Nexavar

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

sorafenib

Saatavilla:

Bayer AG

ATC-koodi:

L01EX02

INN (Kansainvälinen yleisnimi):

sorafenib

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Carcinoma, Hepatocellular; Carcinoma, Renal Cell

Käyttöaiheet:

Hepatocellular carcinomaNexavar is indicated for the treatment of hepatocellular carcinoma.Renal cell carcinomaNexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.Differentiated thyroid carcinomaNexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.

Tuoteyhteenveto:

Revision: 33

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2006-07-19

Pakkausseloste

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEXAVAR 200 MG FILM-COATED TABLETS
sorafenib
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 Nexavar is and what it is used for
2.
What you need to know before you take Nexavar
3.
How to take Nexavar
4.
Possible side effects
5.
How to store Nexavar
6.
Contents of the pack and other information
1.
WHAT NEXAVAR IS AND WHAT IT IS USED FOR
Nexavar is used to treat liver cancer (
_hepatocellular carcinoma_
).
Nexavar is also used to treat kidney cancer (
_advanced renal cell carcinoma_
) at an advanced stage
when standard therapy has not helped to stop your disease or is
considered unsuitable.
Nexavar is used to treat thyroid cancer (
_differentiated thyroid carcinoma_
).
Nexavar is a so-called
_multikinase inhibitor. _
It works by slowing down the rate of growth of cancer
cells and cutting off the blood supply that keeps cancer cells
growing.
2.
WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE NEXAVAR
DO NOT TAKE NEXAVAR
-
IF YOU ARE ALLERGIC
to sorafenib or any of the other ingredients of this medicine (listed
in section
6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Nexavar.
TAKE SPECIAL CARE WITH NEXAVAR
-
IF YOU EXPERIENCE SKIN PROBLEMS.
Nexavar can cause rashes and skin reactions, especially on the
hands and feet. These can usually be treated by your doctor. If not,
your doctor may interrupt
treatment or stop it altogether.
-
IF YOU HAVE HIGH BLOOD PRESSURE.
Nexavar can raise blood pressure, and your doctor

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nexavar 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Red, round, faceted biconvex film-coated tablet, with Bayer cross on
one side and "200" on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hepatocellular carcinoma
Nexavar is indicated for the treatment of hepatocellular carcinoma
(see section 5.1).
Renal cell carcinoma
Nexavar is indicated for the treatment of patients with advanced renal
cell carcinoma who have failed
prior interferon-alpha or interleukin-2 based therapy or are
considered unsuitable for such therapy.
Differentiated thyroid carcinoma
Nexavar is indicated for the treatment of patients with progressive,
locally advanced or metastatic,
differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma,
refractory to radioactive iodine.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nexavar treatment should be supervised by a physician experienced in
the use of anticancer therapies.
Posology
The recommended dose of Nexavar
in adults is 400 mg sorafenib (two tablets of 200 mg) twice daily
(equivalent to a total daily dose of 800 mg).
Treatment should continue as long as clinical benefit is observed or
until unacceptable toxicity occurs.
Posology adjustments
Management of suspected adverse drug reactions may require temporary
interruption or dose
reduction of sorafenib therapy.
When dose reduction is necessary during the treatment of
hepatocellular carcinoma (HCC) and
advanced renal cell carcinoma (RCC), the Nexavar dose should be
reduced to two tablets of 200 mg
sorafenib once daily (see section 4.4).
3
When dose reduction is necessary during the treatment of
differentiated thyroid carcinoma (DTC), the
Nexavar dose should be reduced to 600 mg sorafenib daily in divided
doses (two tablets of 200 mg
and one tabl