Nexavar

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Sorafenib tosilate 274mg equivalent to sorafenib 200 mg; Sorafenib tosilate 274mg equivalent to sorafenib 200 mg

Tillgänglig från:

Bayer New Zealand Limited

INN (International namn):

Sorafenib tosilate 274 mg (equivalent to sorafenib 200 mg)

Dos:

200 mg

Läkemedelsform:

Film coated tablet

Sammansättning:

Active: Sorafenib tosilate 274mg equivalent to sorafenib 200 mg Excipient: Croscarmellose sodium Hypromellose   Iron oxide red Macrogol 3350 Magnesium stearate Microcrystalline cellulose Sodium laurilsulfate Titanium dioxide Active: Sorafenib tosilate 274mg equivalent to sorafenib 200 mg Excipient: Croscarmellose sodium Hypromellose   Iron oxide red Macrogol 3350 Magnesium stearate Microcrystalline cellulose Sodium laurilsulfate Titanium dioxide

Enheter i paketet:

Blister pack, Al/Al foil, 60 tablets

Klass:

Prescription

Receptbelagda typ:

Prescription

Tillverkad av:

Bayer AG

Terapeutiska indikationer:

· Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

Produktsammanfattning:

Package - Contents - Shelf Life: Blister pack, Al/Al foil - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Al/Al foil - 112 tablets - 36 months from date of manufacture stored at or below 25°C

Tillstånd datum:

2006-04-18

Bipacksedel

NEXAVAR® CMI vx4.0
1
NEXAVAR
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING NEXAVAR?
NEXAVAR contains the active ingredient sorafenib tosilate. NEXAVAR is
used to treat advanced liver cancer (hepatocellular
carcinoma), advanced kidney cancer (renal cell carcinoma), or thyroid
cancer (differentiated thyroid carcinoma).
For more information, see Section 1. Why am I using NEXAVAR?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE NEXAVAR?
Do not use if you have ever had an allergic reaction to NEXAVAR or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
NEXAVAR is not recommended for use while breast-feeding because it
could harm the baby.
For more information, see Section 2. What should I know before I take
NEXAVAR?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NEXAVAR and affect how it works.
Tell your doctor or pharmacist if you are taking any
other medicines, including any medicines, vitamins or supplements that
you buy without a prescription from your pharmacy,
supermarket or health food shop.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I TAKE NEXAVAR?
•
THE USUAL DOSE OF NEXAVAR IS TWO 200 MG TABLETS TWICE A DAY. This is
equivalent to 800 mg total daily dose.
•
Your doctor may put you on a lower dose or stop NEXAVAR treatment if
you get severe side effects.
•
Swallow the tablets whole with a full glass of water. Take NEXAVAR
either without food or with a low fat or moderate fat
meal. Do not take this medicine with high fat meals, as this may make
your NEXAVAR less effective.
More instructions can be found in Section 4. How do I take NEXAVAR?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING NEX

Produktens egenskaper

NEXAVAR DS Vx3.0; CCDS V22.0
Page 1 of 26
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
NEXAVAR® Sorafenib tosilate 274 mg (equivalent to sorafenib 200 mg)
film-coated tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NEXAVAR is a multikinase inhibitor targeting several serine/threonine
and receptor tyrosine kinases.
For the full list of Excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
NEXAVAR tablets contain 200 mg of sorafenib (274 mg sorafenib
tosilate). The tablets are film coated
red round, faceted biconvex marked with a Bayer cross on one side and
“200” on the other.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
_Hepatocellular carcinoma _
NEXAVAR is indicated for the treatment of patients with hepatocellular
carcinoma (HCC).
_Renal cell carcinoma _
NEXAVAR is indicated for the treatment of patients with advanced renal
cell carcinoma (RCC).
_Differentiated Thyroid carcinoma _
NEXAVAR is indicated for the treatment of patients with locally
advanced or metastatic, progressive,
differentiated thyroid carcinoma refractory to radioactive iodine.
4.2
Dose and method of administration
_Use in Adults _
Recommended dose
The recommended daily dose of NEXAVAR is 400 mg (2 x 200 mg tablets)
taken twice a day, either
without food or together with a moderate fat meal.
Duration of treatment
Treatment should be continued until the patient is no longer
clinically benefiting from therapy or until
unacceptable toxicity occurs.
Dose titration, dose adjustment, special monitoring advice
Management of suspected adverse medicine reactions may require
temporary interruption and/or
dose reduction of NEXAVAR 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
once daily (see Special warnings and precautions for use).
NEXAVAR DS Vx3.0; CCDS V22.0
Page 2 of 26
When dose reduction is necessary during the treatment of
differentiated thyroid carcinoma, the
NEXAVAR dose sh