trametinib dimethyl sulfoxide equivalent to trametinib 500 micrograms. MEKINIST 2 mg film coated tablet Each film coated tablet contains trametinib dimethyl sulfoxide equivalent to trametinib 2 mg. EXCIPIENTS For the list of excipients, see section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM MEKINIST 0.5 mg film coated tablet Yellow, modified oval, biconvex, film-coated tablets with ‘GS’ debossed on one face and ‘TFC’ on the opposing face. MEKINIST 2 mg film coated tablet Pink, round, biconvex, film-coated tablets with ‘GS’ debossed on one face and ‘HMJ’ on the opposing face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Unresectable or metastatic melanoma MEKINIST in combination with dabrafenib is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma. MEKINIST as a monotherapy is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma and in whom either there is intolerance to BRAF inhibitors or BRAF inhibitors cannot be used. MEKINIST as monotherapy has not demonstrated clinical activity in patients who have progressed on BRAF inhibitor therapy (see section 5.1 Clinical Trials). Adjuvant treatment of melanoma MEKINIST in combination with dabrafenib is indicated for the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of the lymph node(s), following complete resection. Anaplastic thyroid cancer (ATC) MEKINIST in combination with dabrafenib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with a BRAF V600 mutation and with no satisfactory locoregional treatment options. Page 2 of 44 Non-small cell lung ca Læs hele dokumentet