Fotivda

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Tivozanib hydrochloride monohydrate 1mg equivalent to 890 microgram tivozanib

Tersedia dari:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Dosis:

890 mcg

Bentuk farmasi:

Capsule

Komposisi:

Active: Tivozanib hydrochloride monohydrate 1mg equivalent to 890 microgram tivozanib Excipient: Gelatin   Indigo carmine Iron oxide yellow Magnesium stearate Mannitol Titanium dioxide  

Jenis Resep:

Prescription

Indikasi Terapi:

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.

Ringkasan produk:

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

Tanggal Otorisasi:

2018-08-16

Selebaran informasi

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

Karakteristik produk

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