NEXAVAR

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

SORAFENIB AS TOSYLATE

Tilgjengelig fra:

BAYER ISRAEL LTD

ATC-kode:

L01XE05

Legemiddelform:

FILM COATED TABLETS

Sammensetning:

SORAFENIB AS TOSYLATE 200 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

BAYER AG., GERMANY

Terapeutisk gruppe:

SORAFENIB

Terapeutisk område:

SORAFENIB

Indikasjoner:

Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma. Treatment of patients with hepatocellular 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.

Autorisasjon dato:

2023-02-28

Informasjon til brukeren

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS )PREPARATIONS( - 1986
The medicine is dispensed with a doctor’s prescription only
NEXAVAR
®
Film coated Tablets
Each tablet contains:
sorafenib (as tosylate) 200 mg
Inactive and allergenic ingredients: see section 6 ”Further
Information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the
medicine. If you have further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to others. It may harm them, even if it seems to
you that their medical condition is similar.
1( WHAT IS THE MEDICINE INTENDED FOR?
Nexavar is intended to treat:
Patients with advanced renal cell carcinoma
Patients with hepatocellular carcinoma
Patients with differentiated thyroid carcinoma
THERAPEUTIC GROUP: Nexavar belongs to a group of medicines called
multikinase inhibitors and works by slowing the growth
rate of cancerous cells and stopping the blood supply that enables
cancerous cells to grow.
2( BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive (allergic) to sorafenib or to any of the
additional ingredients contained in the medicine. For the list
of inactive ingredients, see section 6 ”Further Information”.
• You are breastfeeding.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
Talk to your doctor or pharmacist before taking Nexavar.
BEFORE TREATMENT WITH NEXAVAR, TELL YOUR DOCTOR IF:
•
YOU EXPERIENCE SKIN PROBLEMS. Nexavar may 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.
•
YOU HAVE HIGH BLOOD PRESSURE. Nexavar may increase blood pressure and
your doctor will usually monitor your blood
pressure and may prescribe you a medicine to treat your high blood
pressure.
•
YOU HAVE OR HAVE HAD AN ANEURYSM )ENLARGEMENT AND WEAKENING OF A BLOOD
VESSEL WALL( OR A TEAR I

Preparatomtale

1
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, biconvex film-coated tablets, debossed with Bayer cross on
one side and "200" on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Renal cell carcinoma
Nexavar is indicated for the treatment of patients with advanced renal
cell carcinoma.
Hepatocellular Carcinoma
Nexavar is indicated for the treatment of patients with hepatocellular
carcinoma (see section 5.1).
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).
When dose reduction is necessary during the treatment of
differentiated thyroid carcinoma (DTC), the
2
Nexavar dose should be reduced to 600 mg sorafenib daily in divided
doses (two tablets of 200 mg
and one tablet of 200 mg twelve hours apart).
If additional dose reduction is necessary, Nexavar may be reduced to
400 mg sorafenib daily in
divided doses (t