Votrient

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

pazopanib

Available from:

Novartis Europharm Limited 

ATC code:

L01XE11

INN (International Name):

pazopanib

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Carcinoma, Renal Cell

Therapeutic indications:

Renal-cell carcinoma (RCC)Votrient is indicated in adults for the first-line treatment of advanced renal-cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.Soft-tissue sarcoma (STS)Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo)adjuvant therapy.Efficacy and safety have only been established in certain STS histological tumour subtypes.

Product summary:

Revision: 31

Authorization status:

Authorised

Authorization date:

2010-06-14

Patient Information leaflet

48
B. PACKAGE LEAFLET
49
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VOTRIENT 200 MG FILM-COATED TABLETS
VOTRIENT 400 MG FILM-COATED TABLETS
pazopanib
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Votrient is and what it is used for
2.
What you need to know before you take Votrient
3.
How to take Votrient
4.
Possible side effects
5.
How to store Votrient
6.
Contents of the pack and other information
1.
WHAT VOTRIENT IS AND WHAT IT IS USED FOR
Votrient is a type of medicine called a
_protein kinase inhibitor. _
It works by preventing the activity of
proteins that are involved in the growth and spread of cancer cells.
Votrient is used in adults to treat:
-
kidney cancer that is advanced or has spread to other organs.
-
certain forms of soft-tissue sarcoma, which is a type of cancer that
affects the supportive tissues
of the body. It can occur in muscles, blood vessels, fat tissue or
other tissues that support,
surround and protect the organs.
50
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VOTRIENT
DO NOT TAKE VOTRIENT
-
IF YOU ARE ALLERGIC
to pazopanib or any of the other ingredients of this medicine (listed
in
section 6).
CHECK WITH YOUR DOCTOR
if you think this applies to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Votrient:
-
if you have
HEART DISEASE.
-
if you have
LIVER DISEASE.
-
if you have had
HEART FAILURE OR A HEART ATTACK.
-
if you have had prior COLLAPSE OF A LUNG.
-
if you have had problems with BLEEDING, BLOOD CLOTS OR NARROWING OF THE ARTERIES.
-
if you have had

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Votrient 200 mg film-coated tablets
Votrient 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Votrient 200 mg film-coated tablets
Each film-coated tablet contains 200 mg pazopanib (as hydrochloride).
Votrient 400 mg film-coated tablets
Each film-coated tablet contains 400 mg pazopanib (as hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Votrient 200 mg film-coated tablets
Capsule-shaped, pink, film-coated tablet with GS JT debossed on one
side.
_ _
Votrient 400 mg film-coated tablets
Capsule-shaped, white, film-coated tablet with GS UHL debossed on one
side.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Renal cell carcinoma (RCC)
Votrient is indicated in adults for the first-line treatment of
advanced renal cell carcinoma (RCC) and
for patients who have received prior cytokine therapy for advanced
disease.
Soft-tissue sarcoma (STS)
Votrient is indicated for the treatment of adult patients with
selective subtypes of advanced soft-tissue
sarcoma (STS) who have received prior chemotherapy for metastatic
disease or who have progressed
within 12 months after (neo) adjuvant therapy.
Efficacy and safety has only been established in certain STS
histological tumour subtypes (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Votrient treatment should only be initiated by a physician experienced
in the administration of
anti-cancer medicinal products.
3
Posology
_Adults _
The recommended dose of pazopanib for the treatment of RCC or STS is
800 mg once daily.
_Dose modifications _
Dose modification (decrease or increase) should be in 200 mg
decrements or increments in a stepwise
fashion based on individual tolerability in order to manage adverse
reactions. The dose of pazopanib
should not exceed 800 mg.
_Paediatric population _
Pazopanib should not be used in children younger than 2 years of age
because of safety concerns with
regard to organ gro