CAPRELSA vandetanib 300mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

vandetanib

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Vandetanib

Authorization status:

Registered

Patient Information leaflet

CAPRELSA™
C
A
P
R
E
L
S
A
™
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 CAPRELSA?
CAPRELSA contains the active ingredient vandetanib. CAPRELSA is used
to treat a type cancer (tumour) in the thyroid gland
(found in the throat near the windpipe) called medullary thyroid
cancer. It is generally used when the cancer has spread to other
parts of the body (metastatic). For more information, see Section 1.
Why am I using CAPRELSA? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CAPRELSA?
Do not use if you have ever had an allergic reaction to vandetanib 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. For more information, see Section 2.
What should I know before I use CAPRELSA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CAPRELSA and affect how it works. 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 CAPRELSA?
•
Follow all directions given to you by your doctor or pharmacist
carefully. They may differ from the information contained in this
leaflet. More instructions can be found in Section 4. How do I use
CAPRELSA? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CAPRELSA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
CAPRESLA
•
If you are about to be start on any new medicine, remind your doctor
and pharmacist that you are taking
CAPRELSA.
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you are taking this medicine.
•
CAPRELSA may increase your chance of getting sunburnt. Be sure to
avoid exposure to the sun.
•
Keep all of your doctor's appointments so that your progress can be
checked.
THINGS YOU
SHOULD NOT DO

Summary of Product characteristics

.
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Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION– CAPRELSA
(VANDETANIB)
VANDETANIB
(CAPRELSA)
MAY
CAUSE
FATAL
OR
LIFE-THREATENING
VENTRICULAR
ARRHYTHMIAS
(INCLUDING
TORSADES
DE
POINTES)
OR
SUDDEN
DEATH.
THESE
OUTCOMES MAY BE MORE LIKELY IN PATIENTS IN WHOM VANDETANIB
SIGNIFICANTLY
PROLONGS THE ELECTROCARDIOGRAM QT INTERVAL.
•
Do not use vandetanib in patients with congenital long QT syndrome
•
Do not start vandetanib therapy if the corrected QT interval is >480
ms
•
Do not start vandetanib therapy in patients with a history of torsades
de pointes or
other ventricular arrhythmias (unless risk factors contributing to
these events have
been corrected)
•
Monitor for QT interval prolongation by periodic ECG measurements as
recommended in the main product information text (see Section 4.4-
SPECIAL
WARNINGS AND PRECAUTIONS FOR USE). Follow the recommendations
there about cessation of CAPRELSA if there is significant QT
prolongation
•
Monitor for, and correct hypokalaemia, hypomagnesaemia and
hypocalcaemia
before starting therapy and periodically during therapy as recommended
in Section
4.4- SPECIAL WARNINGS AND PRECAUTIONS FOR USE
•
Do not use vandetanib concomitantly with any other drug known to
prolong the QT
interval unless there is no appropriate alternative therapy. If such
use is necessary,
more intensive ECG/electrolyte monitoring is indicated
•
Vandetanib has a half-life of around 19 days. Risks of QT prolongation
and
arrhythmia remain for a period of weeks after cessation of therapy
•
Vandetanib is metabolised by CYP3A4. Caution is required if
concomitant
CYP3A4 inhibitors are used, as the extent of increase in vandetanib
exposure (and
consequent risk of QT prolongation) is not well characterised
1
NAME OF THE MEDICINE
Vandetanib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Caprelsa 100mg tablet contains 100mg of vandetanib.
.
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Page 2 of 24
Each Caprelsa 300mg tablet contains 300mg of vandetanib.
For the full list of excipients, see Sect