Fotivda
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
17-07-2023
Fachinformation
(SPC)
17-07-2023
Öffentlichen Beurteilungsberichts
(PAR)
22-11-2017
Wirkstoff:
tivozanib
Verfügbar ab:
Recordati Netherlands B.V.
ATC-Code:
L01EK03
INN (Internationale Bezeichnung):
tivozanib hydrochloride monohydrate
Therapiegruppe:
Antineoplastic agents
Therapiebereich:
Carcinoma, Renal Cell
Anwendungsgebiete:
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. Treatment of advanced renal cell carcinoma.,
Produktbesonderheiten:
Revision: 9
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2017-08-24
Gebrauchsinformation
31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FOTIVDA 890 MICROGRAM HARD CAPSULES
FOTIVDA 1340 MICROGRAM HARD CAPSULES
tivozanib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fotivda is and what it is used for
2.
What you need to know before you take Fotivda
3.
How to take Fotivda
4.
Possible side effects
5.
How to store Fotivda
6.
Contents of the pack and other information
1.
WHAT FOTIVDA IS AND WHAT IT 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOTIVDA
Do not take Fotivda:
•
If you are allergic to tivozanib or any of the other ingredients of
this medicine (listed in
section 6);
•
If you are taking St. John’s Wort (also known as
_Hypericum perforatum_
, a herbal remedy used
for treatment of depression and anxiety).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Fotivda:
•
if you have
HIGH BLOOD PRESSURE
Fotivda can increase your blood pressure. You
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
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
POSOLOGY AND METHOD OF ADMINISTRATION
Fotivda should be supervised by a physician experienced in the use of
anticancer therapies.
Posology
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.
3
No more than one dose of Fotivda must be taken per day.
_Dose modification _
The occurrence of undesirable effects may require temporary
interruption and/or dose reduction of
tivozanib therapy (
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