País: Nueva Zelanda
Idioma: inglés
Fuente: Medsafe (Medicines Safety Authority)
Cobimetinib hemifumarate 22.2mg equivalent to cobimetinib 20 mg
Roche Products (NZ) Ltd
Cobimetinib hemifumarate 22.2 mg (equivalent to cobimetinib 20 mg)
20 mg
Film coated tablet
Active: Cobimetinib hemifumarate 22.2mg equivalent to cobimetinib 20 mg Excipient: Croscarmellose sodium Lactose monohydrate Macrogol 3350 Magnesium stearate Microcrystalline cellulose Polyvinyl alcohol Purified talc Purified water Titanium dioxide
Prescription
F Hoffmann-La Roche Ltd
COTELLIC is indicated for use in combination with ZELBORAF (vemurafenib) for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 63 dose units - 60 months from date of manufacture stored at or below 30°C
2016-04-21
COTELLIC 221027 1 COTELLIC ® _Cobimetinib _ NEW ZEALAND CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about COTELLIC. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking COTELLIC 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 COTELLIC IS USED FOR COTELLIC contains the active ingredient cobimetinib. COTELLIC belongs to a group of medicines called anti-neoplastic (or anti-cancer) agents. COTELLIC is used to treat a type of skin cancer called melanoma that has spread to other parts of the body and cannot be removed by surgery. COTELLIC is used in combination with another medicine called ZELBORAF ® (containing the active ingredient vemurafenib). COTELLIC can only be used if your melanoma has a change (mutation) in the BRAF gene. Your doctor will have tested you for this gene mutation to make sure COTELLIC is suitable for you. The gene mutation has been shown to be involved in the development of melanoma. COTELLIC targets the “MEK” protein and ZELBORAF targets the changed “BRAF” protein. Both proteins are important in controlling cancer cell growth. When used together, these medicines slow down the growth of your cancer. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY COTELLIC HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. COTELLIC is not addictive. This medicine is available only with a doctor's prescription. Safety and effectiveness of COTELLIC in children younger than 18 years have not been established. BEFORE YOU TAKE COTELLIC AS COTELLIC IS TAKEN TOGETHER WITH ZELBORAF, ALSO READ THE CONSUMER MEDICINE INFORMATION FOR ZELBORAF BEFORE YOU TAKE THESE MEDICINES. _WHEN YOU MUST NOT TAKE IT _ 1. DO NOT TAK Leer el documento completo
Cotellic 221027 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Cotellic 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg cobimetinib (22mg of cobimetinib as a hemifumarate salt). Excipient with known effect: Each film-coated tablet contains 36 mg lactose monohydrate. For the full list of excipients, see section List of excipients. 3. PHARMACEUTICAL FORM Film-coated tablets 4. CLINICAL PARTICULAR 4.1 THERAPEUTIC INDICATIONS Cotellic is indicated for use in combination with Zelboraf (vemurafenib) for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation. 4.2 DOSE AND METHOD OF ADMINISTRATION GENERAL Cotellic therapy should only be initiated and supervised by a healthcare professional experienced in the treatment of patients with cancer. Patients treated with Cotellic in combination with Zelboraf must have BRAF V600 mutation- positive melanoma tumour status confirmed by a validated test. PLEASE REFER TO THE FULL PRESCRIBING INFORMATION OF THE COMBINATION PRODUCT(S). DOSE The recommended dose of Cotellic is 60 mg (three 20 mg tablets) once daily for 21 days in a 28 day cycle. Each Cotellic dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (days 1 to 21 - treatment period); followed by a 7 day break in Cotellic treatment (days 22 to 28 - treatment break). Duration of Treatment Treatment with Cotellic should continue until the patient no longer derives benefit or until the development of unacceptable toxicity. Cotellic 221027 2 Delayed or Missed Doses If a planned dose of Cotellic is missed, it can be taken up to 12 hours prior to the next dose to maintain the once-daily regimen. Vomiting In case of vomiting after Cotellic administration, the patient should not take an additional dose of Cotellic on that day, and treatment should be continued as prescribed the following day. DOSE MODIFICATION General Cotellic dose modification should be based on the prescriber’s assessment of in Leer el documento completo