Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Tivozanib hydrochloride monohydrate 1.5mg equivalent to 1340 microgram tivozanib
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
1340 mcg
Capsule
Active: Tivozanib hydrochloride monohydrate 1.5mg equivalent to 1340 microgram tivozanib Excipient: Gelatin Iron oxide yellow Magnesium stearate Mannitol Titanium dioxide
Prescription
Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-na?ve following disease progression after one prior treatment with cytokine therapy for advanced RCC.
Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP CR cap - 21 capsules - 5 years from date of manufacture stored at or below 25°C protect from moisture
2018-08-16
New Zealand Consumer Medicine Information FOTIVDA CMI Ver 4 1 PIL-FOT-NZ-1055-04 FOTIVDA _tivozanib hydrochloride monohydrate _ 890 microgram hard capsules 1340 microgram hard capsules WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using FOTIVDA. This leaflet answers some common questions about FOTIVDA. 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 using FOTIVDA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT FOTIVDA IS USED FOR The active substance in FOTIVDA is tivozanib, which is a protein kinase inhibitor. Tivozanib reduces the supply of blood to the cancer, which slows down the growth and spread of cancer cells. It works by blocking the action of a protein called vascular endothelial growth factor (VEGF). Blocking the action of VEGF prevents the formation of new blood vessels. FOTIVDA is used to treat adults with advanced kidney cancer. It is used where other treatments such as interferon-alpha or interleukin-2 have either not yet been used or have not helped to stop your disease. Your doctor may have prescribed FOTIVDA for another reason. Ask your doctor if you have any questions about why FOTIVDA has been prescribed for you. This medicine is available only with a doctor's prescription. FOTIVDA is not considered habit forming. New Zealand Consumer Medicine Information FOTIVDA CMI Ver 4 2 PIL-FOT-NZ-1055-04 BEFORE YOU USE FOTIVDA _ _ _ _ _WHEN YOU MUST NOT USE IT _ Do not use FOTIVDA if: • you are allergic to tivozanib or any of the other ingredients of this medicine See “Ingredients”; • you are taking St. John’s Wort (also known as Hypericum perforatum, a herbal remedy used for treatment of depression and anxiety). If you are not sure whether you should start Lees het volledige document
FOTIVDA Data Sheet FOTIVDA DS Ver 4 1 SPC-FOT-NZ-1054-04 NEW ZEALAND DATA SHEET - FOTIVDA ® (TIVOZANIB HYDROCHLORIDE MONOHYDRATE) 1. PRODUCT NAME Fotivda 890 microgram hard capsules Fotivda 1340 microgram hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION FOTIVDA 890 MICROGRAM HARD CAPSULES Each hard capsule contains tivozanib hydrochloride monohydrate equivalent to 890 microgram tivozanib. _Excipients with known effect _ Each hard capsule contains trace amounts of tartrazine (E102) (8 12% of the yellow printing ink composition) (see section 4.4). FOTIVDA 1340 MICROGRAM HARD CAPSULES Each hard capsule contains tivozanib hydrochloride monohydrate equivalent to 1340 microgram tivozanib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. FOTIVDA 890 MICROGRAM HARD CAPSULES Hard capsule with dark blue opaque cap and bright yellow opaque body, printed with yellow ink “TIVZ” on the cap and with dark blue ink “LD” on the body. FOTIVDA 1340 MICROGRAM HARD CAPSULES Hard capsule with bright yellow opaque cap and bright yellow opaque body, printed with dark blue ink “TIVZ” on the cap and with dark blue ink “SD” on the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC. 4.2 DOSE AND METHOD OF ADMINISTRATION Fotivda should be supervised by a physician experienced in the use of anticancer therapies. DOSE The recommended dose of tivozanib is 1340 microgram once daily for 21 days, followed by a 7 day rest period to comprise one complete treatment cycle of 4 weeks. This treatment schedule should be continued until disease progression or unacceptable toxicity. FOTIVDA Data Sheet FOTIVDA DS Ver 4 2 SPC-FOT-NZ-1054-04 No more than one dose of Fotivda must be taken per day. _Dose modification _ The Lees het volledige document