Viking Magazine - August 2012 - 22

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Important Product Information
XIAFLEX® (Zï a flex)
(collagenase clostridium histolyticum)
What is the most important information
I should know about XIAFLEX?
XIAFLEX can cause serious side effects, including:
1. Tendon rupture or ligament damage. Receiving
an injection of XIAFLEX may cause damage to a
tendon or ligament in your hand and cause it
to break or weaken. This could require surgery to
fix the damaged tendon or ligament. Call your
healthcare provider right away if you have
trouble bending your injected finger (towards
the wrist) after the swelling goes down or you
have problems using your treated hand after
your follow-up visit.
2. Nerve injury or other serious injury of the hand.
Call your healthcare provider right away if you
get numbness, tingling, or increased pain in your
treated finger or hand after your injection or after
your follow-up visit.
3. Allergic Reactions. Allergic reactions can happen
in people who take XIAFLEX because it contains
foreign proteins.
Call your healthcare provider right away if you have
any of these symptoms of an allergic reaction after
an injection of XIAFLEX:
s HIVES
s SWOLLEN FACE
s BREATHING TROUBLE
s CHEST PAIN
What is XIAFLEX?
XIAFLEX is a prescription medicine used to treat
adults with Dupuytren's contracture when a
" cord " can be felt.
In people with Dupuytren's contracture, there is
thickening of the skin and tissue in the palm of your
hand that is not normal. Over time, this thickened tissue
can form a cord in your palm. This causes one or more
of your fingers to bend toward the palm, so you can not
straighten them.
XIAFLEX should be injected into a cord by a healthcare
provider who is skilled in injection procedures of the hand
and treating people with Dupuytren's contracture. The
proteins in XIAFLEX help to " break " the cord of tissue that
is causing the finger to be bent.
It is not known if XIAFLEX is safe and effective
in children under the age of 18.
What should I tell my healthcare provider
before starting treatment with XIAFLEX?
XIAFLEX may not be right for you. Before receiving
XIAFLEX, tell your healthcare provider if you:
s HAVE HAD AN ALLERGIC REACTION TO A PREVIOUS
XIAFLEX injection.
s HAVE A BLEEDING PROBLEM
s HAVE ANY OTHER MEDICAL CONDITIONS
s ARE PREGNANT OR PLAN TO BECOME PREGNANT
It is not known if XIAFLEX will harm your
unborn baby.
s ARE BREASTFEEDING )T IS NOT KNOWN IF 8)!&,%8 PASSES
into your breast-milk. Talk to your healthcare
provider about the best way to feed your baby
if you receive XIAFLEX.
Tell your healthcare provider about all the medicines
you take, including prescription and non-prescription
medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you use:
a blood thinner medicine such as aspirin, clopidogrel
(PLAVIX®), prasugrel hydrochloride (EFFIENT®), or
warfarin sodium (COUMADIN®). If you are told to stop
taking a blood thinner before your XIAFLEX injection,
your healthcare provider should tell you when to
restart the blood thinner.
How will I receive XIAFLEX?
Your healthcare provider will inject XIAFLEX into
the cord that is causing your finger to bend.
After an injection of XIAFLEX, your affected hand
will be wrapped with a bandage. You should limit
moving and using the treated finger after
the injection.
Do not bend or straighten the fingers of the
injected hand until your healthcare provider says
it is okay. This will help prevent the medicine from
leaking out of the cord.
Do not try to straighten the treated finger yourself.
Keep the injected hand elevated until bedtime.
Call your healthcare provider right away if you have:
s SIGNS OF INFECTION AFTER YOUR INJECTION SUCH AS
fever, chills, increased redness, or swelling
s NUMBNESS OR TINGLING IN THE TREATED lNGER
s TROUBLE BENDING THE INJECTED lNGER AFTER
the swelling goes down
Return to your healthcare provider's office as
directed on the day after your injection. During this
first follow-up visit, if you still have the cord, your
healthcare provider may try to extend the treated
finger to " break " the cord and try to straighten
your finger.
Your healthcare provider will provide you with
a splint to wear on the treated finger. Wear the
splint as instructed by your healthcare provider
at bedtime to keep your finger straight.
Do finger exercises each day, as instructed
by your healthcare provider.
Follow your healthcare provider's instructions
about when you can start doing your normal
activities with the injected hand.
What are the possible side effects
of XIAFLEX?
XIAFLEX can cause serious side effects.
See " What is the most important information
I should know about XIAFLEX? " .
Common side effects with XIAFLEX include:
s SWELLING OF THE INJECTION SITE OR THE HAND
s BLEEDING OR BRUISING AT THE INJECTION SITE
s PAIN OR TENDERNESS OF THE INJECTION SITE
or the hand
s SWELLING OF THE LYMPH NODESGLANDS IN
the elbow or underarm
s ITCHING
s BREAKS IN THE SKIN
s REDNESS OR WARMTH OF THE SKIN
s PAIN IN THE UNDERARM
These are not all of the possible side effects with
XIAFLEX. Tell your healthcare provider about any
side effect that bothers you or does not go away.
Call your doctor for medical advice about
side effects. You may report side effects to
the FDA at 1-800-FDA-1088.
General information about XIAFLEX
Medicines are sometimes prescribed for
purposes other than those listed here.
This is a summary of the most important
information about XIAFLEX. If you would like
more information, talk to your healthcare
provider. You can ask your healthcare provider
for information about XIAFLEX that is written
for health professionals.
For more information visit
www.XIAFLEX.com or call 1-877-663-0412.
Registered trademarks are the property of their
respective owners.
© 2012 Auxilium Pharmaceuticals, Inc.
For US residents only.
40 Valley Stream Parkway
Malvern, PA 19355
www.auxilium.com
0412-020.b
http://www.XIAFLEX.com http://www.auxilium.com
Viking Magazine - August 2012

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