NEXAVAR sorafenib 200 mg (as tosilate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sorafenib tosilate, Quantity: 274 mg (Equivalent: sorafenib, Qty 200 mg)

Available from:

Bayer Australia Ltd

INN (International Name):

sorafenib tosilate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; titanium dioxide; hypromellose; microcrystalline cellulose; sodium lauryl sulfate; macrogol 3350; ferric oxide; magnesium stearate

Administration route:

Oral

Units in package:

60, 112, 120

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Hepatocellular carcinoma. NEXAVAR is indicated for the treatment of patients with advanced 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.

Product summary:

Visual Identification: Film-coated, red, round, faceted biconvex tablets marked with BAYER cross on one side and "200" on the reverse.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2006-09-27

Patient Information leaflet

NEXAVAR® CMI vx2.0
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 USE 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 use
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 USE 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 use NEXAVAR? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NEXAVAR?

Summary of Product characteristics

Nexavar PI VX2.0, CCDS 21
Page 1 of 26
AUSTRALIAN PRODUCT INFORMATION
- NEXAVAR
® (SORAFENIB
TOSILATE) 200 MG TABLET
1
NAME OF THE MEDICINE
Sorafenib tosilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nexavar 200 mg tablets
Each tablet contains 274 mg sorafenib tosilate, equivalent to 200 mg
of sorafenib.
For a full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Nexavar 200 mg tablets
Film-coated, red, round, biconvex tablets 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 advanced
hepatocellular carcinoma.
RENAL CELL CARCINOMA
NEXAVAR is indicated for the treatment of patients with advanced renal
cell carcinoma.
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.
Nexavar PI VX2.0, CCDS 21
Page 2 of 26
_DOSE TITRATION, DOSE ADJUSTMENT, SPECIAL MONITORING ADVICE _
Management of suspected adverse drug 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 section 4.4 SPECIAL WARNINGS AND PRECAUTIONS).
When dose reduction is necessary during the treatment of
differentiated thyroid carcinoma, the
NEXAVAR dose should be reduced to 600 mg daily in divided doses (two
tablets of 200 mg
and one